(147 days)
Not Found
No
The device description and intended use focus solely on mechanical components for controlling fluid and gas flow during endoscopic procedures. There is no mention of any computational or analytical functions, let alone AI/ML.
No.
The device is an accessory to an endoscope, an instrument that allows for visualization, but the device itself does not directly treat a disease or condition. It controls fluid and gas flow and prevents leakage during endoscopic procedures.
No
The device is a collection of sterile components (valves, connectors) designed to control the flow of fluids and gases in an endoscope and prevent leakage or backflow during procedures. Its function is to facilitate the endoscopic procedure, not to diagnose a condition.
No
The device is a collection of physical, sterile units (valves and connectors) intended to be fitted to an endoscope. The description focuses on the mechanical function and physical properties of these components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Endoscope Valve Sets are mechanical components designed to control the flow of fluids and gases within an endoscope during a procedure performed on the patient. They facilitate the endoscopic procedure itself, rather than analyzing samples taken from the patient.
- Intended Use: The intended use clearly describes controlling flow, preventing leakage, and providing irrigation during an endoscopic procedure. There is no mention of analyzing patient samples.
- Device Description: The description focuses on the mechanical function of the valves in relation to the endoscope and the procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic information, or any of the typical characteristics of an IVD.
Therefore, this device is a surgical accessory used during an endoscopic procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
-
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.
-
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.
-
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.
-
Auxiliary Water Connector: 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 (comma separated list FDA assigned to the subject device)
ODC
Device Description
The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device 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 an Auxiliary Water Connector.
-
The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
-
The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
-
The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
-
The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle. And there were no prior submissions for the subject devices.
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
Not Found
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 was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate.
Studies performed:
- Biocompatibility evaluation (MTT Cytotoxicity Test, Skin Sensitization Test, Skin Irritation Test, Acute Systemic Toxicity Test and Pyrogen Test)
- Sterilization Validation (EO sterilization process validated according to ISO11135:2014+A1:2018, ISO 11737-2:2019, ISO 10993-7:2008, USP )
- Shelf Life and Sterile Barrier System Validation (according to ASTM F1980-16, ISO11607-1:2019, ISO11607-2:2019, ASTM F 1929-15, ASTM D 3078-02(2013), DIN 58593-6: 2016, ASTM F88/F88M-15, ASTM D4169-16)
- Performance Data Bench (tests implemented on both subject and predicate device for comparison based on specific product specifications):
- Suction Valve: Endoscope Compatibility, Depression Force, Leakage Test, Suction Flow
- Air/Water Valve: Endoscope Compatibility, Air flow rate, Water flow rate, Leakage Test, Depression Force, Backflow Performance Test
- Biopsy Valve: Endoscope Compatibility, Leakage Test
- Auxiliary Water Connector: Endoscope Compatibility, Leakage Test, Water Flow Rate, Backflow Performance Test
Results:
The results of the nonclinical testing described conclude that the subject device is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 1, 2024
Alton (Shanghai) Medical Instruments Co. Ltd Johnny Song R&D Engineer No.24 Building Jinshao Rd.1688, Baoshan District Shanghai, Shanghai 200949 China
Re: K241285
Trade/Device Name: Disposable Endoscope Valves Set (AF series) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: May 7, 2024 Received: August 29, 2024
Dear Johnny Song:
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.
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"
1
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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, 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
3
Indications for Use
510(k) Number (if known) K241285
Device Name Disposable Endoscope Valves Set (AF series)
Indications for Use (Describe)
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
-
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.
-
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.
-
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.
-
Auxiliary Water Connector: 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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
I. SUBMITTER
Name: Alton (Shanghai) Medical Instruments Co. Ltd.
Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R.
China
Name of contact person: Vivian Li
Position: Director of Quality Department
Tel: +86 21 56771811
Fax: +86 21 66307823
Mail: vivian@alton.com.cn
Date prepared: 2024-09-27
II. Identification of Subjective Device
Device trade name: Disposable Endoscope Valves Set (AF series) Regulation Name: Endoscope and accessories Regulation number: 21CFR 876.1500 Regulation class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product code: ODC
III. Identification of Predicate device
Predicate Submission Number: K220884 Trade/Device Name: Disposable Endoscope Valve Sets Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscope Channel Accessory Product Code: ODC
5
IV. Device description
The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device 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 an Auxiliary Water Connector.
-
The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
-
The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
-
The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
-
The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle. And there were no prior submissions for the subject devices.
V. Indication for use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.
- 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.
6
-
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.
-
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.
