(67 days)
The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.
For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT.
An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies.
Here's a summary of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail criteria. | The document states the device has "increased image size and greater brightness," and "sharp, brilliant quality over the entire image." It also notes the device conforms to the relevant provisions of European Device Directive 93/42/EEC. |
| Substantial Equivalence: The device is claimed to be substantially equivalent to existing devices sold by Richard Wolf, implying it meets similar safety and effectiveness standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states, "Clinical tests performed were not performed."
- Data Provenance: Not applicable, as no clinical tests were performed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. No clinical tests were performed, hence no ground truth established by experts.
4. Adjudication Method for the Test Set
- Not applicable. No clinical tests were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states, "Clinical tests performed were not performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is an endoscope, a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
- Not applicable. No clinical tests were performed to establish ground truth.
8. Sample Size for the Training Set
- Not applicable. This device is an endoscope, and the document focuses on its technological characteristics and equivalence to existing devices rather than a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set was used.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.