(117 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of disposable valves, with no mention of AI or ML.
No
The devices are accessories used to control functions of an endoscope, such as suction and air/water flow, but they do not directly provide therapeutic treatment to the patient.
No
Explanation: The device is an accessory for an endoscope, designed to control suction and air/water functions during a GI Endoscopic procedure. Its purpose is to facilitate the endoscopic procedure and cleanse the lens, not to diagnose a condition.
No
The device description clearly indicates the device is a physical, disposable valve intended to be attached to an endoscope, not a software program. The performance studies also focus on physical properties and testing of a hardware device.
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 a GI Endoscopic procedure. This is a direct interaction with the patient's body during a medical procedure, not an in vitro test performed on samples outside the body.
- Device Description: The description reinforces the function of controlling suction and air/water flow within the endoscope during the procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and mechanical, assisting in the visualization and manipulation during an endoscopy.
N/A
Intended Use / Indications for Use
The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
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. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. 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 endoscopic 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. The suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in 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 device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI Endoscopic procedure
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:
Andorate® Disposable Suction Valve: Assembling Integrity, Endoscope Compatibility, Depression Force, Vacuum Leak Test, Suction Flow Test.
Andorate® Disposable Air/Water Valve: Endoscope Compatibility Testing, Air Leakage Testing, Assembling Integrity Verification, Air Flow Test, Depression Force Testing, Water Flow Test.
All the subject devices are sold in sterile packaging. The subject devices have been sterilized in a validated EO sterilization cycle with a Sterility Assurance Level (SAL) of 10-6. EO residuals are below maximum levels defined in ANSI/AAMI/ISO 10993-7:2008. The devices are not labeled as pyrogen-free.
The Andorate® Disposable Suction and Air/Water have a one (1) year expiration date. Accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and sterility test were conducted, showing the devices maintain sterile barrier and intended performance.
Biocompatibility tests (Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin sensitization, Irritation) were conducted per FDA guideline ISO 10993-1. The subject devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours), and the test results show they are biocompatible.
Clinical testing was not necessary.
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.
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
§ 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.
0
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June 24, 2020
GA Health Company Limited % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155-3708
K200495 Re: Trade/Device Name: Andorate Disposable Air/Water Valve Andorate Disposable Suction Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: February 27, 2020 Received: February 28, 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.
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,
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) K200495
Device Name
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
Indications for Use (Describe)
The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| For use in a HUD-approved HECM Reverse Mortgage |
|---|
| One-Time Premium for use in a FHA-insured Forward Mortgage |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K200495 Page 1 of 5
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: | 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 | |
|---|---|---|
| Telephone: | Chief Executive Officer | |
| +852 2833 9010 | ||
| Email: | cindy@andorate.com |
3. Date Prepared
June 23rd 2020
4. Device Identification
| Trade Device Name: | Andorate® Disposable Suction Valve |
|---|---|
| Common Device Name: | Suction valve for endoscope |
| Product Code: | ODC - Endoscope Channel Accessor |
| Regulation Number: | 876.1500 |
| Classification: | 2 |
| Regulation Name: | Endoscope and Accessories |
| Trade Device Name: | Andorate® Disposable Air/Water Valve |
| Common Device Name: | Air/water valve for endoscope |
| Product Code: | ODC - Endoscope Channel Accessor |
| Regulation Number: | 876.1500 |
| Classification: | 2 |
| Regulation Name: | Endoscope and Accessories |
5. Predicate Device Identification
Predicate Device 510(k) No .: Predicate Device Trade Name: Predicate Device Product Code:
K172916 FUJIFILM Endoscope ODC
6. Device Description:
The subject devices are intended for single-use and are supplied sterile. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. Table 1 shows the components included in the application.
Table 1 - Components included in the application
4
K200495 Page 2 of 5
510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL
| Components | Qty | Classification Name | Regulation
Number | Classification |
|-----------------------------------------|-----|--------------------------------------|----------------------|----------------|
| Andorate® Disposable
Suction Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 |
| Andorate® Disposable
Air/Water Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 |
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 endoscopic 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.
The suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in 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 device.
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.
-
Intended Use: The Andorate® Disposable Suction Valve is used to control the suction function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
-
Intended Use: The Andorate® Disposable Air/Water valve is used to control the air/ water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
9. Technological Characteristics
The following table (Table 2) is summaries of the Andorate® Disposable Suction Valve and Andorate® Disposable Air/Water Valve technological characteristics as compared to the predicate device.
2 Summary of design. features and principles of operation and Table technological characteristics between the subject and predicate devices (suction and air/water valves).
| Specification | Predicate Device | Subject Devices | Substantial
Equivalence |
|---------------|-----------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------|
| Device name | FUJIFILM Endoscope (Suction
and air/water valve) | Andorate® Disposable Suction
Valve and Andorate®
Disposable Air/Water Valve | N/A |
| K number | K172916 | K200495 | N/A |
| Manufacturer | FUJIFILM Corporation | GA Health Company Limited | N/A |
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K200495 Page 3 of 5
510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL
| Product code | FDF, FDS | 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 | No* | Yes | Substantial |
| Equivalent | |||
| Compatibility | FUJIFILM 700 series endoscope | FUJIFILM 700 series endoscope | Identical |
| Intended Use | The suction valve is a medical | ||
| device that is attached to a | |||
| FUJIFILM | |||
| gastrointestinal | |||
| endoscope in order to suck | |||
| mucus or air in the body cavity. |
The air/water valve is a medical
device that is attached to a
FUJIFILM
gastrointestinal
endoscope in order to jet air or
water. | The Andorate® Disposable
Suction Valve is used to control
the suction function of an
endoscope (Fujifilm 700 series)
during a GI Endoscopic
procedure.
The Andorate® Disposable
Air/Water Valve is used to
control the air/water function
of an endoscope (Fujifilm 700
series) during a GI
Endoscopic procedure. | Substantial
Equivalent |
| Environment of
Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,
Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, stainless steel
304, thermoplastic elastomer | Acrylonitrile Butadiene Styrene,
silicone, Stainless Steel 304 | Substantial
Equivalent |
| Packaging | Each model packed in a PE bag
with a carton box | Suction, air/water, biopsy valves
and auxiliary water connector are
housed in a single tray and
packaged in a sealed pouched | Substantial
Equivalent |
| Manufacturing
method | Injection moulding and over-
moulding. | Injection moulding | Substantial
Equivalent |
| Sterilization | Supplied non-sterile
Sterilized after each use | EO gas | Identical |
| Shelf Life | 1 year | 1 year | N/A |
*Remark: The predicate device is supplied as non-sterile and the end-user should be sterilized prior using, while the subject device is sold as sterile in which no sterilization is needed by the end-user prior to using.
10. 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.
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K200495 Page 4 of 5
510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL
10.1 Performance Test
10.1.1Andorate® Disposable Suction Valve
- 10.1.1.1 Assembling Integrity
- 10.1.1.2 Endoscope Compatibility
- 10.1.1.3 Depression Force
- 10.1.1.4 Vacuum Leak Test
- 10.1.1.5 Suction Flow Test
10.1.2Andorate® Disposable Air/Water Valve
- 10.1.2.1 Endoscope Compatibility Testing
- 10.1.2.2 Air Leakage Testing
- 10.1.2.3 Assembling Integrity Verification
- 10.1.2.4 Air Flow Test
- 10.1.2.5 Depression Force Testing
- 10.1.2.6 Water Flow Test
10.2 Sterilization
All the subject devices are sold in sterile packaging. Also, 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 below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 are Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The subject and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.
10.3 Shelf Life
The Andorate® Disposable Suction and Air/Water have 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.
10.4 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 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.
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K200495 Page 5 of 5
510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL
11. 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 device.
12. Conclusion
The subject devices have the same intended use as the predicate device. 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.