The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

Device Description

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy 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 suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

AI/ML Overview

The provided text is a 510(k) Summary for medical device clearance, specifically concerning the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve. It outlines the safety and effectiveness information for these devices and compares them to a predicate device.

However, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for details like:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established.

The provided document describes physical medical devices (valves for bronchoscopes), not an AI/algorithm. Therefore, concepts like "AI assistance," "human readers," "effect size of human readers improve with AI," "standalone algorithm performance," and "training/test sets for an algorithm" are not applicable to the information given.

The document does mention "Performance Test" in Section 9, stating:
"The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications."

While this section indicates that performance tests were done and met specifications, it does not provide the acceptance criteria or the specific performance results in a quantitative manner. It also does not involve human readers, AI, or traditional "ground truth" as it would apply to a diagnostic algorithm.

Conclusion based on the provided text:

The provided document is for physical medical devices (valves), not an AI/algorithm. Therefore, most of the requested information (related to AI performance, human reader studies, training/test sets for AI, ground truth establishment for AI) is not present and not applicable to this submission.

The document states that bench testing was performed and the devices met established specifications. However, the specific quantitative acceptance criteria and the reported performance values are not detailed in this summary.

To answer your request based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly detailed in quantitative terms within the summary, but implied that each test (endoscope compatibility, suction flow, vacuum leak, water leak, pressing force, fatigue, squeegee leak) had "established specifications."
- Reported Device Performance: The document summarily states: "The performance data demonstrated that the subject devices met established specifications." No specific quantitative results are provided.
Sample sized used for the test set and the data provenance: Not applicable to this type of device testing as described. The testing is bench testing on physical units.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for these physical devices would be their ability to perform their mechanical functions according to engineering specifications.
The sample size for the training set: Not applicable (not an AI/ML algorithm).
How the ground truth for the training set was established: Not applicable (not an AI/ML algorithm).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

May 11, 2023

GA Health Company Limited Rainy Lam Assistant Regulatory Affairs Manager 2 On Yiu Street Unit 18, 21/F, Metropole Square Shatin Hong Kong

Re: K230280

Trade/Device Name: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: February 1, 2023 Received: April 12, 2023

Dear Rainy Lam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any 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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K230280

Device Name ANDORATE® Suction Valve ANDORATE® Biopsy Valve

Indications for Use (Describe)

The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.

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 Reqistration 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: cindy.ye@gahealth.com

Lam Wing Yu Assistant Requlatory Affairs Manager Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com

3. Date Prepared

9 May 2023

4. Device Identification

Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:

5. Predicate Device Identification

Predicate Device 510(k) No.: Predicate Device Trade Name: ANDORATE® Suction Valve Suction valve 21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories KTI Bronchoscope Accessory 2 Ear Nose & Throat

ANDORATE® Biopsy Valve Biopsy valve 21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories KTI Bronchoscope Accessory 2 Ear Nose & Throat

K061313 EVIS EXERA II 180 System

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Predicate Device Product Code: EOQ - Bronchoscope (Flexible Or Rigid)

6. Device Description:

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

Components	Qty	Product Code	RegulationNumber	RegulatoryClassification
ANDORATE® SuctionValve	1	KTI – BronchoscopeAccessory	21 CFR 874.4680	2
ANDORATE® BiopsyValve	1	KTI – BronchoscopeAccessory	21 CFR 874.4680	2

Table 1 - Components included in the Submission
-------------------------------------------------	--	--	--	--

The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy 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 suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

7. Indications for Use:

The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.

The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

8. Technological Characteristics

Table 2 summarizes the suction valve and biopsy valve technological characteristics as compared to the predicate device.

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

Specification	Predicate Device	Subject Device	SubstantialEquivalence
Product code	EOQ	KTI	SubstantialEquivalent
RegulatoryClassification	2	2	Identical
Regulation No	21 CFR 874.4680	21 CFR 874.4680	Identical
RegulationDescription	Bronchoscope (Flexible OrRigid)	Bronchoscope Accessory	Identical

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Specification	Predicate Device	Subject Device	SubstantialEquivalence
Indications forUse	The suction valve is depressedto activate suction. The valve isalso used to remove any fluid ordebris adhering to the objectivelens.The biopsy valve is attached tothe instrument channel port, andan EndoTherapy accessory canbe inserted or a syringe can beattached.	The single use ANDORATE®Suction Valve is used to controlthe suction function of anendoscope during theendoscopic procedure.The single use ANDORATE®Biopsy Valve is used to cover theopening to the biopsy/suctionchannel of endoscope. Thebiopsy valve provides access forendoscopic device passage andexchange and minimizes leakageof biomaterial from the biopsyport through the endoscopicprocedure.	SubstantialEquivalent
Compatibility	Olympus® 180 SeriesBronchoscopes	Olympus® 160/180/190/260/290Series Bronchoscopes	SubstantialEquivalent
Environmentof Use	Hospital and or clinics	Hospital and or clinics	Identical
Single Use orReusable	Single Use	Single Use	Identical
Material	Silicone, Polypropylene,Polyethylene	Polyvinyl Chloride, AcrylonitrileButadiene Styrene, SiliconeRubber	SubstantialEquivalent
Manufacturingmethod	Injection molding	Injection molding	Identical
Packaging	Packaged in a sealed pouch	Packaged in a sealed pouch	SubstantialEquivalent
Sterilization	Yes	Yes	SubstantialEquivalent
Shelf Life	3 years	3 years	SubstantialEquivalent

9. Performance Test

The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications.

10. Sterilisation

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

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ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.

11. Shelf Life

The subject devices have a three (3) years shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test in accordance with ASTM F88/F 88M-15, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by dve Penetration. ASTM D 3078-02. Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission, DIN 58953-6, Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to be Sterilized and ISO11737-2, Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process and performance test were conducted after accelerated aging test according to ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. 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 device was conducted in accordance with the FDA quideline "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 suction valve is non-patient contacting device while the biopsy valve is classified as an indirect patient contacting device and surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The biocompatibility test was performed in accordance with the following standards - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test results show that the subject device is biocompatible.

13. Conclusion

The subject devices have the same intended use as the predicate device. Based on comparison of technological characteristics and evaluation of the characteristics through performance testing, the subject devices do not raise different questions of safety and effectiveness compared to the predicate. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.