What is the FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

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

What is the regulatory pathway for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

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

What are the predicate devices for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Endo SmartCap™ (K093665); FUJIFILM Water Tank (K172916).

Who can help prepare an FDA 510(k) submission like Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

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.

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

Q: Who is the manufacturer of Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Ga Health Company Limited filed the 510(k) submission for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector (K200388).

K200388 · Ga Health Company Limited · OCX · Apr 14, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K200388
Device Name	Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
Applicant	Ga Health Company Limited
Product Code	OCX · Gastroenterology, Urology
Decision Date	Apr 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The Vacutore® 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. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. The Vacutore® CO2 Source Tubing with Luer Connector is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

Device Story

The Vacutore system consists of two tubing sets: Air/Water Bottle Tubing and CO2 Source Tubing with Luer Connector. The Air/Water tubing connects an air/CO2 source, a sterile water bottle, and a Fujifilm 500/600/700 series endoscope to provide irrigation to the distal end. The CO2 Source tubing connects a CO2 insufflator to the air/water tubing to supply CO2 for insufflation. Used in hospitals and clinics by medical professionals during GI endoscopic procedures. The devices are designed for 24-hour multi-patient use. The output is the delivery of air, water, or CO2 to the endoscope, which facilitates visualization and procedural access. The device benefits the patient by enabling standard endoscopic irrigation and insufflation functions required for diagnostic or therapeutic GI procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including assembly integrity, endoscope/insufflator compatibility, flow testing, air leak/water backflow testing, and biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity).

Technological Characteristics

Materials: PVC, silicone, polyoxymethylene, polycarbonate, ABS, polypropylene, PTFE. Principle: Fluid/gas delivery via tubing connections. Form factor: Flexible medical tubing sets. Connectivity: Mechanical Luer connectors. Sterilization: EO gas (Air/Water tubing).

Indications for Use

Indicated for use in gastrointestinal endoscopic procedures to connect air/CO2 and sterile water sources to an endoscope for irrigation and insufflation. Intended for 24-hour multi-patient use.

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

Endo SmartCap™ (K093665)
FUJIFILM Water Tank (K172916)

