(112 days)
Not Found
No
The device description and performance studies focus on mechanical function and compatibility, with no mention of AI/ML terms or capabilities.
No
The devices are designed to cover an endoscope biopsy port, facilitate device passage, maintain insufflation, and minimize leakage/enable irrigation, all of which are supportive functions during a diagnostic or therapeutic endoscopic procedure, rather than directly treating a condition or disease.
No
The device description indicates its purpose is to cover the endoscope biopsy port, facilitate device passage, maintain insufflation, and minimize leakage. It also describes a biopsy irrigator for simultaneous irrigation and instrumentation. None of these functions involve diagnosing or detecting a condition.
No
The device description clearly indicates physical components (biopsy valve, biopsy irrigator, backflow valve, irrigation tubing) and bench testing related to physical properties and performance (assembling integrity, leak tests, flow tests). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The description clearly states the device's function is to cover the endoscope biopsy port, facilitate instrument passage, maintain insufflation, and minimize leakage during an endoscopy procedure. This is a device used in vivo (within the body) during a medical procedure.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information. Its purpose is procedural support during the endoscopy.
The device is a medical device used during an invasive procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for 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.
Product codes
ODC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
- 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.
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 Biocompatibility
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 test result shows that the subject devices are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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)
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)
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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
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.