(101 days)
The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.
-
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 designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different 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.
This FDA 510(k) clearance letter pertains to a Disposable Endoscopy Valve Set, which is a Class II device. The document explicitly states that no clinical study was conducted for this submission (K250732) and that no clinical test data is included. Instead, the clearance is based on the device being "substantially equivalent" to a predicate device (Disposable Endoscopy Adapter Set, K220210) through non-clinical performance data, primarily bench testing.
Therefore, many of the requested criteria related to clinical studies, human readers, ground truth, and training sets are not applicable to this specific clearance. I will extract the information that is present in the document regarding the acceptance criteria and the study (bench testing) that supports it.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance for Disposable Endoscopy Valve Set (K250732)
1. Table of acceptance criteria and the reported device performance:
The document details extensive performance characteristics for each component of the Disposable Endoscopy Valve Set. Since the submission relies on substantial equivalence through bench testing, the reported device performance is indicated as "Substantially equivalent supported by bench testing" for each characteristic compared to the predicate device.
Disposable Air/Water Valve:
| Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|
| Appearance: Smooth, clean, uniform color, no defects (flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages, rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe, etc.). Correct assembly. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Same general appearance criteria. |
| Connection Firmness: Withstand axial static tension of 15N for 15s without falling off. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand axial static tension of 15N for 15s without falling off. |
| Fitting Performance: Switch smoothly without obstruction. Return to original position within 1s after pressing. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Switch smoothly without obstruction, cooperate well with endoscope. |
| Corrosion Resistance (Spring): Good corrosion resistance, removable trace if present after wiping. | Substantially equivalent supported by bench testing. (Predicate did not specify spring corrosion resistance, but this implies the proposed device met its own criteria.) |
| Depression Force: Initial pressure between 6.5-9.0N, complete pressure ≤ 13.0N. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Depression force ≤ 12N at 3mm. |
| Air Feeding Performance: Air volume ≥ 950ml/min. No water feeding during air feeding, no water leakage at connection. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Time to reach 8KPa pressure ≤ 12s. |
| Water Feeding Performance: Water volume ≥ 45ml/min. No air feeding during water feeding, no air leakage at connection. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Time to feed 10ml water ≤ 12s. |
| Sealing Performance: a. No air/liquid leakage at endoscope front end (30mm depth) without plugging/pressing. b. Counterflow rate < 0.1ml/min without plugging/pressing. | Substantially equivalent supported by bench testing. Tested against predicate criteria: No water leakage, no liquid and air leakage at connection, no air/liquid leakage at endoscope front end (without plugging/pressing). |
| Size: (Not specified in detail, but implied to be comparable for fitting). | Substantially equivalent supported by bench testing. (Implied that the device's size allows it to fit compatible endoscopes.) |
| Sterile: EO Sterilization | Same as predicate. |
| Material: Silicone Rubber, ABS, SUS304 | Substantially equivalent supported by biocompatibility testing. Same as predicate. |
| Environment Use: Hospital/clinics | Same as predicate. |
Disposable Suction Valve:
| Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|
| Appearance: Smooth, clean, uniform color, no defects (flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages, rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe, etc.). Correct assembly. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Same general appearance criteria. |
| Connection Firmness: Withstand axial static tension of 15N for 15s without falling off. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand axial static tension of 15N for 15s without falling off. |
| Fitting Performance: Switch smoothly without obstruction. Return to original position within 1s after pressing. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Switch smoothly without obstruction, cooperate well with endoscope. |
| Depression Force: Initial pressure between 1.3-5.0N, complete pressure ≤ 12.0N. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Depression force ≤ 12N at 3mm. |
| Suction Performance: Water suction volume ≥ 850ml/min. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Suction 200mL water ≤ 20 seconds. |
| Anti-self-suction Performance: No self-suction when not pressed. | Substantially equivalent supported by bench testing. Tested against predicate criteria: No self-suction when not pressed. |
| Sealing Performance of water feeding: No falling off or water leakage when feeding water from Biopsy Valve inlet. | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test, but implies overall sealing.) |
| Size: (Not specified in detail, but implied to be comparable for fitting). | Substantially equivalent supported by bench testing. (Implied that the device's size allows it to fit compatible endoscopes.) |
| Sterile: EO Sterilization | Same as predicate. |
| Material: ABS, Silicone Rubber, SUS304, PC | Substantially equivalent supported by biocompatibility testing. Same as predicate. |
