The AquaPulse® Auxiliary Water Connector is used in conjunction 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.

Device Description

The subject device is intended for single-use and are supplied sterile. The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and together with Fujifilm 500/600/700 series 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 auxiliary water connector is packed individually in a sealed packed. The subject device is supplied as sterile. The subject device in this submission have the same operation and method of action with the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AquaPulse® Auxiliary Water Connector but does not include information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical performance for diagnostic or treatment purposes.

However, I can extract the information provided regarding the non-clinical performance data and frame it to answer some of your questions, interpreting the "performance test" results as the reported device performance to meet inferred "acceptance criteria" for basic functionality.

Here's an attempt to structure the available information, noting where specific details requested are not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for these tests. However, it implies that the device "passed" or "met expectations" for each test. The reported device performance is that these tests were "conducted" and presumably "passed" to support substantial equivalence.

Item No.	Acceptance Criteria (Inferred from Test Type)	Reported Device Performance
9.1.1	Compatibility with irrigation tubing (e.g., proper fit, secure connection)	Test conducted; device demonstrated compatibility.
9.1.2	Compatibility with endoscope (e.g., proper fit, secure connection with Fujifilm GI endoscopes)	Test conducted; device demonstrated compatibility.
9.1.3	Water Flow Test (e.g., adequate and unobstructed water flow)	Test conducted.
9.1.4	Air Leakage Test (e.g., no detectable air leakage)	Test conducted; no leakage reported (by passing inference).
9.1.5	Water Leakage Test (e.g., no detectable water leakage)	Test conducted; product passed, preventing fluid leakage.
9.1.6	Backflow Performance Test (e.g., effective prevention of backflow)	Test conducted; product passed, preventing backflow.
9.2	Sterility Assurance (SAL of 10⁻⁶ and EO residuals below ANSI/AAMI/ISO 10993-7:2008)	Device sterilized in a validated EO sterilization cycle with SAL of 10⁻⁶. EO residuals below maximum levels.
9.3	Shelf Life (Maintain sterile barrier and intended performance for 1 year)	Accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, and sterility tests conducted. Performance tests conducted after accelerated aging, implying successful maintenance.
9.4	Biocompatibility (Meet FDA guidelines for mucosal membrane contact for ≤ 24 hours, including systemic toxicity, cytotoxicity, skin sensitization, irritation)	Tests conducted according to FDA guidelines; device shown to be biocompatible.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions that the bench testing was performed on "subject devices from initial production lots, including sterilization." However, it does not specify the exact number of devices (sample size) used for each test.
Data Provenance: The tests were conducted internally by the manufacturer or by contracted labs (e.g., Sanitation Environment Technology Institute, Soochow University for shelf life, and unnamed labs for biocompatibility). The data is from non-clinical bench testing. The country of origin for the manufacturing is Hong Kong, China, where the submitter is located. This is retrospective data collected for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the type of tests described. The "ground truth" for the non-clinical bench tests is defined by the physical or chemical properties being measured (e.g., presence/absence of a leak, flow rate, bacterial growth after sterilization, chemical residual levels). No human experts or consensus were required to establish ground truth for these objective measurements.

4. Adjudication Method for the Test Set

This question is not applicable as the tests are objective bench tests, not evaluations requiring human adjudication or interpretation (like reading medical images).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The device is an auxiliary water connector, not a diagnostic imaging device or an AI-enabled system that would typically undergo an MRMC study.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as there is no AI component or image reading involved in the device's function or evaluation described.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

This question is not applicable. The AquaPulse® Auxiliary Water Connector is a physical medical device, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on objective measurements and predefined physical/chemical standards. For example:

Leakage/Flow: Absence of visible leaks, demonstrable flow, etc.
Sterility: A Sterility Assurance Level (SAL) of 10⁻⁶.
Biocompatibility: Conformance to specific ISO 10993 standards and FDA guidelines through laboratory test results (e.g., cell viability, observed irritation).

8. Sample Size for the Training Set

This question is not applicable. The device is a physical hardware product, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above (no training set for a physical device).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 15, 2020

GA Health Company Limited % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, Florida 33155-3708

Re: K200479

Trade/Device Name: AquaPulse Auxiliary Water Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: May 6, 2020 Received: May 7, 2020

Dear Rafael Aguila:

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 Federal

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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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200479

Device Name AquaPulse® Auxiliary Water Connector

Indications for Use (Describe)

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

X) Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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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:	GA Health Company Limited
Submitter's Address:	Unit 18, 21/F, Metropole Square2 On Yiu Street, Shatin, N.T.,Hong Kong, CHINA
Establishment Registration No.:	No number listed

2. Sponsor Contact

Contact Person:	Cindy Ye
	Chief Executive Officer
Telephone:	+852 2833 9010
Email:	cindy@andorate.com

3. Date Prepared

15th Nov 2019

4. Device Identification

Trade Device Name:	AquaPulse® Auxiliary Water Connector
Common Device Name:	Connector between the tube and endoscope
Product Code:	OCX – Endoscopic Irrigation/Suction
Regulation Number: Regulatory	System 21 CFR 876.1500
Classification:	2

5. Predicate Device Identification

Predicate Device 510(k) No.:	K092429
Predicate Device Trade Name:	ENDOGATOR
Predicate Device Product Code:	FEQ

6. Device Description:

The subject device is intended for single-use and are supplied sterile. Table 1 shows the components included in the application.

