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.

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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ANDORATE® Valve Kit, which consists of various endoscopy accessories (Suction Valve, Air/Water Valve, Biopsy Valve, Auxiliary Water Connector). This notification focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a new device meets specific acceptance criteria for a novel functionality, especially regarding AI/machine learning.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI-powered device.

The study described is solely bench testing to demonstrate performance similarity to predicate devices, and biocompatibility testing.

Here's what can be extracted based on your prompt, addressing the lack of information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "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."

It lists the types of tests, implying the acceptance criteria were "met established specifications" or "performed comparably to predicate devices," but does not provide quantitative acceptance criteria or specific performance values for the ANDORATE® Valve Kit or its predicate devices.

Acceptance Criteria Category (Implied)	Specific Tests Performed	Reported Device Performance (General)
Functional Performance (Suction Valve)	Compatibility test, Flow test, Leakage, Pressing force test, Fatigue test	"met established specifications", "performed comparably to predicate devices", "no significant differences"
Functional Performance (Air/Water Valve)	Compatibility test, Flow tests, Leakage, Pressing force test	"met established specifications", "performed comparably to predicate devices", "no significant differences"
Functional Performance (Biopsy Valve)	Vacuum leak, Squeegee leak	"met established specifications", "performed comparably to predicate devices", "no significant differences"
Functional Performance (Auxiliary Water Connector)	Endoscope compatibility, Air leak, Water leak	"met established specifications", "performed comparably to predicate devices", "no significant differences"
Biocompatibility	ISO 10993 standard tests (specific tests like cytotoxicity, sensitization, irritation are typically performed but not detailed here)	"The test result shows that both the subject devices are biocompatible."

2. Sample size used for the test set and data provenance:

Sample Size: The document does not specify the number of units tested for any of the bench tests.
Data Provenance: The tests were "bench testing," meaning laboratory-controlled environments. No patient data or clinical data is mentioned. The company (GA Health Company Limited) is based in Hong Kong, China. The testing location is not specified, but it would typically be a testing facility or the manufacturer's lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The ground truth for this type of device (valves for endoscopes) is established by engineering specifications, functional requirements, and performance against predicate devices, not expert human interpretation of data like images or patient outcomes.

4. Adjudication method for the test set:

This is not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, this was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. The ANDORATE® Valve Kit is a mechanical accessory.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. This device is not an algorithm or software. It is a physical medical device accessory that assists a human operator (the endoscopist).

7. The type of ground truth used:

The "ground truth" for this device's performance is its adherence to engineering specifications, functional requirements, and comparative performance against legally marketed predicate devices in a laboratory setting through bench testing. There is no external "outcomes data" or "pathology" relevant to establishing the ground truth for simple valve functionality.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

This is not applicable. There is no "training set" for this type of device.

Summary

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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

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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

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Indications for Use

Submission Number (if known)

K230932

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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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.

1. Submission Sponsor Submitter's Name: Submitter's Address:
  Establishment Registration No.:

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

1. Device Description:

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The subject devices are intended for single use. Table 1 shows the components included in the submission.

Components	Product Code	RegulationNumber	RegulatoryClassification
ANDORATE® Suction Valve	ODC – Endoscopechannel accessory	21 CFR 876.1500	2
ANDORATE® Air/Water Valve	ODC – Endoscopechannel accessory	21 CFR 876.1500	2
ANDORATE® Biopsy Valve	ODC – Endoscopechannel accessory	21 CFR 876.1500	2
AQUAPULSE® Auxiliary WaterConnector	ODC – Endoscopechannel accessory	21 CFR 876.1500	2

	Table 1 – Components included in the Submission

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.

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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 PredicateDevice	Secondary PredicateDevice	Subject Device	SubstantialEquivalence
Device Name	Endorate Valve Sets	Andorate Biopsy Valve	Andorate Auxiliary WaterConnector	ANDORATE® Valve Kit	N/A
K Number	K181509	K200481	K182998	/	N/A
Product Code	ODC	ODC	OCX	ODC, OCX	SubstantialEquivalent
RegulatoryClassification	2	2	2	2	Identical
Regulation No	21 CFR 876.1500	21 CFR 876.1500	21 CFR 876.1500	21 CFR 876.1500	Identical
RegulationDescription	Endoscope and accessories	Endoscope and accessories	Endoscope and accessories	Endoscope and accessories	Identical
SuppliedSterile	Yes	Yes	Yes	Yes	Identical
Intended Use	The Endorate™ DisposableSuction valve is used tocontrol the suction function ofan endoscope during a GIEndoscopic procedure.The Endorate™ DisposableAir/Water valve is used tocontrol the air/water functionof an endoscope during a GIEndoscopic procedure.The Endorate™ Disposablebiopsy valve is used to coverthe endoscope biopsy portduring an endoscopyprocedure. In addition, thevalve provides access forendoscopic device passageand exchange, helpsmaintain insufflation andminimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure.	The Andorate® Disposablebiopsy valve is used to coverthe endoscope biopsy portduring an endoscopyprocedure. In addition, thevalve provides access forendoscopic device passageand exchange, helpsmaintain insufflation andminimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure.	The Andorate™ AuxiliaryWater Connector is used inconjunction with irrigationtubing (notsupplied), intended toprovide irrigation via irrigationfluids such as sterile watersupplied to the endoscopeduring gastrointestinalendoscopic procedures whenused in conjunction with anirrigation pump.	The single use ANDORATE®Air/Water Valve is used tocontrol the air / water functionof an endoscope during GIendoscopic procedures.The single use ANDORATE®Suction Valve is used tocontrol the suction function ofan endoscope during GIendoscopic procedures.The single use ANDORATE®Biopsy Valve is used to coverthe opening to thebiopsy/suction channel ofOlympus® gastro-intestinalendoscopes. The BiopsyValve provides access forendoscopic device passageand exchange, helpsmaintain insufflation,minimizes leakage ofbiomaterial from the biopsyport through the endoscopicprocedure and providesaccess for irrigation.The single use ANDORATE®Auxiliary Water Connector is	SubstantialEquivalent

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K230932 Page 4 of 4

510(k) Premarket Notification: K230932 Valve Kit GA Health Company Limited CONFIDENTIAL

Specification	Primary Predicate Device	Secondary PredicateDevice	Secondary PredicateDevice	Subject Device	SubstantialEquivalence
				used in conjunction withirrigation tubing, intended toprovide irrigation via irrigationfluids such as sterile watersupplied to the Olympus® GIendoscope duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump. The Auxiliary WaterConnector is manufacturedwith a one-way valve tominimize the risk of cross-contamination of the irrigationsystem.
Environmentof Use	Hospital and or clinics	Hospital and or clinics	Hospital and or clinics	Hospital and or clinics	Identical
Single Use orReusable	Single Use	Single Use	Single Use	Single Use	SubstantialEquivalent
Material	Acrylonitrile-Butadiene-Styrene Copolymer, Silicone,Stainless steel 304	Silicone	Polycarbonate, silicone	Polycarbonate, AcrylonitrileButadiene Styrene,Thermoplastic Elastomer,Silicone Rubber, StainlessSteel	SubstantialEquivalent
Manufacturingmethod	Injection moulding	Injection moulding	Injection moulding	Injection moulding	SubstantialEquivalent
Packaging	Packaged in a sealed pouch	Packaged in a sealed pouch	Packaged in a sealed pouch	Packaged in a sealed pouch	SubstantialEquivalent
Sterilization	EO Gas	EO Gas	EO Gas	EO Gas	SubstantialEquivalent

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.

Regulation Number and Section

§ 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.