Pentax Medical Valve Set

K222980 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · ODC · Nov 21, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222980
• Device Name: Pentax Medical Valve Set
• Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Nov 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. - Disposable Air/Water Valve: 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 Valve: 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 Valve: 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 Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Device Story

Collection of sterile, single-use endoscopic accessories; includes air/water valve, suction valve, biopsy valve, and water jet adapter. Fitted to endoscope working channels/ports; controls fluid/gas flow, suction, and irrigation; prevents back-flow, air inflow, and leakage. Used in hospitals/clinics by medical professionals during GI endoscopic procedures. Mechanical operation; no electronic or software components. Benefits patient by maintaining endoscope function and preventing fluid/gas leakage during procedures.

Clinical Evidence

No clinical data. Bench testing only, including appearance and physical property testing, confirming compliance with ISO 10993 (biocompatibility) and ISO 11135/10993-7 (sterilization).

Technological Characteristics

Materials: Silicone rubber, ABS, SUS304, SUS303, PC. Mechanical flow control valves/adapters. EO sterilization. Compatible with Pentax 90K/90i and K10/i10 series endoscopes. No software or energy source.

Indications for Use

Indicated for use with Pentax endoscopes (90K/90i, K10/i10 series) to control fluid/gas flow, suction, and irrigation, and to prevent leakage during GI endoscopic procedures.

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

• Disposable Endoscopy Adapter Set (K220210)

Submission Summary (Full Text)

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November 21, 2022

Yangzhou Fartley Medical Instrument Technology Co., Ltd. Tina Han, RA Specialist Beizhou Road, Lidian Town, Guangling District Yangzhou, Jiangsu 225106 CHINA

Re: K222980 Trade/Device Name: Pentax Medical Valve Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: September 16, 2022 Received: September 28, 2022

Dear Tina Han:

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 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

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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.

# Shanil P. Haugen -S

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) K222980

Device Name Pentax Medical Valve Set

#### Indications for Use (Describe)

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.

- Disposable Air/Water Valve: 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 Valve: 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 Valve: 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 Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

| 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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### 5.1 Submitter

| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd.<br>Address:Beizhou Road, Lidian Town, Guangling District, Yangzhou<br>225106 Jiangsu, China |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Han Xi<br>RA Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 20, 2022 |

#### 5.2 Device

| Device Name: | Pentax Medical Valve Set |
|----------------------|-----------------------------|
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |

## 5.3 Predicate Device

| Device Name: | Disposable Endoscopy Adapter Set, K220210 |
|----------------------|----------------------------------------------------------|
| Manufacturer: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |

## 5.4 Device Description

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

#### 5.5 Indication for Use:

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to

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Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.

- Disposable Air/Water Valve: 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 Valve: 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 Valve: 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 Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

#### 5.6 Comparison of Technological Characteristics

The Pentax Medical Valve Set consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter which are compatible with Pentax endoscopes,our existing predicated device of Disposable Endoscopy Adapter Set,K220210 also consist of Pentax series of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter.

The Disposable Air/Water Valve, Disposable Suction Valve and Disposable Water Jet Adapter among them are completely same,the only difference is the valve cap of Disposable Biopsy Valve.

Thus,the Pentax Medical Valve Set has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in our existing predicated device of Disposable Endoscopy Adapter Set,K220210. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

