The First Choice and First Choice Plus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.

AI/ML Overview

The provided text is a 510(k) summary for the First Choice and First Choice Plus TENS units. It does not describe a clinical study focused on meeting acceptance criteria for device performance in a typical sense (e.g., diagnostic accuracy metrics). Instead, it's a submission for demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, or improvement in pain scores from a clinical trial) and reported device performance.

Instead, the "acceptance criteria" are implied by meeting regulatory standards and demonstrating substantial equivalence to a predicate device. The "device performance" is primarily considered in terms of its technological characteristics and safety compared to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (as stated in the 510(k))
Technological Equivalence	- Functionality comparison to predicate device (FUJI TENS 804SIII, K893874)	- First Choice: Slightly lower functionality (one pulse rate dial for both channels) than predicate. - First Choice Plus: Identical functionality to predicate, but one pulse rate dial for both channels, plus pulse width adjustment.
Safety Standards Adherence	- Adherence to AAMI/ANSI NS-4 Standard	All required sections were met.
	- Adherence to IEC 60601-1:1990 + a1:1993 + A2: 1995 standards	All units pass.
	- Adherence to IEC 601-1:1988 + a1:1991 + A2:1995 standards	All units pass.
	- Compliance with "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" Final Rule	All units use "shrouded patient cable connector's".
Intended Use Equivalence	- Same intended use as predicate device	"Used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." (Same as predicate)

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

Test Set Sample Size: Not applicable. The submission does not describe a test set in the context of evaluating diagnostic or clinical performance with a specific sample size. The evaluation is based on non-clinical testing against standards and comparison to a predicate device.
Data Provenance: Not applicable. No clinical data or patient data is mentioned.

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

Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in this context. The assessment is regulatory and technical.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No. The document explicitly states: "Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced." Therefore, no MRMC study, or any clinical study comparing human readers with or without AI assistance, was performed or presented.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance Study: No. This submission is for a TENS unit, which is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here. The evaluation focused on the device's adherence to safety and performance standards and its comparison to the technical specifications of a predicate physical device.

7. The Type of Ground Truth Used:

Type of Ground Truth: Not applicable in the context of diagnostic accuracy or clinical outcomes. The "ground truth" for this submission revolves around:
- Regulatory Compliance: Meeting established AAMI/ANSI and IEC standards (e.g., electrical safety, mechanical integrity).
- Technical Specifications: Demonstrating that the device's electrical characteristics and functionality are comparable to the stated specifications of the predicate device.
- Intended Use: Confirming the device's intended use aligns with that of the predicate.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This document describes a physical medical device, not a machine learning model or algorithm that would require a training set.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary of the Study Proving Acceptance Criteria:

The "study" in this context is the non-clinical testing and comparison outlined in section 10.7 ("Non-clinical Testing") and 10.6 ("Technological Comparison to Predicate Devices").

Non-Clinical Testing: The manufacturer conducted tests to ensure the TENS units met all required sections of the AAMI/ANSI NS-4 Standard and passed the IEC 60601-1 and IEC 601-1 standards. They also ensured the use of "shrouded patient cable connector's" to comply with FDA's Final Rule. This testing demonstrates the device's adherence to established safety and performance standards for TENS units.
Technological Comparison: The manufacturer compared the functionality and technical characteristics of the First Choice and First Choice Plus devices to the predicate device, FUJI TENS 804SIII (K893874). They identified slight differences (e.g., single dial for pulse rate control) but concluded that these differences did not introduce new questions of safety or effectiveness. The First Choice Plus also added pulse width adjustment, which was also found to be within acceptable parameters relative to the predicate's overall functionality.

The conclusion (Section 10.9) states that "The First Choice and First Choice Plus have the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874)... The information supplied in this 510(k) illustrate that the devices do not pose any new questions of safety and effectiveness. The First Choice and First Choice Plus are substantially equivalent to the predicate device(s)." This statement, supported by the non-clinical testing and technological comparison, serves as the "proof" that the device meets the implied acceptance criteria for substantial equivalence necessary for 510(k) clearance.

Summary

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10 510(k) Summary

The assigned 510(k) number is: KOZZO 76

10.1 Submitter's Identification:

Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD United Kingdom +44 (0)20 8532 9551 Tel: Fax: +44 (0)20 8532 9551

Contact: Jonathan Bash June 19th 2002 Date Prepared:

10.2 Name of Device:

Proprietary Name:

First Choice 1. First Choice Plus 11.

Common or Usual Name: TENS unit (Transcutaneous Electrical Nerve Stimulator)

Classification Name:

Stimulator, Nerve, Transcutaneous, For Pain Relief.

Predicate Device Information: 10.3

The First Choice and First Choice Plus are equivalent to the FUJI TENS 804SIII (K893874). The First Choice Plus also has pulse width adjustment.

10.4 Device Description:

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.

10.5 Intended Use:

TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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10.6 Technological Comparison to Predicate Devices:

The First Choice has a slightly lower functionality than the FUJI TENS 804SIII (K893874) in that there is only one dial for pulse rate adjustment. This means that both the left and the right channels are controlled by one pulse rate dial as opposed to having two separate dials.

The First Choice Plus has identical functionality to the 804SIII except that both the left and the right channels are controlled by one pulse rate dial as opposed to having two separate dials. It also has pulse width adjustment.

All units use "shrouded patient cable connector's" to comply with the FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."

10.7 Non-clinical Testing:

All required sections of the AAMI/ANSI NS-4 Standard were met. All units pass the required IEC 60601-1:1990 + a1:1993 + A2: 1995 standards. All units pass the IEC 601-1:1988 + a1:1991 + A2:1995 standards.

10.8 Clinical Testing:

Not Applicable as there are no new or innovative aspects that have been introduced.

10.9 Conclusions:

The First Choice and First Choice Plus have the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874).

The information supplied in this 510(k) illustrate that the devices do not pose any new questions of safety and effectiveness. The First Choice and First Choice Plus are substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2002

Mr. Jonathan Bash Director of IT and Special Projects Body Clock Health Care Ltd 108 George Lane South Woodford, London E18 1AD

Re: K022076

Trade/Device Name: First Choice and First Choice Plus Regulation Number: 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 19, 2002 Received: June 26, 2002

Dear Mr. Bash:

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. Iisting 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. Jonathan Bash

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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,

Mark N Milliman

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

Enclosure

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Statement of Indications For Use 8

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

First Choice Device Namels: First Choice Plus

Indications For Use:

The First Choice and First Choice Plus are used for the symptomatic relief and management The First Choice and I first Onoloe Flub are assument in the management of postsurgical and post-traumatic acute pain.

for Mark N. Wilkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022076

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).