For Immediate Release:June 07, 2019

The U.S. Food and Drug Administration today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. IBS is a condition affecting the large intestines that can cause abdominal pain and discomfort typically related to bowel movements.

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, Ph. D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”

The IB-Stim is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear. It contains a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for five days, at which time it is replaced. Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to three consecutive weeks to reduce functional abdominal pain associated with IBS.

IBS is a group of symptoms that occur together, including repeated pain in the abdomen and changes in bowel movements, which may be diarrhea, constipation or both. With IBS, the symptoms can be present without any visible signs of damage or disease in the digestive tract.

The FDA reviewed data from a published clinical study that included 50 patients 11-18 years of age with IBS - 27 patients were treated with the device and 23 patients received a placebo device. The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain and Pain Frequency Severity Duration (PFSD) scores, which incorporate multiple aspects of pain experience. Changes in bowel movements were not evaluated. During the study, patients were allowed to continue stable doses of medication to treat chronic abdominal pain. Worst pain at baseline was similar between the treatment and placebo groups. A repeated measures analysis showed a greater change (improvement) in worst pain from baseline to week three in the treatment group. This effect was also seen at weeks one and two. Greater change was also demonstrated in composite PFSD scores from baseline to week three in the IB-Stim group compared to the placebo group. IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients compared to 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients compared with 26% of patients who received the placebo. During the study, six patients reported mild ear discomfort and three patients reported adhesive allergy at the site of application.

The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris (a condition in which skin cells build up and form scales and itchy, dry patches).

The FDA reviewed the IB-Stim through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

Similar versions of this device for other uses were previously granted marketing authorization by the FDA. The NSS-2 BRIDGE was permitted for marketing in 2017 as an aid to reduce the symptoms of opioid withdrawal. The FDA first cleared a version of the device, known as the Electro Auricular Device, in 2014 for use in acupuncture.

The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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November 15, 2017

Innovative Health Solutions, Inc. (IHS)

℅ Allison Scott, RAC Navigant Consulting

9100 Keystone Crossing, Suite 500

Indianapolis, IN 46240

Re: DEN170018

Trade/Device Name: NSS-2 BRIDGE Regulation Number: 21 CFR 882.5896

Regulation Name: Percutaneous nerve stimulator for substance use disorders Regulatory Class: Class II

Product Code: PZR Dated: March 16, 2017

Received: March 17, 2017 

Dear Allison Scott:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the NSS-2 BRIDGE, a prescription device under 21 CFR Part 801.109 with the following indications for use:

      The NSS-2 System is a percutaneous nerve field stimulator (PNFS) system, that can be used as             an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial       Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the NSS-2 BRIDGE, and substantially equivalent devices of this generic type, into Class II under the generic name percutaneous nerve stimulator for substance use disorders.

FDA identifies this generic type of device as:

      Percutaneous nerve stimulator for substance use disorders. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.

Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This new law provides two options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device type.

On March 17, 2017, FDA received your De Novo requesting classification of the NSS-2 BRIDGE. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the NSS-2 BRIDGE into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request, FDA has determined that, for the previously stated indications for use, the NSS-2 BRIDGE can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks and mitigation measures associated with the device type are summarized in the following table:

Table 1: Identified Risks to Health and Mitigation Measures

Identified Risk                                                        Mitigation Measures

Adverse tissue reaction                                           Biocompatibility evaluation Labeling

Electrical, mechanical, or thermal                           Electromagnetic compatibility testing

hazards leading to user discomfort or                     Electrical, mechanical, and thermal safety testing        

injury                                                                        Non-clinical performance testing    

                                                                                Software verification,   

                                                                                validation and hazard analysis Labeling

Infection                                                                  Sterility testing 

                                                                                Shelf life testing 

                                                                                Labeling

In combination with the general controls of the FD&C Act, the percutaneous nerve stimulator for substance use disorders is subject to the following special controls:

1. The patient-contacting components of the device must be demonstrated to be biocompatible.

2. Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.

3. Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.

4. Software verification, validation, and hazard analysis must be performed.

5. Sterility testing of the percutaneous components of the device must be performed.

6. Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.

7. Labeling must include the following:

     a. A detailed summary of the device technical parameters;

     b. A warning stating that the device is only for use on clean, intact skin;

     c. Instructions for use, including placement of the device on the patient; and

     d. A shelf life.

In addition, this is a prescription device and must comply with 21 CFR 801.109.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a premarket notification containing information on the percutaneous nerve stimulator for substance use disorders they intend to market prior to marketing the device.

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the FD&C Act); 21 CFR 1000-1050.

A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

If you have any questions concerning the contents of the letter, please contact Eric Franca at 301-796-6285 or please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638- 2041 or (301) 796-7100, or at its internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Angela C. Krueger -S

Angela C. Krueger Deputy Director,

     Engineering and Science Review (Acting) Office of Device Evaluation

Center for Devices and Radiological Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 

Food and Drug Administration 10903 New Hampshire Avenue

Document Control Center – WO66-G609 Silver Spring, MD 20993-0002

October 2, 2014

Navigant Consulting, Inc.

Colleen Hittle

Managing Director

30 S. Wacker Drive, Suite 3100

Chicago, Illinois 60606

Re: K140530

Trade/Device Name: Electro Auricular Device Regulation Name: Electro Acupuncture Stimulator Regulatory Class: Unclassified

Product Code: BWK Dated: August 29, 2014

Received: September 2, 2014 

Dear Ms. Colleen Hittle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, Misbranding by reference to premarket notifications (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Enclosure

for

Carlos L. Peña, PhD, MS Director

Division of Neurological and Physical Medicine Devices

Office of Device Evaluation

Center for Devices and Radiological Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: 0MB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K l40530
 

Device Name

EAD (electro auricular device )

Indications for Use (Describe)

The EAD is an electro acupuncture device for use in the practice of acupuncture by qualified practitioner s of acupuncture as determined by the states.
 

