(287 days)
The Disposable Endoscope Valves 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. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: 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 Valves: 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 Valves: 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 Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
The Disposable Endoscope Valves 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. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
The provided text describes the regulatory clearance for "Disposable Endoscope Valves Set" and "Disposable Endoscope Valves Set B" and compares them to predicate devices, but does not contain information related to software or AI performance, or any studies involving human readers or ground truth determination in the context of diagnostic accuracy.
Therefore, I cannot fulfill the request for information regarding AI acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these concepts are not addressed in the provided document.
The document focuses on the substantial equivalence of the physical medical device to legally marketed predicate devices, primarily based on:
- Indications for use: Similar intended purposes.
- Technological characteristics: Similar design, sterilization method, single-use nature, and environment of use. Differences in compatible endoscopes and materials are discussed but deemed not to alter suitability, supported by performance testing and biocompatibility.
- Performance data: Bench testing to demonstrate functionality and biocompatibility testing.
However, I can extract information related to the general performance testing conducted:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests but does not explicitly provide a table of acceptance criteria with corresponding reported performance values in a structured quantitative comparison format. Instead, it states that "All evaluation acceptance criteria were met" for biocompatibility and that "bench testing to support substantial equivalence" was performed for various functional aspects.
| Device Component | Test Performed | Acceptance Criteria (Implied: Met) | Device Performance (Details not provided beyond "met acceptance criteria") |
|---|---|---|---|
| All components | Biocompatibility (Cytotoxicity, Irritation, Sensitization) | In accordance with ISO 10993-1 | Met |
| Disposable Air/Water Valves WS-VO-01 | Time of inflation of 8KPa air | Not explicitly stated | Met (supporting substantial equivalence) |
| Time of injection of 10g water | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Suction Valves WS-VO-02 | Time of suction of 200g water | Not explicitly stated | Met (supporting substantial equivalence) |
| Disposable Biopsy Valves WS-M-01S | Plug-in performance: Depression force, pull out force | Not explicitly stated | Met (supporting substantial equivalence) |
| Sealing performance: Leakage test, flush open force | Not explicitly stated | Met (supporting substantial equivalence) | |
| Fitting test | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Endoscope Water connectors WS-VO-03 | Leakage test under 80Kpa forward pressure | Not explicitly stated | Met (supporting substantial equivalence) |
| Leakage test under 30Kpa reverse pressure | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Air/Water Valves WS-VP-01 | Amount of water feeding | Not explicitly stated | Met (supporting substantial equivalence) |
| Amount of air feeding | Not explicitly stated | Met (supporting substantial equivalence) | |
| Depression force | Not explicitly stated | Met (supporting substantial equivalence) | |
| Sealing performance | Not explicitly stated | Met (supporting substantial equivalence) | |
| Disposable Suction Valves WS-VP-02 | Amount of suction | Not explicitly stated | Met (supporting substantial equivalence) |
| Depression force | Not explicitly stated | Met (supporting substantial equivalence) | |
| All components | Sterilization validation (ISO11135) | In accordance with ISO 11135 | Validated |
| All components | Shelf-life (accelerated aging test) | 3-year shelf-life | Evaluated (and presumably met, as it supports substantial equivalence) |
The remaining points (2-9) cannot be answered. The document does not describe a study involving algorithms, AI, human readers, or diagnostic accuracy. It's a clearance document for physical medical devices (endoscope valves) based on substantial equivalence to existing devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 6, 2021
Wilson Instruments (SHA) Co., LTD Juan Wu, MS Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai, 201702 CHINA
Re: K200769
Trade/Device Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: November 20, 2020 Received: November 27, 2020
Dear Juan Wu:
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
{1}------------------------------------------------
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 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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200769
Device Name Disposable Endoscope Valves Set Disposable Endoscope Valves Set B
Indications for Use (Describe)
The Disposable Endoscope Valves 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. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: 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 Valves: 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 Valves: 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 Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
| 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."
{3}------------------------------------------------
510(k) summary
I. Submitter
Device submitter: WILSON INSTRUMENTS (SHA) CO., LTD Building 5, No.258 Shuangbang Rd., Xujing Town Qingpu Dist, Shanghai, CHINA, 201702
Primary contact person: Juan Wu Regulatory Affairs Phone: +86 21-39290696 ext 8027 Email: wilson.ra803@wilson.sh.cn
Date of preparation: Nov.20, 2020.
