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.

Device Description

The subject devices are intended for single use. The components included are the ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and ANDORATE® Auxiliary Water Connector. The suction valve controls the suction function, the air/water valve controls air and water flow, the biopsy valve covers the biopsy port and allows access for devices, and the auxiliary water connector provides irrigation fluids and has a one-way valve. The devices are packed in a sealed pouch and are supplied sterile.

AI/ML Overview

The provided text is a 510(k) summary for the ANDORATE® Valve Kit, which describes the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically found in AI/ML device submissions.

The ANDORATE® Valve Kit consists of mechanical components (valves and connectors) used with endoscopes. The performance testing outlined is focused on engineering specifications and biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for devices that provide diagnostic or prognostic information based on AI/ML.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets acceptance criteria (especially points 1-7 which pertain to diagnostic performance), the document states that "bench testing was performed to support substantial equivalence on both the subject device and the predicate device." It then lists the types of tests conducted:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with corresponding performance values for a diagnostic AI/ML device. Instead, it states that "the performance data demonstrated that the subject devices met established specifications in the following non-clinical tests." The listed tests are functional and safety-related:

ANDORATE® Suction Valve: Compatibility test, flow test, leakage, and pressing force test.
ANDORATE® Air/Water Valve: Compatibility test, flow tests, leakage, and pressing force test.
ANDORATE® Biopsy Valve: Vacuum leak and squeegee leak.
ANDORATE® Auxiliary Water Connector: Endoscope compatibility, air leak, water leak.

The acceptance criteria for these tests are implied to be "established specifications" but are not explicitly detailed in the provided text (e.g., a specific leakage rate limit or flow rate range).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided, as the device is a mechanical endoscope accessory and not an AI/ML diagnostic device that uses a "test set" of patient data in the typical sense. The "test set" here refers to the physical devices undergoing bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a mechanical accessory, and its performance is evaluated against engineering specifications, not clinical interpretations requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no clinical data or diagnostic assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable, as the device is a mechanical accessory, not an AI-assisted diagnostic tool.

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

This is not applicable, as the device is a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests undertaken is based on engineering specifications and physical measurements (e.g., flow rates, leak resistance, force required for activation). There is no "pathology" or "outcomes data" ground truth as typically understood for diagnostic devices.

8. The sample size for the training set

This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm requiring a training set.

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

This is not applicable, as the device is a mechanical accessory and does not involve an AI/ML algorithm or training set.

In summary, the provided document details the non-clinical (bench) performance testing of a mechanical endoscope accessory kit. It confirms that these tests demonstrated the device met "established specifications," which serves as the implicit acceptance criteria. However, it does not provide the detailed quantitative acceptance criteria or results in a table format, nor does it contain any information relevant to the evaluation of an AI/ML diagnostic tool.

Summary

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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.

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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).

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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

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Indications for Use

Submission Number (if known)

K232118

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

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

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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	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
ANDORATE® Auxiliary Water Connector	OCX – EndoscopicIrrigation/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

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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	SubstantialEquivalence
Device Name	Andorate Auxiliary WaterConnector, Andorate ValvesSet	Andorate DisposableAir/Water Valve, AndorateDisposable Suction Valve	AquaPulse Auxiliary WaterConnector	ANDORATE® Valve Kit	N/A
K Number	K191231	K200495	K200479	/	N/A
Product Code	ODC, OCX	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 Andorate Auxiliary WaterConnector (Model GAR048)is used in conjunction withirrigation tubing (notsupplied), intended toprovide irrigation via irrigationfluids such as sterile watersupplied to the Pentax 90series endoscope duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump.The disposable AndorateValves Set (Model GAR037)consists of one suction valve,one air/water valve and onebiopsy valve.-The Andorate DisposableSuction Valve is used tocontrol the suction function ofan endoscope (for Pentax 90	The Andorate® DisposableSuction Valve is used tocontrol the suction function ofan endoscope (Fujifilm 700series) during a GlEndoscopic procedure. TheAndorate® DisposableAir/Water valve is used tocontrol the air/water functionof an endoscope (Fujifilm 700series) during a GIEndoscopic procedure.	The AquaPulse® AuxiliaryWater Connector is used inconjunction with irrigationtubing (not supplied),intended to provide irrigationvia irrigation fluids such assterile water supplied to theFujifilm GI endoscopesduring 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 Glendoscopic 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 ofgastro-intestinal endoscopes.The Biopsy Valve providesaccess for endoscopic devicepassage and exchange,helps maintain insufflation,minimizes leakage ofbiomaterial from the biopsyport through the endoscopic	SubstantialEquivalent

Table 2 - Summary of design, features and principles of operation and technological characteristics between the subject device and predicate devices

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Specification	Primary Predicate Device	Secondary Predicate Device	Secondary Predicate Device	Subject Device	SubstantialEquivalence
	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.
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	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	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 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

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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.