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K Number
K012279
Device Name
PATTON TRIPOL
Manufacturer
PATTON MEDICAL CORP.
Date Cleared
2002-04-30

(285 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K993055,K971565
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Patton Tripol™ is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.

Device Description

The Patton Tripol™ is a forceps that grasps, coagulates, and transects tissue, utilizing electrical current. The device is compatible with available bipolar generators.

AI/ML Overview

This document is a 510(k) summary for the Patton Tripol™ Bipolar Forceps. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes a medical device (bipolar forceps) that grasps, coagulates, and transects tissue using electrical current. The submission is focused on demonstrating substantial equivalence to existing predicate devices (Dexide Bipolar Forceps II+ Device and Bicoag Coagulating Forceps).

Therefore, I cannot provide the requested information from the provided text, as it pertains to a traditional medical device submission and not to an AI/ML device study.

Here's why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: Not present. Substantial equivalence claims for traditional devices often rely on material properties, design comparisons, and functional testing, not statistical performance metrics like sensitivity/specificity against a ground truth.
  2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/ML model.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.