(106 days)
Not Found
No
The description mentions a microprocessor and embedded software for controlling stimulation parameters, but there is no mention of AI or ML algorithms being used for analysis, decision-making, or adaptation based on data. The control is based on pre-defined parameters and user input (taps).
Yes
The description explicitly states its intended use is for "symptomatic relief and management of chronic intractable pain," which is a therapeutic purpose.
No
Explanation: The device is intended for symptomatic relief and management of chronic intractable pain through electrical stimulation, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a stimulator, battery, USB cable, electrodes, patient cable, push-button, and accelerometer, in addition to embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- SENSUS Function: The SENSUS device is a transcutaneous electrical nerve stimulator. It delivers electrical stimulation to the patient's body (transcutaneous means through the skin) for pain relief. It does not analyze samples taken from the body.
The description clearly states its purpose is to provide electrical stimulation for pain management, which is a therapeutic function performed directly on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.
The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter.
The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector.
The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
patient's body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Verification testing of SENSUS includes electrical, mechanical, and software tests to show that the device meets its target specifications over a range of operating and storage conditions. Validation and performance testing demonstrates that it meets user needs as reflected in the functional specification.
NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient to demonstrate that SENSUS is as safe and effective as the predicate.
The verification, validation and performance data presented in this 510(k) submission demonstrate that the NeuroMetrix SENSUS device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
5. 510(K) SUMMARY
510(k) Summary for NeuroMetrix SENSUS™
SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451 USA
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 314-2781 |
| Date Prepared: | July 23, 2012 |
DEVICE NAME
Proprietary Name: SENSUS Common/Usual Name: Transcutaneous Electrical Nerve Stimulator, TENS Classification Name: 882.5890 GZJ Transcutaneous electrical nerve stimulator for pain relief
PREDICATE DEVICE
EMPI Active Transcutaneous Nerve Stimulator (K090922)
INTENDED USE
The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.
DEVICE DESCRIPTION
SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter.
1
K12//84
The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector.
The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.
COMPARISON TO PREDICATE
The NeuroMetrix SENSUS device and predicate Empi Active Transcutaneous Nerve Stimulator (ACTIVE) have the same intended use, i.e., they are intended for the symptomatic relief and management of chronic intractable pain. The SENSUS Indications for Use represent a subset of the predicate Indications for Use. Specifically, while both SENSUS and the predicate are indicated for the relief and management of chronic intractable pain, the predicate is additionally indicated for the relief of pain associated with arthritis and as an adjunctive treatment for post-surgical and post-trauma acute pain. Both are prescription devices to be used under the direction of a medical professional.
SENSUS and the predicate have the same basic technological characteristics as listed below.
- . One stimulation channel
- Single output mode .
- Patient controlled intensity .
- LED indicators (no intensity display) .
- Powered by rechargeable battery .
SENSUS and the predicate device have output characteristics that are within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators. The basic unit characteristics and output specifications of the two devices are summarized in the tables below.
| Parameter | NeuroMetrix SENSUS | Empi Active Transcutaneous
Nerve Stimulator (K090922) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number | (to be assigned) | K090922 |
| Device Name and Model Number | SENSUS | Active Transcutaneous Nerve
Stimulator |
| Manufacturer | NeuroMetrix | Empi |
| Power Source(s) | 1 rechargeable 3.7V Lithium-
Ion battery | 1 rechargeable battery (type
unknown) |
| Method of Line Current Isolation | Physically isolated; device
cannot connect to electrodes
and battery recharger
concurrently | Physically isolated; device cannot
connect to electrodes and battery
recharger concurrently |
| Patient Leakage Current | | |
| Normal Condition | 2 2012 AUG
NeuroMetrix, Inc. c/o Mr. Rainer Maas Director of QA/RA 62 Fourth Ave. Waltham, MA 02451
Re: K121184
Trade/Device Name: SENSUS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: July 23, 2012 Received: July 24, 2012
Dear Mr. Maas:
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
6
Page 2 - Mr. Rainer Maas
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known):
Device Name: NeuroMetrix SENSUS
Indications for Use:
The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121184
Page 1 of 1
NeuroMetrix, Inc. SENSUS 510(k) Page 12
CONFIDENTIAL