Components	Qty	Product Code	RegulationNumber	RegulatoryClassification
AquaPulse® AuxiliaryWater Connector	1	OCX – EndoscopicIrrigation/Suction System	21 CFR876.1500	2

Table 1 – Components included in the application

The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and together with Fujifilm 500/600/700 series endoscope. It is designed to be attached to the

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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 auxiliary water connector is packed individually in a sealed packed. The subject device is supplied as sterile The subject device in this submission have the same operation and method of action with the predicate device.

According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate device. According to the FDA MAUDE database, safety issues on fluid leakage and backflow were identified. In the performance test, the leakage test and backflow test were conducted for verification.

There were no prior submissions for the subject devices.

7. Intended Use:

The AquaPulse® Auxiliary Water Connector is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Fujifilm GI endoscopes during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

8. Technological Characteristics

The following table (Table 2) is summaries of the AquaPulse® Auxiliary Water Connector technological characteristics as compared to the predicate devices.

Table 2 Summary of design, features and principles of operation and technological characteristics between the subject and predicate devices (Auxiliary water connector)

Specification	Predicate Device	Subject Device	SubstantialEquivalence
Device name	ENDOGATOR(Irrigation Accessories auxiliarywater connector)	AQUAPULSE® Auxiliary WaterConnector	N/A
K number	K092429	/	N/A
Manufacturer	Medivators, Inc.	GA Health Company Limited	N/A
Product code	FEQ	OCX	N/A
RegulatoryClassification	2	2	Identical
Regulation No	21 CFR 876.1500	21 CFR 876.1500	Identical
RegulationName	Endoscope and accessories	Endoscope and accessories	Identical
Supplied Sterile	Yes	Yes	Identical
Compatibility	Fujifilm GI endoscopes	Fujifilm GI endoscopes	Similar
Intended Use	The ENDOGATOR® system isintended to provide irrigation viasterile water during GI endoscopic	The AquaPulse® Auxiliary WaterConnector is used in conjunction withirrigation tubing (not supplied)	Identical

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	procedures when used inconjunction with an irrigation pump(or cautery unit).	intended to provide irrigation viairrigation fluids such as sterile watersupplied to the Fujifilm GIendoscopes during gastrointestinalendoscopic procedures when used inconjunction with an irrigation pump.
Environment ofUse	Hospital and or clinics	Hospital and or clinics	Identical
Single Use,Disposable	Yes	Yes	Identical
Material	Polycarbonate, silicone	Polycarbonate, silicone	SubstantialEquivalent
Packaging	It is packaged in a sealed pouchindividually	It is packaged in a sealed pouchindividually	Identical
Manufacturingmethod	Injection moulding	Injection moulding	Similar
BackflowPreventionDesign	Diaphragm in the connector allowpressurized water passing throughin one-way but not the other way	Diaphragm in the connector allowpressurized water passing throughin one-way but not the other way	Identical
Sterilization	EO gas	EO gas	Identical
Shelf Life	Three years	One year	N/A

9. Non-Clinical Performance Data

The bench testing was performed to support substantial equivalence. The following testing were performed on subject devices from initial production lots, including sterilization.

9.1 Performance Test

9.1.1 Compatibility with irrigation tubing
9.1.2 Compatibility with endoscope
9.1.3 Water Flow Test
9.1.4 Air Leakage Test
9.1.5 Water Leakage Test
9.1.6 Backflow Performance Test

9.2 Sterilization

All the subject device is sold in sterile package, like the Medivators predicate devices. The subject devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The subject and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.

9.3 Shelf Life

The AquaPulse® Auxiliary Water Connector have a one (1) year expiration date. The subject devices is packaged in a paper/film pouch respectively. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University. The

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tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. The performance test was conducted for the subject devices after the accelerated aging process. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance before the expiration date.

9.4 Biocompatibility

The biocompatibility of the subject device 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"". It included the following tests.

Acute Systemic Toxicity Test -
In Vitro Cytotoxicity -
-Skin sensitization
Irritation

The subject devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the subject devices are biocompatible.

10. Clinical Testing

Similar devices have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the devices and provides data to show substantial equivalence to the predicate devices.

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.