(169 days)
The Andorate™ Auxiliary Water Connector (Model GAR027) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Olympus 160 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The Andorate™ Auxiliary Water Connector is intended for single-use and are supplied sterile. Single-use auxiliary water connector help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The auxiliary water connector easily incorporate into infection prevention policies as a single use item. The Andorate™ Auxiliary Water Connector are manufactured for use in conjunction with irrigation tubing, and together with Olympus 160 series endoscopes. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. In the submission, Andorate™ Auxiliary Water Connector is the only subject device. This submission does not include irrigation tubing or irrigation pump. The auxiliary water connector are designed to the auxiliary water port of the endoscopes. The auxiliary water connector consist of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The provided document (K182998) is a 510(k) summary for an auxiliary water connector for endoscopes. This type of device is a physical accessory and not a software algorithm or AI-driven system. Therefore, the questions related to AI/algorithm performance, such as sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets, and sample sizes for training sets, are not applicable to this submission.
The acceptance criteria and proof of device performance (rather than algorithm performance) are based on non-clinical bench testing demonstrating functional equivalence and safety compared to a predicate device.
Here's a summary of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (Andorate™ Auxiliary Water Connector), the "acceptance criteria" are typically defined by functional performance requirements identified through risk analysis and comparison to a predicate device, and the "device performance" is demonstrated through bench testing.
| Test Conducted | Acceptance Criteria (Implied by equivalence claim & typical device performance standards) | Reported Device Performance (Summary from Section 9) |
|---|---|---|
| Compatibility with irrigation tubing | Device correctly connects and forms a secure seal with irrigation tubing. | Tested and supported substantial equivalence. |
| Compatibility with endoscope | Device correctly connects and forms a secure seal with Olympus 160 series endoscopes. | Tested and supported substantial equivalence. |
| Water Flow Test | Adequate water flow through the device for intended irrigation. | Tested and supported substantial equivalence. |
| Air Leakage Test | No air leakage when subjected to relevant pressure. | Conducted for verification; results supported equivalence. |
| Water Leakage Test | No water leakage when subjected to relevant pressure. | Conducted for verification; results supported equivalence. |
| Backflow Performance Test | Effectively prevents backflow of water or biomaterials from the endoscope to the sterile water bottle. | Tested and ensured prevention of backflow. |
| Sterility | Sterility Assurance Level (SAL) of 10^-6; EO residuals below defined maximum levels. | Validated EO sterilization cycle achieved SAL of 10^-6; residuals below limits. |
| Shelf Life (3 years) | Maintained sterile barrier and intended performance after accelerated aging. | Performance testing after accelerated aging confirmed sterile barrier and performance for at least 3 years. |
| Biocompatibility | No adverse biological effects (cytotoxicity, sensitization, irritation). | Tests (Acute Systemic Toxicity, In Vitro Cytotoxicity, Skin Sensitization, Rectal Irritation) showed the device is biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Smartdata performed bench testing to support substantial equivalence. The following testing was performed on Smartdata samples from initial production lots, including sterilization." It does not specify the exact sample size (number of units tested) for each specific test (e.g., how many connectors were tested for backflow).
- Sample Size: Not explicitly stated as a number of units, but "samples from initial production lots."
- Data Provenance: The tests were conducted by Smartdata Suzhou Co., Ltd. (China) and accredited laboratories (e.g., Sanitation Environment Technology Institute, Soochow University, for packaging tests). The data is prospective in the sense that it was generated specifically for this 510(k) submission on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This concept is not applicable as this is a medical device (accessory) and not an AI/algorithm-driven diagnostic/screening tool. Ground truth for device performance is established through engineering and performance specifications and validated through bench testing, not expert interpretation of image data.
4. Adjudication Method for the Test Set
Not applicable. This is not an image-based diagnostic study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done because this is a physical medical device (an auxiliary water connector) and not an AI/imaging algorithm. The study focuses on the device's physical and functional performance, not its impact on human reader accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering Specifications: Design requirements for flow rates, dimensions, connection integrity, and backflow prevention.
- Predicate Device Performance: Benchmarking against the known performance of the legally marketed predicate device (ENDOGATOR FEQ, K092429).
- International Standards: Adherence to relevant standards for sterilization (ANSI/AAMI/ISO 10993-7), biocompatibility (ISO 10993-1), and packaging integrity.
- Risk Analysis: Addressing identified safety concerns, such as fluid leakage and backflow, which were noted in the FDA MAUDE database for similar devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used for an AI model.
§ 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.