(54 days)
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.
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.
The provided document is a 510(k) Premarket Notification summary for the Pentax Medical Valve Set. This document is a regulatory submission for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous scientific study (like for AI/ML devices).
Therefore, the information required to answer the question about acceptance criteria and a study proving a device meets these criteria (especially in the context of AI/ML performance metrics like accuracy, sensitivity, specificity, or MRMC studies) is not present in this document.
Here's why and what information is present:
- Device Type: The Pentax Medical Valve Set is an endoscope accessory, a physical medical device. It is not an AI/ML software device.
- Regulatory Pathway: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This involves comparing technological characteristics, intended use, and assessing any performance differences through bench testing, biocompatibility testing, and sterilization validation. It does not typically involve clinical performance studies in the way an AI/ML device would need to demonstrate its diagnostic or predictive accuracy.
- Non-clinical Performance Data: The document mentions "bench tests were performed on Pentax Medical Valve Set: Appearance, Physical properties. The results of all testing were passing." This implies the device met its internal design specifications for those physical attributes. However, these are not "acceptance criteria" for a diagnostic or predictive performance study as would be seen for AI/ML.
- Clinical Test Data: The document explicitly states: "No Clinical Study is included in this submission." This confirms that no study was conducted to demonstrate clinical performance (e.g., diagnostic accuracy, reader improvement).
In summary, this document does not contain the information required to fill out the table and answer the questions about AI/ML device performance and testing.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.Address:Beizhou Road, Lidian Town, Guangling District, Yangzhou225106 Jiangsu, China |
|---|---|
| Contact Person: | Han XiRA SpecialistPhone: 0086-15051101225Email: th@fartley.com |
| 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 MedicalValve Set(ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion |
|---|---|---|---|
| Indicationfor Use | The Pentax MedicalValve Set is acollection of severalsterile units. It isintended to be fittedto Pentaxendoscopes'workingchannels/ports tocontrol the flow offluids, gases andother materials.- DisposableAir/Water Valve:This unit is | The Disposable EndoscopyAdapter Set is a collection ofseveral sterile units. It isintended to be fitted tomultiple endoscope workingchannels/ports to control theflow of fluids, gases andother materials.- Disposable Air/WaterValve: This unit is intendedto be fitted to an endoscopeair/water channel to controlthe inflow of medical gasesand water, whilst preventingback-flow. | Substantially equivalent |
| Item | Pentax MedicalValve Set(ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion |
| intended to be fittedto an endoscopeair/water channel tocontrol the inflowof medical gasesand water, whilstpreventingback-flow.- Disposable | - Disposable Suction Valve:This unit is intended to befitted to an endoscopesuction channel to control theoperations of suction, whilstpreventing inflow of air.- Disposable Biopsy Valve:This unit is intended to befitted to an endoscope biopsyport to prevent leakage ofgases and body fluids duringan endoscopic procedure.- Disposable Water JetAdapter: This unit isintended to provide irrigationvia sterile water supplyduring GI endoscopicprocedures when used inconjunction with anirrigation pump. | ||
| Suction Valve: Thisunit is intended tobe fitted to anendoscope suctionchannel to controlthe operations ofsuction, whilstpreventing inflowof air.- Disposable BiopsyValve: This unit isintended to be fittedto an endoscopebiopsy port toprevent leakage ofgases and bodyfluids during anendoscopicprocedure.- Disposable WaterJet Adapter: Thisunit is intended toprovide irrigationvia sterile watersupply during GIendoscopicprocedures whenused in conjunctionwith an irrigationpump. | |||
| Product | ODC | ODC | Same |
| Item | Pentax MedicalValve Set(ProposedDevice) | Disposable EndoscopyAdapter Set,K220210 | Discussion |
| Code | |||
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve | |||
| CompatibleEndoscopes | PENTAX GI VideoEndoscope 90K/90iSeries; K10/i10Series | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | Substantially equivalentsupported by benchtesting. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber,ABS, SUS304 | Silicone Rubber, ABS,SUS304 | Substantially equivalentsupported bybiocompatibility testing. |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve | |||
| CompatibleEndoscopes | PENTAX GI VideoEndoscope 90K/90iSeries; K10/i10Series | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | Substantially equivalentsupported by benchtesting. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, SiliconeRubber, SUS304 | ABS, Silicone Rubber,SUS304 | Substantially equivalentsupported bybiocompatibility testing. |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve | |||
| CompatibleEndoscopes | PENTAX GIVideo Endoscope90K/90i Series;K10/i10 Series. | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GIVideo | Substantially equivalentsupported by benchtesting. |
| Item | Pentax MedicalValve Set(ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion |
| Endoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | |||
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber | Silicone Rubber | Same |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Water Jet Adapter | |||
| CompatibleEndoscopes | PENTAX GI VideoEndoscope 90K/90iSeries; K10/i10Series; | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | Substantially equivalentsupported by benchtesting. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Metal Type:PC,SUS303,SiliconeRubberPlastic Type: PC,Silicone Rubber | Metal Type:PC,SUS303,Silicone RubberPlastic Type: PC, SiliconeRubber | Substantially equivalentsupported bybiocompatibility testing. |
| EnvironmentUse | 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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.