Type of Use (Select one or both, as applicable)

C8l Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

-S

Date: 2014.10.02

20:47:21 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 11 99  5.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (1/14) Page 1 of 1 ?SC l'l,bli'1wl  •  s,..,;«;  (301)443-674-0 E F

K140530 Supplement 3 Page 12 of 91

510(k) Summary

Colleen Hittle, RAC Managing Director Navigant Consulting, Inc. 30 S. Wacker Drive

Suite 3100

Chicago IL 60606

Phone: (317) 228-8730

Fax: (317) 228-8701

colleen.hittle@navigant.com

Date: June 23, 2014

Manufacturer: Key Electronics

2533 Centennial Blvd

Jeffersonville, IN 47130 Trade Name: EAD (electro auricular device) Common Name: electro acupuncture device

Classification Name(s): BWK – stimulator, electro-acupuncture

Classification Number: Unclassified

510(k) Number

Device Name

Submitter Name

Primary

Predicate

K050123

P.Stim System

Neuroscience Therapy

Corporation

Reference

Device

K091875

E-Pulse

Medevice Corporation

Device Description

The EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle. 

The device is powered by one 3 Volt lithium ion battery.

The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.

Intended Use(s)

The EAD is an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Appliance: Electro-acupuncture Device

Power supply: 1 x 3V battery (Type CR1220 Lithium)

Output: (Load impedance range 1k-10kQ) max. 3.2V, Impulse interval 1000ms, impulse width 1ms, 'ims I bipolar), max possible total duration of treatment 5x 24 hours Protection level: IP20 Type: B

Duty type: approx. 2h duty I 2h at rest (periodic duty) Weight incl. battery: 4g Dimensions: 36 x 16 x 7 mm Needle Dimensions: 0.5 mm width x 2 mm length

Device Name

EAD

E-Pulse

(Reference   Device)

P.Stim System

(Primary Predicate)

501(k) Number

This Submission

K091875

K050123

Indication for Use

The EAD is an electro   acupuncture device for use in the practice of acupuncture by qualified   practitioners of acupuncture as determined by the

states.

The E-Pulse is an electro   acupuncture device for use in the practice of acupuncture by qualified   practitioners of acupuncture as determined by the

states.

The P-Stim is an electro   acupuncture device for use in the practice of acupuncture by qualified   practitioners of acupuncture as determined by the

states.

Device Description

Battery powered device   generates low frequency and continual electrical pulse which are transmitted   to new endings of the ear. It allows   continued therapy over several days.

The device is controlled   by a micro processor.

Battery powered unit   designed to administer auricular point nerve stimulation treatment for pain   therapy over a 96- hour period via electrical pulsing.

The device   is on for 3 hours and then off for 3 hours.

The device is controlled   by a micro processor.

A micro stimulation   appliance for pain therapy.

The device generates low   frequency and continual electrical pulse which are transmitted to new endings   of the ear. It allows continued   therapy over several days.

The device is controlled   by a micro processor.

Target Population     Patients with acute     Patients with acute     Patients with acute

                                   and chronic pain         and chronic pain         and chronic pain

Human Factors         To be applied by a       To be applied by a        To be applied by a

                                   qualified practitioner    qualified practitioner     qualified practitioner 

                                   of acupuncture             of acupuncture             of acupuncture

Where Used              At the clinic and at        At the clinic and at        At the clinic and at

                                   home                            home                            home

Software Based       Yes                                Yes                               Yes

Performance            2 hours on/2 hours off;   3 hours on/3 hours off;    3 hours on/3 hours off;

                                  pulses with modulating   pulse monophasic at       pulse monophasic at

                                  frequency(1 to 10Hz)      1 Hz                                1 Hz

Power Source         Lithium ion battery           Zinc air battery                     Zinc air battery

Duration                  Up to 120 hours            96 hours                        96 hours

Generator               Attached behind           Attached behind            Attached behind

                                patient ear                    patient ear                     patient ear

Leads                     Four electrode              Three leads that can      Three leads that can

                                needle leads                 attach to needles           attach to needles

Needles                Titanium straight shaft     Titanium hook shaft     Titanium straight shaft

Shape                   Elliptical                            Round                          Elliptical

Non-Clinical Performance Data

Biocompatibility Testing

The biocompatibility evaluation for the adhesive for the EAD device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” May 1, 1995, and International Standard ISO 10993-1 “Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA. The battery of testing included the following tests:

· Cytotoxicity

· Sensitization

· Irritation

The EAD adhesive is considered tissue contacting for a duration of less than 30 days.

The other patient contacting materials contained in the subject device are unchanged from the P-Stim predicate device.

Electrical safety and EMC testing were conducted on the EAD device. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

Software verification and validation testing were conducted and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” The software for this device was considered as a “minor” level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.

Sterilization Validation was conducted on the EAD device needles and wiring harness using the VDMAX25 method according to ISO 11137-2 and ISO 11737-2. Performance and stability of the EAD packaging was validated in accordance with ISO 11607-1 and Accelerated aging of the EAD was performed in accordance with ASTM F1980-07.

Packaging qualifications are according to ISO 11607-1 and machine qualifications for the sealing process are according to ISO 11607-2.

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the EAD device should perform as well as the predicate device in the specified use conditions.

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