| Environment Use: Hospital/clinics | Same as predicate. |
Disposable Biopsy Valve:
| Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|
| Appearance: Smooth, clean, uniform color, no defects (rubber threads, chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe, etc.). Correctly cut and fully opened up. (If with irrigation port: plastic part smooth, clean, uniform color, no defects.) | Substantially equivalent supported by bench testing. Tested against predicate criteria: Same general appearance criteria, correct cutting position and open. |
| Fitting Performance: No falling off, closure not opened when used with endoscope/instruments. No damage. | Substantially equivalent supported by bench testing. Tested against predicate criteria: No falling off, closure not opened. |
| Sealing Performance: No liquid leakage at joints. Lid not opened during simulated use. No leakage at cutting position or lid shift. | Substantially equivalent supported by bench testing. Tested against predicate criteria: No liquid leakage at joints (instrument/pressure cap, biopsy valve/seat) during simulation. |
| Use Performance: Smooth opening/closing of lid, no damage. | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test, but implies overall functionality.) |
| Connection Firmness (if with irrigation port): Withstand axial static tensile force of 15N for 15s without falling off (between Check valve and Biopsy valve). | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test, but implies overall connection firmness.) |
| Liquid Leakage (conical locking connector): No leakage at 300-330kpa for 30-35s. | Substantially equivalent supported by bench testing. (Predicate did not specify such detailed ISO connector tests, but overall sealing performance is mentioned.) |
| Air Leakage (conical locking connector): Leakage ≤ 0.005 pa*m^3 at -80kpa to -88kpa for 15-20s. | Substantially equivalent supported by bench testing. |
| Stress Cracking (conical locking connector): Free of cracking. | Substantially equivalent supported by bench testing. |
| Axial Separation Force: No separation at 35N axial tension for 10s. | Substantially equivalent supported by bench testing. |
| Resistance to Overriding: Not exceed thread/lug at 0.15-0.17 N·m torque for 5-10s. | Substantially equivalent supported by bench testing. |
| Unscrewing Torque: No separation at 0.018-0.020 N·m torque for 10-15s. | Substantially equivalent supported by bench testing. |
| Pressure Resistance (counterflow): Withstand 200KPa. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand 200KPa. |
| Blocking Performance: Closed under pressure ≤ 2kPa in counterflow. | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test.) |
| Opening Pressure: Opened at pressure ≤ 2kPa. | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test.) |
| Sterile: EO Sterilization | Same as predicate. |
| Material: Silicone Rubber, PC | Substantially equivalent supported by biocompatibility testing. Same as predicate. |
| Environment Use: Hospital/clinics | Same as predicate. |
Disposable Water Jet Adapter:
| Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|
| Appearance: Smooth, clean, uniform color, no defects (flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages, etc.). | Substantially equivalent supported by bench testing. Tested against predicate criteria: Same general appearance criteria. |
| Connection Firmness: Withstand axial static tension of 15N for 15s without falling off. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand axial static tension of 15N for 15s without falling off. |
| Leakage: No water leakage at each connection when installed on endoscope. | Substantially equivalent supported by bench testing. Tested against predicate criteria: No leakage at connection. |
| Liquid Leakage (conical locking connector): No leakage at 300-330kpa for 30-35s. | Substantially equivalent supported by bench testing. (Predicate did not specify such detailed ISO connector tests, but overall leakage performance is mentioned.) |
| Air Leakage (conical locking connector): Leakage ≤ 0.005 pa*m^3 at -80kpa to -88kpa for 15-20s. | Substantially equivalent supported by bench testing. |
| Stress Cracking (conical locking connector): Free of cracking. | Substantially equivalent supported by bench testing. |
| Axial Separation Force: No separation at 35N axial tension for 10s. | Substantially equivalent supported by bench testing. |
| Resistance to Overriding: Not exceed thread/lug at 0.15-0.17 N·m torque for 5-10s. | Substantially equivalent supported by bench testing. |
| Unscrewing Torque: No separation at 0.018-0.020 N·m torque for 10-15s. | Substantially equivalent supported by bench testing. |
| Pressure Resistance (counterflow): Withstand 200KPa. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand 200KPa. |
| Blocking Performance: Closed under pressure ≤ 2kPa in counterflow. | Substantially equivalent supported by bench testing. (Predicate did not specify this exact test.) |
| Opening Pressure: Opened at pressure ≤ 2kPa. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Opened at pressure ≤ 2kPa. |
| Fitting Performance: Cooperate well with endoscope and perform corresponding functions. | Substantially equivalent supported by bench testing. Tested against predicate criteria: Cooperate well with endoscope and perform corresponding functions. |
| Sterile: EO Sterilization | Same as predicate. |
| Material: Plastic Type: PC, Silicone Rubber; Metal Type: PC, SUS303, Silicone Rubber | Substantially equivalent supported by biocompatibility testing. Same as predicate. |
| Environment Use: Hospital/clinics | Same as predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test. The document mentions "The results of all testing were passing," implying a sufficient sample size was used for each bench test conducted.
