(124 days)
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.
Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.
The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. It includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope.Some valvemay besold as both sterileand non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Endoscope Valves System) seeking FDA clearance based on substantial equivalence to a predicate device. This type of submission generally focuses on non-clinical testing to demonstrate performance, safety, and equivalence, rather than a clinical study in the traditional sense of evaluating efficacy in human subjects.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" with specific numerical targets in a table format for the performance tests. Instead, it states that "All evaluation acceptance criteria were met" for biocompatibility and that performance testing was conducted to verify "all design specifications" and "substantial equivalence to the predicate device." The reported device performance is summarized as meeting these unspecified criteria.
Here's how we can infer the "acceptance criteria" and "reported performance" based on the described tests:
| Acceptance Criteria (Inferred from testing purpose) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| No cytotoxicity | Met |
| No irritation | Met |
| No intracutaneous reactivity | Met |
| AW Channel Cleaning Adapter: | |
| Adequate Water flow | Met design specifications |
| Performance comparable to predicate device | Met design specifications |
| Suction Cleaning Adapter: | |
| Adequate Suction flow | Met design specifications |
| Performance comparable to predicate device | Met design specifications |
| Compatibility: | |
| Functional with claimed endoscope models | Compatible with all claimed endoscopes (Pentax, Olympus, Fujifilm Gastrointestinal Endoscopes) |
| Sterilization: | |
| Sterility per ISO 11135 | Validated routine control and monitoring parameters established |
| Shelf-life: | |
| 3-year shelf life | Evaluated by accelerated aging test; 3-year shelf-life confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the performance tests (e.g., water flow, suction flow, side-by-side or compatibility tests). The data provenance is implied to be from the manufacturer's internal testing. The country of origin of the manufacturer is China. The nature of the tests (performance, biocompatibility) implies they are prospective tests performed on new device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is usually associated with clinical studies involving human observers or expert reviews of complex data (e.g., medical images). For a device like an endoscope valve system, "ground truth" is established through engineering and laboratory testing protocols, often by qualified technicians and engineers following established standards. The document does not mention the use of experts in the sense of medical specialists establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved. The non-clinical tests described (biocompatibility, water/suction flow, side-by-side, compatibility, sterilization, shelf-life) involve objective measurements and established protocols rather than subjective interpretation requiring adjudication.
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
Not applicable. The submitted device is a physical medical device (endoscope valves system), not an AI-powered diagnostic or assistive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The submitted device is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is based on:
- Biocompatibility: Established ISO standards (ISO 10993-1:2009) and laboratory test results demonstrating the absence of toxic or reactive responses.
- Performance (Water flow, Suction flow): Design specifications and performance characteristics of the predicate device, against which the proposed device was compared ("Side by side test").
- Compatibility: Successful functional operation with the specified endoscope models.
- Sterilization: Adherence to the validated sterilization parameters per ISO 11135.
- Shelf-life: Results from accelerated aging tests projecting a 3-year product life.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of an AI algorithm. The device's design and manufacturing processes are refined through engineering development, not machine learning training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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November 29, 2023
Changzhou Endoclean Medical Device Co., Ltd. Qi Wang QA Manager West Side of 4th Floor, Bldg E2, No.9 Changyang Rd., West Taihu Science and Technology Industrial Park, Wujin Disrict Changzhou, Jiangsu 213149 China
Re: K232244
Trade/Device Name: Disposable Endoscope Valves System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: October 30, 2023 Received: October 30, 2023
Dear Qi Wang:
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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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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, PhD Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Disposable Endoscope Valves System
Indications for Use (Describe)
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.
Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.
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)
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510(k) Summary
l. Submitter
Changzhou Endoclean Medical Device Co., Ltd.
West Side of 4th Floor, Building E2, No.9 Changyang Road, West Taihu Science and Technology Industrial Park, Wujin District, 213149 Changzhou City, Jiangsu Province, China
Establishment Registration Number: 3021349683
Contact person: Ms Wang Qi Position: QA Manager Tel.: +86-0519-68213060 E-mail: lena@endocleanmedical.com
Preparation date:July 11, 2023
Submission Correspondent
Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
II. Proposed Device
| Device Trade Name: | Disposable Endoscope Valves System |
|---|---|
| Common name: | Endoscope Channel Accessory |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: | ODC |
| Review Panel: | Gastroenterology/Urology |
III. Predicate Devices
| 510(k) Number: | K131780 |
|---|---|
| Trade name: | EVIS EXERA III VIDEO SYSTEM |
| Common name: | Endoscope Channel Accessory |
| Classification: | Class II |
| Product Code: | FDF |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
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IV. Device description
The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. It includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope.Some valvemay besold as both sterileand non-sterile.
