Who is the manufacturer of Andorate Biopsy Valve, Andorate Biopsy Irrigator?

Ga Health Company Limited filed the 510(k) submission for Andorate Biopsy Valve, Andorate Biopsy Irrigator (K200481).

What is the FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

ODC. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

DEFENDO™ Disposable Biopsy Valve (K090851); DEFENDO™ Y-Opsy Irrigator (K110088).

Who can help prepare an FDA 510(k) submission like Andorate Biopsy Valve, Andorate Biopsy Irrigator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Andorate Biopsy Valve, Andorate Biopsy Irrigator

K200481 · Ga Health Company Limited · ODC · Jun 18, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K200481
Device Name	Andorate Biopsy Valve, Andorate Biopsy Irrigator
Applicant	Ga Health Company Limited
Product Code	ODC · Gastroenterology, Urology
Decision Date	Jun 18, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

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 Story

Andorate Disposable Biopsy Valve and Biopsy Irrigator are single-use, sterile endoscopic accessories. The valve covers the endoscope biopsy port, facilitating device passage/exchange while maintaining insufflation and preventing biomaterial leakage. The irrigator enables simultaneous irrigation and instrumentation within the biopsy channel, featuring a backflow valve to prevent fluid/biomaterial backflow into irrigation tubing. Used in hospitals and clinics by medical professionals during endoscopic procedures. Devices are manufactured via injection molding; sterilized via EO gas. The valve is made of silicone; the irrigator is made of polycarbonate and silicone. These devices function as mechanical seals and fluid conduits to support standard endoscopic workflows, improving procedural efficiency and maintaining sterile/clean environments during instrumentation.

Clinical Evidence

Bench testing only. No clinical data was required. Performance testing included assembly integrity, endoscope compatibility, vacuum/squeegee leak tests, water flow tests, backflow performance, and biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity). Sterility was validated per ISO 10993-7.

Technological Characteristics

Single-use, sterile, EO-sterilized endoscopic accessories. Biopsy valve: silicone, injection molded. Biopsy irrigator: polycarbonate and silicone, injection molded. Compatibility: Fujifilm and Olympus GI endoscopes. Mechanical principle: sealing and fluid flow regulation. Shelf life: 1 year (valve), 3 years (irrigator).

Indications for Use

Indicated for use during endoscopic procedures to cover the biopsy port, provide access for device passage/exchange, maintain insufflation, minimize biomaterial leakage, and enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

DEFENDO™ Disposable Biopsy Valve (K090851)
DEFENDO™ Y-Opsy Irrigator (K110088)

Related Devices

K232118 — ANDORATE® Valve Kit · Ga Health Company Limited · Oct 16, 2023
K230932 — ANDORATE® Valve Kit · Ga Health Company Limited · Jul 7, 2023
K221331 — Disposable Endoscope Valves System · Changzhou Endoclean Medical Device Co., Ltd. · Sep 8, 2022
K111821 — BIOPSY VALVE · Endochoice, Inc. · Jul 28, 2011
K220884 — Disposable Endoscope Valve Sets · Sml Med-Tech Solutions Limited · Jan 17, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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 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. 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) ### 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." FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 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 Square 2 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 5. 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 Identification Predicate 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 {4}------------------------------------------------ ## 6. Device Description: Table 1 shows the components included in the application. | Components | Qty | Classification Name | Regulation Number | Classification | |------------------------------------------|-----|--------------------------------------|----------------------|----------------| | Andorate® Disposable Biopsy Valve | 1 | ODC – Endoscope Channel Accessory | 876.1500 | 2 | | Andorate® Disposable Biopsy Irrigator | 1 | ODC – Endoscope Channel Accessory | 876.1500 | 2 | 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. 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 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. # 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) {5}------------------------------------------------ | Specification | Predicate Device | Subject Device | Substantial Equivalence | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Device name | DEFENDO™ Disposable Biopsy Valve | ANDORATE® Disposable Biopsy 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 | | Regulation Name | Endoscope and accessories | Endoscope and accessories | Identical | | Supplied Sterile | Yes | Yes | Identical | | Compatibility | Fujifilm GI endoscopes | Fujifilm GI endoscopes | Identical | | Intended Use | The DEFENDO™ Disposable biopsy valve is intended to be 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 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. | Substantial Equivalent | | Environment of Use | Hospital and or clinics | Hospital and or clinics | Identical | | Single Use, Disposable | Yes | Yes | Identical | | Material | Thermoplastic Elastomer | Silicone | Substantial Equivalent | | Packaging | Packaged in a sealed pouch individually | Packaged in a sealed pouch individually | Identical | | Manufacturing method | Injection moulding | Injection moulding | Substantial Equivalent | | 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 | Substantial Equivalence | |---------------|---------------------------|------------------------------------------|----------------------------| | Device name | DEFENDO™ Y-Opsy Irrigator | ANDORATE® Disposable Biopsy Irrigator | N/A | | K number | K110088 | / | N/A | {6}------------------------------------------------ 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 | | Regulation Name | Endoscope and accessories | Endoscope and accessories | Identical | | Supplied Sterile | Yes | Yes | Identical | | Compatibility | Olympus and Fujinon GI endoscopes | Olympus and Fujifilm GI endoscopes | Identical | | Intended Use | The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel. | The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel. | Substantial Equivalent | | Environment of Use | 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 pouch individually | Packaged in a sealed pouch individually | Identical | | Manufacturing method | Injection moulding | Injection moulding | Substantial Equivalent | | 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 {7}------------------------------------------------ #### 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.