Disposable Endoscope Valves System

K232244 · Changzhou Endoclean Medical Device Co., Ltd. · ODC · Nov 29, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K232244
• Device Name: Disposable Endoscope Valves System
• Applicant: Changzhou Endoclean Medical Device Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Nov 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 bio material 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. Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure. Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.

Device Story

System of single-use disposable endoscope accessories; includes air/water valve, suction valve, biopsy valve, water connector, and cleaning adapters. Used in hospitals/clinics by endoscopists/technicians. Valves fit into endoscope ports to control fluid/gas flow and maintain insufflation during procedures. Cleaning adapters facilitate pre-cleaning of endoscope channels by connecting to water containers or air/water cylinders to aspirate reprocessing fluids. Devices are single-use, EO-sterilized, and compatible with various Olympus, Fujifilm, and Pentax endoscope series. Output is mechanical control of endoscope channel functions; assists in maintaining sterile field and proper instrument reprocessing.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (cytotoxicity, irritation, intracutaneous reactivity) per ISO 10993-1:2009. Performance testing included water flow, suction flow, and side-by-side comparison tests. Compatibility testing verified functionality with specified Olympus, Pentax, and Fujifilm endoscopes. Sterilization validated per ISO 11135; 3-year shelf life validated via accelerated aging.

Technological Characteristics

Materials: ABS, SUS 303, TPE, Silicone, PP, PVC. Mechanical valves and adapters for endoscope channel control. EO sterilization (ISO 11135). 3-year shelf life. No software or electronic components.

Indications for Use

Indicated for use by clinicians during endoscopic procedures to facilitate device exchange, maintain insufflation, control suction/irrigation, prevent backflow, and perform pre-cleaning of endoscope channels.

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

• EVIS EXERA III VIDEO SYSTEM (K131780)

Submission Summary (Full Text)

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November 29, 2023

Changzhou Endoclean Medical Device Co., Ltd. Qi Wang QA Manager West Side of 4th Floor, Bldg E2, No.9 Changyang Rd., West Taihu Science and Technology Industrial Park, Wujin Disrict Changzhou, Jiangsu 213149 China

Re: K232244

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: October 30, 2023 Received: October 30, 2023

Dear Qi Wang:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, PhD 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

Submission Number (if known)

K232244

Device Name

Disposable Endoscope Valves System

Indications for Use (Describe)

The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter

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 bio material 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.

Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.

Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

#### 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:July 11, 2023

#### Submission Correspondent

Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: [e-mail]

#### 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 |

#### III. Predicate Devices

| 510(k) Number: | K131780 |
|-----------------|-------------------------------|
| Trade name: | EVIS EXERA III VIDEO SYSTEM |
| Common name: | Endoscope Channel Accessory |
| Classification: | Class II |
| Product Code: | FDF |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |

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### IV. Device description

The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope 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, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare 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 valvemay besold as both sterileand non-sterile.

#### V. Indication for use

Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.

Disposable Suction Cleaning Adapter also as one of accessories of the precleaning endoscopic irrigation. The one end can be connected to the biopsy channel, the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.

| Character<br>istics | Proposed device | Predicate device | Discussion |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product<br>name | AW Channel Cleaning Adapter | AW channel cleaning adapter | Same |
| Indications<br>For Use | Disposable AW Channel<br>Cleaning Adapter, it is<br>attached to the air/water<br>cylinder of the endoscope,<br>used for the air water channel<br>pre-cleaning after the<br>procedure. | During precleaning of the<br>endoscope, the AW channel<br>cleaning adapter is attached<br>to the air/water cylinder of the<br>endoscope. When the button<br>of the adapter is depressed,<br>the water in the water<br>container is fed through the<br>air/ water nozzle of the<br>endoscope to clean the<br>nozzle and air/water<br>channels of the endoscope.<br>Air is continuously fed<br>through the air/water | Similar |
| | | channels when the button is not depressed. | |
| Product Code | ODC | FDF | Different |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | II | Same |
| Environment of use | Hospital and/or clinics | Hospital and/or clinics | Same |
| Compatible endoscopes | EDKN-004007:<br>OLYMPUS Endoscope Series<br>140/160/180/190/240/<br>260/290;<br>EDKN-004010: Pentax<br>Endoscope 90 Series;<br>EDKN-004013: FUJIFILM<br>Endoscope 700 Series; | OLYMPUS Endoscope<br>Series 140/160/180/240/<br>260; | Similar¹ |
| Material | ABS, SUS 303, TPE, Silicone, PP | ABS, SUS 303, TPE, Silicone, PP | Same |
| Single for Use | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Shelf life | 3 years | 3 years | Same |

#### VI. Comparison of technological characteristics with the predicate devices Table 1 General Comparison of AW Channel Cleaning Adapter

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## Table 2 General Comparison of Suction Cleaning Adapter

| Character<br>istics | Proposed device | Predicate device | Discussio<br>n |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Product | Suction Cleaning Adapter | Suction Cleaning Adapter | Same |
| name | | | |
| Indications<br>For Use | Disposable Suction Cleaning<br>Adapter also as one of<br>accessories of the pre-<br>cleaning endoscopic irrigation.<br>The one end can be connected<br>to the biopsy channel, the<br>other end be connected to the<br>water container. It is used to<br>aspirate reprocessing fluids<br>through the instrument channel<br>port of the endoscope. | The suction cleaning adapter<br>is used to aspirate<br>reprocessing fluids through<br>the<br>instrument channel port of<br>the endoscope. | Same |
| Product<br>Code | ODC | FDF | Different |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | 11 | Same |
| Environme<br>nt of use | Hospital and/or clinics | Hospital and/or clinics | Same |
| Compatibl<br>e<br>endoscop<br>es | EDKN-004007:<br>OLYMPUS Endoscope<br>Series<br>140/160/180/190/240/<br>260/290;<br>EDKN-004010: Pentax<br>Endoscope 90 Series;<br>EDKN-004013: FUJIFILM<br>Endoscope 700 Series; | OLYMPUS Endoscope<br>Series 140/160/180/240/<br>260; | Similar¹ |
| Material | Silicone, ABS,PVC | Silicone, ABS,PVC | Silicone,<br>ABS,PVC |
| Single for<br>Use | Yes | Yes | Same |
| Sterilizatio<br>n | EO | EO | Same |
| | | | |
| Shelf life | 3 years | 3 years | Same |
| | | | |

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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.

#### 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 accordance with ISO 10993-1:2009 for the body contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited(< 24hours)". 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:

AW Channel CleaningAdapter

- Water flow test
- Side by side test

Suction CleaningAdapter

- Suction flow test
- Side by side test

In addition, the compatibility testing was conduct to support that the proposed device are 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.

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#### VIII. Clinical Testing

No clinical study is included in this submission.

#### IX. Conclusion

The proposeddevice has the same indication for useand 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.