| Item | Pentax Medical<br>Valve Set(Proposed<br>Device) | Disposable Endoscopy<br>Adapter Set, K220210 | Discussion |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indication<br>for Use | The Pentax Medical<br>Valve Set is a<br>collection of several<br>sterile units. It is<br>intended to be fitted<br>to Pentax<br>endoscopes'<br>working<br>channels/ports to<br>control the flow of<br>fluids, gases and<br>other materials.<br>- Disposable<br>Air/Water Valve:<br>This unit is | The Disposable Endoscopy<br>Adapter Set is a collection of<br>several sterile units. It is<br>intended to be fitted to<br>multiple endoscope working<br>channels/ports to control the<br>flow of fluids, gases and<br>other materials.<br>- Disposable Air/Water<br>Valve: This unit is intended<br>to be fitted to an endoscope<br>air/water channel to control<br>the inflow of medical gases<br>and water, whilst preventing<br>back-flow. | Substantially equivalent |
| Item | Pentax Medical<br>Valve Set(Proposed<br>Device) | Disposable Endoscopy<br>Adapter Set, K220210 | Discussion |
| | intended to be fitted<br>to an endoscope<br>air/water channel to<br>control the inflow<br>of medical gases<br>and water, whilst<br>preventing<br>back-flow.<br>- Disposable | - Disposable Suction Valve:<br>This unit is intended to be<br>fitted to an endoscope<br>suction channel to control the<br>operations of suction, whilst<br>preventing inflow of air.<br>- Disposable Biopsy Valve:<br>This unit is intended to be<br>fitted to an endoscope biopsy<br>port to prevent leakage of<br>gases and body fluids during<br>an endoscopic procedure.<br>- Disposable Water Jet<br>Adapter: This unit is<br>intended to provide irrigation<br>via sterile water supply<br>during GI endoscopic<br>procedures when used in<br>conjunction with an<br>irrigation pump. | |
| | Suction Valve: This<br>unit is intended to<br>be fitted to an<br>endoscope suction<br>channel to control<br>the operations of<br>suction, whilst<br>preventing inflow<br>of air.<br>- Disposable Biopsy<br>Valve: This unit is<br>intended to be fitted<br>to an endoscope<br>biopsy port to<br>prevent leakage of<br>gases and body<br>fluids during an<br>endoscopic<br>procedure.<br>- Disposable Water<br>Jet Adapter: This<br>unit is intended to<br>provide irrigation<br>via sterile water<br>supply during GI<br>endoscopic<br>procedures when<br>used in conjunction<br>with an irrigation<br>pump. | | |
| Product | ODC | ODC | Same |
| Item | Pentax Medical<br>Valve Set(Proposed<br>Device) | Disposable Endoscopy<br>Adapter Set,K220210 | Discussion |
| Code | | | |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve | | | |
| Compatible<br>Endoscopes | PENTAX GI Video<br>Endoscope 90K/90i<br>Series; K10/i10<br>Series | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes;<br>PENTAX GI Video<br>Endoscope 90K/90i Series,<br>K10/i10 Series;<br>Fujifilm® 500/600/<br>700 series endoscopes | Substantially equivalent<br>supported by bench<br>testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber,<br>ABS, SUS304 | Silicone Rubber, ABS,<br>SUS304 | Substantially equivalent<br>supported by<br>biocompatibility testing. |
| Environment<br>Use | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve | | | |
| Compatible<br>Endoscopes | PENTAX GI Video<br>Endoscope 90K/90i<br>Series; K10/i10<br>Series | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes;<br>PENTAX GI Video<br>Endoscope 90K/90i Series;<br>K10/i10 Series;<br>Fujifilm® 500/600/<br>700 series endoscopes | Substantially equivalent<br>supported by bench<br>testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, Silicone<br>Rubber, SUS304 | ABS, Silicone Rubber,<br>SUS304 | Substantially equivalent<br>supported by<br>biocompatibility testing. |
| Environment<br>Use | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve | | | |
| Compatible<br>Endoscopes | PENTAX GI<br>Video Endoscope<br>90K/90i Series;<br>K10/i10 Series. | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes;<br>PENTAX GI<br>Video | Substantially equivalent<br>supported by bench<br>testing. |
| Item | Pentax Medical<br>Valve Set(Proposed<br>Device) | Disposable Endoscopy<br>Adapter Set, K220210 | Discussion |
| | | Endoscope 90K/90i Series;<br>K10/i10 Series;<br>Fujifilm® 500/600/<br>700 series endoscopes | |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber | Silicone Rubber | Same |
| Environment<br>Use | Hospital/clinics | Hospital/clinics | Same |
| Water Jet Adapter | | | |
| Compatible<br>Endoscopes | PENTAX GI Video<br>Endoscope 90K/90i<br>Series; K10/i10<br>Series; | Olympus<br>140/160/180/190/240/260/2<br>90 series endoscopes;<br>PENTAX GI Video<br>Endoscope 90K/90i Series;<br>K10/i10 Series;<br>Fujifilm® 500/600/<br>700 series endoscopes | Substantially equivalent<br>supported by bench<br>testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Metal Type:PC,<br>SUS303,Silicone<br>Rubber<br>Plastic Type: PC,<br>Silicone Rubber | Metal Type:PC,<br>SUS303,Silicone Rubber<br>Plastic Type: PC, Silicone<br>Rubber | Substantially equivalent<br>supported by<br>biocompatibility testing. |
| Environment<br>Use | Hospitals/clinics | Hospitals/clinics | Same |

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#### 5.7 Non-clinical Performance Data

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .

The following bench tests were performed on Pentax Medical Valve Set: Appearance, Physical properties. The results of all testing were passing.

## 5.8 Clinical Test Data

No Clinical Study is included in this submission.

#### 5.9 Conclusion

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In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Pentax Medical Valve Set is substantially equivalent to our existing predicated device of Disposable Endoscopy Adapter Set,K220210.