The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

Device Description

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 biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.

The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.

The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.

Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:

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

The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.

Andorate® Disposable Biopsy Valve:

Acceptance Criteria Category	Reported Device Performance (Tests Conducted)
Mechanical Integrity	Assembling Integrity
Compatibility	Endoscope Compatibility
Leakage Prevention	Vacuum Leak Test
Leakage Prevention	Squeegee Leak Test

Andorate® Disposable Biopsy Irrigator:

Acceptance Criteria Category	Reported Device Performance (Tests Conducted)
Compatibility	Compatibility with irrigation tubing
Compatibility	Compatibility with endoscope
Functionality	Water Flow Test
Leakage Prevention	Vacuum Leak Test
Leakage Prevention	Water Leakage Test
Leakage Prevention	Squeegee Leak Test
Fluid Dynamics	Backflow Performance Test

General Performance Criteria (Both Devices):

Acceptance Criteria Category	Reported Device Performance (Tests Conducted)
Sterility Assurance	EO sterilization cycle validated to SAL 10⁻⁶
Sterilization Residuals	EO residuals below levels defined in ANSI/AAMI/ISO 10993-7:2008
Shelf Life	Accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test, sterility test, performance test after accelerated aging (results imply maintenance of sterile barrier and intended performance)
Biocompatibility	Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin Sensitization, Irritation (results show biocompatibility for mucosal membrane contact < 24 hours per ISO 10993-1)

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

The document states that the bench testing was performed on "subject devices from initial production lots, including sterilization." It does not specify the exact sample size (number of devices) used for each test. The data provenance is implied to be from internal testing by GA Health Company Limited, likely from their production facility in Hong Kong, China (per Submitter's Address). The studies are retrospective in the sense that they are performed on manufactured products to demonstrate existing properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Information for points 3-9 cannot be provided from the given text. This document describes the 510(k) premarket notification for traditional mechanical medical devices (biopsy valves and irrigators), not a device incorporating Artificial Intelligence (AI) or machine learning. Therefore, concepts like expert ground truth, reader studies, training sets, test sets for algorithms, and standalone AI performance are not relevant to the described studies and are not mentioned in the document. The "ground truth" for these devices is established through engineering and material science bench testing, confirming physical and functional properties against predefined specifications, rather than clinical interpretation. Clinical testing was explicitly stated as "not necessary to support substantial equivalence data."

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 18, 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: K200481

Trade/Device Name: Andorate Biopsy Valve Andorate Biopsy Irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: June 5, 2020 Received: June 9, 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.

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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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200481

Device Name

Andorate® Disposable Biopsy Valve and Andorate® Biopsy Irrigator

Indications for Use (Describe)

The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

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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FORM FDA 3881 (7/17)

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

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510(k) Premarket Notification: Traditional Biopsy Valve and Biopsy Irrigator GA Health Company Limited

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.:	3014749926

2. Sponsor Contact

Contact Person:

Cindy Ye – Chief Executive Officer

Telephone:	+852 2833 9010
Email:	cindy@andorate.com

3. Date Prepared

29 May 2020

4. Device Identification

Trade Device Name:	Andorate® Disposable Biopsy Valve
Regulation Name:	Endoscope and accessories
Product Code:	ODC
Regulation Number:	21 CFR 876.1500
Regulatory Class:	2
Trade Device Name:	Andorate® Disposable Biopsy Irrigator
Regulation Name:	Endoscope and accessories
Product Code:	ODC
Regulation Number:	21 CFR 876.1500
Regulatory Class:	2
Predicate Device IdentificationPredicate Device 510(k) No.:	K090851
Predicate Device Trade Name:	DEFENDO™ Disposable Biopsy V
Predicate Device Product Code:	ODC

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

alve

K110088 DEFENDO™ Y-Opsy Irrigator ODC

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6. Device Description:

Table 1 shows the components included in the application.

