(95 days)
Not Found
No
The device description and intended use clearly describe mechanical valves and connectors for controlling air, water, and suction during endoscopic procedures. There is no mention of any computational or data-driven components that would suggest the use of AI or ML. The performance studies are based on bench testing of physical properties like flow, leakage, and force, not on algorithmic performance.
No.
These devices are accessories used to control functions of an endoscope during GI procedures, such as air/water flow, suction, and access/containment for biopsy. They do not directly treat or diagnose a disease or condition, which is the definition of a therapeutic device.
No
The devices described (Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Water Connector) are accessories used to control functions of an endoscope during GI procedures (e.g., controlling air/water, suction, providing access for instruments, irrigation). Their function is purely operational and assistive to the endoscopic procedure, not to diagnose a condition.
No
The device description clearly outlines physical components (valves, connectors) made of materials and designed for mechanical interaction with an endoscope, indicating it is a hardware device, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device descriptions clearly state that these devices are used during GI endoscopic procedures to control functions of the endoscope (air/water, suction, biopsy port access, irrigation). They are not used to analyze biological samples outside of the body.
- The function of these devices is mechanical and procedural. They facilitate the endoscopic procedure itself by controlling flow, providing access, and maintaining insufflation. They do not perform any diagnostic testing on biological material.
Therefore, these devices fall under the category of surgical or procedural accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 Olympus® 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 via irrigation fluids such as sterile water supplied to the Olympus® 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.
Product codes (comma separated list FDA assigned to the subject device)
OCX, ODC
Device Description
The subject devices are intended for single use. The components included in the submission are the ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and AQUAPULSE® 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 Olympus 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Compatibility test
- Flow test
- Leakage
- Pressing force test
- Fatigue test for suction valve
- Vacuum leak and squeegee leak for biopsy valve
- Endoscope compatibility
- Air leak
- Water leak for auxiliary water connector
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
July 7, 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, CHINA
Re: K230932 Trade/Device Name: ANDORATE® Valve Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX, ODC Dated: June 8, 2023 Received: June 8, 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 (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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen -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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
ANDORATE® Valve Kit
Indications for Use (Describe)
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 Olympus® aastro-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 Olympus® 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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3
K230932 Page 1 of 4 510(k) Premarket Notification: K230932 Valve Kit GA Health Company Limited CONFIDENTIAL
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
8 June 2023
4. Device Identification
- Device Name: Common Name: Requlation Number: Regulation Name: Product Code: Product Code Name:
Regulation Class: Device Panel:
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 .: Secondary Predicate Device Trade Name: Secondary Predicate Device Product Code: 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
K181509 Endorate Valve Sets ODC - Endoscope Channel Accessory K200481 Biopsy Valve ODC - Endoscope Channel Accessory K182998 Andorate Auxiliary Water Connector OCX - Endoscopic Irrigation/Suction System
-
- Device Description:
4
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 |
| AQUAPULSE® Auxiliary Water
Connector | ODC – Endoscope
channel accessory | 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 Olympus 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 Olympus® 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.
5
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 Olympus® 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.
Table 2 - Summary of design, features and principles of operation and technological characteristics between the subject device and predicate devices
| Specification | Primary Predicate Device | Secondary Predicate
Device | Secondary Predicate
Device | Subject Device | Substantial
Equivalence |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device Name | Endorate Valve Sets | Andorate Biopsy Valve | Andorate Auxiliary Water
Connector | ANDORATE® Valve Kit | N/A |
| K Number | K181509 | K200481 | K182998 | / | N/A |
| Product Code | ODC | 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 Endorate™ Disposable
Suction valve is used to
control the suction function of
an endoscope during a GI
Endoscopic procedure.
The Endorate™ Disposable
Air/Water valve is used to
control the air/water function
of an endoscope during a GI
Endoscopic procedure.
The Endorate™ 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. | 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. | The Andorate™ 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 endoscope
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 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
Olympus® 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 | Substantial
Equivalent |
6
K230932 Page 4 of 4
510(k) Premarket Notification: K230932 Valve Kit GA Health Company Limited CONFIDENTIAL
| Specification | Primary Predicate Device | Secondary Predicate
Device | Secondary Predicate
Device | Subject Device | Substantial
Equivalence |
|---------------------------|---------------------------------------------------------------------------------|-------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | | | | used in conjunction with
irrigation tubing, intended to
provide irrigation via irrigation
fluids such as sterile water
supplied to the Olympus® 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. | |
| 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 | Acrylonitrile-Butadiene-
Styrene Copolymer, Silicone,
Stainless steel 304 | Silicone | Polycarbonate, silicone | Polycarbonate, Acrylonitrile
Butadiene Styrene,
Thermoplastic Elastomer,
Silicone Rubber, Stainless
Steel | 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, pressing force test and fatigue 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
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.