(61 days)
Not Found
No
The device description and performance studies focus on the physical components and fluid/air flow characteristics of tubing and connectors, with no mention of data processing, algorithms, or AI/ML terms.
No
The device's sole function is to connect an air/CO2 source, a sterile water source, and an endoscope to supply air/CO2 and water during procedures, not to treat a condition or disease.
No
The device description states that it is intended for supplying air/CO2 and water during gastrointestinal endoscopic procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (connector, tubing) intended to connect physical sources (air/CO2, water) to a physical device (endoscope). There is no mention of software as a component or function of the device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used to "supply air/CO2 and water during gastrointestinal endoscopic procedures." This is a procedural support function, not a diagnostic one.
- Device Description: The description details how the devices connect to an endoscope and sources of air/CO2 and water. This aligns with their role in facilitating the endoscopic procedure itself.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status or disease. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
- Bench Testing: The performance studies described are bench tests focused on the physical and functional aspects of the tubing and connectors (flow rates, pulling force, leaks, etc.). These are typical tests for medical devices used in procedures, not for IVDs which would involve analytical performance testing.
The devices described are accessories used to support a medical procedure (endoscopy), not devices that perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Protego Air Water Connector
The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing
Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Protego Hybrid Tubing
Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2. water and irrigation during endoscopic procedures in coniunction with an irrigation pump. It is a 24-hour multi-patient use device.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile.
The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
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 on both the subject device and the predicate device. The following bench testing was performed on the subject device - endoscope compatibility test, connector pulling force test, connector/tubing pulling force test and backflow prevention test for air water connector, air flow test, water flow test, water leak test and bottle cap compatibility test for air water bottle tubing and air flow test, water flow test, air leak test, flow clamp test and backflow prevention test for hybrid tubing. The performance data demonstrated that the subject devices met established specifications.
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.
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August 1, 2023
GA Health Company Limited Wing Yu Lam Assistant Regulatory Affairs Manager Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, HONG KONG
Re: K231602
Trade/Device Name: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: June 1, 2023 Received: June 1, 2023
Dear Wing Yu Lam:
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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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 -S
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
Submission Number (if known)
Device Name
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
ndications for Use (Describe)
Protego Air Water Connector
The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing
Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Protego Hybrid Tubing
Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2. water and irrigation during endoscopic procedures in coniunction with an irrigation pump. It is a 24-hour multi-patient use device.
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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3
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
Submitter's Name: Submitter's Address:
Establishment Reqistration No.:
2. Sponsor Contact
GA Health Company Limited Unit 18, 21/F, Metropole Square 2 On Yiu Street, Shatin, N.T, Hong Kong. CHINA 3014749926
Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindy.ye@gahealth.com
Lam Wing Yu Assistant Requlatory Affairs Manager Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com
3. Date Prepared
1 June 2023
4. Device Identification
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
Device Name: Common Name: Classification Number: Protego Air Water Connector Air Water Connector 21 CFR 876.1500 Endoscope and accessories OCX Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
Protego Air Water Bottle Tubing Air Water Bottle Tubing 21 CFR 876.1500 Endoscope and accessories OCX Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
Protego Hybrid Tubing Hybrid Tubing 21 CFR 876.1500
4
| Classification Name: | Endoscope and accessories |
|---|---|
| Product Code: | OCX |
| Product Code Name: | Endoscopic Irrigation/Suction System |
| Regulation Class: | 2 |
| Device Panel: | Gastroenterology/Urology |
5. Predicate Device Identification
Primary Predicate Device 510(k) No.: Primarv Predicate Device Trade Name: Primary Predicate Device Product Code: Secondary Predicate Device 510(k) No .: Secondary Predicate Device Trade Name: Secondary Predicate Device Product Code:
K191366 Andorate Air Water Bottle Tubing OCX - Endoscopic Irrigation/Suction System K102855 Universal Irrigation Solution Hybrid
OCX - Endoscopic Irrigation/Suction System
6. Device Description:
The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. Table 1 shows the components included in the submission.
