(57 days)
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Not Found
No
The summary describes electrodes for neurostimulation and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for use with transcutaneous neurostimulation devices, which are typically used for therapeutic purposes such as pain relief or muscle stimulation.
No
The text states that the electrodes are intended for use with "transcutaneous neurostimulation devices." Neurostimulation is a treatment, not a diagnostic procedure.
No
The 510(k) summary describes "Neurostimulation Electrodes," which are hardware components, not software.
Based on the provided information, the Everlast Neurostimulation Electrodes are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with transcutaneous neurostimulation devices." This describes a device used on the body (transcutaneous) for nerve stimulation, which is a therapeutic or diagnostic procedure performed directly on a patient.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Use in a laboratory setting.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Everlast Neurostimulation Electrodes, as described, are external electrodes used in conjunction with a neurostimulation device applied to the skin.
Therefore, based solely on the provided text, the Everlast Neurostimulation Electrodes are not an IVD.
N/A
Intended Use / Indications for Use
The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.
Product codes
GXY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
DEC 1 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan P. Jeffery President Axelgaard Manufacturing Company, Limited 1667 South Mission Road Fallbrook, California 92028-4115
Re: K983741 Everlast Neurostimulation Electrodes Trade Name: Regulatory Class: II Product Code: GXY Dated: October 21, 1998 October 22, 1998 Received:
Dear Mr. Jeffery:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Dan P. Jeffery
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
to co.erda
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment I b
Page of
510(k) Number (if known):___ K 983741
Device Name: Everlast Neurostimulation Electrodes
Indications For Use:
The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of General Restorative Devices
510(k) Number. K983741
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)