(161 days)
A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable anoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve. This is a single-use device.
Wilson's Disposable Endoscope Valves Set A collects three types of valve products into one package unit. Disposable Endoscope Valves Set A can make it convenient for the replacement of Air/Water Valves, Suction Valves, Biopsy Valve during an endoscopic procedure. And these three types' valves can realize their intended uses respectively.
The provided text describes a 510(k) premarket notification for a medical device: Disposable Endoscope Valves Set A. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML devices (e.g., diagnostic accuracy, reader studies).
Therefore, the information required to answer your specific questions about "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "MRMC studies," etc., is not present in the provided document.
The document states:
- "The Disposable Endoscope Valves Set A of Wilson has taken the biocompatibility, sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission."
This indicates that some performance testing was done, but the details of these tests (specific acceptance criteria, sample sizes, methodology, and results) are not included in the publicly available summary (510(k) Sumary/Clearance Letter). These details would typically be found in the full 510(k) submission, which is not publicly released in its entirety.
Based on the available text, here's what can be inferred and what remains unknown regarding performance demonstration:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The device is for "endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials." Implied criteria would relate to these functions (e.g., proper sealing, fluid/gas control, ease of use, compatibility).
- Reported Performance: No specific numerical performance metrics are provided. The general statement is that "Test data and report information are included in this submission" and that the device is "substantially equivalent to predicate devices with regard to safety and effectiveness."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). These would likely be bench tests or in-vitro tests, not clinical data sets in the way AI/ML models are evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. "Ground truth" in the sense of expert consensus labels for diagnostic images is not relevant here. Performance testing for this type of mechanical device would involve engineering specifications, material compatibility, and functional tests (e.g., seals holding pressure, flow rates).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This method is used for establishing ground truth in image interpretation studies, not for the functional testing of a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a mechanical device, not an AI diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, "ground truth" refers to established engineering standards, physical properties of materials, and functional performance benchmarks (e.g., a valve successfully prevents retrograde flow under specified pressures, or a seal maintains integrity for a certain duration). It's not data derived from human interpretation or patient outcomes in the sense of diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document DOES tell us about the device and its clearance process:
- Device Name: Disposable Endoscope Valves Set A
- Intended Use: To be fitted to endoscope working channels/ports to control function and prevent retrograde flow of fluids, gases, and other materials. Includes suction, air/water, and biopsy valves. Single-use.
- Regulatory Class: Class II, Product Code ODC, under 21 CFR 876.1500 (Endoscope and accessories).
- Predicate Devices: OLYMPUS DISPOSABLE SUCTION VALVE (K920025), OLYMPUS DISPOSABLE BIOPSY VALVE (K911412), EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I(MH-438) (K001241).
- Demonstration of Safety and Effectiveness: Through "biocompatibility, sterility and performance testing in accordance to Food and Drug Administration related guidance and recognized international standards." It applies "EO sterilization method, which is also same as that of SE product."
- Conclusion: The device is "substantially equivalent to predicate devices with regard to safety and effectiveness."
This document highlights the differences in regulatory review processes for different types of medical devices. For a mechanical device like an endoscope valve, the focus is on physical and material properties, sterilization, and functional performance against established engineering standards and comparison to similar predicate devices, rather than the complex clinical study designs seen for AI/ML or diagnostic imaging devices.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Wilson Instruments (Shanghai) Company Limited Lijuan Zhang Regulatory Affairs Manager Building 5, No.258 Shuangbang Road Xujing Town, Qingpu District Shanghai China
K151714 Re:
Trade/Device Name: Disposable Endoscope Valves Set A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: November 6, 2015 Received: November 10, 2015
Dear Lijuan Zhang,
This letter corrects our substantially equivalent letter of December 3, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
008_Indications for Use
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame, with a white background.
Indications for Use
510(k) Number (if known): Device Name: Indications for Use:
Disposable Endoscope Valves Set A A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve.
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
Prescription Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
This is a single-use device.
Concurrence of CDRH, Office of In Vitro Diagnostic Devices and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Jun 23th, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Wilson Instruments (Shanghai) Company Limited |
|---|---|
| Address: | Building 5, No.258 Shuangbang Road, Xujing TownQingpu DistrictShanghai China |
| Contact Name: | Xin HUANG |
| Telephone No.: | +86 (021) 39290005 |
| Fax No.: | +86 (021) 66311472 |
| Email Address: | xhuang@heyinovo.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | Disposable Endoscope Valves Set A |
|---|---|
| Model Name: | VO series, M series |
| Common Name: | Endoscope Channel Accessory |
| Regulatory Classification: | 21 CFR876.1500 Endoscope and Accessories |
| Product Code: | ODC |
| Classification Panel: | Gastroenterology/Urology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows:
OLYMPUS CORP. OLYMPUS DISPOSABLE SUCTION VALVE has been cleared by FDA through 510(k) No.K920025 (Decision Date -03/24/1992).
OLYMPUS CORP. OLYMPUS DISPOSABLE BIOPSY VALVE has been cleared by FDA through 510(k) No.K911412 (Decision Date —06/28/1991).
THE OLYMPUS OPTICAL CO. EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I(MH-438) have been cleared by FDA through 510(k) No.K001241 (Decision Date -05/09/2000).
{5}------------------------------------------------
5. Description of the Device [21 CFR 807.92(a)(4)]
Wilson's Disposable Endoscope Valves Set A collects three types of valve products into one package unit. Disposable Endoscope Valves Set A can make it convenient for the replacement of Air/Water Valves, Suction Valves, Biopsy Valve during an endoscopic procedure. And these three types' valves can realize their intended uses respectively.
6. Intended Use [21 CFR 807.92(a)(5)]
A collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes a suction valve, an air/water valve, and a biopsy valve. This is a single-use device.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
As the reason that the working situation, environment and the intended use of Wilson's Disposable Endoscope Valves Set A are the same as the intended uses' combination from the similar Olympus Disposable Suction Valve, Olympus Disposable Biopsy Valve and EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I(MH-438), the technological characteristics of this product series are designed to make same as that of the equivalence product structure for compatible endoscope, and the application of materials over different parts of the product series are also be designed to be equal or better respectively and etc. It applies EO sterilization method, which is also same as that of SE product.
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
The Disposable Endoscope Valves Set A of Wilson has taken the biocompatibility, sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Wilson Instruments (Shanghai) Company Limited concludes that Disposable Endoscope Valves Set A is substantially equivalent to predicate devices with regard to safety and effectiveness.
§ 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.