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

Intended 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.

Technological Characteristics

Materials: SIR, ABS, TPE, PVC, Stainless steel (304, 17-4PH, 303). Components: Air/water valves, suction valves, biopsy valves, water connectors. Energy: Passive mechanical flow control. Connectivity: None. Sterilization: Ethylene Oxide (EO). Form factor: Single-use, endoscope-specific interface components.

Indications for Use

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.

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)
• EndoGator™ System (K092429)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] ext 8027 Email: [e-mail]

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 -

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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.