(182 days)
Not Found
Not Found
No
The summary describes a simple electrode for electrical stimulation and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device itself is an electrode, an interface between a patient's skin and an electrical stimulator, which is the therapeutic device. The electrodes are not providing the therapy but are part of a system that does.
No
The device, Neuro-muscular Electrodes, is described as a "disposable, conductive adhesive interface" intended for use with electrical stimulators (TENS and EMS). Its function is to deliver electrical stimulation, not to diagnose a condition.
No
The 510(k) summary describes "Neuro-muscular Electrodes," which are physical, disposable components intended for use with electrical stimulators. This clearly indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are a "disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator." This describes a device that interacts with the patient's body externally for therapeutic purposes (electrical stimulation).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on bodily samples.
The device is an external medical device used for electrical stimulation, not an IVD.
N/A
Intended Use / Indications for Use
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).
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.
Product codes
GXY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioner or therapist
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number: (if known)
Device Name: DermaBioSafe Neuro-muscular Electrodes
Indications for Use:
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).
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