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K Number
K980177
Device Name
SUGITRON MODEL: IEC
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1998-07-07

(168 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

is idendical to the Surgitron as a preammendment device such as:

  • Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

  • Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

    • Hemostasis Control of Bleeding, Epilation, Telangiectasia
    • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
    • 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 information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the "Surgitron Model: IEC" device, indicating that it has been found substantially equivalent to a pre-amendment device.

Specifically, the text includes:

  • FDA 510(k) clearance letter: This letter confirms that the device can be marketed in the US.
  • Indications for Use: A list of medical procedures for which the Surgitron device is intended, such as various cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar procedures.

There is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or details about test sets.
  • The number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • The type of ground truth used.
  • Training set sample sizes or how ground truth for the training set was established.

Therefore, I cannot fulfill your request for these specific details based on 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.