TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

Device Description

A portable TENS device for pain control.

AI/ML Overview

The CLASSIC TENS™ device, a transcutaneous electrical nerve stimulator (TENS) for pain relief, did not require a study proving its performance against acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway based on substantial equivalence to a predicate device.

Instead of clinical performance testing, the submission focused on comparing the technological characteristics and labeling of the CLASSIC TENS™ to a legally marketed predicate device (Matrix I, K895473).

Here's a breakdown of the information based on the provided text, addressing your points as much as possible within the context of a 510(k) submission for a TENS device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Technological Equivalence to Predicate Device	The CLASSIC TENS™ "has technological characteristics which are substantially equivalent to those of the predicate device, as determined by bench testing." It differs only by the use of jacks and cables compliant with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables".
Electrical Output Equivalence	Bench testing demonstrated that the output characteristics of CLASSIC TENS™ "are substantially equivalent to that of the predicate device."
Safety and Effectiveness	Any differences between the devices "do not pose new questions of safety and effectiveness."
Labeling Equivalence	The labeling of the CLASSIC TENS™ "is substantially equivalent to that of the predicate device."
Intended Use Equivalence	Intended use matches the predicate: "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable. The device relies on bench testing for technological comparison, not a "test set" of patient data in the typical sense.
Data Provenance: Not applicable. The "testing" involved bench testing of the device itself against the predicate device's specifications, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth in this context refers to the characteristics and performance of the predicate device, established by previous FDA clearance and regulatory standards, not by individual experts assessing a test set.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No Multi-Reader Multi-Case (MRMC) study was done. This type of study is typically used for diagnostic or screening devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This TENS device is a therapeutic device, and its clearance was based on substantial equivalence through bench testing, not clinical performance studies involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, a standalone evaluation was done, but not in the context of an "algorithm." The "Nonclinical Testing" section states "Bench testing demonstrated that the output characteristics or CLASSIC TENS™ are substantially equivalent to that of the predicate device." This means the device's electrical output and technological features were directly evaluated and compared to the predicate without human intervention in operating the device for patient therapy during the evaluation.

7. The Type of Ground Truth Used

The ground truth used was the established performance and safety profile of the predicate device (Matrix I, K895473), as determined by its prior FDA clearance and existing regulatory standards for TENS devices. The "bench testing" served to confirm that the CLASSIC TENS™ adhered to these established parameters.

8. The Sample Size for the Training Set

Not applicable. As a TENS device, there is no "training set" in the context of machine learning. The device's design and manufacturing are based on established engineering principles and regulatory standards for TENS units.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary of the Study (Bench Testing and Comparison):

The "study" in this context refers to the bench testing performed to demonstrate the substantial equivalence of the CLASSIC TENS™ to its predicate device, Matrix I (K895473).

Objective: To show that the CLASSIC TENS™ has comparable technological characteristics, electrical output, and intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
Methodology:
- Technological Comparison: The physical design, components (specifically, the jacks and cables), and overall technological characteristics of the CLASSIC TENS™ were compared to the predicate. The only noted difference was the use of FDA-compliant jacks and cables.
- Nonclinical Testing (Bench Testing): Specific tests were performed on the CLASSIC TENS™ to measure its electrical output characteristics (e.g., waveform, intensity, frequency) and these were compared directly to the known output characteristics of the predicate device.
- Labeling Comparison: The proposed labeling for the CLASSIC TENS™ was reviewed and compared to the predicate device's labeling to ensure consistency in indications for use, warnings, and instructions.
Results/Conclusion: The bench testing and comparisons demonstrated that the CLASSIC TENS™ is "substantially equivalent" to the predicate device. This equivalence formed the basis for the FDA's 510(k) clearance, allowing the device to be marketed.

Summary

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11 Appendix E: 510 (k) Summary

510(k) Summary

Stimulator, Nerve, Transcutaneous, For Pain Relief

A portable TENS device for pain control.

postsurgical and posttraumatic acute pain.

KD20437

Submitter's Information:

Christian E. Hunt Care Rehab 1124 Dominion Ct McLean, VA 22102

February 5, 2002

CLASSIC TENS™

84GZJ; 21 CFR 882.5890.

Matrix I (K895473)

Patient Cables"

of the predicate device.

TENS device

Class II

Phone: 1-703-448-9644 FAX: 1-703-356-2182.

Date of preparation:

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Predicate Device:

Description of Device:

Intended Use:

Technological Comparison:

Labeling Comparison:

Nonclinical Testing:

Clinical Testing:

Conclusions from Testing:

Not applicable.

TENS™ are substantially equivalent to that of the predicate device.

The CLASSIC TENSTM is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.

TENS is used for symptomatic relief and management of chronic

intractable pain and/or as an adjunctive treatment in the management of

The CLASSIC TENSTM has technological characteristics which are

substantially equivalent to those of the predicate device, as determined by bench testing. It differs technologically only by the use of jacks and cables which comply with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and

The labeling of the CLASSIC TENS™ is substantially equivalent to that

Bench testing demonstrated that the output characteristics or CLASSIC

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Mr. Christian E. Hunt Care Rehab, Inc. P. O. Box 580 1124 Dominion Court McLean, Virginia 22102

Re: K020437

Trade Name: CLASSIC TENSTM Regulation Number: 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Code: GZJ Dated: February 5, 2002 . Received: February 8, 2002

Dear Mr. Hunt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Christian Hunt

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loket withination. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Malm M Mllersa

Witten. Ph.D .. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 4

510(k) Number:

Device Name: CLASSIC TENS™

Indications for Use:

TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mcllerson
(Division Sign-Off)

510(k) N

Regulation Number and Section

§ 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).