(375 days)
Not Found
No
The summary describes a conductive cream for electrotherapy, with no mention of AI or ML.
No.
The device is a conductive cream used to increase skin conductivity for electrotherapy treatment, not a therapeutic device itself. It's an accessory to therapeutic devices like TENS and NMES units.
No
Explanation: The device, Thera-Cream™, is a conductive cream used to increase skin conductivity for electrotherapy treatment (TENS and NMES). It is not described as analyzing or interpreting biological signals to provide diagnostic information. Its function is to facilitate therapy, not to diagnose a condition.
No
The device description clearly states that Thera-Cream™ is a "conductive cream," which is a physical substance and therefore a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to increase skin conductivity for electrotherapy treatment. This is a topical application for a physical therapy modality, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces its function as a conductive cream applied to the skin surface.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a biological sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
Therefore, Thera-Cream™ is a medical device used in conjunction with electrotherapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GYB
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024181, K951727, K925466, K782055, K020180
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 I
Duluth, GA 30096 | Phone: (770) 622-0933
Fax: (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 Marketed
Predicate 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:
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).
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.
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".
1
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.
2
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.
3
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
4
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