- Data Provenance: The bench tests were performed by "Yangzhou Fartley Medical Instrument Technology Co., Ltd." which is based in China. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical study was performed, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests was established by objective measurements against predefined engineering specifications and comparison to the predicate device's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical study or expert review of images/data occurred that would necessitate an adjudication method. Bench tests are objective measurements against defined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The device is a physical endoscopy valve set, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The device is a physical endoscopy valve set, not an algorithm. Standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" was established by objective engineering specifications and measurements as defined in the test protocols, and comparative performance verification against the predicate device.
8. The sample size for the training set:
- Not Applicable. No algorithm or AI component requiring a training set is part of this device.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
FDA 510(k) Clearance Letter - Disposable Endoscopy Valve Set
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Yangzhou Fartley Medical Instrument Technology Co,. Ltd
Xi Han
Regulatory Affairs Manager
Beizhou Road
Yangzhou, Jiangsu 225106
China
Re: K250732
Trade/Device Name: Disposable Endoscopy Valve Set
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: ODC
Dated: March 11, 2025
Received: March 11, 2025
Dear Xi 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 (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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K250732 - Xi Han Page 2
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 (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-reporting-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-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-devices/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-advice-comprehensive-regulatory-
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K250732 - Xi Han Page 3
assistance/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,
SIVAKAMI VENKATACHALAM -S
for
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250732
Device Name: Disposable Endoscopy Valve Set
Indications for Use (Describe):
The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.
-
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 designed to prevent backflow and 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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K250732, Page 1 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
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.
1.1 Submitter
Submitted by: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Address: Beizhou Road, Lidian Town, Guangling District, Yangzhou 225106 Jiangsu, China
Contact Person: Han Xi
RA Specialist
Phone: 0086-15051101225
Email: th@fartley.com
Date Prepared: May 13, 2025
1.2 Device
Device Name: Disposable Endoscopy Valve Set
Classification Name: Endoscope Channel Accessory
Regulatory Class: II
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and Accessories
Product Code: ODC
1.3 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
1.4 Device Description
The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different 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.
1.5 Indication for Use:
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K250732, Page 2 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.
-
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.
1.6 Comparison of Technological Characteristics
The Disposable Endoscopy Valve Set consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter, 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 Endoscopy 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 | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| Indication for Use | The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.- 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 | The Disposable Endoscopy Adapter Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.- 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 | Substantially equivalent |
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K250732, Page 3 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump. | 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. | ||
| Product Code | ODC | ODC | Same |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve Compatible Endoscopes | PENTAX GI Video Endoscope i20 Series | Olympus 140/160/180/190/240/260/290 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series，K10/i10 Series;Fujifilm® 500/600/700 series endoscopes. | Substantially equivalent supported by bench testing. |
| Performance Characteristics | - Appearancea. The surface of Plastic part should be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on;b. The surface of Rubber part should be smooth, clean, uniform in colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, | - Appearancea. The surface of Plastic part should be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on; | Substantially equivalent supported by bench testing. |
