The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and 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 the pain signal travelling to the brain.

AI/ML Overview

The devices, "Body Clock Stimplus Pro" and "Body Clock Stimplus," are Transcutaneous Electrical Nerve Stimulators (TENS units) intended for pain relief.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no specific, quantitative acceptance criteria defined for device performance (e.g., a certain level of pain reduction in percentage, or a specific range of electrical output). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion	Reported Device Performance (or Justification for Equivalence)
Intended Use	The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and acute post-traumatic pain. This is stated to be the same as the predicate device (Solitens Modified - Stimplus Pro, K913522).
Technological Characteristics	Body Clock Stimplus Pro: Declared as identical to the predicate device (Solitens Modified - Stimplus Pro, K913522). This implies all technical specifications like intensity, power, timer settings (15s/30s), and frequency switch are the same. Body Clock Stimplus: Declared as very similar and having features that are substantially equivalent to the predicate. Differences noted: timer selection (manual, 30s, 60s vs. 15s/30s on predicate/Pro) and a Rhythm Switch instead of a Frequency Switch. The document concludes that despite these minor differences, it is technically substantially equivalent.
Safety Standards / Non-clinical Testing	All units are CE marked (compliant with EEC Directive 93/42/EEC Annex V). Compliance with multiple international and European standards is reported: ISO 9002, ISO 13488, EN 46002, EN 60601-1-2:1993, IEC 601-1:1988 + A1:1991 + A2:1995, EN60601-1:90 + A1:93 + A2:95 + A13:96. This indirectly serves as an acceptance criterion for electrical safety, electromagnetic compatibility, and quality management systems.
Clinical Performance	"Not Applicable as there are no new or innovative aspects that have been introduced." The device is considered substantially equivalent to a legally marketed predicate, implying that its clinical performance for the stated indications is expected to be the same as the predicate.

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

Sample Size for Test Set: Not applicable. The submission explicitly states "Clinical Testing: Not Applicable." The basis for clearance is substantial equivalence to a predicate device, not a new clinical performance study.
Data Provenance: Not applicable, as no new clinical testing was performed. The data provenance would refer to the existing predicate device's historical performance and regulatory clearance.

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

Not applicable. No new clinical trials were conducted to establish a ground truth for the device's performance.

4. Adjudication Method for the Test Set:

Not applicable. No new clinical trials with a test set requiring adjudication were conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Testing: Not Applicable." TENS units are typically evaluated for efficacy in pain relief through clinical trials; however, for this 510(k), equivalence to an already approved device negated the need for new clinical trials.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a TENS unit, not an AI/algorithm-based diagnostic or assistive system. Its function is direct electrical stimulation, not processing data or providing outputs for human interpretation.

7. The Type of Ground Truth Used:

The implicit "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate device (Solitens Modified - Stimplus Pro, K913522), as determined by its prior regulatory clearance. The current submission argues that the new devices are so similar (identical or substantially equivalent) that their performance, and thus their "ground truth," would be the same.

8. The Sample Size for the Training Set:

Not applicable. This device is a TENS unit, not typically involving a "training set" in the context of machine learning or complex diagnostic algorithms. The design and manufacturing are based on established engineering principles and safety standards, rather than data-driven model training.

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

Not applicable, as there is no "training set" in this context.

Summary

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KC41354

AUG 2 0 2004

10 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

10.1 Submitter's Identification:

Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD United Kingdom

Tel: +44 (0)20 8532 9551 Fax: +44 (0)20 8532 9551

Rashelle Preston Contact: 18 May 2004 Date Prepared:

10.2 Name of Device:

Proprietary Name:

Body Clock Stimplus Pro 1.
II. Body Clock Stimplus

Common or Usual Name:

TENS unit (Transcutaneous Electrical Nerve Stimulator)

Classification Name:

Stimulator, Nerve, Transcutaneous, For Pain Relief.

10.3 Predicate Device Information:

The Body Clock Stimplus Pro is identical to the Solitens Modified (Stimplus Pro) (K913522) The Body Clock Stimplas is very similar to the Solitens Modified (Stimplus Pro) (K913522)

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 the pain signal travelling to the brain.

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10.5 Intended Use:

TENS is used for the symptomatic relief and management of chronic intractable pain and/or as TENS is used for the symptomatio roller and wants of post-traumatic acute pain.

10.6_Technological Comparison to Predicate Device:

The Body Clock Stimplus Pro is identical to the predicate device (the Solitens Modified -The Body Olock Othinblus is very similar to the predicate device and has Rorrouze). The Bouy Choics that are substantially equivalent to the predicate device.