II. Device
Trade Name of Device: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Common name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: II Product code: ODC Review Panel: Gastroenterology/Urology
III. Predicate Devices
| Trade name: | DEFENDO™ Disposable Air/Water Valve for GI Endoscopes |
|---|---|
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC |
| Premarket Notification: | K102409 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Disposable Suction Valve for GI Endoscopes |
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC, FDF |
| Premarket Notification: | K102581 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Biopsy Valve for Olympus and Fujinon EndoscopesDEFENDO™ Biopsy Valve for Pentax Endoscopes |
{4}------------------------------------------------
Endoscopes and accessories Common name: Classification: Class II, 21 CFR 876.1500 ODC Product Code: Premarket Notification: K090851 Medivators Inc formerly Byrne Medical Manufacturer: Trade name: EndoGator™ System Common name: Endoscopes and accessories Class II, 21 CFR 876.1500 Classification: FEQ Product Code: Premarket Notification: K092429
Manufacturer: Medivators Inc formerly Byrne Medical
IV. Device description
The Disposable Endoscope Valves 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. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
V. Indications for use
The Disposable Endoscope Valves 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. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: 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 Valves: 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 Valves: 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 Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
{5}------------------------------------------------
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
VI Comparison of technological characteristics with the predicate devices
The Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B have similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
| Devicefeature | DisposableAir/WaterValves (subject device) | DEFENDO™ DisposableAir/Water Valve K102409(predicate device) | Discussion |
|---|---|---|---|
| Picture | WS-VO-01WS-VP-01 | Same structure | |
| Indicationsfor use | The device is intended to befitted to an endoscopeair/water channel to controlthe inflow of medical gasesand water, whilst preventingback-flow. | The DEFENDO™Disposable Air/Water Valveis intended to be used tocontrol the air/water functionon an endoscope during aGI endoscopic procedure. | Substantiallyequivalent. Bothdevices are usedwith theendoscopes tocontrol theair/water function. |
| Product code | ODC | ODC | Substantiallyequivalent. |
| Regulationnumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
Table 1 Substantial equivalence discussion - Disposable Air/Water Valve
{6}------------------------------------------------
K200769 Page 4 of 11 pages
| Compatibleendoscopes | OlympusWS-VO-01:140/160/180/190/240/260/290 series endoscopesWS-VP-01: PENTAX GIVideo Endoscope90K/90i Series; K10/i10Series | Olympus140/160/180/240/260series endoscopes | Substantiallyequivalentsupported byperformancetesting. |
|---|---|---|---|
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | WS-VO-01: SIR, ABS, TPE,Stainless steel 304WS-VP-01: SIR, ABS, TPE,Stainless steel 304 | PC, TPE, Stainless steel 304 | Substantiallyequivalent,bothdevicesareevaluatedaccording to ISO10993-1. |
| Environmentof use | Hospitals/clinics | Hospitals/clinics | Identical |
{7}------------------------------------------------
| Devicefeature | Disposable Suction Valves(subject device) | DEFENDO™ DisposableSuction Valve for GIEndoscopes K102581(predicate device) | Discussion |
|---|---|---|---|
| Picture | WS-VO-02Image: Disposable Suction Valve | Image: DEFENDO Disposable Suction Valve | Same structure |
| WS-VP-02Image: Disposable Suction Valve | |||
| Indicationsfor use | The device is intended to befitted to an endoscopesuction channel to controlthe operations of suction,whilst preventing inflow ofair. | The DEFENDO™Disposable Suction Valve isintended to be used tocontrol the suction functionon an endoscope during aGI endoscopic procedure. | Substantiallyequivalent. Bothdevices are usedwith theendoscopes tocontrol the suctionfunction. |
| Product code | ODC | ODC | Substantiallyequivalent. |
| Regulationnumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatibleendoscopes | WS-VO-02: Olympus140/160/180/190/240/260/290 series endoscopesWS-VP-02: PENTAX GIVideo Endoscope90K/90i Series; K10/i10Series | Olympus140/160/180/190/240/260series endoscopes | Substantiallyequivalentsupported byperformancetesting. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | WS-VO-02: SIR, ABS, TPE,Stainless steel 304, Stainlesssteel 17-4PHWS-VP-02: SIR, ABS, TPE,Stainless steel 304 | NBR, PC, TPE, Stainlesssteel 304 | Substantiallyequivalent, bothdevices areevaluatedaccording to ISO10993-1. |
