(91 days)
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI 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 single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.
The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation fluids such as sterile water supplied to the Gl endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of crosscontamination of the irrigation system.
The subject devices are intended for single use. The components included are the ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and ANDORATE® Auxiliary Water Connector. The suction valve controls the suction function, the air/water valve controls air and water flow, the biopsy valve covers the biopsy port and allows access for devices, and the auxiliary water connector provides irrigation fluids and has a one-way valve. The devices are packed in a sealed pouch and are supplied sterile.
The provided text is a 510(k) summary for the ANDORATE® Valve Kit, which describes the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically found in AI/ML device submissions.
The ANDORATE® Valve Kit consists of mechanical components (valves and connectors) used with endoscopes. The performance testing outlined is focused on engineering specifications and biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for devices that provide diagnostic or prognostic information based on AI/ML.
Therefore, for the requested information regarding acceptance criteria and a study proving the device meets acceptance criteria (especially points 1-7 which pertain to diagnostic performance), the document states that "bench testing was performed to support substantial equivalence on both the subject device and the predicate device." It then lists the types of tests conducted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance values for a diagnostic AI/ML device. Instead, it states that "the performance data demonstrated that the subject devices met established specifications in the following non-clinical tests." The listed tests are functional and safety-related:
- ANDORATE® Suction Valve: Compatibility test, flow test, leakage, and pressing force test.
- ANDORATE® Air/Water Valve: Compatibility test, flow tests, leakage, and pressing force test.
- ANDORATE® Biopsy Valve: Vacuum leak and squeegee leak.
- ANDORATE® Auxiliary Water Connector: Endoscope compatibility, air leak, water leak.
The acceptance criteria for these tests are implied to be "established specifications" but are not explicitly detailed in the provided text (e.g., a specific leakage rate limit or flow rate range).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided, as the device is a mechanical endoscope accessory and not an AI/ML diagnostic device that uses a "test set" of patient data in the typical sense. The "test set" here refers to the physical devices undergoing bench 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 is not applicable as the device is a mechanical accessory, and its performance is evaluated against engineering specifications, not clinical interpretations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no clinical data or diagnostic assessment requiring adjudication.
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 is not applicable, as the device is a mechanical accessory, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests undertaken is based on engineering specifications and physical measurements (e.g., flow rates, leak resistance, force required for activation). There is no "pathology" or "outcomes data" ground truth as typically understood for diagnostic devices.
8. The sample size for the training set
This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm or training set.
In summary, the provided document details the non-clinical (bench) performance testing of a mechanical endoscope accessory kit. It confirms that these tests demonstrated the device met "established specifications," which serves as the implicit acceptance criteria. However, it does not provide the detailed quantitative acceptance criteria or results in a table format, nor does it contain any information relevant to the evaluation of an AI/ML diagnostic tool.
§ 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.