(126 days)
Not Found
No
The device description and performance studies focus on mechanical components and fluid control, with no mention of AI/ML technologies.
No.
The device is a system of valves and connectors intended to enable operator control of endoscope channels and prevent fluid backflow rather than performing a therapeutic function itself.
No
The device is an accessory for endoscopes, designed to control the function of working channels/ports and prevent retrograde flow, not to diagnose medical conditions.
No
The device description clearly outlines physical components (valves, connector) made of materials and intended to be fitted to endoscopes. The performance studies focus on physical characteristics like sealing, flow, strength, and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being fitted to an endoscope to control the flow of gases, water, and enable access for other endoscopic devices. It is used during an endoscopic procedure on a patient.
- Device Description: The description reinforces that the valves are used with endoscopes to control functions and prevent backflow of materials during a procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens in vitro (outside the body) for diagnostic purposes. IVDs are typically used to test samples like blood, urine, or tissue to diagnose diseases or conditions.
- Performance Studies: The performance studies focus on the physical performance of the valves (sealing, flow, strength, compatibility) and biocompatibility, not on the accuracy or reliability of a diagnostic test.
The device is an accessory used with an endoscope for procedural purposes, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.
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 biomaterial 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.
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
The Endoscope Valves System are used to fit to multiple endoscopes 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 and a water connector. 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)
Non-Clinical Testing:
Biocompatibility testing: 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
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September 8, 2022
Changzhou Endoclean Medical Device Co., Ltd. Wang Qi, QA Manager West Side of 4th Floor, Building E2, No.9 Changyang Road Changzhou. Jiangsu 213149 CHINA
Re: K221331 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: August 9, 2022 Received: August 10, 2022
Dear Wang Qi:
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 statutes and regulations administered by other Federal agencies. You must comply with all the
1
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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K221331
Device Name Disposable Endoscope Valves System
Indications for Use (Describe)
The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.
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 biomaterial 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.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) summary-K221331
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: Aug. 09, 2022
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 |
| Valves name | Classification name | Regulation number | Classification |
|---|---|---|---|
| Biopsy Valve | ODC- endoscope channel accessory | 876.1500 | Class II |
| Air/Water Valve; | ODC- endoscope channel accessory | 876.1500 | Class II |
| Suction Valve | ODC- endoscope channel accessory | 876.1500 | Class II |
| Water Jet Connector | ODC- endoscope channel accessory | 876.1500 | Class II |
Table 1 Valves included in this submission
4
III. Predicate Devices
- 510(k) Number: K090851 a. Common name: Endoscopes and accessories Classification: 21 CFR 876.1500 Product Code: ODC Trade name: DEFENDO™ Biopsy Valve for Olympus and Fujinon Endoscopes DEFENDOTM Biopsy Valve for Pentax Endoscopes Manufacturer: Medivators Inc formerly Byrne Medical
- 510(k) Number: K200769 b. Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Manufacturer: Wilson Instruments (SHA) Co., LTD.
- C. 510(k) Number: K102409 Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: DEFENDO™ Disposable Air/Water Valve for GI Endoscopes Manufacturer: Medivators Inc formerly Byrne Medical
IV. Device description
The Endoscope Valves System are used to fit to multiple endoscopes 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 and a water connector. 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 mav be sold as both sterile and non-sterile.
V. Indication for use
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, and a water connector.
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 biomaterial during an endoscopic procedure.
