(87 days)
Apex self-adhesive electrodes are intended to be used in TENS (Transcutaneous Electrical Stimulation) and NMES (NeuroMuscular Electrical Stimulation) applications.
Com-Patch, Self Adhesive Electrodes Models: AP-0981201, AP-0981203, AP-0981208, and AP-0981209
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for "Com-Patch, Self Adhesive Electrodes," which states that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses:
- The device name and models
- Regulation number, name, and class
- Product codes
- The date the 510(k) was filed and received
- Confirmation of substantial equivalence based on indications for use
- Regulatory requirements and contacts for further information
It does NOT include:
- A table of acceptance criteria or reported device performance
- Sample sizes or data provenance for any test sets
- Information about experts or ground truth establishment
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training sets
- How ground truth for training sets was established
The document's purpose is to grant market clearance based on substantial equivalence, not to detail the results of performance studies against specific acceptance criteria.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 5 2001
Mr. Alan Chang Apex Medical Corp. 10th Fl., No. 31, Lane 169, Kang Ning St. His Chih Chen, Taipei Hsien, 221, Taiwan, R.O.C.
Re: K012140
Trade/Device Name: Com-Patch, Self Adhesive Electrodes Models: AP-0981201, AP-0981203, AP-0981208, and AP-0981209 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: July 3, 2001 Received: July 10, 2001
Dear Mr. Chang:
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.
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Page 2 - Mr. Chang
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Marl n Milken
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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012 510(k) Number : Device Name : Apex self adhesive electrodes
Indications For Use:
Apex self-adhesive electrodes are intended to be used in TENS (Transcutaneous Electrical Stimulation) and NMES (NeuroMuscular Electrical Stimulation) applications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | x | OR | Over-The-Counter-Use____ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| (Division Sign-Off) | |||
| Division of General, Restorative and Neurological Devices | |||
| 510(k) Number | K012190 |
§ 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).