The Ultima Five™ external, non-invasive, non-narcotic, electrotherapy device is indicated for use as an adjunctive therapy in providing symptomatic pain relief for chronic, acute, or post-operative pain.

Device Description

The Ultima Five consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

AI/ML Overview

The provided text is a 510(k) summary for the Ultima Five™ Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study as would be done for a novel device or a device with new intended uses.

Therefore, many of the requested elements for a detailed study description, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, are not present in this 510(k) summary.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (Ultima Five™)
Electrical Output Equivalence	Produces the exact same electrical output as the Easy Med TN-28C.
- Frequency	Same frequency as the Easy Med TN-28C.
- Waveform	Same waveform as the Easy Med TN-28C.
- Modes	Similar modes to the Easy Med TN-28C.
- Voltage Output Range	Same voltage output range as the Easy Med TN-28C.
- Dual Channel Output Performance	Same dual channel output performance as the Easy Med TN-28C.
- Pulse Widths	Identical pulse widths to the Easy Med TN-28C.
- Max Output Values	Identical max output values to the Easy Med TN-28C.
Intended Use Equivalence	Indicated for use as an adjunctive therapy in reducing the level of chronic, acute, and post-surgical pain, similar to the predicate.
Safety and Effectiveness	Substantially equivalent to the legally marketed predicate device (Easy Med TN-28C).
Display Functionality	Utilizes an LCD screen to display the settings. (This is a feature improvement, not a direct equivalence to the predicate's stated performance, but is noted as part of the summary).

Explanation: The acceptance criteria for a 510(k) submission are largely implicit in the concept of "substantial equivalence." The device must be as safe and effective as a legally marketed predicate device. For TENS devices, this primarily constitutes demonstrating equivalent electrical performance and similar intended use. The "study" here is a comparative analysis of technical specifications between the proposed device and the predicate.

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

Sample Size for Test Set: Not applicable. There was no "test set" in the traditional sense of a clinical or retrospective data study aimed at evaluating diagnostic accuracy or treatment efficacy against a specific outcome. The submission relies on a technical comparison to a predicate device.
Data Provenance: Not applicable in the context of a dataset. The data provenance is from the technical specifications of the Ultima Five™ and the predicate device, the Easy Med TN-28C.

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

Not applicable. Ground truth as typically understood (e.g., expert consensus on medical images or pathology results) is not relevant for this type of submission focused on technical equivalence for a TENS device.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. TENS devices are not typically evaluated using MRMC studies, which are common for diagnostic imaging AI. The aim here is to show equivalent electrical output and intended use to a predicate, not to assess a human reader's improvement with AI assistance.

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

Yes, in a way. The "performance" being assessed is the inherent electrical output characteristics of the device itself, independent of a human operator's actions beyond setting the parameters. This is a "standalone" technical performance evaluation. However, it's not an algorithm-only performance in the context of AI, but rather the device's physical output.

7. The Type of Ground Truth Used:

Technical Specifications and Intended Use: The "ground truth" for this submission is the established technical specifications of the predicate device (Easy Med TN-28C) and its legally marketed intended use. The Ultima Five™ is compared directly against these documented characteristics.

8. The Sample Size for the Training Set:

Not applicable. There was no "training set" in the context of machine learning or AI algorithm development.

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

Not applicable. As no training set was used, no ground truth needed to be established for one.

Summary

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KC83494

Pain Management Technologies, Inc. 510(k) submission Ultima Five™

510(k) Summary of Safety and Effectiveness (As described in 21 CFR 807.92)

JAN - 6 2009

Date Prepared:

Trade Name/Device:

9-1-08

Ultima Five™

Applicant Information:

Pain Management Technologies, Inc. 1340 Home Ave. Bidg. A Akron, OH 44310 800-239-7880 (phone) 888-304-5454 (fax) Contact: Joshua Lefkovitz

Registration No. 1528161

Device Generic Name:

Classification:

TENS (Transcutaneous Electrical Nerve Stimulator)

Class II (21CFR 882.1320) Classification Name: Transcutaneous electrical nerve stimulator for pain relief Product Code: GZJ Regulation number 21 CFR 882.5890

Predicate Devices:

Device Description:

Statement of intended use:

The Easy Med TN-28C, TN-28C- K040253

The Ultima Five is indicated for use as an adjuctive therapy in reducing the level of chronic, acute, and post surgical pain.

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Summary of technology of the Utima Five vrs. the predicate EasyMed device: The Ultima Five and the Easymed TN28c generate the exact same electrical output. They produce the same frequency. The same wave form and similar modes. The same voltage output range, as well as the same dual channel output

performance. Pulse widths and max output values are identical as well. The Ultima Five utilizes an LCD screen to display the settings .

.

Pain Management Technologies, Inc.

And Children Children

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

JAN - 6 2009

Pain Management Technologies, Inc. % Mr. Josh Lefkovitz 1340 Home Avenue, Building A Akron, Ohio 44310

Re: K083494

Trade/Device Name: Ultima Five™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutancous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: October 21, 2008 Received: November 25, 2008

Dear Mr Lefkovitz:

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 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.

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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Page 2 - Mr. Josh Lefkovitz

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807:97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pain Management Technologies, Inc. 510(k) submission Ültima Five™

Indications for Use Statement

510k Number: N/A

Device Name: Ultima Five™M

Indication for Use:

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

510(k) Number_

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).