(282 days)
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.
The document provided is a 510(k) summary for the END-200 Tubeset, a medical device. It does not describe a study involving an AI algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, most of the requested information about AI study design and performance criteria is not applicable to this document.
However, I can extract the non-clinical testing performed and the general acceptance of the device based on that testing.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria are not explicitly stated. Instead, the document mentions that the device "met its performance acceptance criteria" after testing.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Does not affect delivery pressure accuracy of the insufflator. | "met its performance acceptance criteria." (Implying it did not affect accuracy.) |
| Compatible with the endoscope system. | Demonstrated to be compatible. |
| Tubeset remained attached to the endoscope during use. | Remained attached. |
| Device could be maneuvered as intended. | Could be maneuvered as intended. |
| Did not cause any tissue injury during use. | Did not cause any tissue injury. |
| Biocompatibility (Cytotoxicity, Sensitization, and Irritation) for mucosal, limited duration contact according to ISO 10993 standards. | Passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not specified in the document for any of the non-clinical or animal testing.
- Data Provenance: Not specified. The document only mentions "Bench Testing" and "Animal Testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical and animal testing for a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical and animal testing for a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing:
- Bench Testing: The ground truth would be established by the engineering specifications and measurement standards for pressure accuracy.
- Animal Testing: The ground truth would be based on direct observation of the device's function, attachment, maneuverability, and assessment of tissue for injury by qualified animal study personnel (e.g., veterinarians, pathologists).
- Biocompatibility Testing: The ground truth is laboratory testing results conforming to ISO 10993 standards.
8. The sample size for the training set
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
9. How the ground truth for the training set was established
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
§ 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.