(95 days)
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® Suction Valve is used to control the suction 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 Olympus® 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 via irrigation fluids such as sterile water supplied to the Olympus® GI 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 cross-contamination of the irrigation system.
The subject devices are intended for single use. The components included in the submission are ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and AQUAPULSE® Auxiliary Water Connector.
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.
The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and Olympus endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The subject devices are packed in a sealed pouch and are supplied sterile. The subject devices in this submission have the same operation and method of action with the predicate devices.
The provided document is a 510(k) Premarket Notification for the ANDORATE® Valve Kit, which consists of various endoscopy accessories (Suction Valve, Air/Water Valve, Biopsy Valve, Auxiliary Water Connector). This notification focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a new device meets specific acceptance criteria for a novel functionality, especially regarding AI/machine learning.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI-powered device.
The study described is solely bench testing to demonstrate performance similarity to predicate devices, and biocompatibility testing.
Here's what can be extracted based on your prompt, addressing the lack of information where applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The performance data demonstrated that the subject devices met established specifications in the following non-clinical tests."
It lists the types of tests, implying the acceptance criteria were "met established specifications" or "performed comparably to predicate devices," but does not provide quantitative acceptance criteria or specific performance values for the ANDORATE® Valve Kit or its predicate devices.
| Acceptance Criteria Category (Implied) | Specific Tests Performed | Reported Device Performance (General) |
|---|---|---|
| Functional Performance (Suction Valve) | Compatibility test, Flow test, Leakage, Pressing force test, Fatigue test | "met established specifications", "performed comparably to predicate devices", "no significant differences" |
| Functional Performance (Air/Water Valve) | Compatibility test, Flow tests, Leakage, Pressing force test | "met established specifications", "performed comparably to predicate devices", "no significant differences" |
| Functional Performance (Biopsy Valve) | Vacuum leak, Squeegee leak | "met established specifications", "performed comparably to predicate devices", "no significant differences" |
| Functional Performance (Auxiliary Water Connector) | Endoscope compatibility, Air leak, Water leak | "met established specifications", "performed comparably to predicate devices", "no significant differences" |
| Biocompatibility | ISO 10993 standard tests (specific tests like cytotoxicity, sensitization, irritation are typically performed but not detailed here) | "The test result shows that both the subject devices are biocompatible." |
2. Sample size used for the test set and data provenance:
- Sample Size: The document does not specify the number of units tested for any of the bench tests.
- Data Provenance: The tests were "bench testing," meaning laboratory-controlled environments. No patient data or clinical data is mentioned. The company (GA Health Company Limited) is based in Hong Kong, China. The testing location is not specified, but it would typically be a testing facility or the manufacturer's lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The ground truth for this type of device (valves for endoscopes) is established by engineering specifications, functional requirements, and performance against predicate devices, not expert human interpretation of data like images or patient outcomes.
4. Adjudication method for the test set:
This is not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, this was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. The ANDORATE® Valve Kit is a mechanical accessory.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is not an algorithm or software. It is a physical medical device accessory that assists a human operator (the endoscopist).
7. The type of ground truth used:
The "ground truth" for this device's performance is its adherence to engineering specifications, functional requirements, and comparative performance against legally marketed predicate devices in a laboratory setting through bench testing. There is no external "outcomes data" or "pathology" relevant to establishing the ground truth for simple valve functionality.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" for this type of device.
§ 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.