| Environmentof use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 2 Substantial equivalence discussion – Suction Valve
{8}------------------------------------------------
K200769 Page 6 of 11 pages
{9}------------------------------------------------
| Devicefeature | Disposable Biopsy Valves(subject device) | DEFENDO™ Biopsy Valve(predicateK090851 device) | Discussion |
|---|---|---|---|
| Picture | Same structure | ||
| Indicationsfor use | The device is intended to befitted to an endoscopebiopsy port to preventleakage of gases and bodyfluids during an endoscopicprocedure | The DEFENDO™ Disposable Biopsy Valve isindicated for covering theendoscope biopsy portduring an endoscopyprocedure. The valveprovides access forendoscopic device passageand exchange, helpsmaintain sufflation andminimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure. | Substantiallyequivalent. Bothdevices are usedon the endoscopesbiopsy port toprevent leakage. |
| Product code | ODC | ODC | Substantiallyequivalent. |
| Regulationnumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatibleendoscopes | Olympus140/160/180/190/240/260/290 series endoscopes | Olympus GI endoscopes | Substantiallyequivalent, bothdevices are usedfor Olympus GIendoscopes. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | Silicon rubber | TPE | Different while bothdevices areevaluatedaccording to ISO10993-1. |
| Environmentof use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 3 Substantial equivalence discussion – Biopsy Valve
{10}------------------------------------------------
K200769 Page 8 of 11 pages
{11}------------------------------------------------
| Table 4 Substantial equivalence discussion – Water Connector | |||
|---|---|---|---|
| Devicefeature | Disposable EndoscopeWater Connectors (subjectdevice) | EndoGator™ SystemK092429(predicatedevice) | Discussion |
| Indicationsfor use | The device is intended toprovide irrigation via sterilewater supply during GIendoscopic procedureswhen used in conjunctionwith an irrigation pump. | The EndoGator™ system(tubing and accessories toaccommodate variousendoscopes and irrigationpumps) is intended toprovide irrigation via sterilewater supply during GIendoscopic procedureswhen used in conjunctionwith an irrigation pump (orcautery unit) | Substantiallyequivalent. Bothdevices are usedto provide irrigationduring GIendoscopicprocedures. |
| Picture | Image: Disposable Endoscope Water Connectors | Image: EndoGator System | The predicatewater connector isa component of theEndoGator™system. Bothdevices consist ofluer taper to beconnected to thewater tubing,connector beconnected to theendoscope and theintermediate checkpiece to preventbackflow. |
| Product code | ODC | FEQ | Different as thepredicate deviceconsists of apump, tubing andaccessories. |
| Regulationnumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
{12}------------------------------------------------
K200760 Page 10 of 11
| Classification | II | II | Page 10 of 11 pages |
|---|---|---|---|
| Compatibleendoscopes | Olympus140/160/180/190/240/260/290 series endoscopes | Olympus GI endoscopes | Substantiallyequivalent, bothdevices are used forOlympus GIendoscopes. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | SIR, PVC, PC, Stainlesssteel 303 | NBR, SIR, ABS | Different while bothdevices areevaluatedaccording to ISO10993-1. |
| Environment of use | Hospitals/clinics | Hospitals/clinics | Identical |
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met.
Performance testing
WILSON INSTRUMENTS (SHA) CO., LTD has performed bench testing to support substantial equivalence. The following tests were performed on the subject devices and predicate devices.
Disposable Air/Water Valves WS-VO-01:
- Time of inflation of 8KPa air -
- -Time of injection of 10g water
Disposable Suction Valves WS-VO-02:
-
Time of suction of 200g water -
Disposable Biopsy Valves WS-M-01S: -
Plug-in performance: Depression force, pull out force -
-
Sealing performance: Leakage test, flush open force -
-
Fitting test -
{13}------------------------------------------------
Disposable Endoscope Water connectors WS-VO-03:
- Leakage test under 80Kpa forward pressure -
- -Leakage test under 30Kpa reverse pressure
Disposable Air/Water Valves WS-VP-01:
- Amount of water feeding -
- Amount of air feeding -
- -Depression force
- -Sealing performance
Disposable Suction Valves WS-VP-02:
- -Amount of suction
- -Depression force
Sterilization and Shelf-life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. 3-year shelf-life of the device has been evaluated by accelerated aging test.
VIII Conclusion
The Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B are substantially equivalent to the predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.