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K250732, Page 4 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| defects, blooming, singe and so on;c. Spring surface should be smooth and clean, without flashes, oil stains, scratches, deformations and so on;d. The assembly direction and position of each part should be correct and the assembly should be in place.- Connection firmnessPentax I20 Air/Water Valve shall be able to withstand axial static tension of 15N for 15s without falling off.- Fitting performancePentax I20 Air/Water Valve should be switched smoothly without obstruction. After pressing down on the lid, it can quickly and smoothly return to its original position within 1s.- Corrosion resistanceThe Spring should have good corrosion resistance, if there is a corrosion trace, it can be removed after wiping.- Depression forceThe initial pressure of the Pentax I20 Air/Water Valve should be between 6.5 and 9.0N, and the complete pressure should be no more than 13.0N.- Air feeding performanceThe air feeding volume of Pentax I20 Air/Water Valve should be greater than or equal to 950ml per minute. There shall be no water feeding during air feeding, and should be no water leakage at the connection between the Air/Water Valve and the endoscopic Air/Water Valve hole seat.- Water feeding performanceThe water feeding volume of Pentax I20 Air/Water Valve should be greater than or equal to 45ml per minute. There shall be no air feeding during water feeding, and should be no air leakage at the connection between the Air/Water Valve and the endoscopic | b. The surface of Rubber part should be smooth, clean, uniform in colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe and so on;c. Spring surface should be smooth and clean, without flashes, oil stains, scratches, deformations and so on;d. The assembly direction and position of each part should be correct and the assembly should be in place.- Connection firmnessAir/Water Valve shall be able to withstand axial static tension of 15N for 15s without falling off.- Fitting performancea. Air/Water Valve should be switched smoothly and with no obstruction.b. When Air/Water Valve is used in combination with the corresponding endoscope, they can cooperate well and be able to perform corresponding functions.- Depression forceAir/Water Valve shall be pressed down for a distance of 3mm, and the depression force shall not exceed 12N.- Air feeding performance |
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K250732, Page 5 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| Air/Water Valve hole seat.- Sealing performancea. Without plugging or pressing the Pentax I20 Air/Water Valve, the front end of the endoscope should have no air or liquid leakage at a maximum depth of 30mm in the water.b. Without plugging or pressing the Pentax I20 Air/Water Valve, the counterflow rate should be less than 0.1ml/min.- Size | The time required to feed air into the closed container to make its pressure reach 8KPa shall not exceed 12s.- Water feeding performanceFeed water into the measuring cylinder to 10ml, and the time required shall not exceed 12s.- Sealing performancea. The hole of Air/Water Valve shall be free of water leakage. There shall be no liquid and air leakage at the connection between Air/Water Valve and the endoscopic Air/Water Valve hole seat.b. Without plugging or pressing the Air/Water Valve, there should be no air and liquid leakage at the front end of the endoscope. | ||
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber, ABS, SUS304 | Silicone Rubber, ABS, SUS304, | Substantially equivalent supported by biocompatibility testing. |
| Environment Use | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve Compatible Endoscopes | PENTAX GI Video Endoscope i20 Series; | Olympus 140/160/180/190/240/260/290 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series; K10/i10 Series;Fujifilm® 500/600/700 series endoscopes. | Substantially equivalent supported by bench testing. |
Page 10
K250732, Page 6 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| Performance Characteristics | - Appearancea. The surface of Plastic part should be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on;b. The surface of Rubber part should be smooth, clean, uniform in colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe and so on;c. Spring surface should be smooth and clean, without flashes, oil stains, scratches, deformations and so on;d. The assembly direction and position of each part should be correct and the assembly should be in place.- Connection firmnessa. Pentax I20 Suction Valve shall be able to withstand axial static tension of 15N for 15s without falling off.- Fitting performancea. Pentax I20 Suction Valve should be switched smoothly without obstruction. After pressing down on the lid, it can quickly and smoothly return to its original position within 1s.- Depression forcea. The initial pressure of the Pentax I20 Suction Valve should be between 1.3 and 5.0N, and the complete pressure should be no more than 12.0N.- Suction performancea. The water suction volume of Pentax I20 Suction Valve shall be no less than 850ml per minute.- Anti-self-suction performanceWhen the Pentax I20 Suction Valve are not pressed (working), there shall be no self-suction.