| Components | Qty | Product Code | Regulation
Number | Regulatory
Classification |
|------------------------------------|-----|--------------------------------------------------|----------------------|------------------------------|
| Protego Air Water
Connector | 1 | OCX — Endoscopic
Irrigation/Suction
System | 21 CFR 876.1500 | 2 |
| Protego Air Water Bottle
Tubing | 1 | OCX — Endoscopic
Irrigation/Suction
System | 21 CFR 876.1500 | 2 |
| Protego Hybrid Tubing | 1 | OCX — Endoscopic
Irrigation/Suction
System | 21 CFR 876.1500 | 2 |
Table 1 - Components included in this Submission
The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
7. Indications for Use:
The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
5
Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.
8. Technological Characteristics
Table 2.1 and Table 2.2 summarizes the subject devices technological characteristics as compared to the predicate devices.
Table 2.1 Summary of design, features and principles of operation and technological characteristics between the Air Water Connector, Air Water Bottle Tubing and predicate device
| Specification | Primary Predicate
Device | Subject Device | Subject Device | Substantial
Equivalence |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device name | Andorate Air Water Bottle
Tubing
(GAR025) | Protego Air Water
Connector
(201001) | Protego Air Water Bottle
Tubing
(202001) | N/A |
| K number | K191366 | K231602 | K231602 | N/A |
| Manufacturer | GA Health Company
Limited | GA Health Company
Limited | GA Health Company
Limited | N/A |
| Product code | OCX | OCX | OCX | Identical |
| Regulatory
Classification | 2 | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscopic
Irrigation/Suction System | Endoscopic
Irrigation/Suction System | Endoscopic
Irrigation/Suction System | Identical |
| Intended Use | The Air/Water Bottle
Tubing is to connect an
air/CO2 source, a sterile
water source (water
bottle), and an endoscope
to supply air/CO2 and
water during
gastrointestinal
endoscopic procedures. It
is a 24-hour multi-patient
use device. | The single use Protego Air
Water Connector is
intended to connect an
air/CO2 source, a sterile
water source and an
endoscope to supply
air/CO2 and water during
gastrointestinal
endoscopic procedures. | Protego Air Water Bottle
Tubing is to connect an
air/CO2 source, a sterile
water source (water
bottle), and an endoscope
to supply air/CO2 and
water during
gastrointestinal
endoscopic procedures. It
is a 24-hour multi-patient
use device. | Substantial
Equivalent |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or
Reusable | 24-hour Use | Single Use | 24-hour Use | Identical |
| Material | Acrylonitrile butadiene
styrene, Silicone Rubber,
Polyoxymethylene,
Polyvinyl chloride,
Thermoplastic elastomers, | Polycarbonate, Silicone
Rubber | Acrylonitrile butadiene
styrene, Silicone Rubber,
Polyoxymethylene,
Polyvinyl chloride,
Polycarbonate,
Polyethylene,
Thermoplastic elastomers, | Substantial
Equivalent |
6
| Specification | Primary Predicate
Device | Subject Device | Subject Device | Substantial
Equivalence |
|-------------------------|---------------------------------------------------------|--------------------------------------------|---------------------------------------------------------|----------------------------|
| Device name | Andorate Air Water Bottle
Tubing
(GAR025) | Protego Air Water
Connector
(201001) | Protego Air Water Bottle
Tubing
(202001) | N/A |
| K number | K191366 | K231602 | K231602 | N/A |
| Manufacturer | GA Health Company
Limited | GA Health Company
Limited | GA Health Company
Limited | N/A |
| | Polycarbonate,
Polyethylene | | | |
| Manufacturing
method | Injection molding,
Compression molding,
Extrusion | Injection molding,
Compression molding | Injection molding,
Compression molding,
Extrusion | Substantial
Equivalent |
| Packaging | Packaged in a sealed
pouch | Packaged in a sealed
pouch | Packaged in a sealed
pouch | Substantial
Equivalent |
| Sterilization | Yes | Yes | Yes | Substantial
Equivalent |
| Shelf Life | 3 years | 3 years | 3 years | Substantial
Equivalent |
Table 2.2 Summary of design, features and principles of operation and technological characteristics between the Hybrid Tubing and predicate device
| Specification | Secondary Predicate Device | Subject Device | Substantial
Equivalence |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device name | ENDOGATORTM Endoscopic Disposable