V. Indication for use
Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.
Disposable Suction Cleaning Adapter also as one of accessories of the precleaning endoscopic irrigation. The one end can be connected to the biopsy channel, the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.
| Characteristics | Proposed device | Predicate device | Discussion |
|---|---|---|---|
| Productname | AW Channel Cleaning Adapter | AW channel cleaning adapter | Same |
| IndicationsFor Use | Disposable AW ChannelCleaning Adapter, it isattached to the air/watercylinder of the endoscope,used for the air water channelpre-cleaning after theprocedure. | During precleaning of theendoscope, the AW channelcleaning adapter is attachedto the air/water cylinder of theendoscope. When the buttonof the adapter is depressed,the water in the watercontainer is fed through theair/ water nozzle of theendoscope to clean thenozzle and air/waterchannels of the endoscope.Air is continuously fedthrough the air/water | Similar |
| channels when the button is not depressed. | |||
| Product Code | ODC | FDF | Different |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | II | Same |
| Environment of use | Hospital and/or clinics | Hospital and/or clinics | Same |
| Compatible endoscopes | EDKN-004007:OLYMPUS Endoscope Series140/160/180/190/240/260/290;EDKN-004010: PentaxEndoscope 90 Series;EDKN-004013: FUJIFILMEndoscope 700 Series; | OLYMPUS EndoscopeSeries 140/160/180/240/260; | Similar¹ |
| Material | ABS, SUS 303, TPE, Silicone, PP | ABS, SUS 303, TPE, Silicone, PP | Same |
| Single for Use | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Shelf life | 3 years | 3 years | Same |
VI. Comparison of technological characteristics with the predicate devices Table 1 General Comparison of AW Channel Cleaning Adapter
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Table 2 General Comparison of Suction Cleaning Adapter
| Characteristics | Proposed device | Predicate device | Discussion |
|---|---|---|---|
| Product | Suction Cleaning Adapter | Suction Cleaning Adapter | Same |
| name | |||
| IndicationsFor Use | Disposable Suction CleaningAdapter also as one ofaccessories of the pre-cleaning endoscopic irrigation.The one end can be connectedto the biopsy channel, theother end be connected to thewater container. It is used toaspirate reprocessing fluidsthrough the instrument channelport of the endoscope. | The suction cleaning adapteris used to aspiratereprocessing fluids throughtheinstrument channel port ofthe endoscope. | Same |
| ProductCode | ODC | FDF | Different |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | 11 | Same |
| Environment of use | Hospital and/or clinics | Hospital and/or clinics | Same |
| Compatibleendoscopes | EDKN-004007:OLYMPUS EndoscopeSeries140/160/180/190/240/260/290;EDKN-004010: PentaxEndoscope 90 Series;EDKN-004013: FUJIFILMEndoscope 700 Series; | OLYMPUS EndoscopeSeries 140/160/180/240/260; | Similar¹ |
| Material | Silicone, ABS,PVC | Silicone, ABS,PVC | Silicone,ABS,PVC |
| Single forUse | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Shelf life | 3 years | 3 years | Same |
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1 The proposed device has different compatibility scope than predicate device, for this different, the performance testing to the proposed device has included compatibility testing to all compatible endoscopes claimed, the testing results shown that the proposed devices are compatibility with all endoscopes claimed. So, this different does not affect the safety and effectiveness of proposed device.
VII. Non-Clinical Testing
The non-clinical tests were conducted to verify that the proposed device met all design specifications as was substantial equivalence to the predicate device.
Biocompatibility testing
Biocompatibility of the Disposable Endoscope Valves System were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface -Mucosal Membrane" with a contact duration of "Limited(< 24hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Intracutaneous Reactivity.All evaluation acceptance criteria were met.
Performance testing
The following performance testing was performed on the proposed device:
AW Channel CleaningAdapter
- Water flow test
- Side by side test
Suction CleaningAdapter
- Suction flow test
- Side by side test
In addition, the compatibility testing was conduct to support that the proposed device are compatibility with commercially endoscopes(i.e., Pentax, Olympus, and Fujifilm Gastrointestinal Endoscopes).
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.
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VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposeddevice has the same indication for useand has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate 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.