(191 days)
E.G. Scan™ Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus.
E.G. Scan™ Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ Controller. E.G. Scan™ Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis. The E.G. Scan™ Esophagoscope Probe is disposable. E.G. Scan™ esophagoscope system is a fransnasal 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.
The provided text describes a medical device, the E.G. Scan™ Esophagoscope System, and its submission for 510(k) clearance. However, it does not contain information about acceptance criteria, specific device performance metrics (numerical or otherwise), or any study details (sample sizes, expert qualifications, adjudication methods, ground truth establishment, MRMC studies, or standalone performance studies).
The document primarily focuses on:
- Device Identification: Company, device name, classification.
- Predicate Devices: Listing similar devices already on the market to establish substantial equivalence.
- Device Description: What the device is and how it works (captures images of the esophagus).
- Intended Use: Endoscopic access and examination of the larynx and esophagus.
- Safety and Performance Data (General): Mentions electrical, mechanical, environmental safety, EMC, transportation, and disinfection performance testing according to standards (EN/IEC 60601-1, EN/IEC 60601-2-18, EN/IEC 60601-1-2). It states "All test results were satisfactory." but provides no specifics.
- FDA Clearance Letter: Confirms 510(k) clearance based on substantial equivalence to predicate devices.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text.
In summary, none of the requested information about acceptance criteria or specific study details is available in the provided document.
§ 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.