(50 days)
The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
Resistick Solid Laparoscopic Electrodes
This document is a 510(k) clearance letter from the FDA for a medical device (Resistick Solid Laparoscopic Electrodes) that was issued in 1997. It explicitly states that the device is substantially equivalent to devices marketed prior to 1976.
Therefore, this document does not contain any information about acceptance criteria, study performance, or AI/software validation studies. These types of studies and the regulatory framework around them, especially for AI/ML devices, did not exist at the time this clearance was issued.
The document only confirms that the FDA reviewed the submission and determined that the device is "substantially equivalent" to predicate devices, allowing it to be marketed.
To answer your request, I would need a different type of document, specifically a more recent regulatory submission or clinical study report for an AI-powered medical device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Mr. J. Robert Saron President Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902 Re: K971621 Resistick Solid Laparoscopic Electrodes Dated: April 30, 1997 Received: May 1, 1997 Regulatory class: II 21 CFR §884.4160/Product code: 85 KNF
Dear Mr. Saron:
We have reviewed your Section 510(k) notification of intent to market the device 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 53 1 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4616. 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,
hillian Yi
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Resistick Solid Laparoscopic Electricies
INDICATION FOR USE
The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
7100 - 30th Avenue North, St. Petersburg, FL 33710-2902 (S13) 384-2323 Fax: (813) 347-9144
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).