Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and fluid control, with no mention of AI/ML or image processing.

Therapeutic

No.
The device components (suction valve, air/water valve) control endoscope functions to assist in imaging or cleaning, rather than directly treating a medical condition.

Diagnostic

No

The devices described (suction valve and air/water valve for endoscopes) are used to control functions (suction, air/water flow) during endoscopic procedures to improve image clarity or assist in the procedure itself, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly indicates physical components (suction valve, air/water valve) that attach to an endoscope and control physical functions (suction, air/water flow). This is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the devices are used to control suction and air/water flow during endoscopic procedures to assist in visualization. This is a direct interaction with the patient's body and the endoscope, not an in vitro test performed on a sample taken from the body.
Device Description: The description reinforces the intended use by explaining how the valves attach to the endoscope and their function in managing fluids and air during the procedure.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely procedural and related to the operation of the endoscope within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The single use andorate® Suction Valve is used to control the suction 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.

Product codes (comma separated list FDA assigned to the subject device)

ODC

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

GI endoscopic procedures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital and or clinics

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was performed on both the subject device and the predicate device to support substantial equivalence. The performance data demonstrated that the subject devices met established specifications in the following non-clinical tests:

Suction Valve:

Endoscope Compatibility Test
Suction Flow Test
Vacuum Leak Test
Pressing Force Test

Air/water Valve:

Endoscope Compatibility Test
Air Flow Test
Water Flow Test
Water Leakage Test
Pressing Force Test
Backflow Prevention Test

Biocompatibility testing was also 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 test results showed that both subject devices are biocompatible.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180341

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2022

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

Re: K213095

Trade/Device Name: andorate Suction Valve, andorate Air/Water Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: December 13, 2021 Received: December 16, 2021

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

1

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,

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 Health

Enclosure

2

Indications for Use

510(k) Number (if known) K213095

Device Name andorate® Suction Valve andorate® Air/Water Valve

Indications for Use (Describe)

The single use andorate® Suction Valve is used to control the suction of an endoscope during GL 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)
-------------------------------------------------	--

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

K213095 Page 1 of 4

510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve 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 Registration No.:

2. Sponsor Contact

2 On Yiu Street, Shatin, N.T, Hong Kong. CHINA 3014749926

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

Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindy@gahealth.net

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

3. Date Prepared

16 November 2021

4. Device Identification

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

andorate® Suction Valve Suction valve for endoscope 21 CFR 876.1500 Endoscope and accessories ODC Endoscope channel accessory 2 Gastroenterology/Urology

andorate® Air/Water Valve Air/Water valve for endoscope 21 CFR 876.1500 Endoscope and accessories ODC Endoscope channel accessory 2 Gastroenterology/Urology

4

5. Predicate Device Identification

Predicate Device 510(k) No .: Predicate Device Trade Name: Predicate Device Product Code: K180341 FUJIFILM 600 Series Endoscope EG-600WR v2 FDS – Endoscope and Accessories

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 | Regulation
Number | Regulatory
Classification |
|------------------------------|-----|--------------------------------------|----------------------|------------------------------|
| andorate® Suction Valve | 1 | ODC – Endoscope
channel accessory | 21 CFR 876.1500 | 2 |
| andorate® Air/Water
Valve | 1 | ODC – Endoscope
channel accessory | 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.

There were no prior submissions for the subject devices.

7. Intended Use:

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.

8. Technological Characteristics

Table 2 summarizes the suction valve and air/water valve 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

5

K213095 Page 3 of 4

510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL

| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product code | FDS | ODC | Substantial
Equivalent |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscope and accessories | Endoscope and accessories | Identical |
| Intended Use | This product is the suction button
used in combination with our
endoscopes in medical facilities.
Do not use this product for any
other purpose.

This product is the air/water
button used in combination with
our endoscopes in medical
facilities. Do not use this product
for any other purpose. | The single use andorate®
Suction Valve is used to control
the suction function of an
endoscope during GI endoscopic
procedures.

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.

Suction Valve

1. Endoscope Compatibility Test
1. Suction Flow Test
1. Vacuum Leak Test
1. Pressing Force Test

6

K213095 Page 4 of 4

510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL

Air/water Valve

1. Endoscope Compatibility Test
1. Air Flow Test
1. Water Flow Test
1. Water Leakage Test
1. Pressing Force Test
1. Backflow Prevention Test

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

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.