-
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
| Attribute | Subject device | Predicative device (K220884) | Discussion/
Conclusion |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Manufacturer | Alton (Shanghai) Medical
Instruments Co. Ltd | SML Med-Tech Solutions Limited | / |
| Trade name | Disposable Endoscope Valves Set
(AF series) | Disposable Endoscope Valve Sets | / |
| Regulation name | Endoscope and accessories | Endoscope and accessories | Same |
| Regulatory Class | II | II | Same |
| Product code | ODC | ODC | Same |
| Clinical characteristics | | | |
| Indications for use | The Disposable Endoscope Valve
Sets 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 an Auxiliary Water
Connector. | The Disposable Endoscope Valve Same
Sets 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
an Auxiliary Water Connector.
- 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. - 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. - Biopsy Valve: This unit is
intended to be fitted to an | Same |
| Attribute | Subject device | Predicative device (K220884) | Discussion/
Conclusion |
| | intended to be fitted to an
endoscope biopsy port to prevent
leakage of gases and body fluids
during an endoscopic procedure. - Auxiliary Water Connector: This
unit is intended to provide
irrigation via sterile water supply
during GI endoscopic procedures
when used in conjunction with an
irrigation pump. | endoscope biopsy port to prevent
leakage of gases and body fluids
during an endoscopic procedure. - Auxiliary Water Connector: This
unit is intended to provide irrigation
via sterile water supply during GI
endoscopic procedures when used
in conjunction with an irrigation
pump. | |
| Compatible
endoscopes | AF-DVS3-O, AF-DVS4-O,
AF-BVC-O: Olympus® 140/ 160/
180/ 190/ 240/ 260/ 290 Series GI
Endoscope
AF-DVS3-P, AF-DVS4-P,
AF-BVC-P: Pentax® 90/ i10 GI
Endoscope
AF-DVS3-F, AF-DVS4-F,
AF-BVC-F: Fujifilm® 700 Series
GI Endoscope | SML002_LP01_AW: Olympus®
140/160/ 180/ 190/ 240/ 260/ 290
Series GI Endoscope
SML001_PT01_AW: Pentax®
90/i10 GI Endoscope
SML003_FJ01_AW: Fujifilm® 700
Series GI Endoscope | Same |
| General technological characteristics | | | |
| Device
composition and
specifications | AF-DVS3-O: Air/Water Valve+
Suction Valve+ Biopsy Valve
AF-DVS4-O: Air/Water Valve+
Suction Valve+ Biopsy Valve+
Auxiliary Water Connector
AF-BVC-O: Biopsy Valve
AF-DVS3-P: Air/Water Valve+
Suction Valve+ Biopsy Valve
AF-DVS4-P: Air/Water Valve+
Suction Valve+ Biopsy Valve+
Auxiliary Water Connector
AF-BVC-P: Biopsy Valve
AF-DVS3-F: Air/Water Valve+
Suction Valve+ Biopsy Valve
AF-DVS4-F: Air/Water Valve+
Suction Valve+ Biopsy Valve+
Auxiliary Water Connector
AF-BVC-F: Biopsy Valve | SML002: Air/Water Valve+ Suction
Valve+ Biopsy Valve+ Auxiliary
Water Connector
SML001: Air/Water Valve+ Suction
Valve+ Biopsy Valve
SML003: Air/Water Valve+ Suction
Valve+ Biopsy Valve | Same |
| Principle
of | Biopsy Valve: The Biopsy valve | Biopsy Valve: The Biopsy valve | Same |
| Attribute | Subject device | Predicative device (K220884) | Discussion/
Conclusion |
| | port to prevents gas and liquid | port to prevents gas and liquid from | |
| | from overflowing from the forceps
port, the cross cutting on the | overflowing from the forceps port,
the cross cutting on the surface can | |
| | surface can reduce friction
between the instrument and the | reduce friction between the
instrument and the forceps port. | |
| | forceps port.
Air/Water Valve: The principal | Air/Water Valve: The principal axis
of Air/Water valve is equipped with | |
| | axis of Air/Water valve is
equipped with different sizes of | different sizes of sealing rings,
which use spring to control advance | |
| | sealing rings, which use spring to
control advance and retreat, and | and retreat, and control the water
supply and air supply function of | |
| | control the water supply and air
supply function of endoscope in | endoscope in endoscopic surgery.
Suction Valve: The principal axis of | |
| | endoscopic surgery.
Suction Valve: The principal axis | Suction valve is equipped with
different sizes of sealing rings, | |
| | of Suction valve is equipped with
different sizes of sealing rings, | which use spring to control advance
and retreat, and endoscope suction | |
| | which use spring to control
advance and retreat, and | function in endoscopic surgery.
