(202 days)
No
The device description explicitly states that the current controller is implemented "solely in hardware" and the device runs a "single set program". There is no mention of adaptive algorithms, learning, or any components typically associated with AI/ML.
Yes
The device is intended for the symptomatic relief and management of chronic intractable pain, which constitutes a therapeutic use.
No
The device description clearly states its intended use is for "symptomatic relief and management of chronic intractable pain" through the application of electrical currents, making it a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is an oval-shaped physical device with an On/Off button, LED light, and uses electrode pads, indicating it is a hardware device that applies electrical stimulation. It also mentions a micro-controller and hardware implementation for current control.
Based on the provided text, the Synapse Transcutaneous Electrical Stimulation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain" through "Transcutaneous Electrical Stimulation." This involves applying electrical currents to the body, not analyzing samples taken from the body.
- Device Description: The description details a device that applies electrical currents via electrode pads. It focuses on the electrical stimulation aspect and its physical characteristics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
Therefore, the Synapse Transcutaneous Electrical Stimulation Device falls under the category of a therapeutic medical device, specifically a Transcutaneous Electrical Nerve Stimulator (TENS) device, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
GZJ
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 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing demonstrates conformance with electrical safety and electromagnetic compatibility requirements of IEC 60601-1 and IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (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 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 (800) 638-2041 or (301) 796-7100 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
2
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) |
|---|
| ------------------------------------------------- |
| Research Use (Per 21 CFR 361.1, Subpart B) |
|---|
| Over-The-Counter Use (21 CFR 361) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
SPONSOR
Synapse Electroceutical Limited 1 Churchill Court, Hortons Way Westerham, Kent, TN16 1BT, England, UK
Contact Person: John Gildersleeve Telephone: +44 (0) 1959 569 433 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 +1 301 706 0731
DEVICE NAME
| Trade Name | Synapse Transcutaneous Electrical Stimulation Device |
|---|---|
| Common Name | Transcutaneous Electrical Nerve Stimulator |
| Classification Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| (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
4
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
Electrical Stimulation Device | NeuroMetrix, Inc SENSUS
Unit | | | |
|-----------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|--|--|
| Power Source(s) | Non rechargeable 3V Lithium
maganese coin cell battery | 1 rechargeable 3.7V Lithium-
ion battery | | | |
| Method of Line Current
Isolation | n/a - no connection to line
current | Physically isolated; device
cannot connect to electrodes
and battery recharger
concurrently | | | |
| Number of Output Modes | One (1) | One (1) | | | |
| Number of Output Channels | One (1) | One (1) | | | |
| Regulated Current or
Regulated Voltage? | Current | Current | | | |
| Software/Firmware/Microproc
essor Control? | Yes | Yes | | | |
5
| Parameter | Synapse Transcutaneous
Electrical Stimulation Device | NeuroMetrix, Inc SENSUS
Unit |
|-----------------------------------------|----------------------------------------------------------------------------------|---------------------------------|
| Automatic Overload Trip? | No – hardware is limited by
design not to accept demand for
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
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
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.