Who can help prepare an FDA 510(k) submission like Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

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

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing

Q: Who is the manufacturer of Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

Ga Health Company Limited filed the 510(k) submission for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602).

Q: What is the FDA product code for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

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

Q: What is the regulatory pathway for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

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

Q: What are the predicate devices for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

Andorate Air Water Bottle Tubing (K191366); Universal Irrigation Solution Hybrid (K102855).

K231602 · Ga Health Company Limited · OCX · Aug 1, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K231602
Device Name	Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
Applicant	Ga Health Company Limited
Product Code	OCX · Gastroenterology, Urology
Decision Date	Aug 1, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended 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 conjunction with an irrigation pump. It is a 24-hour multi-patient use device.

Device Story

Protego Air Water Connector, Air Water Bottle Tubing, and Hybrid Tubing are endoscopic accessories. Devices connect air/CO2 sources and sterile water bottles to endoscopes to facilitate irrigation and insufflation during GI procedures. Hybrid Tubing integrates with irrigation pumps. Used in hospitals/clinics by medical professionals. Devices act as fluid/gas conduits; no active electronic processing. Output is physical delivery of air, CO2, or water to the endoscope. Benefits include maintaining clear visualization and patient safety during endoscopy. Single-use (Connector) or 24-hour multi-patient use (Tubing) designs.

Clinical Evidence

Bench testing only. Testing included endoscope compatibility, connector/tubing pulling force, backflow prevention, air/water flow rates, leak testing, and bottle cap compatibility. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Sterilization validated per ISO 11135/ISO 10993-7. Shelf life validated via accelerated aging (ASTM F1980-16) and packaging integrity tests (ASTM F88, F1929, D3078).

Technological Characteristics

Materials: Polycarbonate, Silicone Rubber, Polyvinyl chloride, Polyoxymethylene, Polyethylene, Acrylonitrile butadiene styrene. Manufacturing: Injection/compression molding, extrusion. Sterile (EO, SAL 10^-6). Shelf life: 3 years. Connectivity: Mechanical connection to endoscope/pump. No software/electronics.

Indications for Use

Indicated for patients undergoing gastrointestinal endoscopic procedures requiring air/CO2, water, or irrigation supply.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Andorate Air Water Bottle Tubing (K191366)
Universal Irrigation Solution Hybrid (K102855)

Related Devices

K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing · Changzhou Endoclean Medical Device Co., Ltd. · Oct 7, 2022
K193250 — Irrigation Tubing with CO2 or Air · Keymed (Medical and Industrial Equipment) , Ltd. · Apr 6, 2020
K231418 — ENDOGATOR Hybrid Irrigation Tubing · Medivators · Aug 14, 2023
K191366 — Vacutore Air/Water Bottle Tubing · Smartdata Suzhou Co., Ltd. · Sep 6, 2019
K220785 — Clean Connecting Tube · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Sep 27, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. 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) K231602 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.