Related Devices

K191366 — Vacutore Air/Water Bottle Tubing · Smartdata Suzhou Co., Ltd. · Sep 6, 2019
K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing · Changzhou Endoclean Medical Device Co., Ltd. · Oct 7, 2022
K231471 — Air/Water Bottle Tubing, CO2 Source Tubing · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Sep 8, 2023
K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing · Ga Health Company Limited · Aug 1, 2023
K102855 — UNIVERSAL IRRIGATION SOLUTION HYBRID · Byrne Medical, Inc. · Nov 19, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 14, 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 Re: K200388 > Trade/Device Name: Vacutore Air/Water Bottle Tubing Vacutore CO2 Source Tubing with Luer Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX. FCX Dated: April 1, 2020 Received: March 30, 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 510(k) Number (if known) K200388 Device Name Vacutore Air/Water Bottle Tubing, Vacutore CO2 Source Tubing with Luer Connector Indications for Use (Describe) The Vacutore 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. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. The Vacutore CO2 Source Tubing with Luer Connector is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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](mailto: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: | GA Health Company Limited | |----------------------|--------------------------------------------------------------------------------------| | Submitter's Address: | Unit 18, 21/F, Metropole Square 2 On Yiu Street ,Shatin, N.T, Hong Kong, CHINA | ### 2. Sponsor Contact | Contact Person: | Cindy Ye Chief Executive Officer | |-----------------|-------------------------------------| | Telephone: | +852 2833 9010 | | Email: | cindy@andorate.com | # 3. Date Prepared 13th April 2020 ### 4. Device Identification Trade Device Name: Vacutore® Air/Water Bottle Tubing Common Device Name: Air/Water Tubing for Endoscope Classification Name: OCX - Endoscopic Irrigation/Suction System Regulation Number: 876.1500 Classification: 2 Regulation Name: Endoscope and accessories. Trade Device Name: Vacutore® CO2 Source Tubing with Luer Connector Common Device Name: CO2 Source Tubing Classification Name: FCX - Insufflator, Automatic Carbon-Dioxide For Endoscope Regulation Number: 876.1500 Classification: 2 Regulation Name: Endoscope and accessories. # 5. Predicate Device Identification Predicate Device 510(k) No .: K093665 Predicate Device Trade Name: Endo SmartCap™ Predicate Device Product Code: FAJ Predicate Device 510(k) No.: K172916 Predicate Device Trade Name: FUJIFILM Water Tank Predicate Device Product Code: FDF, FDS {4}------------------------------------------------ There are two predicate devices as mentioned above. The primary predicate device is Endo SmartCap™ (K093665). The secondary predicate device is FUJIFILM Water Tank (K172916). ### 6. Device Description: The Vacutore® Air/Water Bottle Tubing and CO2 Source Tubing with Luer Connector (Hereafter called CQ2 Source Tubing) are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO2 Source Tubing is supplied in non-sterile. Table 1 shows the components included in the application. | Table 1 – Components Included in the application | | | | | |----------------------------------------------------------------|-----|---------------------------------------------------------------------|----------------------|----------------| | Components | Qty | Classification Name | Regulation Number | Classification | | Vacutore® Air/Water Bottle Tubing (GAR088US) | 1 | OCX - Endoscopic Irrigation/Suction System | 876.1500 | 2 | | Vacutore® Air/Water Bottle Tubing (GAR090US) | 1 | OCX - Endoscopic Irrigation/Suction System | 876.1500 | 2 | | Vacutore® CO2 Source Tubing with Luer Connector (GAR047) | 1 | FCX - Insufflator, Automatic Carbon- Dioxide For Endoscope | 876.1500 | 2 | #### Tahle 1. Components included in the application The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Fujifilm 500/600 and 700 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope. The Vacutore® CO2 Source Tubing with Luer Connector is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in sealed package, sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. 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 are conducted for verification. There were no prior submissions for the Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector. #### 7. Intended Use: The Vacutore® Air/Water Bottle Tubing is to connect an air/CQ2 source, a sterile water source (water bottle), and an endoscope to supply endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. {5}------------------------------------------------ The Vacutore® CO2 Source Tubing with Luer Connector is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. # 8. Technological Characteristics Table 2, 3 and 4 summarize the Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector technological characteristics as compared to the predicate device from Endo SmartCap™ and FUJIFILM Water Tank. Table 2 Summary of design, features and principles of operation between the Vacutore® Air/Water Bottle Tubing (GAR088US) technological characteristics as compared to the predicate devices. | Specification | Predicate Device | Proposed Device | Substantial Equivalence | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Device name | Endo SmartCapTM | Vacutore® Air/Water Bottle Tubing | N/A | | K number | K093665 | --- | N/A | | Manufacturer | Medivators, Inc. | GA Health Company Limited | N/A | | Product code | FAJ | OCX | N/A | | Classification | 2 | 2 | Identical | | Regulation No | 876.1500 | 876.1500 | Identical | | Regulation Name | Endoscope and accessories | Endoscope and accessories | Identical | | Supplied Sterile | Yes | Yes | Identical | | Compatibility | Fujinon® Endoscopes | Fujifilm 500/600 series endoscope | Substantial Equivalent | | Indications for Use | ENDO SMARTCAPTM Tubing is intended to be used with an air or CO2 source and/ or pump along with a sterile water source to supply air or CO2 and sterile water to an gastrointestinal endoscope during endoscopic procedures | The Vacutore® 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. