(70 days)
Not Found
No
The 510(k) summary describes a passive electrode device and explicitly states that AI, DNN, or ML were "Not Found" in the description.
No.
The device itself is an electrode, which is a component intended to be used with therapeutic devices (Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units), but it is not a therapeutic device on its own.
No
The device is described as an electrode for use with nerve stimulators and muscle stimulators, which are therapeutic devices, not diagnostic ones. Its function is to deliver current, not to diagnose a condition.
No
The device description clearly states it is a multi-layer structure containing physical components like hydrogel, conducting film, and backing material, which are hardware.
Based on the provided information, the Mantra Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrode is for use with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units. These are devices used for external stimulation of nerves and muscles, not for testing samples taken from the human body (which is the core of IVD).
- Device Description: The description details the physical structure of the electrode and its components, all of which are related to conducting electrical signals to the skin. There is no mention of reagents, calibrators, controls, or any components used for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the Mantra Electrode falls under the category of an external medical device used for electrical stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.
Product codes
GXY
Device Description
The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Mantra International Ltd. P.O. Box 800 Oxford, OH 45056 Tel: (740) 549-5703 FAX: (740) 549-5701
SEP 2 2 2004
510(k) Summary
| Contact Person: | Brent Reider |
|---|---|
| Date of Preparation: | July 7, 2004 |
| Trade Name: | Mantra Electrode |
| Common Name: | Cutaneous electrode |
| Classification Name: | electrode, cutaneous |
| Product Code: | GXY |
| Regulation Class: | 2 |
| Regulation Number: | 882.1320 |
Description of the Device: - The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors.
The Mantra Electrode is intended to be used with Transcutaneous Intended Use: Nerve Stimulator and Electronic Muscle Stimulator Units.
Technical Characteristics: The technical characteristics of the Mantra Electrode are identical to the predicate device. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.
This product is substantially equivalent to the Uni-Substantial Equivalence: Patch Electrode Model Re-Ply® manufactured by Uni-Patch, Inc., Wabasha, Minnesota (K983097).
Substantial equivalence is based upon:
- . The Mantra Electrode has the same indications for use as the predicate device.
1
- The Mantra Electrode has equivalent technological characteristics and instructions . for use, as compared to the predicate device.
- The device meets the mandatory performance standards. .
:
- The biocompatibility of the electrodes has been established. .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2004
Mantra International Ltd. C/o Mr. Robert B. Spertell RBS Technologies, LLC 10235 Glade Avenue Chatsworth, California 91311
Re: K041902
Trade/Device Name: Mantra Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 25, 2004 Received: July 14, 2004
Dear Mr. Spertell:
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 - Mr. Robert B. Spertell
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 yours,
Mark A. Wilkerson
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
K 041902 510(k) Number (if known):
Device Name: Mantra Electrode
The Mantra Electrode is intended to be used with Transcutaneous Indications for Use: Nerve Stimulator and Electronic Muscle Stimulator Units.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Mellers
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041902