- Sealing performance of water feedingWhen feeding water from the Biopsy Valve inlet, the Pentax I20 Suction Valve shall be free of falling off or water leakage.-Size | - Appearancea. The surface of Plastic part should be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on;b. The surface of Rubber part should be smooth, clean, uniform in colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe and so on;c. Spring surface should be smooth and clean, without flashes, oil stains, scratches, deformations and so on;d. The assembly direction and position of each part should be correct and the assembly should be in place.- Connection firmnessSuction Valve shall be able to withstand axial static tension of 15N for 15s without falling off.- Fitting performancea. Suction Valve should be switched smoothly and with no obstruction.b. When Suction Valve is used in combination with the corresponding endoscope, they can cooperate well and be | Substantially equivalent supported by bench testing. |
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K250732, Page 7 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| able to perform corresponding functions.- Depression forceSuction Valve shall be pressed down for a distance of 3mm, and the depression force shall not exceed 12N.- Suction performanceThe suction time of 200mL water shall not exceed 20 seconds.- Anti-self-suction performanceWhen the Suction Valve is not pressed (working), there shall be no self-suction. | |||
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, Silicone Rubber, SUS304, PC | ABS, Silicone Rubber, SUS304 | Substantially equivalent supported by biocompatibility testing. |
| Environment Use | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve Compatible Endoscopes | PENTAX GI Video Endoscope 90K/90i Series; K10/i10 SeriesPENTAX GI Video Endoscope i20 Series;Note: Different model matches the different endoscopes, more details, please refer to Section Device Description. | Olympus 140/160/180/190/240/260/290 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series; K10/i10 Series;Fujifilm® 500/600/700 series endoscopes. | Substantially equivalent supported by bench testing. |
| Performance Characteristics | - Appearancea. The surface of Biopsy Valve should be smooth, clean ,uniform in colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, | - Appearancea. The surface of Biopsy Valve should be smooth, clean ,uniform in | Substantially equivalent supported by bench testing. |
Page 12
K250732, Page 8 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| defects, blooming, singe and so on.b. Cutting position is correct and fully opened up.c. If Biopsy valve is with irrigation port, the surface of Plastic part should be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on.- Fitting performanceWhen Biopsy Valve is used in combination with the corresponding endoscope and endoscopic instruments, it shall not fall off, and the closure shall not be opened. The Biopsy Valve should not be damaged.- Sealing performanceWhen Biopsy Valve is used in combination with the corresponding endoscope and endoscopic instruments, there shall be no liquid leakage at each joint. When Pentax Biopsy valve is for simulated use, the lid should not be opened. There shall be no leakage at the cutting position of the lid and the lid must not shift.- Use performanceThe opening and closing of the lid shall be smooth, and the Biopsy Valve shall have no damage.- Connection firmnessIf Biopsy valve is with irrigation port, the connection between Check valve and Biopsy valve should be able to withstand axial static tensile force of 15N for 15s without falling off.- Liquid leakageApply the pressure on the conical locking connector between 300kpa and 330kpa for 30s to 35s, and the inner conical locking connector | colour, with no rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe and so on.b. Cutting position is correct and fully opened up.- Fitting performanceWhen Biopsy Valve is used in combination with the corresponding endoscope and endoscopic instruments, it shall not fall off, and the closure shall not be opened.- Sealing performanceIn simulation use, when Suction Valve works, there shall be no liquid leakage at the joint between the instrument and the pressure cap of Biopsy Valve (when there is no instrument penetration, observe the opening of the pressure cap of Biopsy Valve) and the joint between Biopsy valve and Biopsy Valve seat. |
Page 13
K250732, Page 9 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| shall have no leakage.- Air leakageApply the pressure on the conical locking connector between -80kpa and -88kpa for 15s to 20s, and the leakage shall not exceed 0.005 pa * m 3.- Stress crackingConical locking connector shall be free of cracking.- Axial separation forceAfter bearing the axial tension of 35N for 10s, the inner conical locking connector of Biopsy Valve shall not separate from the connection of reference connector.- Resistance to overridingWhen bearing the torque of 0,15 N·m to 0,17 N·m for 5-10 seconds, the inner conical locking connector of Biopsy Valve shall not exceed the thread or lug of the reference connector.- Unscrewing torqueWhen unscrewing torque is between 0,018 N·m to 0,020 N·m. for 10-15 seconds, the inner conical locking connector of Biopsy Valve shall not separate from the connection of reference connector.- Pressure resistance in counterflow directionThe counterflow direction of Biopsy Valve shall be able to withstand the pressure of 200KPa.- Blocking performanceBiopsy Valve should be closed under pressure of no more than 2kPa in counterflow direction. |
