For the TENS function: TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain.
For the EMS function: The Ultima NMS/EMS is indicated for: Relaxation of muscle spasm. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Prevention of venous thrombosis of the calf. muscles immediately after surgery. Maintaining or increasing range of motion.

Device Description

For the TENS function: A portable TENS device for pain relief.
For the EMS function: A portable EMS device for the re-education of muscles.
The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.
The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).
In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.
The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.
The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no control over the devices outputs; the Programs are pre-set by the Treating Physician.
The use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" is utilised to further ensure no hazards exist.

AI/ML Overview

Acceptance Criteria and Device Performance for TensCare Ultima NMS/EMS

This document summarizes the acceptance criteria and supporting study information for the TensCare Ultima NMS/EMS device based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not contain explicit, quantitative acceptance criteria for the TensCare Ultima NMS/EMS device in the form of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices and performance in the European market.

The primary "acceptance criteria" appear to be:

Substantial Equivalence: The electrical, EMC, and software technologies, as well as the passive and active electrical components and PCB layout, are identical or virtually identical to the predicate devices.
Safety and Effectiveness: Bench testing, VVT (Verification, Validation, and Testing), and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. Also, the device prevents simultaneous use of TENS and EMS functions.
Post-Market Performance (EU): Review of customer complaints, returned products, and post-market feedback from over two years in the European market (in its TENS form) demonstrates performance as intended.

Acceptance Criteria (Inferred)	Reported Device Performance
Technological Substantial Equivalence to Predicate Devices:	The electrical, EMC, and software technologies (CPU series, passive/active electrical components, PCB layout) are identical or virtually identical to the TensCare Ultima TENS (K020846) for TENS functions and TensCare XL-Y3 (K011543) for EMS functions. EMS functions are software-derived and virtually identical.
Output Characteristics Substantial Equivalence to Predicate Devices:	Bench testing demonstrates that the output characteristics of the TensCare Ultima NMS/EMS are substantially equivalent to those of the two predicate devices.
Safety of Combined Functions:	Bench Testing, VVT, and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. It is not possible to use TENS and EMS functions simultaneously due to mechanical integrity. The device includes 'shrouded patient cable connectors' for safety.
Patient Control Restriction Option:	The device has a Doctor Important anti-Misuse feature: Lock facility, allowing the Treating Physician to pre-set programs, preventing patient control over device outputs.
Post-Market Performance (European Market - TENS form):	Over two years of data from the European market (for the TENS form) including customer complaints, returned products, and post-market feedback, demonstrated that the product performed as intended to its specified requirements.

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

Sample Size: Not applicable in the context of an AI/algorithm-based device as this device is a physical medical stimulator. The "testing" primarily involved bench testing, VVT, risk analysis, and post-market surveillance.
Data Provenance:
- Bench Testing, VVT, Risk Analysis: Likely internal company data.
- Post-Market Feedback: European Market data from the TENS form of the product over two years.

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

Not applicable. The product is a physical device, and its safety and effectiveness were assessed through engineering comparisons, bench testing, and review of existing market performance, rather than through expert-driven ground truth establishment for an AI algorithm.

4. Adjudication Method for the Test Set:

Not applicable. This is not an AI/algorithm-based device requiring an adjudication process for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The text explicitly states: "Clinical Testing was not necessary as no new or innovative aspects have been introduced." This indicates that the device's performance was not evaluated in a clinical trial comparing it against human performance or AI assistance.

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

Not applicable. This device is a physical medical stimulator, not an algorithm.

7. The Type of Ground Truth Used:

For the TensCare Ultima NMS/EMS, the "ground truth" for its safety and effectiveness was established through:

Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the two predicate devices (TensCare Ultima TENS (K020846) and TensCare XL-Y3 (K011543)). The new device's equivalence to these legally marketed devices forms the basis of its clearance.
Bench Test Results: Objective measurements of electrical output characteristics.
VVT (Verification, Validation, and Testing): Standard engineering validation processes.
Risk Analysis (FMEA): Identification and mitigation of potential hazards.
Post-Market Surveillance Data: Real-world performance data (customer complaints, returned products) from the European market for the TENS functions.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable. As noted above, this device does not involve a "training set" for an AI algorithm.

