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K Number
K983208
Device Name
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-02-22

(161 days)

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

Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:

    1. Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
    1. Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
    1. Hemostasis control of bleeding, epilation, and telangiectasia.
    1. Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
    1. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for the "Wallach Quantum 500 Electrosurgical Generator."

While it lists the indications for use of the device, it does not include any information about:

  • Specific acceptance criteria (e.g., performance metrics, thresholds).
  • Any study design, data, or results that demonstrate the device meets acceptance criteria.
  • Sample sizes, data provenance, expert qualifications, or ground truth methodologies.
  • Whether MRMC or standalone performance studies were conducted.

The letter primarily communicates the FDA's finding of substantial equivalence based on a submission (K983208), but the details of that submission, including performance studies, are not present in the provided document.

§ 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.