Disposable Endoscope Valves System

K221331 · Changzhou Endoclean Medical Device Co., Ltd. · ODC · Sep 8, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221331
• Device Name: Disposable Endoscope Valves System
• Applicant: Changzhou Endoclean Medical Device Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Sep 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector. Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water. Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction. Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

Device Story

Disposable endoscope accessory system; includes air/water valve, suction valve, biopsy valve, and water jet connector. Used in hospital/clinic settings by endoscopists. Valves fit into endoscope ports/channels to control suction, gas/water inflow, and maintain insufflation during procedures; biopsy valve allows instrument exchange while minimizing biomaterial leakage; water jet connector prevents liquid backflow. Single-use, sterile, EO-sterilized. Benefits include maintaining endoscope function and preventing cross-contamination via single-use design.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility (cytotoxicity, irritation, intracutaneous reactivity) per ISO 10993-1. Performance testing included sealing, air leakage, water flow, suction flow, and backflow prevention. Compatibility verified with specified endoscope models. Sterilization validated per ISO 11135; 3-year shelf-life validated via accelerated aging.

Technological Characteristics

Single-use, EO-sterilized accessories. Materials: Thermoplastic elastomer (TPE), silicone, ABS, NBR, and stainless steel (SUS 303). Dimensions/form factor specific to endoscope ports. No energy source or software. Mechanical operation for fluid/gas control.

Indications for Use

Indicated for use in patients undergoing endoscopic procedures requiring endoscope channel access, insufflation, suction, or fluid/gas control. Compatible with Olympus, Fujifilm, and Pentax endoscope series. Contraindications not specified.

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™ Biopsy Valve for Olympus and Fujinon Endoscopes (K090851)
• Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (K200769)
• DEFENDO™ Disposable Air/Water Valve for GI Endoscopes (K102409)

Submission Summary (Full Text)

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September 8, 2022

Changzhou Endoclean Medical Device Co., Ltd. Wang Qi, QA Manager West Side of 4th Floor, Building E2, No.9 Changyang Road Changzhou. Jiangsu 213149 CHINA

Re: K221331 Trade/Device Name: Disposable Endoscope Valves System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: August 9, 2022 Received: August 10, 2022

Dear Wang Qi:

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 statutes and regulations administered by other Federal agencies. You must comply with all the

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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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

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) K221331

Device Name Disposable Endoscope Valves System

#### Indications for Use (Describe)

The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.

Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.

Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.

Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.

Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) summary-K221331

### l. Submitter

Changzhou Endoclean Medical Device Co., Ltd.

West Side of 4th Floor, Building E2, No.9 Changyang Road, West Taihu Science and Technology Industrial Park, Wujin District, 213149 Changzhou City, Jiangsu Province, China

Establishment Registration Number: 3021349683

Contact person: Ms Wang Qi

Position: QA Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: Aug. 09, 2022

### II. Proposed Device

| Device Trade Name: | Disposable Endoscope Valves System |
|--------------------|------------------------------------|
| Common name: | Endoscope Channel Accessory |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: | ODC |
| Review Panel: | Gastroenterology/Urology |

| Valves name | Classification name | Regulation number | Classification |
|---------------------|----------------------------------|-------------------|----------------|
| Biopsy Valve | ODC- endoscope channel accessory | 876.1500 | Class II |
| Air/Water Valve; | ODC- endoscope channel accessory | 876.1500 | Class II |
| Suction Valve | ODC- endoscope channel accessory | 876.1500 | Class II |
| Water Jet Connector | ODC- endoscope channel accessory | 876.1500 | Class II |

### Table 1 Valves included in this submission

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#### III. Predicate Devices

- 510(k) Number: K090851 a. Common name: Endoscopes and accessories Classification: 21 CFR 876.1500 Product Code: ODC Trade name: DEFENDO™ Biopsy Valve for Olympus and Fujinon Endoscopes DEFENDOTM Biopsy Valve for Pentax Endoscopes Manufacturer: Medivators Inc formerly Byrne Medical
- 510(k) Number: K200769 b. Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Manufacturer: Wilson Instruments (SHA) Co., LTD.
- C. 510(k) Number: K102409 Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: DEFENDO™ Disposable Air/Water Valve for GI Endoscopes Manufacturer: Medivators Inc formerly Byrne Medical

### IV. Device description

The Endoscope Valves System are used to fit to multiple endoscopes working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.

It includes an air/water valve, a suction valve, a biopsy valve and a water connector. All valves are single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope. Some valve mav be sold as both sterile and non-sterile.

### V. Indication for use

The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, and a water connector.

Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.

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Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.

Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.

Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.

#### VI. Comparison of technological characteristics with the predicate devices

| Item | Proposed device | Predicate device<br>(K090851) | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Disposable Biopsy<br>Valves | Disposable Biopsy<br>Valves | - |
| Product Code | ODC | ODC | same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications<br>for Use | The Biopsy Valves is<br>intended to be fitted to<br>an endoscope biopsy<br>port to enable access<br>for/exchange of<br>endoscopic devices<br>while maintaining<br>insufflation and<br>minimizing leakage of<br>bio material during an<br>endoscopic procedure. | The DEFENDO™<br>Disposable Biopsy<br>Valve is indicated for<br>covering the<br>endoscope biopsy port<br>during an endoscopy<br>procedure. The valve<br>provides access for<br>endoscopic device<br>passage and<br>exchange, helps<br>maintain sufflation and<br>minimizes leakage of<br>biomaterial from the<br>biopsy port throughout<br>the endoscopic<br>procedure. | similar |
| Compatible<br>endoscopes | EDKN-004001/<br>EDKN-004006/<br>EDKN-004012: | Olympus®<br>Endoscopes &<br>Fujifilm® Endoscopes | Similar¹ |
| | OLYMPUS Endoscope<br>Series<br>140/160/180/190/240/<br>260/290; & FUJIFILM<br>Endoscope 700 Series;<br>EDKN-004009: Pentax<br>Endoscope 90 Series; | (100301)<br>Pentax® Endoscopes<br>(100302) | |
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | Thermoplastic<br>elastomer | Silicone | Different2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |

Table 2 Substantial equivalence discussion - Biopsy Valve

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Table 3 Substantial equivalence discussion –Air/Water Valves

| Item | Proposed device | Predicate device<br>(K102409) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Disposable Air/Water<br>Valves | DEFENDO™<br>Disposable Air/Water<br>Valve | - |
| Product Code | ODC | ODC | same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications for Use | The Disposable<br>Air/Water Valve, it is<br>intended to be fitted to<br>an endoscope Air/water<br>channel to enable the<br>operator to control<br>inflow of medical gases<br>and water. | The Single Use<br>Air/Water<br>Valve is intended to be<br>used to control the<br>air/water function on an<br>endoscope during a GI<br>endoscopic procedure. | similar |
| Compatible<br>endoscopes | EDKN-004007:<br>OLYMPUS Endoscope<br>Series | OLYMPUS Endoscope<br>Series | Similar1 |

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| | 140/160/180/190/240/<br>260/290;<br>EDKN-004010: Pentax<br>Endoscope 90 Series;<br>EDKN-004013:<br>FUJIFILM Endoscope<br>700 Series; | 140/160/180/240/ 260; | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------|
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | Silicone, ABS, TPE,<br>SUS 303 | PC, TPE, Stainless<br>steel 304 | Similar2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |

# Table 4 Substantial equivalence discussion --Suction Valve

| Item | Proposed device | Predicate device<br>(K200769) | Discussion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product<br>name | Disposable Suction<br>Valves | Disposable Suction<br>Valves | - |
| Product<br>Code | ODC | ODC | same |
| Regulation<br>No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications<br>for Use | The Disposable Suction<br>Valve is intended to be<br>fitted to an endoscope<br>suction channel to<br>enable the operator to<br>control suction. | The device is intended<br>to be fitted to an<br>endoscope suction<br>channel to control the<br>operations of suction,<br>whilst preventing inflow<br>of air. | similar |
| Compatible<br>endoscope<br>s | EDKN-004008:<br>OLYMPUS Endoscope<br>Series<br>140/160/180/190/240/<br>260/290; | WS-VO-02: Olympus<br>140/160/180/190/240/2<br>60/290 series<br>endoscopes | Similar¹ |

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| | EDKN-004011: Pentax<br>Endoscope 90 Series;<br>EDKN-004014:<br>FUJIFILM Endoscope<br>700 Series; | WS-VP-02: PENTAX GI<br>Video Endoscope<br>90K/90i Series; K10/i10<br>Series | |
|------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------|
| Environme<br>nt of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | SUS 303, ABS, TPE,<br>NBR, | WS-VO-02: SIR, ABS,<br>TPE, Stainless steel<br>304, Stainless steel<br>17-4PH;<br>WS-VP-02: SIR, ABS,<br>TPE, Stainless steel<br>304 | Similar2 |
| Single for<br>Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |

Table 5 Substantial equivalence discussion –Water Jet Connector

| Item | Proposed device | Predicate device<br>(K200769) | Discussion |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product<br>name | Disposable Water Jet<br>Connector | Disposable Endoscope<br>Water Connectors | - |
| Product<br>Code | ODC | ODC | same |
| Regulation<br>No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications<br>for Use | The Water Jet Connector is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery. | The device is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. | similar |

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K221331 Page 7 of 8

| Compatible<br>endoscopes | EDKN-004002&<br>EDKN-004003:<br>OLYMPUS Endoscope<br>Series<br>140/160/180/190/240/<br>260/290;<br>EDKN-004004: Pentax<br>Endoscope 90 Series;<br>EDKN-004005:<br>FUJIFILM Endoscope<br>700 Series; | Olympus<br>140/160/180/190/240/2<br>60/290 series<br>endoscopes | Similar1 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------|
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | PC, TPR, NBR, SUS<br>303 | SIR, PVC, PC,<br>Stainless steel 303 | Similar2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |

1 The proposed device has different compatibility scope than predicate device, for this different, the performance testing to the proposed device has included compatibility testing to all compatible endoscopes claimed, the testing results shown that the proposed devices are compatibility with all endoscopes claimed. So, this different does not affect the safety and effectiveness of proposed device.

2 The difference in the materials and colors does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices has been performed on the final finished device which includes all construction materials and color additives. The test results show pass the requirements.

### VII. Non-Clinical Testing

The non-clinical tests were conducted to verify that the proposed device met all design specifications as was substantial equivalence to the predicate device.

#### Biocompatibility testing

Biocompatibility of the Disposable Endoscope Valves System were evaluated in

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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 Intracutaneous Reactivity. All evaluation acceptance criteria were met.

### Performance testing

The following performance testing was performed on the proposed device:

Biopsy Valves

- -Sealing performance test
- Strength of assemble -

#### Air/Water Valves

- Air leakage test -
- Water flow test -

Suction Valves

- -Suction flow test
Water Jet Connectors

- -Positive pressure performance test
- Backpressure performance test -
- Backflow Prevention Test -

In addition, the compatibility testing was conducted to support that the proposed device is compatibility with commercially endoscopes (i.e., Pentax, Olympus, and Fujifilm Gastrointestinal Endoscopes).

### 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. Clinical Testing

No clinical study is included in this submission.

# IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.