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K Number
K080187
Device Name
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
Manufacturer
OLSEN MEDICAL
Date Cleared
2008-05-09

(105 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K002752,K884656
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

Device Description

OLSEN MEDICAL Single Use Bayonet Bipolar Irrigating Forceps is packaged sterile with a nonpyrogenic fluid pathway. It consists of an inlet pathway running into a transparent rigid PVC tube attached to the right hand prong of the bayonet forceps. This gives the surgeon a visual of the fluid pathway which facilitates the local fluid irrigation through the forceps. The device is for Single Use Only and is designed for use with bipolar electrosurgical units.

AI/ML Overview

The provided text describes a 510(k) summary for the Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, algorithms, or ground truth as would be done for an AI/ML device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document

  • states the device "meet[s] or exceed[s] the minimum qualification criteria for the predicate device."
  • "conforms to applicable ASTM and ISO Standards."
  • "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

However, specific numerical acceptance criteria (e.g., "coagulation time

§ 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.