(44 days)
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No
The summary describes a simple electrical cable and does not mention any AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as transferring electrical current from a generator to a coagulating instrument, indicating it's an accessory to a surgical tool, not a device that directly provides therapy itself.
No
Explanation: The device, Bipolar Cables, is intended to transfer electrical current for electrosurgery (coagulation), which is a treatment rather than a diagnostic procedure.
No
The device is described as "Bipolar Cables" which are physical components used to transfer electrical current. The performance studies listed involve physical testing of these cables (visual inspection, electrical continuity, insulation, leakage, and strain relief testing), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transfer electrical current from a electrosurgical generator to a coagulating instrument." This describes a device used during a surgical procedure to deliver energy to tissue, not a device used to test samples outside the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for use in an electrosurgical setting, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
2
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)