Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

Device Description

The Prizm Medical Inc.'s Thera-Cream™ product is used prior to electrode placement to reduce the impedance (resistance to alternating current), which increases the skin conductivity during electrotherapy treatment. Electrotherapy treatment includes the use of TENS (Transcutaneous Electrical Nerve Stimulators) and NMES (Neuromuscular Electrical Stimulators).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Thera-Cream™ device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

Device identification: Trade name, common name, classification, product code.
Intended Use: "Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes."
Predicate devices: A list of previously marketed devices to which Thera-Cream™ is compared for substantial equivalence.
Similarities and Differences to Predicate Devices: Thera-Cream™ shares the same intended use and incorporates "conductive copper salts" like the predicate Conduct-Mist™. The primary difference highlighted is Thera-Cream™'s "moisturizing cream base" versus Conduct-Mist™'s liquid/water base.
FDA determination: The FDA's letter indicating substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, the text would need to include:

Specific performance metrics (e.g., impedance reduction levels, conductivity values) along with thresholds that define "acceptance."
Details of a study (e.g., number of subjects, experimental design, results) demonstrating that the device achieved these performance metrics.

Summary

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Prizm Medical, Inc. Thera-Cream™ 510(k) # K032239

JUL 3 0 2004

Attachment 2

510(k) Summary - Revised

Submitted By:	Prizm Medical, Inc.3400 Corporate Way, Suite IDuluth, GA 30096	Phone: (770) 622-0933Fax: (770) 622-9392
Contact Person:	Julie Stephens
Date Prepared:	05/18/04
Trade/Proprietary Name:	Thera-Cream™
Common Name:	Electroconductive Cream
Classification Name:	Electroconductive Media (21 CFR 882.1275)
Product Code:	GYB, Neurology
Legally MarketedPredicate Devices:	Conduct-Mist™ - 510(k) Numbers: K024181 & K951727;Conductive Aloe Vera Gel - 510(k) Number: K925466;SignaCreme® - 510(k) Number: K782055; Ultra/Phonic White- Preamendment; ReliefBand® Conductivity Gel: 510(k)Number K020180

Device Description:

Intended Use:

Similarities and Differences of the Thera-Cream™ product to the Predicate Device:

Similarities

The Prizm Medical Inc.'s Thera-Cream™ product has the same intended use as the predicate products. Specifically, both the Conduct-Mist™ product and the Thera-Cream™ product use "conductive copper salts" which "increases the skin conductivity".

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Attachment 2 (Continued)

510(k) Summary - Revised

Differences

The Prizm Medical Inc.'s Thera-Cream™ product utilizes a "moisturizing cream base" combined with the "conductive copper salts" that is rubbed onto the skin surface prior to garment electrode placement. The Conduct-Mist™ product utilizes a liquid/water base combined with the "conductive copper salts" that can be sprayed on the skin surface prior to garment electrode placement.

The Prizm Medical Inc.'s Thera-Cream™ product utilizes a "moisturizing cream base"
which moisturizes skin. The Conduct-Mist™ product does not contain moisturizing ingredients.

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Image /page/2/Picture/1 description: The image shows a seal or logo. The logo is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the logo is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Prizm Medical, Inc. C/o Ms. Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K032239

Trade/Device Name: Thera-Cream™ Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: II Product Code: GYB Dated: May 18, 2004 Received: May 19, 2004

Dear Ms. Stephens:

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.

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Page 2 - Ms. Julie Stephens

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Milliken

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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Indications for Use

510(k) Number (if known): K032239

Device Name: Prizm Medical, Inc. Thera-Cream™

Indications for Use:

Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy Thera-Cream - 15 a bonuted for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

Prescription Use _ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulhearn

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

Page 1 of 1

510(k) Number K032234

Regulation Number and Section

§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).