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K Number
K980758
Device Name
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
Manufacturer
MICROLINE PENTAX, INC.
Date Cleared
1998-03-27

(28 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K970826,K973648
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.

Device Description

The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.

AI/ML Overview

The provided text describes a 510(k) summary for the "3 MM Selec-Tip" Laparoscopic Instruments, a medical device. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with performance metrics in the same way an AI/ML device would.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's a submission for a traditional medical device, not an AI/ML diagnostic tool that would typically involve such studies.

Specifically:

  • No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance criteria for the "3 MM Selec-Tip" Laparoscopic Instruments. Its purpose is to demonstrate substantial equivalence to predicate devices, not to measure specific clinical performance.
  • No sample size for the test set or data provenance: No test sets or data for performance evaluation are mentioned.
  • No number of experts or qualifications for ground truth: No ground truth establishment is described as there is no diagnostic or AI/ML component being evaluated.
  • No adjudication method: Not applicable given the nature of the device and submission.
  • No multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so such a study would not apply.
  • No standalone (algorithm only) performance study: This is not an algorithm-based device.
  • No type of ground truth used: Not applicable.
  • No sample size for the training set: Not applicable, as there is no AI/ML model being trained.
  • No description of how ground truth for the training set was established: Not applicable.

The document primarily focuses on:

  • Device Identification: "3 MM Selec-Tip" Laparoscopic Instruments
  • Predicate Devices: "Selecta-Tip" (K970826) and Richard Wolf Medical Instruments (K973648)
  • Device Description: Non-sterile, reusable small diameter instruments for cutting and dissecting abdominal tissue in endoscopic/laparoscopic procedures, usable with monopolar electrosurgical generators.
  • Substantial Equivalence: Claiming that technical specifications, materials, and physical appearance differences do not affect safety or effectiveness compared to predicates.
  • Indications For Use: Cutting and dissecting various abdominal tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

§ 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.