(90 days)
No
The description focuses on standard embedded software control of electrical stimulation parameters and a simple electrode peeling detection mechanism. There is no mention of AI, ML, or related concepts.
Yes
The device is described as a "transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain," which is a therapeutic purpose.
No
The device is described as a transcutaneous electric nerve stimulation device for symptomatic relief and management of chronic intractable pain. Its function is to deliver electrical stimulation, not to diagnose conditions.
No
The device description explicitly states it is a transcutaneous electrical nerve stimulator with hardware components including a microprocessor, high-voltage circuit, battery, push-button, and LED. It also connects to disposable electrodes.
Based on the provided information, the NeuroMetrix SENSUS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain." This describes a therapeutic device that applies electrical stimulation to the body, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a device that generates electrical pulses and delivers them through electrodes placed on the patient's body. This aligns with a therapeutic device, not an IVD.
- Anatomical Site: The device is applied to the "patient's body," specifically mentioning attachment to a patient's leg. IVDs typically involve testing biological samples (blood, urine, tissue, etc.) outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the NeuroMetrix SENSUS is a therapeutic device used for pain management through electrical stimulation, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / 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.
The device may be used during sleep. The device is labeled for use only with the NeuroMetrix SENSUS Electrode.
Product codes
GZJ
Device Description
The SENSUS device, is a transcutaneous electrical nerve stimulator with a single output mode. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including pulse shape, amplitude (current), duration, pattern, and frequency. The device is powered by a permanent rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the patient through disposable, single-patient use electrodes placed on the patient's body. The device is labeled for use only with the SENSUS Electrode (K121816), to which it connects through insulated female medical snap connectors embedded within its housing.
The device has a push-button that initiates stimulation, and controls the intensity. The device has a single two color LED for indication of stimulation status, battery charging, and error conditions.
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
Two instances of the validation protocol were run. The difference between the two runs was the duration of time the SENSUS Electrode was left on the skin prior to initiating electrode peeling. In one run it was 10 minutes and in the other it was 40 minutes. In each run, 66 tests were conducted, each with a different subject and SENSUS Electrode to maintain statistical independence. The hydrogel on the SENSUS Electrodes was stressed to mimic prior use of the electrodes.
The same 66 subjects were used in the two protocol runs, but a different SENSUS Electrode was used in each test: therefore a total of 132 SENSUS Electrodes were evaluated. Each test used a randomly chosen electrode peel rate. At the beginning of a test, the SENSUS Electrode was placed on the subject and a therapy session was initiated. After 10 or 40 minutes, depending on the outer electrode was peeled away from the skin at the designated peel rate. The electrode area remaining on the skin at the instant when stimulation halted was logged. A test failure was defined as a remaining contact area less than 3.5 cm2.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Validation of electrode peeling detection
Sample Size: 132 tests, with 66 tests in each of two protocol runs, using 66 different subjects and 132 different SENSUS Electrodes.
Key Results:
A detection failure was defined as failing to halt stimulation when the remaining skin contact area of the peeling electrode was less than 3.5 cm². The prospective validation sample size was set to 60 tests and the primary acceptance criterion was a failure rate of 0%. At this failure rate level (i.e., 0 out of 60 tests), the upper bound of the one-sided 95% confidence interval was 4.9% which indicates a 95% confidence that the true failure rate was below 5%. The lower bound of all two-sided confidence intervals includes a true failure rate of 0%.
The average remaining electrode contact area detected by the modified device was 10.2 ± 2.1 cm² (range 6.9 - 19.5 cm²) for the 10 minute run and 10.1 ± 1.7 cm² (range 7.5 - 18.0 cm²) for the 40 minute run. There were 0 failures among the 66 tests in both protocol runs. On the basis of these results, detection of electrode peeling was validated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130919
JUL 0 2 2013
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: | March 31, 2013 |
DEVICE NAME
Proprietary Name: Classification Name:
SENSUS Common/Usual Name: Transcutaneous Electrical Nerve Stimulator, TENS 882.5890 GZJ Transcutaneous electrical nerve stimulator for pain relief
PREDICATE DEVICE
NeuroMetrix SENSUS (K121184)
INTENDED 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.
The device may be used during sleep. The device is labeled for use only with the NeuroMetrix SENSUS Electrode.
DEVICE DESCRIPTION
The SENSUS device, is a transcutaneous electrical nerve stimulator with a single output mode. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including pulse shape, amplitude (current), duration, pattern, and frequency. The device is powered by a permanent rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the patient through disposable, single-patient use electrodes placed on the patient's body. The device is labeled for use only with the SENSUS Electrode (K121816), to which it connects through insulated female medical snap connectors embedded within its housing.
The device has a push-button that initiates stimulation, and controls the intensity. The device has a single two color LED for indication of stimulation status, battery charging, and error conditions.
1
COMPARISON TO PREDICATE
The SENSUS device subject to this submission is a modification of the predicate SENSUS device The two tables below provide a comparison of basic unit characteristics and output (K121184). specifications.
Basic Unit Characteristics
| Parameter | Modified SENSUS | Predicate SENSUS | |
|---|---|---|---|
| 510(k) Number | Same | K121184 | |
| Device Name and Model Number | Same | SENSUS | |
| Manufacturer | Same | NeuroMetrix | |
| Power Source(s) | Same | 1 rechargeable 3.7V Lithium-Ion | |
| battery | |||
| Method of Line Current Isolation | Same | Physically isolated; device cannot | |
| connect to electrodes and battery | |||
| recharger concurrently | |||
| Patient Leakage Current | |||
| Normal Condition | Same | 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: April 1, 2013 Received: April 3, 2013 |
Dear Rainer 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
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Page 2 - 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K130919
Device Name: _ 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.
The device may be used during sleep. The device is labeled for use only with the NeuroMetrix SENSUS Electrode.
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)
Joyce M. Whang -S
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number _K130919
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