(124 days)
Not Found
No
The device description and intended use focus on mechanical components for controlling flow and access during endoscopic procedures. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No.
The device is a system of valves and adapters designed to facilitate the operation and cleaning of an endoscope, not to directly treat a medical condition.
No
This device describes components (valves, connectors, adapters) used to control functions and assist with cleaning endoscopes. It does not mention any function related to diagnosing a medical condition.
No
The device description clearly outlines physical components (valves, connectors, adapters) and their intended use in controlling flow and providing access during endoscopic procedures. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device's function as controlling the flow of gases, water, and enabling access for endoscopic devices during an endoscopic procedure. It is used in conjunction with an endoscope to facilitate the procedure itself.
- Device Description: The description reinforces the device's role as an accessory to endoscopes, controlling channels and preventing backflow.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
- Performance Studies: The performance studies focus on the device's functionality, compatibility with endoscopes, sterilization, and shelf-life, not on the accuracy or reliability of diagnostic results from analyzing biological samples.
- Predicate Device: The predicate device (EVIS EXERA III VIDEO SYSTEM) is an endoscopic system, further indicating the device's role in endoscopic procedures, not in vitro diagnostics.
In summary, the Disposable Endoscope Valves System is an accessory used during an endoscopic procedure to manage the endoscope's functions. It does not perform any diagnostic testing on biological samples outside the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
The Endoscope Valves System are used to fit to multiple endoscope working channels/ports to enable an endoscope 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 Adapter and suction cleaning adapter. All valves are 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 valve may be sold as both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and/or clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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(
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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).
2
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
3
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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4
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. |
5
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.
| Character
| istics | Proposed device | Predicate device | Discussion |
|---|---|---|---|
| Product | |||
| name | AW Channel Cleaning Adapter | AW channel cleaning adapter | Same |
| Indications | |||
| 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. | During precleaning of the | ||
| endoscope, the AW channel | |||
| cleaning adapter is attached | |||
| to the air/water cylinder of the | |||
| endoscope. When the button | |||
| of the adapter is depressed, | |||
| the water in the water | |||
| container is fed through the | |||
| air/ water nozzle of the | |||
| endoscope to clean the | |||
| nozzle and air/water | |||
| channels of the endoscope. | |||
| Air is continuously fed | |||
| through 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 Series | |||
| 140/160/180/190/240/ | |||
| 260/290; | |||
| EDKN-004010: Pentax | |||
| Endoscope 90 Series; | |||
| EDKN-004013: FUJIFILM | |||
| Endoscope 700 Series; | OLYMPUS Endoscope | ||
| Series 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
6
Table 2 General Comparison of Suction Cleaning Adapter
| Character
istics | Proposed device | Predicate device | Discussio
n |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Product | Suction Cleaning Adapter | Suction Cleaning Adapter | Same |
| name | | | |
| Indications
For Use | 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 suction cleaning adapter
is used to aspirate
reprocessing fluids through
the
instrument channel port of
the endoscope. | Same |
| Product
Code | ODC | FDF | Different |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | 11 | Same |
| Environme
nt of use | Hospital and/or clinics | Hospital and/or clinics | Same |
| Compatibl
e
endoscop
es | EDKN-004007:
OLYMPUS Endoscope
Series
140/160/180/190/240/
260/290;
EDKN-004010: Pentax
Endoscope 90 Series;
EDKN-004013: FUJIFILM
Endoscope 700 Series; | OLYMPUS Endoscope
Series 140/160/180/240/
260; | Similar¹ |
| Material | Silicone, ABS,PVC | Silicone, ABS,PVC | Silicone,
ABS,PVC |
| Single for
Use | Yes | Yes | Same |
| Sterilizatio
n | EO | EO | Same |
| | | | |
| Shelf life | 3 years | 3 years | Same |
| | | | |
7
8
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(