(33 days)
FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.
BATCH #6060 CONDUCTIVE GEL
The document provided is a 510(k) clearance letter for the "BATCH #6060 Conductive Gel." This type of document from the FDA primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria and specific statistical results.
Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets them is not available in the provided text.
Here's a breakdown of why and what information is present:
Why the requested information is not available:
- Nature of 510(k) Clearance: A 510(k) submission typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and performance, but it doesn't necessarily require extensive, standalone clinical studies with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) would. For simple, lower-risk devices like conductive gels, performance data might be limited to bench testing (e.g., conductivity, impedance reduction, biocompatibility) and comparisons to the predicate device's known performance, rather than complex human-in-the-loop or multi-reader studies.
- Document Content: The provided text is the FDA's clearance letter, not the original 510(k) submission itself. The clearance letter confirms that the FDA reviewed the submission and found the device substantially equivalent. It summarizes the regulatory decision but does not detail the specific performance data or study methodologies presented by the manufacturer in their submission.
Specific Points from your Request and why they cannot be answered from the text:
- Table of acceptance criteria and the reported device performance: Not present. The letter states the device is for use with TENS and EMS and "is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin." However, no numerical performance targets (acceptance criteria) or specific performance results (e.g., "impedance reduced by X%," "conductivity of Y S/m") are mentioned.
- Sample size used for the test set and the data provenance: Not present. No details about any test sets, sample sizes, or data origin for performance evaluation are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. This type of detail is relevant for diagnostic or image-based AI devices, not for a conductive gel. No ground truth establishment is described.
- Adjudication method: Not applicable/Not present for the same reason as above.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/Not present. This is relevant for diagnostic devices where human readers interpret data, often in radiology or pathology. A conductive gel does not involve human interpretation in this manner.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable/Not present. This applies to AI algorithms. No algorithm is part of this device.
- Type of ground truth used: Not applicable/Not present.
- Sample size for the training set: Not applicable/Not present. This applies to AI/machine learning models.
- How the ground truth for the training set was established: Not applicable/Not present.
In summary, the provided document confirms the regulatory clearance of a conductive gel but does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in scientific publications or specific sections of a 510(k) submission that describe performance testing.
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DEC 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George K.C. Chen President and CEO Skylark Device Company Limited 12th Floor, 34 Section 3 Chung Shan North Road Taipei Taiwan ROC
Re: K983964 Batch #6060 Conductive Gel Trade Name: Regulatory Class: II Product Code: IKC Dated: November 2, 1998 Received: November 6, 1998
Dear Mr. Chen:
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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.
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Page 2 - Mr. George K.C. Chen
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 requlation (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/ccrh/dsmamain.html".
Sincerely yours,
Colin M. Witton, Ph. D., M.
M. Witten, Ph.D., M.D. Cel. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K98 3964 |
|---|---|
| --------------------------- | ---------- |
BATCH #6060 CONDUCTIVE GELsvice Name:
Indications For Use:
FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983964
Over-The-Counter Use
Prescription Use `er 21 CFR 801.109) OR
§ 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).