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K Number
K131131
Device Name
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
Manufacturer
INTROMEDIC CO., LTD
Date Cleared
2013-06-21

(60 days)

Product Code
EOX
Regulation Number
874.4710
Type
Special
Panel
EN
Reference & Predicate Devices
K120702
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

E.G. Scan™ II Esophagoscope System Is Intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.

Device Description

E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ II Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ II Controller. E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis. The E.G Scan™ II Esophagoscope Probe is disposable. E.G. Scan™ II Esophagoscope system is a transnasal esophagoscope designed to capture images of the esophagus. Captured images are viewed via the E.G. View™ Software for diagnosis of diseases related to the esophagus.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the E.G. Scan™ II Esophagoscope System, primarily focusing on its substantial equivalence to a predicate device.

It lists:

  • Device Name: E.G. Scan™ II Esophagoscope System
  • Indication for Use: Endoscopic access and examination of the larynx, esophagus, and gastroesophageal junction.
  • Predicate Device: E.G. Scan™ Esophagoscope System (K120702) from IntroMedic Co., Ltd.
  • Safety, EMC, and Performance Data: States that the device has the same device characteristics as the predicate device (intended use, material, design, use concept). It also mentions biocompatibility testing (cytotoxicity, sensitization, irritation by ISO 10993-1) and conformity to electrical safety (IEC 60601-1, IEC 60601-2-18) and EMC standards (IEC 60601-1-2).

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about a study to prove performance, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for either test or training sets.
  • Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of AI improvement.
  • Details of a standalone (algorithm only) performance study.

The submission focuses on establishing substantial equivalence based on similar design, intended use, technological characteristics, and conformance to general medical device safety standards, rather than a clinical performance study with specific acceptance criteria.

§ 874.4710 Esophagoscope (flexible or rigid) and accessories.

(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.