Auxiliary Water Connector: The | |
| | endoscope suction function in
endoscopic surgery. | principal axis of Auxiliary Water
Connector is equipped with sealing | |
| | Auxiliary Water Connector: The
principal axis of Auxiliary Water | rings, which used to prevent
leakage. One end is connected to an | |
| | Connector is equipped with
sealing rings, which used to | irrigation pump and the other to a
pipe. It acts as a connector through | |
| | prevent leakage. One end is
connected to an irrigation pump | which water passes. | |
| | and the other to a pipe. It acts as a
connector through which water | | |
| | passes. | | |
| Material | Air/Water Valve: ABS, Silicone
Rubber, TPE, Stainless steel 304 | Air/Water Valve: ABS, Silicone
Rubber, TPE, Stainless steel 304 | Same |
| | Suction Valve: ABS, PC, Silicone
Rubber, Stainless steel 304 | Suction Valve: ABS, PC, Silicone
Rubber, Stainless steel 304 | |
| | Biopsy Valve: Silicone Rubber | Biopsy Valve: Silicone Rubber | |
| | Water Connector: PC, Silicone
Rubber | Water Connector: PC, Silicone
Rubber | |
| Sterilization | Ethylene Oxide sterilization | Ethylene Oxide sterilization | Same |
| Attribute | Subject device | Predicative device (K220884) | Discussion/
Conclusion |
| Single use/reuse | For single use | For single use | Same |
| Shelf life | 3 years | Not known | Different,
see
discussion 1 |
VI. Comparison of technological characteristics with the predicate device
7
K241285
8
K241285
9
Discussion on differences between the subject device and the predicate device
Discussion 1: Although shelf life between the subject device and the predicate device is different, sterile process validation and shelf-life validation including performance test are performed on the subject device according to relevant standards, such differences will not affect the safety and effectiveness of the subject device.
VII. Summary of substantial equivalence discussion
Based on the above comparison table, the subject device and the predicate device are totally same on design features and performance specifications. There are no differences on device composition, specification and component material used as well on both devices. the only differences between the subject device and the predicate device are the sterile barrier system and other packages used for both devices. As all sterile process validation and shelf-life validation including performance test, transportation simulated test and biocompatibility tests are performed on the subject device according to relevant standards, such differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled.
VIII. Summary of Non-clinical Data
Non-clinical testing for Disposable Endoscope Valves Set was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed.
A Biocompatibility
The biocompatibility evaluation for the Disposable Endoscope Valves Set was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing
10
within a risk management process"" September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
- MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical . devices -- Part 5: Tests for In Vitro cytotoxicity
- Skin Sensitization Test, Skin Irritation Test: ISO 10993-10:2010, Biological . evaluation of medical devices -- Part 10: Tests for irritation and sensitization
- . Acute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
A Sterilization Validation
The EO sterilization of the Disposable Endoscope Valves Set has been validated according to the following applicable standards:
- ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization
- ISO 11737-2:2019 Sterilization of Medical Device-Microbiological . methods-part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals
- USP Bacterial endotoxins test .
- A Shelf Life and Sterile Barrier System
Shelf Life and Sterile Barrier System of the Disposable Endoscope Valves Set has been validated according to the following applicable standards:
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices
- . ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
- . ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
- ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous . page 7 of 9
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Medical Packaging by Dye Penetration
- ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks . in Flexible Packaging by Bubble Emission
- DIN 58593-6: 2016 Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
- . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM D4169-16 Standard practice for performance testing of shipping ● containers and systems (DC-13, Level II)
- Performance Data Bench A
The performance tests were implemented on both the subject device and the predicate device to demonstrate substantial equivalence according to the specific product specification as below listed:
Suction Valve:
- Endoscope Compatibility
- Depression Force
- Leakage Test
- Suction Flow
Air/Water Valve:
- Endoscope Compatibility
- Air flow rate
- Water flow rate
- Leakage Test
- Depression Force
- Backflow Performance Test
Biopsy Valve:
- Endoscope Compatibility
- Leakage Test
Auxiliary Water Connector:
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- Endoscope Compatibility
- Leakage Test
- Water Flow Rate
- Backflow Performance Test
- A Performance Data – Animal
N/A, no animal studies are available for the subject device.
IX. Summary of Clinical Data
N/A, no clinical studies are available for the subject device.
X. Conclusions
In conclusion, the technological characteristics, features, specifications, materials, principle of operation, and intended use of the subject device substantially equivalent to the predicate devices quoted above. The differences between the subjective device and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.