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device | Substantial Equivalent | | Environment of Use | Hospital and or clinics | Hospital and or clinics | Identical | | Material | Methyl methacrylate- acrylonitrile-butadiene-styrene copolymer, Polycarbonate, Polyethylene, Polyvinyl Chloride, Thermoplastic Elastomer | Polyvinyl Chloride, Silicone, Polyoxymethylene, Polycarbonate, Acrylonitrile Butadiene Styrene | Substantial Equivalent | | Packaging | Each model packed separately in a seal pouched | Each model packed separately in a seal pouched | Identical | {6}------------------------------------------------ | Manufacturing method | Injection moulding and extrusion | Injection moulding and extrusion | Substantial Equivalent | |-------------------------|-------------------------------------|----------------------------------|---------------------------| | Sterilization | EO gas | EO gas | Identical | | Shelf Life | Three years | One year | Substantial Equivalent | Table 3 Summary of design, features and principles of operation between the Vacutore® Air/Water Bottle Tubing (GAR090US) technological characteristics as compared to the predicate devices. | Specification | Predicate Device | Proposed Device | Substantial Equivalence | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Device name | FUJIFILM Water Tank | Vacutore® Air/Water Bottle Tubing | N/A | | K number | K172916 | | N/A | | Manufacturer | Fujifilm Corporation | GA Health Company Limited | N/A | | Product code | FDS, FDF | OCX | 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 system scopes | Fujifilm 700 series endoscope | Substantial Equivalent | | Indications for Use | The Water Tank Model WT-603 is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose. | The Vacutore® 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. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. | Substantial Equivalent | | Environment of Use | Hospital and or clinics | Hospital and or clinics | Identical | | Material | Silicone Rubber, Poly (4- methyl-1-pentene) | Polyvinyl Chloride, Silicone, Polyoxymethylene, Polycarbonate, Acrylonitrile Butadiene Styrene | Substantial Equivalent | | Packaging | Each model packed in a PE bag with a carton box | Each model packed separately in a seal pouch | Substantial Equivalent | | Manufacturing method | Injection moulding | Injection moulding and extrusion | Substantial Equivalent | | Sterilization | Supplied non-sterile Sterilized in a daily basis | EO gas | Substantial Equivalent* | | Shelf Life | One year | One year | Identical | | Specification | Predicate Device | Proposed Device | Substantial Equivalence | | Device name | Endo SmartCap™ CO2 Source Tubing | Vacutore® CO2 Source Tubing with Luer Connector | N/A | | K number | K093665 | --- | N/A | | Manufacturer | Medivators, Inc. | GA Health Company Limited | N/A | | Product code | FAJ | FCX | 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 | No | Identical | | Indications for Use | ENDO SMARTCAP™ CO2 Source Tubing with Luer Input is intended to be used with a CO2 insufflator along with ENDO SMARTCAP™ Irrigation Tubing or ENDOGATOR™ Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures | The Vacutore® CO2 Source Tubing with Luer Connector is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. | Substantial Equivalent | | Environment of Use | Hospital and or clinics | Hospital and or clinics | Identical | | Material | Polycarbonate, Polyvinyl Chloride, high impact polystyrene, Polyethylene terephthalate, polytetrafluoroethylene | Polyvinyl Chloride, polypropylene, Polycarbonate, polytetrafluorethylene, | Substantial Equivalent | | Packaging | Each model packed separately in a PE bag | Each model packed separately in a seal pouched | Identical | | Manufacturing method | Injection moulding | Injection moulding | Substantial Equivalent | | Shelf Life | Three years | Three years | Substantial Equivalent | {7}------------------------------------------------ *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 using. Table 4 Summary of design, features and principles of operation between the Vacutore® CO₂ Source Tubing with Luer Connector (GAR047) technological characteristics as compared to the predicate devices. {8}------------------------------------------------ # 9. Non-Clinical Performance Data The bench testing was performed to support substantial equivalence. The following testing were performed on GA Health samples from initial production lots, includingsterilization. #### 9.1 Performance Test # 9.1.1 Vacutore® Air/Water Bottle Tubing - Assembling Integrity 9.1.1.1 - 9.1.1.2 Endoscope Compatibility - Compatibility with Bottle 9.1.1.3 - Two-Way Valve Integrity 9.1.1.4 - Flow Clamp Test 9.1.1.5 - 9.1.1.6 Air Flow Test - 9.1.1.7 Water Flow Test - 9.1.1.8 24-hour use test # 9.1.2 Vacutore® CO2 Source Tubing with Luer Connector - Assembling Integrity 9.1.2.1 - 9.1.2.2 Compatibility with CO2 Insufflator - Compatibility with air/water bottle tubing 9.1.2.3 - CO2 delivery test 9.1.2.4 - Water delivery test 9.1.2.5 - Air leak test 9.1.2.6 - Water backflow test 9.1.2.7 #### 9.2 Sterilization Vacutore® Air/Water Bottle Tubing is sold in sterile package. The subject device has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10-6. 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 Vacutore® Air/Water Bottle Tubing, and the predicate devices, are not labeled as pyroqen-free because they do not have any blood or cerebrospinal fluid contact. Vacutore® CO2 Source Tubing with Luer Connector is supplied as non-sterile. #### 9.3 Shelf Life The Vacutore® Air/Water Bottle Tubing has a one (1) year shelf life and the Vacutore® CO2 Source Tubing with Luer Connector has a three (3) year shelf life, based on the design and existing sterile barrier data from existing packaging. The subject devices are packaged in a paper/film pouch respectively like other sterile products currently manufactured. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University, which is an CNAS accredited laboratory. 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 after the accelerated aging process. The test result can imply that the air/water bottle tubing can provide and maintain a sterile barrier and its intended performance for at least one (1) year. It also implies that the CO2 source tubing maintains its intended performance for at least three (3) years. {9}------------------------------------------------ #### 9.4 Biocompatibility The biocompatibility of the Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector 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 air/water bottle tubing and CO2 source tubing are classified as surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the air/water bottle tubing is biocompatible. #### 9.5 Simulated Use Testing Simulated use testing of the subject devices was conducted. The test results can imply that the subject devices provide sufficient backflow prevention with the intended devices and verified 24-hour multi-patient use. # 10. Clinical Testing Similar devices have been on the market for many vears 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. # 11. Conclusion Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector has the same intended use as the predicate devices. Based on the technological characteristics and overall performance of the devices in bench testing, It is believes that no significant differences exist between the subject devices and the predicate devices. The Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector, and the predicate device are substantially equivalent.