Synapse Transcutaneous Electrical Stimulation Device

K143198 · Synapse Electroceutical Limited · GZJ · May 27, 2015 · Neurology

Device Facts

• Record ID: K143198
• Device Name: Synapse Transcutaneous Electrical Stimulation Device
• Applicant: Synapse Electroceutical Limited
• Product Code: GZJ · Neurology
• Decision Date: May 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and management of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.

Device Story

Transcutaneous electrical nerve stimulator (TENS) for chronic intractable pain management; delivers pre-programmed micro-currents via external electrode pads. Device is oval, compact (7x4x2 cm), non-reusable, and battery-powered. Micro-controller manages current sequences; hardware-based linear current controller regulates output. Operates for 48-hour cycles; total treatment course 12 days (6 units). LED indicator displays status (active, dormant, low current/poor contact). Used by patients for home-based pain relief. Output affects nerve signaling to provide symptomatic relief. Benefits include non-invasive, automated, long-duration pain management during daily activities or sleep.

Clinical Evidence

Bench testing only. Device demonstrated conformance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards. No clinical data provided.

Technological Characteristics

Non-rechargeable 3V Lithium-manganese coin cell battery. Housing: Makrolon (injection molded). Output: Single channel, regulated current. Connectivity: None. Sterilization: Not specified. Software: Micro-controller based, hardware-limited current control. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients. May be used during sleep.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NeuroMetrix SENSUS™ (K130919)

Reference Devices

• Covidien Uni-Patch electrode series (K915333)

Submission Summary (Full Text)

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Synapse Electroceutical Limited % Mary Dadone Martin, Blank & Associates 3905 Rhode Harbor Rd Edgewater, Maryland 21037

Re: K143198

Trade/Device Name: Synapse Transcutaneous Electrical Stimulation Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: April 27, 2015 Received: April 27, 2015

Dear Ms. Dadone,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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 notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K143198

#### Device Name

Synapse Transcutaneous Electrical Stimulation Device

Indications for Use (Describe)

The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and managemt of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.

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

| <label><input checked="true" type="checkbox"/> Research Use (Per 21 CFR 361.1, Subpart B)</label> |
|---------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 361)</label> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

#### SPONSOR

Synapse Electroceutical Limited 1 Churchill Court, Hortons Way Westerham, Kent, TN16 1BT, England, UK

Contact Person: John Gildersleeve Telephone: [phone] Fax: +44 (o) 1959 565 281 Date Prepared 29 Sep 2014

#### APPLICATION CORRESPONDENT

Mary Dadone for Martin, Blanck & Associates 3905 Rhode Harbor Rd Edgewater, MD 21037 [phone]

#### DEVICE NAME

| Trade Name | Synapse Transcutaneous Electrical Stimulation Device |
|---------------------|---------------------------------------------------------------------------------------------------|
| Common Name | Transcutaneous Electrical Nerve Stimulator |
| Classification Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief<br>(21 CFR 882.5890, Product Code GZJ) |

#### PREDICATE DEVICE

NeuroMetrix SENSUS™ (K130919)

#### DEVICE DESCRIPTION

The function of the Synapse Transcutaneous Electrical Stimulation Device is to apply a series of pre-programmed micro-currents of varying frequency, amplitude and duration to the patient via electrode pads. A micro-controller is used to set the current demands to a linear current controller implemented solely in hardware.

The Synapse Transcutaneous Electrical Stimulation Device is oval shaped and measures approximately 7 cm wide by 4 cm high by 2 cm deep. It is activated by pressing the On/Off button. There is single set program which runs in specific sequence for 48 hours after which time the unit will turn itself off and should be replaced with

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## K143198 - S001

another unit until the end of the prescribed course of treatment. The devices are packaged in quantities of 6 so that the total treatment duration is 12 days.

The Synapse Transcutaneous Electrical Stimulation Device has an LED light which indicates operational status: unit off, treatment active, treatment dormant (waiting for next active session), or current too low (e.g., interruption during treatment due to poor skin contact of the electrodes)

Only Covidien's Uni-Patch electrode series are recommended for use with the Synapse Transcutaneous Electrical Nerve Stimulator. These electrodes are cleared for marketing by the FDA and are provided with stimulating electrode hydrogel (K915333); Synapse Order Code EP84910)

#### INDICATIONS USE

The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and management of chronic intractable pain. The Synapse Transcutaneous Electrical Nerve Stimulator may be used during sleep.

### COMPARISON TO PREDICATE

The table below provides a comparison of the Synapse Transcutaneous Electrical Stimulation Device to the NeuroMetrix SENSUS™ (K130919) predicate.

| Parameter | Synapse Transcutaneous<br>Electrical Stimulation Device | NeuroMetrix, Inc SENSUS<br>Unit | | | |
|-----------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|--|--|
| Power Source(s) | Non rechargeable 3V Lithium<br>maganese coin cell battery | 1 rechargeable 3.7V Lithium-<br>ion battery | | | |
| Method of Line Current<br>Isolation | n/a - no connection to line<br>current | Physically isolated; device<br>cannot connect to electrodes<br>and battery recharger<br>concurrently | | | |
| Number of Output Modes | One (1) | One (1) | | | |
| Number of Output Channels | One (1) | One (1) | | | |
| Regulated Current or<br>Regulated Voltage? | Current | Current | | | |
| Software/Firmware/Microproc<br>essor Control? | Yes | Yes | | | |

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| Parameter | Synapse Transcutaneous<br>Electrical Stimulation Device | NeuroMetrix, Inc SENSUS<br>Unit |
|-----------------------------------------|----------------------------------------------------------------------------------|---------------------------------|
| Automatic Overload Trip? | No – hardware is limited by<br>design not to accept demand for<br>other currents | Yes |
| Automatic No-Load Trip? | User warned via LED flash rate | Yes |
| Automatic Shut Off? | Yes | Yes |
| User Override Control? | Yes | Yes |
| Indicator Display: | Yes | Yes |
| Timer Range | 48 hours | 60 minutes |
| Compliance with Voluntary<br>Standards? | IEC60601-1, IEC 60601-1-2 | IEC60601-1, IEC 60601-1-2 |
| Weight (lbs., oz.) | 0.088 lbs (1.4 oz) | 2.9 oz |
| Dimensions (in.) [W x H x D] | 7cm x 4 cm x 2cm | 18 mm x 63mm x 176 mm |
| Housing Materials and<br>Construction | Makrolon TM, injection moulded | Plastic, Velcro straps (nylon) |

As shown in the above table, the Synapse Transcutaneous Electrical Stimulation Device has similar characteristics to the predicate device. The primary difference is that the Synapse Transcutaneous Electrical Stimulation Device is a non-reusable unit that provides a pre-programmed treatment regime whereas the predicate device is a reuseable, rechargeable device. These differences and the minor differences in size, weight, and materials do not raise any new types of safety or effectiveness questions.

### NON-CLINICAL TESTING

Test results included in the 510(k) demonstrate conformance with the electrical safety and electromagnetic compatibility requirements of IEC 60601-1 Medical electrical equipment - part 1: General requirements for basic safety and essential performance 2005 (3rd edition) plus Amendments 1:2006 and 2:2007 and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (edition 2007).

#### CONCLUSION

The verification, validation, and performance data presented in this 510(k) pre-market notification demonstrate that the Synapse Transcutaneous Electrical Stimulation Device is substantially equivalent to and as safe and effective as the predicate device.