(142 days)
No
The device description and intended use focus on mechanical components for controlling fluid and gas flow during endoscopy. There is no mention of AI, ML, image processing, or data analysis capabilities.
No.
This device is an accessory that controls fluids, gases, and materials during an endoscopic procedure, but it does not directly treat or diagnose a disease or condition.
No
The device is described as controlling the flow of fluids, gases, and other materials during endoscopic procedures, and providing irrigation. Its function is operational and supportive to the endoscopic procedure, not to diagnose a condition.
No
The device description clearly states it is a collection of "sterile units" intended to be "fitted to multiple endoscope working channels/ports," which are physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Disposable Endoscopy Adapter Set is described as a collection of sterile units intended to be fitted to endoscope working channels/ports to control the flow of fluids, gases, and other materials during an endoscopic procedure.
- Lack of Sample Analysis: The device does not perform any analysis on samples taken from the body. Its function is purely mechanical and related to the operation of the endoscope itself.
- Intended Use: The intended use clearly describes controlling flow and preventing leakage during the procedure, not analyzing biological samples.
Therefore, the Disposable Endoscopy Adapter Set is a medical device used in conjunction with an endoscope for procedural support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Endoscopy Adapter 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.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Product codes
ODC
Device Description
The Disposable Endoscopy Adapter 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. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
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/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 proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing.
No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
June 17, 2022
Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 China
Re: K220210
Trade/Device Name: Disposable Endoscopy Adapter Set Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: May 9, 2022 Received: May 16, 2022
Dear Ethan Liu:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-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-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).
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
Device Name
Disposable Endoscopy Adapter Set
The Disposable Endoscopy Adapter 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.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Address:Beizhou Road, Lidian Town, Guangling District, Yangzhou
225106 Jiangsu, China |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ethan Liu
RA Specialist
Shanghai Thinkwell Consulting Co., Ltd
Address: Room 211/6F, Xinling Road, Minhang District, Shanghai,
China.
Phone: 0086-15216699240
Email: xtdeepwater@126.com |
| Date Prepared: | Jan 27, 2022 |
5.2 Device
| Device Name: | Disposable Endoscopy Adapter Set |
|---|---|
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.3 Predicate Device
| Device Name: | Disposable Endoscope Valves Set, Disposable Endoscope
Valves Set B, K200769 |
|----------------------|--------------------------------------------------------------------------------|
| Manufacturer: | Wilson Instruments (SHA) Co., LTD |
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.4 Device Description
The Disposable Endoscopy Adapter 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. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set
4
Image /page/4/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are bold and interconnected, with a slight slant to the right. A yellow line extends from the top right of the "Y", adding a touch of color to the otherwise monochromatic design. The overall impression is of a modern and dynamic logo.
may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
5.5 Indication for Use:
The Disposable Endoscopy Adapter 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.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
5.6 Comparison of Technological Characteristics
The Disposable Endoscopy Adapter Set has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Wilson Instruments (SHA) Co., LTD's Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Disposable Endoscopy
Adapter Set(Proposed
Device) | Disposable Endoscope Valves
Set, Disposable Endoscope
Valves Set B, K200769 | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indication
for Use | The Disposable Endoscopy
Adapter 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. | 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. | Substantially
equivalent |
| | - Disposable Air/Water
Valve: This unit is intended
to be fitted to an endoscope
air/water channel to control
the inflow of medical gases
and water, whilst
preventing back-flow. | - 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 | |
| | - Disposable Suction Valve: | | |
| Item | Disposable Endoscopy
Adapter Set(Proposed
Device) | Disposable Endoscope Valves
Set, Disposable Endoscope
Valves Set B, K200769 | Discussion |
| | This unit is intended to be
fitted to an endoscope
suction channel to control
the operations of suction,
whilst preventing inflow of
air. | back-flow. | |
| | - Disposable Biopsy Valve:
This unit is intended to be
fitted to an endoscope
biopsy port to prevent
leakage of gases and body
fluids during an endoscopic
procedure. | - 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 Water Jet
Adapter: This unit is
intended to provide
irrigation via sterile water
supply during GI
endoscopic procedures
when used in conjunction
with an irrigation pump. | - 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 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. 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: | |
| Item | Disposable Endoscopy
Adapter Set(Proposed
Device) | Disposable Endoscope Valves
Set, Disposable Endoscope
Valves Set B, K200769 | Discussion |
| | | The device is intended to be
fitted to an endoscope suction
channel to enable the operator
to control suction whilst
preventing inflow of air. | |
| Product
Code | ODC | ODC | Same |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve | | | |
| Compatible
Endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | WS-VO-01:Olympus
140/160/180/190/240/260/2 90
series endoscopes
WS-VP-01: PENTAX GI
Video Endoscope 90K/90i
Series, K10/i10 Series | Substantially
equivalent
supported by
bench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber, ABS,
SUS304 | WS-VO-01: SIR, ABS, TPE,
Stainless steel 304
WS-VP-01: SIR, ABS, TPE,
Stainless steel 304 | Substantially
equivalent
supported by
biocompatibility
testing. |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve | | | |
| Compatible
Endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | WS-VO-02: Olympus
140/160/180/190/240/260/2 90
series endoscopes
WS-VP-02: PENTAX GI
Video Endoscope 90K/90i
Series; K10/i10 Series | Substantially
equivalent
supported by
bench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, Silicone Rubber,
SUS304 | WS-VO-02: SIR, ABS, TPE,
Stainless steel 304 | Substantially
equivalent |
| Item | Disposable Endoscopy
Adapter Set(Proposed
Device) | Disposable Endoscope Valves
Set, Disposable Endoscope
Valves Set B, K200769 | Discussion |
| | | WS-VP-02: SIR, ABS, TPE,
Stainless steel 304 | biocompatibility
testing. |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve | | | |
| Compatible
Endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | Olympus
140/160/180/190/240/260/290
series endoscopes | Substantially
equivalent
supported by
bench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber | Silicone Rubber | Same |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Water Jet Adapter | | | |
| Compatible
Endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | Olympus
140/160/180/190/240/260/290
series endoscopes | Substantially
equivalent
supported by
bench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Metal Type:PC,
SUS303,Silicone Rubber
Plastic Type: PC, Silicone
Rubber | NBR, SIR, ABS | Substantially
equivalent
supported by
biocompatibility
testing. |
| Environment
Use | Hospitals/clinics | Hospitals/clinics | Same |
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K220210
Page 3 of 6
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Image /page/7/Picture/0 description: The image shows the word "ARTLEY" in a stylized, italicized font. The letters are primarily blue, with a yellow accent on the right side of the "Y". The font appears to be bold and slanted, giving the word a dynamic and modern look. The overall design is clean and simple, with a focus on the word itself.
5.7 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical
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Image /page/8/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are bold and slightly slanted to the right, giving the word a dynamic appearance. A thin, yellow line extends from the top of the "Y", adding a subtle accent to the overall design.
devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing.
5.8 Clinical Test Data
No Clinical Study is included in this submission.
5.9 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Endoscopy Adapter Set is substantially equivalent to Wilson Instruments (SHA) Co., LTD's currently marketed Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769.