Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
K200769 · Wilson Instruments (Sha) Co., Ltd. · ODC · Jan 6, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K200769
Device Name
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Applicant
Wilson Instruments (Sha) Co., Ltd.
Product Code
ODC · Gastroenterology, Urology
Decision Date
Jan 6, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector. - Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow. - Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. - Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure. - Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device. - Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow. - Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
Device Story
Disposable sterile valve set for GI endoscopes; includes air/water valves, suction valves, biopsy valves, and water connectors. Components attach to endoscope working channels/ports to regulate fluid/gas flow, prevent retrograde flow, and maintain insufflation. Operated by clinicians in hospitals/clinics during endoscopic procedures. Air/water valves control gas/water inflow; suction valves manage suction; biopsy valves prevent leakage during instrument passage; water connectors facilitate irrigation via external pump. Single-use design reduces cross-contamination risk compared to reusable alternatives.
Clinical Evidence
Bench testing only. No clinical data provided. Performance testing included inflation/injection timing, suction capacity, depression/pull-out forces, and leakage testing under pressure. Biocompatibility testing (cytotoxicity, irritation, sensitization) met ISO 10993-1 requirements. Sterilization validated to ISO 11135; 3-year shelf-life validated via accelerated aging.
Indicated for use in patients undergoing GI endoscopic procedures requiring control of fluids, gases, and irrigation via endoscope working channels/ports. Used with compatible Olympus and Pentax GI endoscopes.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
DEFENDO™ Disposable Air/Water Valve for GI Endoscopes (K102409)
DEFENDO™ Disposable Suction Valve for GI Endoscopes (K102581)
DEFENDO™ Biopsy Valve for Olympus and Fujinon Endoscopes (K090851)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 6, 2021
Wilson Instruments (SHA) Co., LTD Juan Wu, MS Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai, 201702 CHINA
Re: K200769
Trade/Device Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: November 20, 2020 Received: November 27, 2020
Dear Juan Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K200769
Device Name Disposable Endoscope Valves Set Disposable Endoscope Valves Set B
#### Indications for Use (Describe)
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
- Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
- Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
- Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) summary
# I. Submitter
Device submitter: WILSON INSTRUMENTS (SHA) CO., LTD Building 5, No.258 Shuangbang Rd., Xujing Town Qingpu Dist, Shanghai, CHINA, 201702
Primary contact person: Juan Wu Regulatory Affairs Phone: +86 21-39290696 ext 8027 Email: wilson.ra803@wilson.sh.cn
Date of preparation: Nov.20, 2020.
# II. Device
Trade Name of Device: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Common name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: II Product code: ODC Review Panel: Gastroenterology/Urology
# III. Predicate Devices
| Trade name: | DEFENDO™ Disposable Air/Water Valve for GI Endoscopes |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC |
| Premarket Notification: | K102409 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Disposable Suction Valve for GI Endoscopes |
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC, FDF |
| Premarket Notification: | K102581 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Biopsy Valve for Olympus and Fujinon Endoscopes<br>DEFENDO™ Biopsy Valve for Pentax Endoscopes |
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Endoscopes and accessories Common name: Classification: Class II, 21 CFR 876.1500 ODC Product Code: Premarket Notification: k090851 Medivators Inc formerly Byrne Medical Manufacturer: Trade name: EndoGator™ System Common name: Endoscopes and accessories Class II, 21 CFR 876.1500 Classification: FEQ Product Code: Premarket Notification: k092429
#### Manufacturer: Medivators Inc formerly Byrne Medical
# IV. Device description
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
# V. Indications for use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
- Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
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The Disposable Endoscope Valves Set B is 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 includes a suction valve, an air/water valve.
- Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
- Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
# VI Comparison of technological characteristics with the predicate devices
The Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B have similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
| Device<br>feature | Disposable<br>Air/Water<br>Valves (subject device) | DEFENDO™ Disposable<br>Air/Water Valve k102409<br>(predicate device) | Discussion |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Picture | WS-VO-01<br><br>WS-VP-01<br> | | Same structure |
| Indications<br>for use | The device is intended to be<br>fitted to an endoscope<br>air/water channel to control<br>the inflow of medical gases<br>and water, whilst preventing<br>back-flow. | The DEFENDO™<br>Disposable Air/Water Valve<br>is intended to be used to<br>control the air/water function<br>on an endoscope during a<br>GI endoscopic procedure. | Substantially<br>equivalent. Both<br>devices are used<br>with the<br>endoscopes to<br>control the<br>air/water function. |
| Product code | ODC | ODC | Substantially<br>equivalent. |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
Table 1 Substantial equivalence discussion - Disposable Air/Water Valve
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K200769 Page 4 of 11 pages
| Compatible<br>endoscopes | Olympus<br>WS-VO-01:<br>140/160/180/190/240/260/2<br>90 series endoscopes<br>WS-VP-01: PENTAX GI<br>Video Endoscope<br>90K/90i Series; K10/i10<br>Series | Olympus<br>140/160/180/240/260<br>series endoscopes | Substantially<br>equivalent<br>supported by<br>performance<br>testing. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | WS-VO-01: SIR, ABS, TPE,<br>Stainless steel 304<br>WS-VP-01: SIR, ABS, TPE,<br>Stainless steel 304 | PC, TPE, Stainless steel 304 | Substantially<br>equivalent,<br>both<br>devices<br>are<br>evaluated<br>according to ISO<br>10993-1. |
| Environment<br>of use | Hospitals/clinics | Hospitals/clinics | Identical |
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| Device<br>feature | Disposable Suction Valves<br>(subject device) | DEFENDO™ Disposable<br>Suction Valve for GI<br>Endoscopes k102581<br>(predicate device) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Picture | WS-VO-02<br>Image: Disposable Suction Valve | Image: DEFENDO Disposable Suction Valve | Same structure |
| | WS-VP-02<br>Image: Disposable Suction Valve | | |
| Indications<br>for use | The device is intended to be<br>fitted to an endoscope<br>suction channel to control<br>the operations of suction,<br>whilst preventing inflow of<br>air. | The DEFENDO™<br>Disposable Suction Valve is<br>intended to be used to<br>control the suction function<br>on an endoscope during a<br>GI endoscopic procedure. | Substantially<br>equivalent. Both<br>devices are used<br>with the<br>endoscopes to<br>control the suction<br>function. |
| Product code | ODC | ODC | Substantially<br>equivalent. |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatible<br>endoscopes | WS-VO-02: Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes<br><br>WS-VP-02: PENTAX GI<br>Video Endoscope<br>90K/90i Series; K10/i10<br>Series | Olympus<br>140/160/180/190/240/260<br>series endoscopes | Substantially<br>equivalent<br>supported by<br>performance<br>testing. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| | | | |
| Material | WS-VO-02: SIR, ABS, TPE,<br>Stainless steel 304, Stainless<br>steel 17-4PH<br>WS-VP-02: SIR, ABS, TPE,<br>Stainless steel 304 | NBR, PC, TPE, Stainless<br>steel 304 | Substantially<br>equivalent, both<br>devices are<br>evaluated<br>according to ISO<br>10993-1. |
| Environment<br>of use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 2 Substantial equivalence discussion – Suction Valve
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K200769 Page 6 of 11 pages
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| Device<br>feature | Disposable Biopsy Valves<br>(subject device) | DEFENDO™ Biopsy Valve<br>(predicate<br>k090851 device) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Picture | | | Same structure |
| Indications<br>for use | The device is intended to be<br>fitted to an endoscope<br>biopsy port to prevent<br>leakage of gases and body<br>fluids during an endoscopic<br>procedure | The DEFENDO™ Disposable Biopsy Valve is<br>indicated for covering the<br>endoscope biopsy port<br>during an endoscopy<br>procedure. The valve<br>provides access for<br>endoscopic device passage<br>and exchange, helps<br>maintain sufflation and<br>minimizes leakage of<br>biomaterial from the biopsy<br>port throughout the<br>endoscopic procedure. | Substantially<br>equivalent. Both<br>devices are used<br>on the endoscopes<br>biopsy port to<br>prevent leakage. |
