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K Number
K965241
Device Name
BIPOLAR SUCTION COAGULATOR
Manufacturer
KIRWAN SURGICAL PRODUCTS, INC.
Date Cleared
1997-02-28

(79 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K960455
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

Device Description

The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

AI/ML Overview

The provided text is a summary of safety and effectiveness for a Bipolar Suction Coagulator. It details various safety and performance standards met by the device. However, it does not contain the specific information requested about acceptance criteria, device performance metrics (sensitivity, specificity, accuracy, etc.), details of a study (sample size, data provenance, ground truth establishment, expert qualifications), or comparative effectiveness studies with AI or standalone algorithm performance.

The document primarily focuses on:

  • Intended Use: Soft tissue surgical procedures requiring fluid evacuation and low-energy coagulation.
  • Biological Safety: Materials tested according to ISO 10993-1.
  • Sterilization Safety: Validated to a SAL of 10-6 using EtO sterilization.
  • Performance Testing: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18.
  • Substantial Equivalence: To Bipolar Suction Coagulator, K960455.

Therefore, I cannot populate the requested table or answer the specific questions because the necessary data is not present in the provided input. This document describes regulatory compliance and testing for a physical medical device, not the performance metrics of a diagnostic or AI-driven system.

§ 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.