Tubing Kit
(100602) | Protego Hybrid Tubing
(203001) | N/A |
| K number | K102855 | K231602 | N/A |
| Manufacturer | BYRNE MEDICAL, INC. | GA Health Company Limited | N/A |
| Product code | OCX | OCX | Identical |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscopic Irrigation/Suction System | Endoscopic Irrigation/Suction System | Identical |
| Intended Use | The Universal Irrigation Solution Hybrid
(tubing and accessories to
accommodate various endoscopes and
irrigation pumps) is intended to provide
irrigation via sterile water and to supply
air (via an air pump) along with sterile
water during GI endoscopic procedures
when used in conjunction with an
irrigation pump or cautery unit. | Protego Hybrid Tubing is intended to
connect an air/CO2 source, a sterile
water source and an endoscope to
supply air/CO2, water and irrigation
during endoscopic procedures in
conjunction with an irrigation pump. It is
a 24-hour multi-patient use device. | Substantial
Equivalent |
7
| Specification | Secondary Predicate Device | Subject Device | Substantial
Equivalence |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device name | ENDOGATOR™ Endoscopic Disposable
Tubing Kit
(100602) | Protego Hybrid Tubing
(203001) | N/A |
| K number | K102855 | K231602 | N/A |
| Manufacturer | BYRNE MEDICAL, INC. | GA Health Company Limited | N/A |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or
Reusable | 24-hour Use | 24-hour Use | Identical |
| Material | Polycarbonate, Thermoplastic
Elastomer, Polyvinyl Chloride,
Polyethylene, Methyl methacrylate-
acrylonitrile-butadiene-styrene
copolymer | Polycarbonate, Silicone Rubber
Polyvinyl chloride, Polyoxymethylene,
Polyethylene, Acrylonitrile butadiene
styrene | Substantial
Equivalent |
| Manufacturing
method | Injection molding, Compression molding,
Extrusion | Injection molding, Compression molding,
Extrusion | Substantial
Equivalent |
| Packaging | Packaged in a sealed pouch | Packaged in a sealed pouch | Substantial
Equivalent |
| Sterilization | Yes | Yes | Substantial
Equivalent |
| Shelf Life | 3 years | 3 years | Substantial
Equivalent |
9. Performance Test
The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed on the subject device - endoscope compatibility test, connector pulling force test, connector/tubing pulling force test and backflow prevention test for air water connector, air flow test, water flow test, water leak test and bottle cap compatibility test for air water bottle tubing and air flow test, water flow test, air leak test, flow clamp test and backflow prevention test for hybrid tubing. The performance data demonstrated that the subject devices met established specifications.
10. Sterilisation
All the subject devices are sold in a sterile package. 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 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
11. Shelf Life
The subject devices have a three (3) years shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test in accordance with ASTM F88/F 88M-15, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by
8
dye Penetration, ASTM D 3078-02, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. DIN 58953-6. Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to be Sterilized and ISO11737-2, Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process and performance test were conducted after accelerated aging test according to ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life.
12. Biocompatibility
The biocompatibility of the subject device was conducted in accordance with the FDA quideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing is conducted on subject device in accordance with the ISO 10993 standard. The suction valve is non-patient contacting device while the biopsy valve is classified as an indirect patient contacting device and surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The biocompatibility test was performed in accordance with the following standards - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test results show that all the subject devices are biocompatible.
13. Conclusion
The subject devices have the same intended use as the predicate device. Based on comparison of technological characteristics and evaluation of the characteristics through performance testing, the subject devices do not raise different questions of safety and effectiveness compared to the predicate. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.