| Product code | ODC | ODC | Substantially<br>equivalent. |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatible<br>endoscopes | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes | Olympus GI endoscopes | Substantially<br>equivalent, both<br>devices are used<br>for Olympus GI<br>endoscopes. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | Silicon rubber | TPE | Different while both<br>devices are<br>evaluated<br>according to ISO<br>10993-1. |
| Environment<br>of use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 3 Substantial equivalence discussion – Biopsy Valve
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K200769 Page 8 of 11 pages
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| Table 4 Substantial equivalence discussion – Water Connector | | | |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>feature | Disposable Endoscope<br>Water Connectors (subject<br>device) | EndoGator™ System<br>k092429<br>(predicate<br>device) | Discussion |
| Indications<br>for use | The device is intended to<br>provide irrigation via sterile<br>water supply during GI<br>endoscopic procedures<br>when used in conjunction<br>with an irrigation pump. | The EndoGator™ system<br>(tubing and accessories to<br>accommodate various<br>endoscopes and irrigation<br>pumps) is intended to<br>provide irrigation via sterile<br>water supply during GI<br>endoscopic procedures<br>when used in conjunction<br>with an irrigation pump (or<br>cautery unit) | Substantially<br>equivalent. Both<br>devices are used<br>to provide irrigation<br>during GI<br>endoscopic<br>procedures. |
| Picture | Image: Disposable Endoscope Water Connectors | Image: EndoGator System | The predicate<br>water connector is<br>a component of the<br>EndoGator™<br>system. Both<br>devices consist of<br>luer taper to be<br>connected to the<br>water tubing,<br>connector be<br>connected to the<br>endoscope and the<br>intermediate check<br>piece to prevent<br>backflow. |
| Product code | ODC | FEQ | Different as the<br>predicate device<br>consists of a<br>pump, tubing and<br>accessories. |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
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K200760 Page 10 of 11
| Classification | II | II | Page 10 of 11 pages |
|--------------------------|--------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------|
| Compatible<br>endoscopes | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes | Olympus GI endoscopes | Substantially<br>equivalent, both<br>devices are used for<br>Olympus GI<br>endoscopes. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | SIR, PVC, PC, Stainless<br>steel 303 | NBR, SIR, ABS | Different while both<br>devices are<br>evaluated<br>according to ISO<br>10993-1. |
| Environmen<br>t of use | Hospitals/clinics | Hospitals/clinics | Identical |
# VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
# Biocompatibility testing
Biocompatibility of the Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met.
# Performance testing
WILSON INSTRUMENTS (SHA) CO., LTD has performed bench testing to support substantial equivalence. The following tests were performed on the subject devices and predicate devices.
Disposable Air/Water Valves WS-VO-01:
- Time of inflation of 8KPa air -
- -Time of injection of 10g water
Disposable Suction Valves WS-VO-02:
- Time of suction of 200g water -
Disposable Biopsy Valves WS-M-01S:
- Plug-in performance: Depression force, pull out force -
- Sealing performance: Leakage test, flush open force -
- Fitting test -
{13}------------------------------------------------
Disposable Endoscope Water connectors WS-VO-03:
- Leakage test under 80Kpa forward pressure -
- -Leakage test under 30Kpa reverse pressure
Disposable Air/Water Valves WS-VP-01:
- Amount of water feeding -
- Amount of air feeding -
- -Depression force
- -Sealing performance
Disposable Suction Valves WS-VP-02:
- -Amount of suction
- -Depression force
### Sterilization and Shelf-life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. 3-year shelf-life of the device has been evaluated by accelerated aging test.
### VIII Conclusion
The Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B are substantially equivalent to the predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
