(35 days)
The subject device of this premarket notification submission is Indicated for use to cut and or coagulate during laparoscopical surgical procedures.
Solid Laparoscopic Electrodes
This document is a 510(k) premarket notification approval letter from the FDA for Solid Laparoscopic Electrodes manufactured by Aaron Medical Industries, Inc. As such, it does not contain the detailed study information typically found in a clinical trial report or a submission supporting AI-based device approval.
Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these aspects are not part of this type of regulatory correspondence for a traditional medical device (not an AI/ML device).
The letter confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, meaning its safety and effectiveness are considered comparable. The "Indications For Use" state: "The subject device of this premarket notification submission is indicated for use to cut and/or coagulate during laparoscopic surgical procedures."
For traditional medical devices, "acceptance criteria" are typically related to engineering specifications, biocompatibility, sterilization, and basic functional performance tests, rather than diagnostic accuracy metrics as would be seen for AI/ML devices. The "study that proves the device meets the acceptance criteria" would refer to the testing and documentation submitted to demonstrate compliance with these engineering and safety standards, not a clinical study in the sense of a multi-reader, multi-case assessment.
In summary, the provided document does not contain the information requested in your prompt because it is a regulatory approval letter for a traditional medical device, not a study report for an AI/ML diagnostic device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1997
Mr. J. Robert Saron President Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re : K971674 Solid Laparoscopic Electrodes Regulatory Class: II Product Code: GEI Dated: May 5, 1997 Received: May 7, 1997
Dear Mr. Saron:
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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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will
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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. ની
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.
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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510iki Number lif known): __ - Kaziera
Device Name
Indications For Use:
The subject device of this premarket notification submission is The subject device of this premarket noctrication Bandson
Indicated for use to cut and or coagulate during laparoscopical would surgical procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
09
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.