(288 days)
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
The Single Use Endoscope Valves Set collects three types of valve products into one package unit, and which are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
This is single-use device and supplied sterile.
There are three main components included, which are Air/Water Valve, Suction Valve and Biopsy Valve.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
There are three models for fitting to varied endoscopes as AMH-EV-01; AMH-EV-02; AMH-EV-03. The main differences between models are physical size of components for varied endoscopes interface, but they share same indication for use, materials and components form.
This document is a 510(k) Premarket Notification from Anrei Medical (Hangzhou) Co., Ltd. for their "Single Use Endoscope Valves Set." It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided document, there is no clinical study or human subject testing described. The document explicitly states: "No clinical study is included in this submission." (Page 6)
Therefore, it is impossible to answer questions related to acceptance criteria proved by a study involving human subjects or AI performance. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices.
However, I can extract information regarding the non-clinical acceptance criteria and "performance" as it relates to demonstrating substantial equivalence for THIS device.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
Since this submission is a 510(k) for a medical device (endoscope valves), the "acceptance criteria" and "performance" are primarily related to demonstrating substantial equivalence to predicate devices through a series of non-clinical tests, rather than clinical efficacy involving human patients or complex AI algorithm performance.
The document discusses various non-clinical tests conducted to prove the device meets design specifications and is substantially equivalent.
1. Table of Non-Clinical Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Standard | Acceptance Criteria (Implied by SE claim) | Reported Device Performance (as stated in document) |
|---|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Vitro cytotoxicity) | Device should not show cytotoxicity. | "the results shown that the proposed devices has same biocompatibility with predicate devices." |
| ISO 10993-10:2010 (Irritation and delay-type hypersensitivity) | Device should not cause irritation or hypersensitivity. | "the results shown that the proposed devices has same biocompatibility with predicate devices." | |
| Sterilization | ISO 11135:2014 (Ethylene oxide sterilization process) | Device must be sterile after the process. | "the results shown that the proposed devices has same sterilization performance with predicate devices." |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Residuals should be within acceptable limits. | "the results shown that the proposed devices has same sterilization performance with predicate devices." | |
| USP40 NF35 (Bacterial Endotoxins Test) | Device must pass bacterial endotoxin limits. | "the results shown that the proposed devices has same sterilization performance with predicate devices." | |
| Packaging Integrity | ASTM D 3078-02(2013) (Leaks in Flexible Packaging by Bubble Emission) | Packaging should be free of leaks. | "the results shown that the proposed devices has same package performance with predicate devices." |
| ASTM F 1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Packaging seals should not allow dye penetration. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| DIN 58953-6:2016 (Microbial barrier testing of packaging materials) | Packaging should provide an effective microbial barrier. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Packaging seals should meet specified strength requirements. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| ASTM F1140/F1140M-13 (Internal Pressurization Failure Resistance of Unrestrained Packages) | Packaging should withstand internal pressure without failure. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| Shelf Life | ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) | Device should maintain performance stability for the claimed shelf life (3 years). Test results should show 3-year shelf life does not affect performance. | "the results shown that the proposed devices meet the requirements of claimed shelf life." and "The testing results shown that 3 years shelf life would not affect the performance of proposed device." |
| Device Performance | Tensile strength, water and gas flow rates, pressure maintenance, water and air flow leakage, backflow, insertion and removal, endoscope compatibility and insertion force, etc. | Performance should be comparable to predicate devices. | "The results shown that the proposed device has same performance with predicate device." This is a blanket statement for multiple functional performance aspects. Specific numerical results are not provided in this summary, but the claim is equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify..." without providing the number of units tested.
- Data Provenance: The tests were conducted by Anrei Medical (Hangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a non-clinical device performance and substantial equivalence study for a physical device, not an AI or diagnostic imaging study requiring expert radiologists or clinicians to establish ground truth for a test set. The "ground truth" for these tests are the objective measurements against established engineering and biological standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, this is not a study requiring human interpretation or multi-reader adjudication. The results are objective measurements from laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to compare human performance with and without AI assistance. This submission is for a physical endoscope accessory, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is also relevant to AI algorithms. This submission is for a physical medical device.
7. The Type of Ground Truth Used:
- Objective Test Standards and Predicate Device Performance. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM, DIN, USP) for biocompatibility, sterility, packaging, and shelf-life, and by direct comparison of the proposed device's functional performance against the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. This question applies to machine learning models, not physical medical devices undergoing non-clinical testing for substantial equivalence.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, this pertains to machine learning models.
§ 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.