(30 days)
The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve.
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The Andorate Disposable Suction Valve is used to control the suction of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
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The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
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The Andorate Disposable biopsy valve is used 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 Andorate® Valves Set and Andorate® Auxiliary Water Connector are intended for single-use and are supplied sterile. Single-use valves sets and auxiliary water connector help preventing potential safety risks and eliminate the need for manual cleaning and reprocessing. The valves set and auxiliary water connector are easily incorporated into infection prevention policies as a single use item.
The Andorate® Auxiliary Water Connector is manufactured for use in conjunction with irrigation tubing, and together with Pentax 90 series endoscope. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. The auxiliary water connector is designed 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 Andorate® Valves Set is manufactured for use with Pentax 90 series endoscope. The suction, air/water, and biopsy valves are housed in a single tray and packaged in sealed packed. The valves set is sold as a sterile device.
- The Suction Valve component of the Andorate® Valves Set is designed to o 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 endoscopic 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 component of the Andorate® Valves Set is intended to O 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 subject devices in this submission have the same operation and method of action as the predicate devices. In the submission, Andorate® Valves Set and Andorate® Auxiliary Water Connector are the only subject device. This submission does not include irrigation tubing or irrigation pump.
The provided document describes the K191231 submission for the Andorate® Valves Set (GAR037) and Andorate® Auxiliary Water Connector (GAR048). This is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics against those criteria, and information about expert consensus, training sets, and MRMC studies is not available in this document as it's typically required for software-as-a-medical-device (SaMD) or AI-driven diagnostic devices.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics for the proposed devices in the way an AI/SaMD 510(k) summary would. Instead, it lists the types of non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on functional and safety aspects. The reported performance is generally stated as having met the requirements, implying equivalence to the predicates.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Andorate® Valves Set (GAR037) | ||
| Assembling Integrity (Suction Valve, Biopsy Valve) | Maintain structural integrity upon assembly. | Testing performed; implicit compliance. |
| Endoscope Compatibility (All Valves) | Compatible with Pentax 90 series Endoscopes. | Testing performed; implicit compliance. |
| Depression Force (Suction Valve, Air/Water Valve) | Operate within acceptable force ranges. | Testing performed; implicit compliance. |
| Vacuum Leak Test (Suction Valve, Biopsy Valve) | No significant vacuum leakage. | Testing performed; implicit compliance. |
| Suction Flow Test (Suction Valve) | Achieve adequate suction flow. | Testing performed; implicit compliance. |
| Air Leakage Testing (Air/Water Valve) | No significant air leakage. | Testing performed; implicit compliance. |
| Water Flow Test (Air/Water Valve) | Achieve adequate water flow. | Testing performed; implicit compliance. |
| Squeegee Leak Test (Biopsy Valve) | No significant leakage during device passage/exchange. | Testing performed; implicit compliance. |
| Andorate® Auxiliary Water Connector (GAR048) | ||
| Compatibility with Irrigation Tubing | Compatible with standard irrigation tubing. | Testing performed; implicit compliance. |
| Compatibility with Endoscope | Compatible with Pentax 90 series Endoscopes. | Testing performed; implicit compliance. |
| Water Flow Test | Achieve adequate water flow. | Testing performed; implicit compliance. |
| Air Leakage Test | No significant air leakage. | Testing performed; implicit compliance. |
| Water Leakage Test | No significant water leakage. | Testing performed; implicit compliance. |
| Backflow Performance Test | Prevent backflow of water/biomaterials. (Explicitly mentioned: "prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.") | Testing performed; implicit compliance. |
| Sterilization | SAL of 10^-6 for EO sterilization. EO residuals below ANSI/AAMI/ISO 10993-7. | Achieved SAL of 10^-6. EO residuals below maximum levels. |
| Shelf Life | Maintain sterility and intended performance for 3 years. | Demonstrated through accelerated aging, packaging integrity tests. |
| Biocompatibility | Meet ISO 10993 guidelines for mucosal membrane contact. | Tests (Systemic Toxicity, Cytotoxicity, Skin Sensitization, Irritation) show biocompatibility. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size of Test Set: The document does not specify exact sample sizes for each non-clinical performance test. It states that "Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization." This implies a representative sample was tested, but no specific number is given.
- Data Provenance: The tests were performed on "Smartdata samples from initial production lots," which would originate from Smartdata Suzhou Co., Ltd. in China. The data is retrospective in the sense that it was collected from manufactured devices for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable and not provided. The devices are physical medical instruments (valves and connectors), not diagnostic or AI-driven devices that would require expert consensus for ground truth. Performance was evaluated through objective bench testing.
4. Adjudication Method for the Test Set
- This is not applicable as the tests performed are objective bench tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on reader performance. The devices in this submission are accessories for endoscopes, not diagnostic tools.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone (algorithm only) study was not done. This is relevant for AI algorithms. The devices are mechanical accessories, not algorithms.
7. Type of Ground Truth Used
- The "ground truth" for the performance tests was defined by established engineering and medical device standards, functional requirements, and comparison to the predicate devices. For example, for a "Vacuum Leak Test," the ground truth is simply the absence of leakage beyond a specified threshold, determined by the test method. For biocompatibility, it's compliance with ISO 10993 standards.
8. Sample Size for the Training Set
- Not applicable. These are physical hardware devices; there is no "training set" in the context of an AI/ML algorithm. Their design and manufacturing processes are developed through traditional engineering methods and validated through bench testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for these devices.
§ 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.