The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

Device Description

The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

AI/ML Overview

This document is a 510(k) premarket notification for the AquaPulse® Irrigation Tubing, submitted by GA Health Company Limited to the FDA. The purpose of this notification is to demonstrate that the AquaPulse® Irrigation Tubing is substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request, focusing on typical acceptance criteria and study information for medical devices, specifically highlighting what is not present in this 510(k) summary since it's for a relatively simple device where clinical studies are often not required for substantial equivalence.

1. Table of acceptance criteria and reported device performance:

The document summarizes performance testing, but does not provide a detailed table of acceptance criteria and specific performance values with pass/fail results. Instead, it offers a general statement about meeting specifications.

Performance Characteristic	Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance
Flow Performance	Assumed to be comparable to predicate device	"met established specifications"
Sterility	Sterility Assurance Level (SAL) of $10^{-6}$	Achieved $10^{-6}$ SAL via validated EO sterilization cycle
EO Residuals	Below maximum levels defined in ANSI/AAMI/ISO 10993-7	Below maximum levels
Shelf Life	Maintain sterile barrier and intended performance for 1 year	Demonstrated through accelerated aging, packaging integrity, and performance tests
Biocompatibility	Meet ISO 10993-1 requirements for surface devices with mucosal membrane contact for ≤ 24 hours	Test results indicate biocompatibility
Backflow Prevention	Prevent backflow	Diaphragm design allows one-way flow, identical to predicate

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

Test Set Sample Size: Not explicitly stated for any of the performance tests (flow, sterility, shelf life, biocompatibility).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of detail is often not included in a 510(k) summary for bench testing.

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

Not applicable (N/A). This document describes testing for a physical medical device (irrigation tubing) where performance is measured objectively (e.g., flow rate, sterility, chemical residue). It does not involve expert-established ground truth like in an AI/imaging device study.

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

N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench testing of device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No. An MRMC study is not relevant for this type of device. The study described is a series of bench tests comparing the subject device to a predicate device.

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

No. This is not an AI/algorithm-based device. The "standalone" performance refers to the device's inherent functional characteristics (flow, sterility, etc.) as evaluated in the bench tests.

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

Objective measurements and established scientific standards. For example:
- Flow Performance: Likely compared to established predicate performance or engineering specifications.
- Sterility: Measured against a Sterility Assurance Level (SAL) of 10^-6.
- EO Residuals: Measured against limits defined by ANSI/AAMI/ISO 10993-7.
- Biocompatibility: Evaluated according to ISO 10993-1 guidelines through biological tests.

8. The sample size for the training set:

N/A. This device does not use machine learning or AI, and therefore does not have a "training set" in that context.

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

N/A. As there is no training set for an AI/ML model, this question is not applicable.

Summary

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December 10, 2020

GA Health Company Limited Cindy Ye Chief Executive Officer Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CHINA

Re: K202560

Trade/Device Name: AquaPulse® Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: November 4, 2020 Received: November 9, 2020

Dear Cindy Ye:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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-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). 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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Indications for Use

510(k) Number (if known) K202560

Device Name AquaPulse® Irrigation Tubing

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)

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K202560 Page 1 of 3

510(k) Premarket Notification: Traditional Irrigation Tubing 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 Reqistration No.:

2. Sponsor Contact

Cindy Ye Chief Executive Officer Telephone: +852 2833 9010

GA Health Company Limited Unit 18, 21/F, Metropole Square

2 On Yiu Street ,Shatin, N.T,

Hong Kong. CHINA

3014749926

Email: cindv@gahealth.net

Lam Wing Yu Senior Product Compliance Specialist Telephone: +852 2833 9010 Email: rainy@gahealth.net

3. Date Prepared

10 Dec 2020

4. Device Identification

Trade Device Name: Common Name: Product Code: Produce Code Name: Requlation Number: Requlation Name: Requlatory Classification: Device Panel:
AquaPulse® Irrigation Tubing Irrigation tubing for endoscope ОСХ Endoscopic Irrigation/Suction System 21 CFR 876.1500 Endoscope and accessories 2 Gastroenterology/Urology

5. Predicate Device Identification

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

6. Device Description:

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7. Indications for Use:

8. Technological Characteristics

Table 2 summarizes the irrigation tubing 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	Predicate Device	Subject Device	SubstantialEquivalence
Product code	FEQ	OCX	Identical
RegulatoryClassification	2	2	Identical
Regulation No	21 CFR 876.1500	21 CFR 876.1500	Identical
RegulationDescription	Endoscope and accessories	Endoscope and accessories	Identical
Compatibility	Olympus® AFU-100, Olympus®OFP, ERBE® EIP2 or EGP-100Irrigation Pumps	Olympus® OFP, Endo Status™EGA-500 and Endogator® EGP-100 Irrigation Pump	SubstantialEquivalent
Indications forUse	The ENDOGATOR® system isintended to provide irrigation viasterile water during Glendoscopic procedures whenused in conjunction with anirrigation pump (or cautery unit).	The 24 hour use AquaPulse®Irrigation Tubing (tubing andaccessories to accommodatevarious GI endoscopes andirrigation pumps) is intended toprovide irrigation via a sterilewater bottle duringgastrointestinal endoscopicprocedures when used inconjunction with an irrigationpump.	SubstantialEquivalent
Environmentof Use	Hospital and or clinics	Hospital and or clinics	Identical
Single Use,Disposable	24-hour use then discard	24-hour use then discard	Identical
Material	Polycarbonate and PolyvinylChloride	Polycarbonate and PolyvinylChloride	SubstantialEquivalent
Packaging	Irrigation tubing is packaged in asealed pouch	Irrigation tubing is packaged in asealed pouch	Identical
Manufacturingmethod	Injection molding and extrusion	Injection molding and extrusion	Identical

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BackflowPreventionDesign	Diaphragm in the connectorallow pressurized water passingthrough in one-way but not theother way	Diaphragm in the connectorallow pressurized water passingthrough in one-way but not theother way	Identical
Sterilization	EO gas	EO gas	Identical
Shelf Life	3 years	1 year	SubstantialEquivalent

9. Performance Test

The bench testing was performed to support substantial equivalence such as verification tests on flow performances of subject devices and predicate devices. The performance data demonstrated that the subject devices met established specifications.

10. Sterilization

All the subject devices are sold in a sterile package. 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 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.

11. Shelf Life

The subject devices have a one (1) year shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test and performance test were conducted after accelerated aging test. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life.

12. 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". 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.

13. 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.