Summary

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i(02397)

MAR 0 3 2003

SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared:	19th November 2002
Name of Device:
Proprietary name:	TensCare Ultima NMS/EMS
Common name:	For the TENS function - TENS device
	For the PMS/EMS function - Powered Muscle Stimulator
Classification name:	For TENS functionsStimulator, Nerve, Transcutaneous, for Pain Relief - 84GZJ; 21 CFR 882.5890.
	For EMS functionsPowered Muscle Stimulator for re-education of muscles - IPF; 21 CFR 890.5850
Device Classification:	For both TENS & EMS functions - Class II
Predicate Device:	For the TENS functionTensCare Ultima TENS – (K020846)
	For the EMS functionTensCare XL-Y3 - (K011543)
Device Description:	For the TENS functionA portable TENS device for pain relief.
	For the EMS functionA portable EMS device for the re-education of muscles.
Intended Purpose/Use:	For the TENS function

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SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

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

For the EMS function

The Ultima NMS/EMS is indicated for:

Relaxation of muscle spasm .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation .
Muscle re-education .
Prevention of venous thrombosis of the calf . muscles immediately after surgery
Maintaining or increasing range of motion .

The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.

The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).

In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.

The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.

The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no

Technological Comparison:

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SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

		control over the devices outputs; the Programsare pre-set by the Treating Physician.
		• The use of 'shrouded patient cableconnectors' to comply with FDA's Final Rule"Medical Devices: Establishment ofPerformance Standards for Electrode LeadWires and Patient Cables" is utilised to furtherensure no hazards exist.
Labelling Comparison:		The Labelling is substantially equivalent to thatof the predicate devices.
Non-Clinical Testing:		The results of Bench Testing demonstrate thatthe output characteristics of the TensCareUltima NMS/EMS are substantially equivalentto those of the two predicate devices.
Clinical Testing:		Clinical Testing was not necessary as no new orinnovative aspects have been introduced.
Safety of the Combination functions:		The TensCare Ultima NMS/EMS combines thefunctions of a TENS device and an EMS(Electrical Muscle Stimulator) or PoweredMuscle Stimulator, into one package. BenchTesting, VVT and Risk Analysis, includingFMEA, demonstrate that the device performs asintended, with no harm to the User. Also, it isnot possible to use the TENS and the EMSfunctions simultaneously. Mechanical integrityensures that only one function can be selected atany one time.
Further safety information:		The "TensCare Ultima NMS/EMS" device hasbeen on the European Market for the past two

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SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

vears, in it's TENS form. During this time a review of Customer Complaints, Returned Product and the results of Post Market Feedback, has demonstrated that the product has performed as Intended, to it's Specified Requirements. The data analysed is summarised in this submission and the full data is available upon request. The Certificate of authority to CE Mark the "TensCare Ultima in accordance with the Medical Device Directive 93/42/EEC is included in Section 12 of this submission.

Conclusions:

The TensCare Ultima NMS/EMS is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 3 2003

TensCare Ltd. C/O: Mr. Bernard Tremaine Medical Device & QA Consultancy 76, Stockport Road Timperley, Chesire WA15 7SN. UK

Re: K023997 Dated: November 29, 2002 Received: December 3, 2002

Trade/Device Name: TensCare Ultima NMS/EMS Model XL-A3 Regulation Numbers: 21 CFR 890.5850 and 21 CFR 882.5890 Regulation Names: Powered muscle stimulator and Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: IPF, GZJ

Dear Mr. Tremaine:

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.

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

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Page 2 - Mr. Tremaine

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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-. 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,

Miriam C. Provost

for 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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SECTION 2 GENERAL INFORMATION

INTENDED USE / PURPOSE STATEMENT

TensCare Ultima NMS/EMS

For the TENS function

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

and;

For the EMS function

The Ultima NMS/EMS is indicated for the following;

Relaxation of muscle spasm .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation .
Muscle re-education .
Prevention of venous thrombosis of the calf . muscles immediately after surgery
Maintaining or increasing range of motion .

iriam C. Provost

(Division Sign-Off) Division of General Restorative and Neurologics revices

510(k) Number: K023997

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).