(78 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or data processing.
No
The device is an auxiliary water connector that facilitates irrigation during endoscopic procedures. It does not exert any direct therapeutic effect on the patient. Its function is to connect tubing and prevent backflow, which is an accessory function to the irrigation process rather than a therapeutic action itself.
No
The device is an auxiliary water connector used for irrigation during gastrointestinal endoscopic procedures, providing fluids to the endoscope. It does not perform any diagnostic function such as detecting, identifying, or quantifying a disease or condition. Its purpose is to facilitate the procedure by delivering water and preventing backflow.
No
The device description clearly indicates it is a physical connector with a backflow valve, intended for single-use and supplied sterile. It is a hardware component used in conjunction with tubing and endoscopes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation during gastrointestinal endoscopic procedures. This is a procedural aid, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a connector with a backflow valve used to deliver irrigation fluid to an endoscope. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on in vitro testing.
Therefore, the AquaPulse® Auxiliary Water Connector falls under the category of a medical device used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AquaPulse® Auxiliary Water Connector is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Fujifilm GI endoscopes during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The subject device is intended for single-use and are supplied sterile. The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and together with Fujifilm 500/600/700 series endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle. The auxiliary water connector is packed individually in a sealed packed. The subject device is supplied as sterile The subject device 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
gastrointestinal
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 to support substantial equivalence. Tests included: Compatibility with irrigation tubing, Compatibility with endoscope, Water Flow Test, Air Leakage Test, Water Leakage Test, Backflow Performance Test. 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. Shelf-life testing included accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and sterility test. Biocompatibility tests were conducted in accordance with FDA guidelines and ISO 10993-1, including Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin sensitization, and Irritation. The subject devices are biocompatible for mucosal membrane contact for a limited duration (not more than 24 hours). Clinical testing was not necessary due to the device's history and lack of direct patient contact.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL) of 10-6 for EO sterilization.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 15, 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: K200479
Trade/Device Name: AquaPulse Auxiliary Water Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: May 6, 2020 Received: May 7, 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
1
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 (QS) 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 medical devices and radiation-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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name AquaPulse® Auxiliary Water Connector
Indications for Use (Describe)
The AquaPulse® Auxiliary Water Connector is used in conjunction tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Fujifilm GI endoscopes during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
| 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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
| Submitter's Name: | 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.: | No number listed |
2. Sponsor Contact
| Contact Person: | Cindy Ye |
|---|---|
| Chief Executive Officer | |
| Telephone: | +852 2833 9010 |
| Email: | cindy@andorate.com |
3. Date Prepared
15th Nov 2019
4. Device Identification
| Trade Device Name: | AquaPulse® Auxiliary Water Connector |
|---|---|
| Common Device Name: | Connector between the tube and endoscope |
| Product Code: | OCX – Endoscopic Irrigation/Suction |
| Regulation Number: Regulatory | System 21 CFR 876.1500 |
| Classification: | 2 |
5. Predicate Device Identification
| Predicate Device 510(k) No.: | K092429 |
|---|---|
| Predicate Device Trade Name: | ENDOGATOR |
| Predicate Device Product Code: | FEQ |
6. Device Description:
The subject device is intended for single-use and are supplied sterile. Table 1 shows the components included in the application.
| Components | Qty | Product Code | Regulation
Number | Regulatory
Classification |
|-----------------------------------------|-----|-----------------------------------------------|----------------------|------------------------------|
| AquaPulse® Auxiliary
Water Connector | 1 | OCX – Endoscopic
Irrigation/Suction System | 21 CFR
876.1500 | 2 |
Table 1 – Components included in the application
The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and together with Fujifilm 500/600/700 series endoscope. It is designed to be attached to the
4
auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The auxiliary water connector is packed individually in a sealed packed. The subject device is supplied as sterile The subject device 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.
7. Intended Use:
The AquaPulse® Auxiliary Water Connector is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Fujifilm GI endoscopes during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
8. Technological Characteristics
The following table (Table 2) is summaries of the AquaPulse® Auxiliary Water Connector 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 (Auxiliary water connector)
| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------|
| Device name | ENDOGATOR
(Irrigation Accessories auxiliary
water connector) | AQUAPULSE® Auxiliary Water
Connector | N/A |
| K number | K092429 | / | N/A |
| Manufacturer | Medivators, Inc. | GA Health Company Limited | N/A |
| Product code | FEQ | OCX | N/A |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Fujifilm GI endoscopes | Fujifilm GI endoscopes | Similar |
| Intended Use | The ENDOGATOR® system is
intended to provide irrigation via
sterile water during GI endoscopic | The AquaPulse® Auxiliary Water
Connector is used in conjunction with
irrigation tubing (not supplied) | Identical |
5
| | procedures when used in
conjunction with an irrigation pump
(or cautery unit). | intended to provide irrigation via
irrigation fluids such as sterile water
supplied to the Fujifilm GI
endoscopes during gastrointestinal
endoscopic procedures when used in
conjunction with an irrigation pump. | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Environment of
Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,
Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, silicone | Polycarbonate, silicone | Substantial
Equivalent |
| Packaging | It is packaged in a sealed pouch
individually | It is packaged in a sealed pouch
individually | Identical |
| Manufacturing
method | Injection moulding | Injection moulding | Similar |
| Backflow
Prevention
Design | Diaphragm in the connector allow
pressurized water passing through
in one-way but not the other way | Diaphragm in the connector allow
pressurized water passing through
in one-way but not the other way | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | One year | 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 Compatibility with irrigation tubing
- 9.1.2 Compatibility with endoscope
- 9.1.3 Water Flow Test
- 9.1.4 Air Leakage Test
- 9.1.5 Water Leakage Test
- 9.1.6 Backflow Performance Test
9.2 Sterilization
All the subject device is 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 10°. 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 subject and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.
9.3 Shelf Life
The AquaPulse® Auxiliary Water Connector have a one (1) year expiration date. The subject devices is packaged in a paper/film pouch respectively. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University. The
6
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 device 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"". 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.