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K Number
K972415
Device Name
MINISITE*BIPOLAR FORCEPS** DEVICE
Manufacturer
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Cleared
1997-09-19

(84 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K912544
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Minisite* Bipolar Forceps** Device is intended for use during laparoscopic bipolar coagulation.

Device Description

The Minisite* Bipolar Forceps** Device is a laparoscopic coagulating forceps device that is intended to be passed down a laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) Premarket Notification Summary for the "Minisite* Bipolar Forceps** Device" by United States Surgical Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device (Everest Medical BiCOAG Forceps K912544) for regulatory clearance.

Here's a breakdown of what the document does include:

  • Device Description: A laparoscopic coagulating forceps device for electrosurgical energy under laparoscopic visualization, intended for use with bipolar outputs of compatible electrosurgical generators.
  • Intended Use/Indications For Use: For use during laparoscopic bipolar coagulation.
  • Materials: Patient contact materials evaluated for biocompatibility in accordance with ISO Standard # 10993-1.
  • Regulatory Status: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

What is missing from the provided text, and therefore cannot be addressed in the requested format, includes:

  • A table of acceptance criteria and reported device performance.
  • Details about a study (sample size, data provenance, ground truth establishment, expert involvement, adjudication method, MRMC studies, standalone performance).
  • Any quantitative data on device efficacy or safety beyond biocompatibility.

In summary, the provided document is a regulatory clearance letter and summary, not a technical report detailing performance study results.

§ 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.