(28 days)
The disposable Endorate™ valves sets consists of one suction valve, one air/water valve and one biopsy valve.
The Endorate™ Disposable Suction valve is used to control the suction function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ Disposable Air/Water valve is used to control the air/water function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ 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 Endorate™ valve set consists of one suction valve, one air/water valve and one biopsy valve. The Endorate™ device is intended for single-use, and is supplied sterile. Sterile, singleuse suction valve, air/water valve and biopsy valve help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single use item. 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 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 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 Endorate™ Disposable Biopsy Valves are manufactured in two configurations - one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. Both Olympus®/Fujinon® and Pentax® versions are sold as non-sterile device, individually packed.
This document describes the Smartdata Suzhou Co., Ltd. Endorate™ Valves Sets (K181509), which includes a suction valve, air/water valve, and biopsy valve, and its substantial equivalence to predicate devices. The information provided heavily relies on comparisons with existing predicate devices rather than independent performance metrics with acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a typical "Pass/Fail" format with specific thresholds. Instead, it demonstrates substantial equivalence through a direct comparison of technological characteristics and performance in bench testing to predicate devices (DEFENDO™ Disposable Suction Valve K102581, DEFENDO™ Disposable Air/Water Valve K102409, and DEFENDO™ Disposable Biopsy Valve K090851). The performance is reported as meeting the functional requirements through "bench testing."
Below is a summary of the non-clinical tests performed and the implied "performance" relative to the predicate, demonstrating that the device functions as intended and is similar to the predicate.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Disposable Suction Valve | Scope Compatibility | Compatible with specified endoscopes (e.g., Olympus 140/160/180/190/240/260 series). | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Valve Depression Force | Functional depression force similar to predicate. | Bench testing performed. (Implicitly met based on SE claim) | |
| Leak Test | No leakage during operation. | Bench testing performed. (Implicitly met based on SE claim) | |
| Disposable Air/Water Valve | Scope Compatibility | Compatible with specified endoscopes. | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Valve Depression Force | Functional depression force similar to predicate. | Bench testing performed. (Implicitly met based on SE claim) | |
| Air Ventilation and Insufflation | Proper air flow and insufflation as intended. | Bench testing performed. (Implicitly met based on SE claim) | |
| Water Flow Performance | Proper water flow as intended. | Bench testing performed. (Implicitly met based on SE claim) | |
| Biopsy Valve | Scope Compatibility | Compatible with specified endoscopes (Olympus/Fujinon and Pentax GI endoscopes). | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Leak Testing | Minimizes leakage of biomaterial. | Bench testing performed. (Implicitly met based on SE claim) | |
| Squeegee Performance | Provides access for device passage and exchange, helps maintain insufflation. | Bench testing performed. (Implicitly met based on SE claim) | |
| Sterilization & Shelf Life | Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶, EO residuals below ISO 10993-7. | Validated EO sterilization cycle achieved SAL of 10⁻⁶. EO residuals below maximum levels. |
| Shelf Life | Maintain sterile barrier for at least three years. | Three (3) year expiration date supported by accelerated aging, seal strength, dye penetration, and packaging persistence bacteria performance of pouches. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the "initial production lots" subjected to bench testing. The data provenance is implied to be from internal testing by Smartdata Suzhou Co., Ltd. (China), and it is a retrospective evaluation against predicate devices rather than a prospective study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study did not involve establishing ground truth through expert consensus for a test set, as it was a bench testing comparison to predicate devices, not a diagnostic or AI performance study.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an endoscopic accessory, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the entire non-clinical performance evaluation can be considered a "standalone" evaluation of the device's mechanical and functional characteristics. However, this terminology usually applies to AI algorithms. For this medical device (endoscopic valves), the "standalone" performance refers to its ability to meet its functional requirements (e.g., suction, air/water control, biopsy access, leakage prevention) as demonstrated through the bench tests without human intervention in the operation beyond initiating the tests.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was inherent in the design specifications, functional requirements, and established performance of the legally marketed predicate devices. The device was considered to meet "ground truth" if its performance in bench tests was found to be substantially equivalent to the predicate devices and met basic functional expectations. Industry standards (e.g., ISO 10993-7 for sterilization) also served as a form of ground truth for specific parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this 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.