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K Number
K141790
Device Name
AQANIFE
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2015-03-06

(247 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

Instrument for flexible endoscopy for dissection of tissue e.g. in endoscopic submucosal dissection (ESD) and for haemostasis during this procedure.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the AqaNife electrosurgical cutting and coagulation device, indicating that it has been found substantially equivalent to predicate devices.

The text includes:

  • The device name: AqaNife
  • Regulation number and name: 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
  • Regulatory class: II
  • Product code: GEI
  • Indications for Use: Instrument for flexible endoscopy for dissection of tissue e.g. in endoscopic submucosal dissection (ESD) and for haemostasis during this procedure.

However, there is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, or study type (retrospective/prospective) for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is primarily an administrative letter from the FDA concerning market clearance, not a detailed report of a performance study.

§ 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.