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K250732, Page 10 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| - Opening pressureBiopsy Valve shall be opened at the pressure not greater than 2kPa. | |||
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber, PC | Silicone Rubber | Substantially equivalent supported by biocompatibility testing. |
| Environment Use | Hospital/clinics | Hospital/clinics | Same |
| Disposable Water Jet Adapter Compatible Endoscopes | PENTAX GI Video Endoscope 90K/90i Series; K10/i10 Series;PENTAX GI Video Endoscope i20 Series;Note: Different model matches the different endoscopes, more details, please refer to Section Device Description. | Olympus 140/160/180/190/240/260/290 series endoscopes; PENTAX GI Video Endoscope 90K/90i Series; K10/i10 Series;Fujifilm® 500/600/700 series endoscopes. | Substantially equivalent supported by bench testing. |
| Performance Characteristics | - AppearanceThe surface of Plastic part shall be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on.- Connection firmnessDisposable Water Jet Connector shall be able to withstand axial static tension of 15N for 15s without falling off.- LeakageInstall Disposable Water Jet Adapter on the corresponding endoscope, and each connection of Disposable Water Jet Adapter should have no water leakage.- Liquid leakageApply the pressure on the conical locking connector between 300kpa and 330kpa for 30s | - AppearanceThe surface of Plastic part shall be smooth, clean and uniform in colour, and there should be no defects such as flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages and so on; the surface of Metal part should be smooth and clean, without burrs, oil stains, sharp edge blunt and so on.- Connection firmnessDisposable Water Jet Connector shall be able to withstand axial static tension of 15N for 15s without falling off. | Substantially equivalent supported by bench testing. |
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K250732, Page 11 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| to 35s, and the inner conical locking connector shall have no leakage.- Air leakageApply the pressure on the conical locking connector between -80kpa and -88kpa for 15s to 20s, and the leakage shall not exceed 0.005 pa * m3.- Stress crackingConical locking connector shall be free of cracking.- Axial separation forceAfter bearing the axial tension of 35N for 10s, the inner conical locking connector of Disposable Water Jet Adapter shall not separate from the connection of reference connector.- Resistance to overridingWhen bearing the torque of 0,15 N·m to 0,17 N·m for 5-10 seconds, the inner conical locking connector of Disposable Water Jet Adapter shall not exceed the thread or lug of the reference connector.- Unscrewing torqueWhen unscrewing torque is between 0,018 N·m to 0,020 N·m. for 10-15 seconds, the inner conical locking connector of Disposable Water Jet Adapter shall not separate from the connection of reference connector.- Pressure resistance in counterflow directionThe counterflow direction of Disposable Water Jet Adapter shall be able to withstand the pressure of 200KPa.- Blocking performanceDisposable Water Jet Adapter should be closed under pressure of no more than 2kPa in counterflow direction.- Opening pressureThe Disposable Water Jet Adapter shall be opened at the pressure not greater than 2kPa.- Fitting performanceWhen Disposable Water Jet Connector is used in combination with the corresponding endoscope, they can cooperate well and be able to perform corresponding functions. | - Fitting performanceWhen Disposable Water Jet Connector is used in combination with the corresponding endoscope, they can cooperate well and be able to perform corresponding functions.- LeakageThe connection of Disposable Water Jet Connector should have no leakage.- Pressure resistance in counterflow directionThe counterflow direction of Disposable Water Jet Connector shall be able to withstand the pressure of 200KPa.- Opening pressureThe Disposable Water Jet Connector shall be opened at the pressure not greater than 2kPa. |
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K250732, Page 12 of 12
Section 11 510(k) Summary
Disposable Endoscopy Valve Set
| Item | Disposable Endoscopy Valve Set (Proposed Device) | Disposable Endoscopy Adapter Set, K220210 | Discussion |
|---|---|---|---|
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Plastic Type: PC, Silicone Rubber Metal Type:PC, SUS303,Silicone Rubber | Plastic Type: PC, Silicone Rubber | Substantially equivalent supported by biocompatibility testing. |
| Environment Use | Hospitals/clinics | Hospitals/clinics | Same |
1.7 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 Disposable Endoscopy Valve Set: Appearance, Physical properties. The results of all testing were passing.
1.8 Clinical Test Data
No Clinical Study is included in this submission.
1.9 Conclusion
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 Disposable Endoscopy 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.