Each of the units is made from the same mould and feature the same number of function Each or the units is made them the edentical, namely the Intensity Switch, the Power Switch, Switches. The fancilent and the Time Selector Switches. The timer selection on the units differ the Ulinbladel. On the Body Clock Stimplus Pro and predicate device, the user can choose to very cally 15 seconds or 30 seconds. On the Body Clock Stimplus, the user can choose between manual, 30 seconds and 60 seconds.

Both units also have switches providing the user with adjustable stimulation control. On the predicate unit and Body Clock Stimplus Pro is the Frequency Switch. On the Body Clock Stimplus, there is a Rhythm Switch.

Each of the units have their remaining features in common, including a low battery indicator, stimulation switch and LED display on the tope of the unit, passive contact plate and battery compartment on the underside of the unit and gold plate tip. In essence the predicate device oon the Body Clock Stimplus Pro are almost identical to the Body Clock Stimplus and are technically substantially equivalent.

10.7 Non-clinical Testing:

All Units are fully CE marked i.e. compliant with EEC Directive 93/42/EEC Annex V, . classified as "Internally powered Equipment Type BF. They are intended for continuous operation."
150 9002 .
ISO 13488 .
EN 46002 .
EN 60601-1-2:1993 (EEC Directive 89/336/EEC) .
IEC 601-1:1988 + A1:1991 + A2:1995 .
EN60601-1:90 + A1:93 + A2:95 + A13:96 .

10.8 Clinical Testing:

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

10.9 Conclusions:

The Body Clock Stimplus Pro and the Body Clock Stimplus have the same intended use and similar technical characteristics to the Solitens Modified (Stimplus Pro) (K913522).

The information supplied in this 510(k) illustrate that the device does not pose any new questions of safety and effectiveness. The Body Clock Stimplus is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo with three stylized birds in flight, arranged diagonally from the upper right to the lower left. The birds are depicted with simple, curved lines, suggesting movement and freedom. The birds are enclosed within a partial circle, which appears to be a border or frame for the logo. The logo has a minimalist design, focusing on the essence of flight and nature.

AUG 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rashelle Preston Director of Special Projects Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD England

Re: K041359

K041339
Trade/Device Name: Body Clock Stimplus and Body Clock Stimplus Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: May 18, 2004 Received: May 21, 2004

Dear Ms. Preston:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premained instantially equivalent (for the indications referenced and nave uctchilliou the devices marketed predicate devices marketed in interstants for use stated in the encrosule) to regally manation in the Medical Device American so Love Hised. Prus commerce prior to May 28, 1770, the enatified in accordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accerdance while a preval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous at the Act . The and Cosment Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, liging of You may, therefore, market the devices sayser of the manual registration, listing of
general controls provisions of the Act include requirements for annual registration and general controls provisions of the Fee netals readers reading misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me) eising major regulations affecting your device can
may be subject to such additional controls. Existing major and conditions Fif may be subject to such additional controlise 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 docs not mean Please be advised that FDA s issuated or a belevice complies with other requirements of the Act
emplies made a determination that your device complies with other requirements that FDA has made a decermination administered by other Federal agencies. You must of any redelal statues and regulations and manadine, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set C. F. Part 807), tabeling (21 CFR Part 820), good manat 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin nationing your article quisalence of your device to allegally
prematice to wheation. The FDA finding of substantial and this permits vour premarket in the rive 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), please
rs the list of the same on the compares and 160 methose note the requiried If you desire specific advice for your de needed on the see note the regulation entitled, contact the Office of Compliance at (301) 597 1007 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obt "Misbranding by reference to premarkst nothleadon (or or on the Division of Small)
other general information on your responsibilities under the Act from the 1800 638-200 other general information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-ifrememain html Manufacturers, International and Consumer Priseibults and views and main.html

Sincerely yours,

Mark N. Milken

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): ___________________________________________________________________________________________________________________________________________________

Device Name/s:

Body Clock Stimplus Pro Body Clock Stimplus

Indications For Use:

The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief The Bouy Clock Stimplus FTO und Dody Orean Strilland as an adjunctive treatment in the and management of post-surgical and post-traumatic acute pain.

Mark A. Milken

Division of General, Restorative, and Neurological Devices

510(k) Number

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 General, Restorative and Neurological Devices 510(k) Number _

Prescription Use X (Per 21 CFR 801.109)

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).