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K Number
K012571
Device Name
REPROCESSED HARMONIC
Manufacturer
STERILMED, INC.
Date Cleared
2001-11-07

(90 days)

Product Code
NLQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K941897,K930352
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Reprocessed Harmonic Scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.

Device Description

Harmonic scalpels are part of an ultrasonic system and are intended to be used in soft tissue surgery for simultaneous cutting and hemostasis. The system consists of a generator/foot switch, handle, connecting hose, and a scalpel blade. Only the handle and scalpel blade are reprocessed. The generator/foot switch and hose components of the device are not included as part of this submission. Harmonic scalpels can be manufactured using aluminum with a nickel chrome alloy edge or a titanium alloy (with or without a coating.) These scalpels are available in a variety of lengths, outer circumferences, angles, and sharpness.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for reprocessed ultrasonic scalpels, specifically addressing a supplemental validation submission. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable to this document.

The document discusses:

  • Device: Reprocessed Ultrasonic Scalpel (various Ethicon models listed).
  • Clearance: The FDA has determined the reprocessed devices are substantially equivalent to legally marketed predicate devices.
  • Validation: It mentions that supplemental validation data was provided as required for reprocessed single-use devices, and "bench testing to demonstrate appropriate functional characteristics" and "process validation testing for cleaning and sterilization" were performed. However, specific acceptance criteria and detailed performance results from these tests are not provided in this letter.
  • Indications for Use: Soft tissue incisions when bleeding control and minimal thermal injury are desired.

N/A