(110 days)
The single use andorate® Suction Valve is used to control the suction of an endoscope during GL endoscopic procedures.
The single use andorate® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.
The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
This is a 510(k) premarket notification for andorate Suction Valve and andorate Air/Water Valve. The document states that performance tests were conducted to support substantial equivalence to a predicate device. However, the document does not provide specific acceptance criteria or detailed results of these tests in a quantitative manner that would allow for a table of acceptance criteria and reported performance. It only lists the types of tests performed.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The provided document lists the types of performance tests conducted but does not specify the numerical acceptance criteria or the quantitative results of these tests.
| Performance Test | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document with quantitative values) |
|---|---|---|
| Suction Valve | ||
| Endoscope Compatibility Test | (e.g., Compatible with specified endoscopes) | Met established specifications |
| Suction Flow Test | (e.g., Flow rate within X-Y range) | Met established specifications |
| Vacuum Leak Test | (e.g., Leakage below Z level) | Met established specifications |
| Pressing Force Test | (e.g., Force within A-B range) | Met established specifications |
| Air/water Valve | ||
| Endoscope Compatibility Test | (e.g., Compatible with specified endoscopes) | Met established specifications |
| Air Flow Test | (e.g., Flow rate within X-Y range) | Met established specifications |
| Water Flow Test | (e.g., Flow rate within P-Q range) | Met established specifications |
| Water Leakage Test | (e.g., Leakage below R level) | Met established specifications |
| Pressing Force Test | (e.g., Force within C-D range) | Met established specifications |
| Backflow Prevention Test | (e.g., No backflow detected) | Met established specifications |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set or the data provenance. It only states that "bench testing was performed."
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 study involved bench testing (performance tests) of a medical device (suction and air/water valves), not data analysis requiring expert interpretation or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for bench testing of a 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 the study involved bench testing of a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable for bench testing of a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states that the performance data "demonstrated that the subject devices met established specifications."
8. The sample size for the training set
This information is not applicable as the study involved bench testing of a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an AI model. For the device itself, the "ground truth" or acceptable performance standards for the bench tests would have been established based on engineering specifications and relevant regulatory guidelines.
§ 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.