5
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.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device | Predicate device
(K090851) | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Disposable Biopsy
Valves | Disposable Biopsy
Valves | - |
| Product Code | ODC | ODC | same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications
for Use | The Biopsy Valves 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. | The DEFENDO™
Disposable Biopsy
Valve is indicated for
covering the
endoscope biopsy port
during an endoscopy
procedure. The valve
provides access for
endoscopic device
passage and
exchange, helps
maintain sufflation and
minimizes leakage of
biomaterial from the
biopsy port throughout
the endoscopic
procedure. | similar |
| Compatible
endoscopes | EDKN-004001/
EDKN-004006/
EDKN-004012: | Olympus®
Endoscopes &
Fujifilm® Endoscopes | Similar¹ |
| | OLYMPUS Endoscope
Series
140/160/180/190/240/
260/290; & FUJIFILM
Endoscope 700 Series;
EDKN-004009: Pentax
Endoscope 90 Series; | (100301)
Pentax® Endoscopes
(100302) | |
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | Thermoplastic
elastomer | Silicone | Different2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |
Table 2 Substantial equivalence discussion - Biopsy Valve
6
Table 3 Substantial equivalence discussion –Air/Water Valves
| Item | Proposed device | Predicate device
(K102409) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Disposable Air/Water
Valves | DEFENDO™
Disposable Air/Water
Valve | - |
| Product Code | ODC | ODC | same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications for Use | The 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. | The Single Use
Air/Water
Valve is intended to be
used to control the
air/water function on an
endoscope during a GI
endoscopic procedure. | similar |
| Compatible
endoscopes | EDKN-004007:
OLYMPUS Endoscope
Series | OLYMPUS Endoscope
Series | Similar1 |
7
| | 140/160/180/190/240/
260/290;
EDKN-004010: Pentax
Endoscope 90 Series;
EDKN-004013:
FUJIFILM Endoscope
700 Series; | 140/160/180/240/ 260; | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------|
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | Silicone, ABS, TPE,
SUS 303 | PC, TPE, Stainless
steel 304 | Similar2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |
Table 4 Substantial equivalence discussion --Suction Valve
| Item | Proposed device | Predicate device
(K200769) | Discussion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product
name | Disposable Suction
Valves | Disposable Suction
Valves | - |
| Product
Code | ODC | ODC | same |
| Regulation
No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications
for Use | The Disposable Suction
Valve is intended to be
fitted to an endoscope
suction channel to
enable the operator to
control suction. | The device is intended
to be fitted to an
endoscope suction
channel to control the
operations of suction,
whilst preventing inflow
of air. | similar |
| Compatible
endoscope
s | EDKN-004008:
OLYMPUS Endoscope
Series
140/160/180/190/240/
260/290; | WS-VO-02: Olympus
140/160/180/190/240/2
60/290 series
endoscopes | Similar¹ |
8
| | EDKN-004011: Pentax
Endoscope 90 Series;
EDKN-004014:
FUJIFILM Endoscope
700 Series; | WS-VP-02: PENTAX GI
Video Endoscope
90K/90i Series; K10/i10
Series | |
|------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------|
| Environme
nt of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | SUS 303, ABS, TPE,
NBR, | WS-VO-02: SIR, ABS,
TPE, Stainless steel
304, Stainless steel
17-4PH;
WS-VP-02: SIR, ABS,
TPE, Stainless steel
304 | Similar2 |
| Single for
Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |
Table 5 Substantial equivalence discussion –Water Jet Connector
| Item | Proposed device | Predicate device
(K200769) | Discussion |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product
name | Disposable Water Jet
Connector | Disposable Endoscope
Water Connectors | - |
| Product
Code | ODC | ODC | same |
| Regulation
No. | 21 CFR 876.1500 | 21 CFR 876.1500 | same |
| Class | Class II | Class II | same |
| Indications
for Use | The Water Jet Connector is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery. | The device is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air. | similar |
9
K221331 Page 7 of 8
| Compatible
endoscopes | EDKN-004002&
EDKN-004003:
OLYMPUS Endoscope
Series
140/160/180/190/240/
260/290;
EDKN-004004: Pentax
Endoscope 90 Series;
EDKN-004005:
FUJIFILM Endoscope
700 Series; | Olympus
140/160/180/190/240/2
60/290 series
endoscopes | Similar1 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------|
| Environment of Use | Hospital and/or clinics | Hospital and/or clinics | same |
| Material | PC, TPR, NBR, SUS
303 | SIR, PVC, PC,
Stainless steel 303 | Similar2 |
| Single for Use | Yes | Yes | same |
| Sterilization | EO | EO | same |
| Shelf life | 3 years | 3 years | same |
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.
2 The difference in the materials and colors does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices has been performed on the final finished device which includes all construction materials and color additives. The test results show pass the requirements.
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
10
accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (