(44 days)
The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.
Not Found
This document is a 510(k) clearance letter for an electrosurgical bipolar cable. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device and adherence to manufacturing standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found for complex AI/ML-enabled devices or those requiring clinical performance studies to demonstrate safety and effectiveness.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "The American Biosurgical Inc. bipolar cables were designed and are manufactured in compliance with ANSI/AAMI Standards" and mentions "Testing Procedures Include: 100% Visual Inspection, Electrical Continuity Testing, Cable Insulation, Leakage, and Strain Relief Testing." However, it does not specify quantitative acceptance criteria (e.g., specific resistance values, insulation breakdown voltage thresholds) or report specific performance values from these tests. These would typically be detailed in a separate test report or device specification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "Testing Procedures have been established in the standard operating procedures of the American Biosurgical, Inc. GMP Manual to ensure all products are manufactured to the ANSI/AAMI Standards." This implies manufacturing quality control rather than a specific clinical or performance test set as would be relevant for AI devices. There is no mention of sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a cable, not a diagnostic or therapeutic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device would be its adherence to established engineering and safety standards after manufacturing, verified through physical and electrical testing, not clinical outcomes or expert interpretation.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three distinct lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 1997
Mr. Michael Socoloff President American Biosurgical, Inc. 6665-B Corners Industrial Court Norcross, Georgia 30092
Re: K972901
Trade Name: American Biosurgical Electrosurgical Bipolar Cable/Cord Regulatory Class: II Product Code: GEI Dated: August 4, 1997 Received: August 6, 1997
Dear Mr. Socoloff:
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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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. Michael Socoloff
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,
Sincerely yours,
ia 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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972901
Exhibit A
INDICATIONS FOR USE
The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.
Compliance: The American Biosurgical Inc. bipolar cables were designed and are manufactured in compliance with ANSI/AAMI Standards.
Testing Procedures: Testing Procedures have been established in the standard operating procedures of the American Biosurgical, Inc. GMP Manual to ensure all products are manufactured to the ANSUAAMI Standards.
Testing Procedures Include:
100% Visual Inspection Electrical Continuity Testing Cable Insulation, Leakage, and Strain Relief Testing
fccellle
of General Restorativ
Prescription Use
(Per 21 CFR 801.109)
§ 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.