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510(k) Data Aggregation
(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.
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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.
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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.
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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.
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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.
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