Acceptance Criteria	Reported Device Performance
No new questions of safety and effectiveness compared to predicate device	"The TensCare "Ulitima XL-A1" is substantially equivalent to the predicate device and any differences between the devices do not pose any new questions of safety and effectiveness." (Clinical testing was not necessary as no new or innovative aspects were introduced).
Output characteristics substantially equivalent to predicate devices	"The results of Bench Testing demonstrate that the output characteristics of the TensCare Ultima are substantially equivalent to those of the two predicate devices."
Performance as intended to specified requirements (post-market review)	"During this time [5 months on European Market] 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."

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

Sample Size (Test Set): Not applicable. The "test set" here refers to post-market surveillance data, not a formal clinical trial test set. The submission mentions a "review of Customer Complaints, Returned Product and the results of Post Market Feedback" over 5 months. The exact number of customer complaints, returned products, or feedback instances is not specified.
Data Provenance: European Market (specifically, the product had been on the European Market for 5 months). The data is retrospective, gathered from existing market feedback.

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

Not applicable. The "ground truth" for the post-market review was operational performance based on customer complaints and returns, not expert consensus on specific cases.

4. Adjudication Method for the Test Set

Not applicable. As described above, this was a post-market review, not a clinical trial with case adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing was not necessary as no new or innovative aspects have been introduced."

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

Not applicable. This device is a TENS unit, not an AI algorithm. Its performance is inherent to the device's electrical output, not an algorithm's classification or diagnostic ability. The "standalone performance" was assessed via bench testing of its output characteristics.

7. The Type of Ground Truth Used

Bench Test: Comparison against the output characteristics of the predicate devices.
Post-Market Review: Actual product performance (customer complaints, returned products, post-market feedback).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design is based on established TENS technology and predicate devices.

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

Not applicable, as there is no training set for this type of device.

Summary

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MAY 2 1 2002

SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared:

12th March 2002

Name of Device:

Proprietary name:

TensCare Ultima

TENS device

Common name:

Classification name:

Stimulator, Nerve, Transcutaneous, for Pain Relief - 84GZJ; 21 CFR 882.5890.

Device Classification:

Predicate Device:

Device Description:

Intended Purpose/Use:

Technological Comparison:

Referer: 6TGZE9, 21 CFR 820.30...

Class II

FDTENS 2010 K994266

A portable TENS device for pain relief.

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.

The TensCare Ultima XL-A1 has basic technological characteristics that are substantially equivalent to the predicate device. The same Microprocessor is used to control all functions and the use of pre-set output energy levels selectable by depression of a Button (as opposed to rotational control knobs on the predicate devices) is the same on both units. The electronic circuitry is virtually identical. and 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", applies to both units.

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K020846

SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS

The Labelling is substantially equivalent to that Labelling Comparison: of the predicate device. The results of Bench Testing demonstrate that Non-Clinical Testing: the output characteristics of the TensCare Ultima are substantially equivalent to those of the two predicate devices. Clinical Testing was not necessary as no new or Clinical Testing: innovative aspects have been introduced. The TensCare "Ultima XL- A1" device has Further safety information: been on the European Market for the past 5 months. 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.

Conclusions:

The TensCare "Ulitima XL-A1" is substantially equivalent to the predicate device and any differences between the devices do not pose any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2002

TensCare Ltd. C/O Bernard J. Tremaine Medical Device & QA Consultancy 76, Stockport Road Timperley, Cheshire WA15 7SN United Kingdom

Re: K020846

Trade/Device Name: Ultima TENS Model XL-A1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: March 12, 2002 Received: March 15, 2002

Dear Mr. Tremaine:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 20, 1978, in eccordance with the provisions of the Federal Food, Drug, de nees may o ocen rollation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controlly profice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back acceral 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 r rouse be advised that i be mination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I vacual bakated and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Bernard J. Tremaine

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable the electronic forum in the quality systems (QB) regulations 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) This letter witi anow you to oegin maine of substantial equivalence of your device to a legally prematicate 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 11 you desire specific acrison. 0 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 France 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 594-669 office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Misoranang responsibilities under the Act may be obtained from the Other general informational 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,

uriam 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

Ultima Tens XL-A1

"For the symptomatic relief of chronic intractable pain"

Muriam C. Provost

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

510(k) Number K020846

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).