(29 days)
The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated "reduced stick" electrodes.
Electrosurgical Tip Cleaner
The provided document is a 510(k) clearance letter from the FDA for the "AARON Electrosurgical Tip Cleaner." It indicates that the device has been found substantially equivalent to a predicate device for its indicated use. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The letter explicitly states: "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..." This means the device was cleared based on its similarity to existing, legally marketed devices, rather than requiring a new, specific performance study with defined acceptance criteria and statistical analysis as would be detailed in a clinical trial report or a more comprehensive premarket approval (PMA) submission.
Therefore, I cannot populate the requested tables and information based on the content of this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 097
Mr. J. Robert Saron President AARON Medical Industries, Inc. ---------7100 30th Avenue North St. Petersburg, Florida 33710-2902
参 Re:
K971805 Trade Name: AARON Electrosurgical Tip Cleaner Regulatory Class: II Product Code: GEI Dated: May 13, 1997 Received: May 15, 1997
Dear Mr. Saron:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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. J. Robert Saron
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) 594-4595. 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,
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
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Page 1 of 1
K971805 510(k) Number (if known):_
Device Name: _Electrosurgical_Tip_Cleaner
Indications For Use:
The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated "reduced stick" electrodes.
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(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 of General Restorative Devices | |
| 510(k) Number | K971805 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.