Components	Qty	Classification Name	RegulationNumber	Classification
Andorate® DisposableBiopsy Valve	1	ODC – EndoscopeChannel Accessory	876.1500	2
Andorate® DisposableBiopsy Irrigator	1	ODC – EndoscopeChannel Accessory	876.1500	2

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 Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

8. Technological Characteristics

The following table (Table 2 - 3) is summaries of the subject devices 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 (Biopsy valve)

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Specification	Predicate Device	Subject Device	SubstantialEquivalence
Device name	DEFENDO™ DisposableBiopsy Valve	ANDORATE® DisposableBiopsy Valve	N/A
K number	K090851	/	N/A
Manufacturer	Medivators, Inc	GA Health Company Limited	N/A
Product code	ODC	ODC	N/A
Classification	2	2	Identical
Regulation No	876.1500	876.1500	Identical
RegulationName	Endoscope and accessories	Endoscope and accessories	Identical
Supplied Sterile	Yes	Yes	Identical
Compatibility	Fujifilm GI endoscopes	Fujifilm GI endoscopes	Identical
Intended Use	The DEFENDO™ Disposablebiopsy valve is intended to becover the endoscope biopsy portduring an endoscopy procedure.In addition, the valve providesaccess for endoscopic devicepassage and exchange, helpsmaintain insufflation andminimizes leakage of biomaterialfrom the biopsy port throughoutthe endoscopic procedure.	The Andorate® Disposablebiopsy valve is used to cover theendoscope biopsy port during anendoscopy procedure. Inaddition, the valve providesaccess for endoscopic devicepassage and exchange, helpsmaintain insufflation andminimizes leakage of biomaterialfrom the biopsy port throughoutthe endoscopic procedure.	SubstantialEquivalent
Environment ofUse	Hospital and or clinics	Hospital and or clinics	Identical
Single Use,Disposable	Yes	Yes	Identical
Material	Thermoplastic Elastomer	Silicone	SubstantialEquivalent
Packaging	Packaged in a sealed pouchindividually	Packaged in a sealed pouchindividually	Identical
Manufacturingmethod	Injection moulding	Injection moulding	SubstantialEquivalent
Sterilization	EO gas	EO gas	Identical
Shelf Life	Three years	One year	N/A

Table 3 Summary of design, features and principles of operation and technological characteristics between the subject and predicate devices (biopsy irrigator)

Specification	Predicate Device	Subject Device	SubstantialEquivalence
Device name	DEFENDO™ Y-Opsy Irrigator	ANDORATE® DisposableBiopsy Irrigator	N/A
K number	K110088	/	N/A

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K200481 Page 14of 510(k) Premarket Notification: Traditional Biopsy Valve and Biopsy Irrigator GA Health Company Limited CONFIDENTIAL

Manufacturer	Medivators, Inc	GA Health Company Limited	N/A
Product code	ODC	ODC	N/A
Classification	2	2	Identical
Regulation No	876.1500	876.1500	Identical
RegulationName	Endoscope and accessories	Endoscope and accessories	Identical
Supplied Sterile	Yes	Yes	Identical
Compatibility	Olympus and Fujinon GIendoscopes	Olympus and Fujifilm GIendoscopes	Identical
Intended Use	The DEFENDO™ Y-OpsyIrrigator is intended to enablesimultaneous irrigationandinstrumentationintheendoscope's biopsy channel.	The Andorate® Disposable BiopsyIrrigator is intended to enablesimultaneous irrigationandinstrumentationintheendoscope's biopsy channel.	SubstantialEquivalent
Environment ofUse	Hospital and or clinics	Hospital and or clinics	Identical
Single Use,Disposable	Yes	Yes	Identical
Material	Polycarbonate, silicone	Polycarbonate, silicone	Similar
Packaging	Packaged in a sealed pouchindividually	Packaged in a sealedpouchindividually	Identical
Manufacturingmethod	Injection moulding	Injection moulding	SubstantialEquivalent
Sterilization	EO gas	EO gas	Identical
Shelf Life	Three years	Three years	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 Andorate® Disposable Biopsy Valve

9.1.1.1 Assembling Integrity
9.1.1.2 Endoscope Compatibility
9.1.1.3 Vacuum Leak Test
9.1.1.4 Squeegee Leak Test

9.1.2 Andorate® Disposable Biopsy Irrigator

9.1.2.1 Compatibility with irrigation tubing
9.1.2.2 Compatibility with endoscope
9.1.2.3 Water Flow Test
9.1.2.4 Vacuum Leak Test
9.1.2.5 Water Leakage Test
9.1.2.6 Squeegee Leak Test

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9.1.2.7 Backflow Performance Test

9.2 Sterilization

All the subject devices are 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 106. 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 subiect and the predicate devices, are not labeled as pvrogen-free because thev do not have any blood or cerebrospinal fluid contact.

9.3 Shelf Life

The Andorate® Disposable Biopsy Irrigator has a three (3) year expiration date and the Andorate® Disposable Biopsy Valve has a one (1) year expiration date. The subject devices are packaged in a paper/film pouch respectively. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University. The 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 Biocompatibilitv

The biocompatibility of the subject devices were 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.