DERMABIOSAFE by COMPLETE PRODUCT RESOURCES

DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "DermaBioSafe Neuro-muscular Electrodes". It primarily concerns the regulatory approval of the device and its indications for use.

Based on the provided text, there is no information about:

Acceptance criteria or reported device performance
Details of any study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone studies, or training set information)

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to existing devices rather than requiring new clinical performance studies with acceptance criteria and detailed study designs as might be found for novel technologies or higher-risk devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from this document. The document's purpose is to grant regulatory clearance, not to detail device performance studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2008

Complete Product Resources % Mr. John Walsh President 92 Argonaut # 200 Aliso Viejo, California 92656

Re: K080298

Trade/Device Name: DermaBioSafe Neuro-Muscular Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Codc: GXY Dated: July 8, 2008 Received: July 11, 2008

Dear Mr. Walsh:

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. Iisting 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 - Mr. John Walsh

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 Biometric's (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. Millman

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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Indications for Use

510(k) Number: (if known)

Device Name: DermaBioSafe Neuro-muscular Electrodes

Indications for Use:

These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a licensed practitioner or therapist.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart C)

Mark McMillan

(Division Sign-Off Division of General, Restorative, and Neurologic 510(k) Number

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).