(91 days)
Not Found
No
The device description and intended use describe simple mechanical valves and connectors for controlling fluid and air flow during endoscopic procedures. There is no mention of any computational or analytical functions that would typically involve AI/ML. The performance studies are bench tests evaluating mechanical properties.
No.
The devices are accessories for controlling functions and providing access or irrigation during GI endoscopic procedures; they do not directly treat a disease or condition.
No
Explanation: The devices described are accessories for endoscopes (valves, connectors) that control functions like suction, air/water flow, or provide irrigation during GI endoscopic procedures. Their purpose is to facilitate the procedure itself, not to diagnose a condition.
No
The device description clearly outlines physical components (valves, connector) intended for single use and supplied sterile, indicating a hardware-based medical device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is to control functions of an endoscope during GI endoscopic procedures (suction, air/water flow, biopsy port access, irrigation). This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the mechanical functions of the valves and connector in facilitating the endoscopic procedure. There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of Diagnostic Elements: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. These devices do not perform such analysis.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical functionality and compatibility of the devices with endoscopes, not studies evaluating diagnostic accuracy.
In summary, these devices are accessories used to facilitate a medical procedure (endoscopy), not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.
The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation fluids such as sterile water supplied to the Gl endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of crosscontamination of the irrigation system.
Product codes
ODC, OCX
Device Description
The subject devices are intended for single use. The components included in the submission are: ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and ANDORATE® Auxiliary Water Connector.
The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while 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 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 is manufactured for use in conjunction with irrigation tubing, and endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The subject devices are packed in a sealed pouch and are supplied sterile. The subject devices in this submission have the same operation and method of action with the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI (Gastrointestinal)
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
Bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The performance data demonstrated that the subject devices met established specifications in the following non-clinical tests: compatibility test, flow test, leakage and pressing force test for suction valve; compatibility test, flow tests, leakage and pressing force test for air/water valve; vacuum leak and squeegee leak for biopsy valve; and endoscope compatibility, air leak, water leak etc. for auxiliary water connector respectively.
Key Metrics
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
October 16, 2023
GA Health Company Limited Wing Yu Lam Assistant Regulatory Affairs Manager Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, Hong Kong China
Re: K232118
Trade/Device Name: ANDORATE® Valve Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC, OCX Dated: July 12, 2023 Received: July 17, 2023
Dear Wing Yu Lam:
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 (OS) 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).
2
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/deviceadvice-comprehensive-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.
Sivakami Venkatachalam -S
for
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 HealthCenter for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ANDORATE® Valve Kit
Indications for Use (Describe)
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.
The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation fluids such as sterile water supplied to the Gl endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of crosscontamination of the irrigation system.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
-
- Submission Sponsor Submitter's Name: Submitter's Address:
Establishment Registration No.:
- Submission Sponsor Submitter's Name: Submitter's Address:
2. Sponsor Contact
GA Health Company Limited Unit 18, 21/F, Metropole Square 2 On Yiu Street, Shatin, N.T, Hong Kong, CHINA 3014749926
Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindv.ve@gahealth.com
Lam Wing Yu Assistant Requlatory Affairs Manager Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com
3. Date Prepared
29 March 2023
4. Device Identification
- Device Name: Common Name: Requlation Number: Requlation Name: Product Code: Product Code Name:
Regulation Class: Device Panel:
ANDORATE® Valve Kit Valve Kit for endoscope 21 CFR 876.1500 Endoscope and accessories ODC, OCX Endoscope Channel Accessory, Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
5. Predicate Device Identification Primary Predicate Device 510(k) No .:
Primary Predicate Device Trade Name:
Primary Predicate Device Product Code:
Secondary Predicate Device 510(k) No .: Secondary Predicate Device Trade Name:
Secondary Predicate Device Product Code: Secondary Predicate Device 510(k) No .:
K191231 Andorate Auxiliary Water Connector, Andorate Valves Set ODC - Endoscope Channel Accessory OCX - Endoscopic Irrigation/Suction System K200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve ODC - Endoscope Channel Accessory K200479
5
Secondary Predicate Device Trade Name:
AquaPulse Auxiliary Water Connector Secondary Predicate Device Product Code: OCX - Endoscopic Irrigation/Suction System
6. Device Description:
The subject devices are intended for single use. Table 1 shows the components included in the submission.
| Components | Product Code | Regulation
Number | Regulatory
Classification |
|-------------------------------------|-----------------------------------------------|----------------------|------------------------------|
| ANDORATE® Suction Valve | ODC – Endoscope
channel accessory | 21 CFR 876.1500 | 2 |
| ANDORATE® Air/Water Valve | ODC – Endoscope
channel accessory | 21 CFR 876.1500 | 2 |
| ANDORATE® Biopsy Valve | ODC – Endoscope
channel accessory | 21 CFR 876.1500 | 2 |
| ANDORATE® Auxiliary Water Connector | OCX – Endoscopic
Irrigation/Suction System | 21 CFR 876.1500 | 2 |
| Table 1 - Components included in the Submission |
|---|
| ------------------------------------------------- |
The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while 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 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 is manufactured for use in conjunction with irrigation tubing, and endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The subject devices are packed in a sealed pouch and are supplied sterile. The subject devices in this submission have the same operation and method of action with the predicate devices.
There were no prior submissions for the subject devices.
7. Intended Use:
The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic
6
device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.
The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation fluids such as sterile water supplied to the GI endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system.
8. Technological Characteristics
Table 2 summarizes the valve kit technological characteristics as compared to the predicate devices.
| Specification | Primary Predicate Device | Secondary Predicate Device | Subject Device | Substantial
Equivalence | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device Name | Andorate Auxiliary Water
Connector, Andorate Valves
Set | Andorate Disposable
Air/Water Valve, Andorate
Disposable Suction Valve | AquaPulse Auxiliary Water
Connector | ANDORATE® Valve Kit | N/A |
| K Number | K191231 | K200495 | K200479 | / | N/A |
| Product Code | ODC, OCX | ODC | OCX | ODC, OCX | Substantial
Equivalent |
| Regulatory
Classification | 2 | 2 | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied
Sterile | Yes | Yes | Yes | Yes | Identical |
| Intended Use | The Andorate Auxiliary Water
Connector (Model GAR048)
is used in conjunction with
irrigation tubing (not
supplied), intended to
provide irrigation via irrigation
fluids such as sterile water
supplied to the Pentax 90
series endoscope during
gastrointestinal endoscopic
procedures when used in
conjunction with an irrigation
pump.
The disposable Andorate
Valves Set (Model GAR037)
consists of one suction valve,
one air/water valve and one
biopsy valve.
-The Andorate Disposable
Suction Valve is used to
control the suction function of
an endoscope (for Pentax 90 | The Andorate® Disposable
Suction Valve is used to
control the suction function of
an endoscope (Fujifilm 700
series) during a Gl
Endoscopic procedure. The
Andorate® Disposable
Air/Water valve is used to
control the air/water function
of an endoscope (Fujifilm 700
series) during a GI
Endoscopic procedure. | The AquaPulse® Auxiliary
Water Connector is used in
conjunction with irrigation
tubing (not supplied),
intended to provide irrigation
via irrigation fluids such as
sterile water supplied to the
Fujifilm GI endoscopes
during gastrointestinal
endoscopic procedures when
used in conjunction with an
irrigation pump. | The single use ANDORATE®
Air/Water Valve is used to
control the air / water function
of an endoscope during Gl
endoscopic procedures.
The single use ANDORATE®
Suction Valve is used to
control the suction function of
an endoscope during GI
endoscopic procedures.
The single use ANDORATE®
Biopsy Valve is used to cover
the opening to the
biopsy/suction channel of
gastro-intestinal endoscopes.
The Biopsy Valve provides
access for endoscopic device
passage and exchange,
helps maintain insufflation,
minimizes leakage of
biomaterial from the biopsy
port through the endoscopic | Substantial
Equivalent |
Table 2 - Summary of design, features and principles of operation and technological characteristics between the subject device and predicate devices
7
| Specification | Primary Predicate Device | Secondary Predicate Device | Secondary Predicate Device | Subject Device | Substantial
Equivalence |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | series Endoscope) during a GI Endoscopic procedure. | | | procedure and provides access for irrigation. | |
| | -The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure. | | | The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation via irrigation fluids such as sterile water supplied to the GI endoscope | |
| | -The Andorate Disposable biopsy valve is used 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. | | | during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system. | |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or
Reusable | Single Use | Single Use | Single Use | Single Use | Substantial
Equivalent |
| Material | Polycarbonate, Acrylonitrile Butadiene Styrene, silicone, Stainless Steel 304 | Acrylonitrile Butadiene Styrene, silicone, Stainless Steel 304 | Polycarbonate, silicone | Polycarbonate, Acrylonitrile Butadiene Styrene, Silicone Rubber, Parylene-N, Stainless Steel 304 | Substantial
Equivalent |
| Manufacturing
method | Injection moulding | Injection moulding | Injection moulding | Injection moulding | Substantial
Equivalent |
| Packaging | Packaged in a sealed pouch | Packaged in a sealed pouch | Packaged in a sealed pouch | Packaged in a sealed pouch | Substantial
Equivalent |
| Sterilization | EO Gas | EO Gas | EO Gas | EO Gas | Substantial
Equivalent |
9. Performance Test
The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The performance data demonstrated that the subject devices met established specifications in the following non-clinical tests such as compatibility test, flow test, leakage and pressing force test for suction valve and compatibility test, flow tests, leakage and pressing force test for air/water valve, vacuum leak and squeegee leak for biopsy valve and endoscope compatibility, air leak, water leak etc. for auxiliary water connector respectively.
10. Biocompatibility
The biocompatibility of the subject devices was conducted in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing is conducted on subject device in accordance with the ISO 10993 standard. The test result shows that both the subject devices are biocompatible.
11.Conclusion
8
The subject devices have the same intended use as the predicate devices. Based on the technological characteristics and overall performance of the devices in bench testing, there are no significant differences exist between the subject devices and the predicate devices. The subject devices do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.