(56 days)
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.
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.
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.
This document is a 510(k) Pre-Market Notification from GA Health Company Limited to the FDA for their Vacutore® Air/Water Bottle Tubing and Vacutore® CO2 Source Tubing with Luer Connector. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device's meeting of specific acceptance criteria in the context of an AI/ML study.
Therefore, the requested information for acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not applicable to this type of regulatory submission. This document pertains to traditional medical devices, not AI/ML-driven software.
The document primarily focuses on demonstrating that the new devices are as safe and effective as existing (predicate) devices through:
- Comparison of Technological Characteristics: Tables 2, 3, and 4 extensively compare the design, features, principles of operation, materials, and other specifications of the Vacutore® devices to their predicate devices.
- Non-Clinical Performance Data (Bench Testing): Section 9 describes various bench tests performed to ensure the devices meet their intended functional requirements.
Here's a breakdown of the relevant information provided, aligning with the spirit of your request as much as possible for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for AI/ML performance metrics. Instead, it describes various performance tests conducted to show functional equivalence to predicate devices and ensure safety and efficacy. The reported "performance" is that the devices passed these tests.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Vacutore® Air/Water Bottle Tubing | Assembling Integrity | Components are securely assembled and functional. | Passed (implied by overall conclusion) |
| Endoscope Compatibility | Compatible with specified Fujifilm endoscopes. | Passed (implied by overall conclusion) | |
| Compatibility with Bottle | Compatible with sterile water bottle. | Passed (implied by overall conclusion) | |
| Two-Way Valve Integrity | Valve functions correctly without leakage or backflow. | Passed (implied by overall conclusion) | |
| Flow Clamp Test | Clamp maintains proper flow control. | Passed (implied by overall conclusion) | |
| Air Flow Test | Delivers adequate air flow. | Passed (implied by overall conclusion) | |
| Water Flow Test | Delivers adequate water flow. | Passed (implied by overall conclusion) | |
| 24-hour use test | Maintains performance and integrity for 24 hours of use. | Passed (demonstrates 24-hour multi-patient use) | |
| Vacutore® CO2 Source Tubing with Luer Connector | Assembling Integrity | Components are securely assembled and functional. | Passed (implied by overall conclusion) |
| Compatibility with CO2 Insufflator | Compatible with CO2 insufflator. | Passed (implied by overall conclusion) | |
| Compatibility with air/water bottle tubing | Compatible with Vacutore® Air/Water Bottle Tubing. | Passed (implied by overall conclusion) | |
| CO2 delivery test | Delivers adequate CO2. | Passed (implied by overall conclusion) | |
| Water delivery test | Delivers adequate water. | Passed (implied by overall conclusion) | |
| Air leak test | No air leakage. | Passed (leakage test conducted for verification) | |
| Water backflow test | Prevents water backflow. | Passed (indicates sufficient backflow prevention) | |
| Sterilization | EO sterilization cycle | Sterility Assurance Level (SAL) of 10-6. | Achieved (validated EO sterilization cycle with SAL 10-6) |
| EO residuals | Below maximum levels defined in ANSI/AAMI/ISO 10993-7:2008. | Achieved | |
| Shelf Life (Air/Water Bottle Tubing) | Accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, sterility | Maintains sterile barrier and intended performance for 1 year. | Passed (implies performance for at least one year) |
| Shelf Life (CO2 Source Tubing) | Accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, sterility | Maintains intended performance for 3 years. | Passed (implies performance for at least three years) |
| Biocompatibility | Acute Systemic Toxicity, In Vitro Cytotoxicity, Skin Sensitization, Irritation | Device is biocompatible for mucosal membrane contact ≤ 24 hours. | All tests passed, device shown to be biocompatible. |
| Simulated Use Testing | 24-hour multi-patient use, backflow prevention | Maintains performance and prevents backflow in simulated use. | Provided sufficient backflow prevention and verified 24-hour multi-patient use. |
2. Sample size used for the test set and the data provenance:
The document states that the bench testing was performed on "GA Health samples from initial production lots." It does not specify the exact number of units tested for each "test set" (i.e., for each individual test like air flow or leak test).
- Sample Size: Not explicitly stated as a number of devices per test.
- Data Provenance: The tests were performed in-house by GA Health Company Limited (the manufacturer). This is direct prospective testing of their own new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical device, and the "ground truth" for performance is determined by established engineering and medical device standards and functional testing, not by expert interpretation in a clinical or image-based context.
4. Adjudication method for the test set:
Not applicable for a physical device's bench testing. Performance is measured against physical specifications and validated test methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI/ML product for medical image interpretation or diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for these physical devices is based on:
- Engineering Specifications: Design tolerances, material properties, and functional requirements.
- Established Standards: e.g., ANSI/AAMI/ISO 10993-7:2008 for biocompatibility.
- Functional Performance: Direct measurement and observation of device operation (e.g., flow rates, leak prevention, integrity).
- Predicate Device Performance: The predicate devices themselves set a de-facto standard for expected performance and safety, against which the new device is compared to show substantial equivalence.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.
{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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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 Square2 On Yiu Street ,Shatin, N.T,Hong Kong, CHINA |
2. Sponsor Contact
| Contact Person: | Cindy YeChief 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 | RegulationNumber | Classification |
| Vacutore® Air/Water BottleTubing(GAR088US) | 1 | OCX - EndoscopicIrrigation/SuctionSystem | 876.1500 | 2 |
| Vacutore® Air/Water BottleTubing(GAR090US) | 1 | OCX - EndoscopicIrrigation/SuctionSystem | 876.1500 | 2 |
| Vacutore® CO2 SourceTubing with Luer Connector(GAR047) | 1 | FCX - Insufflator,Automatic Carbon-Dioxide ForEndoscope | 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 | SubstantialEquivalence |
|---|---|---|---|
| Device name | Endo SmartCapTM | Vacutore® Air/Water BottleTubing | 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 |
| RegulationName | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Fujinon® Endoscopes | Fujifilm 500/600 seriesendoscope | SubstantialEquivalent |
| Indications forUse | ENDO SMARTCAPTM Tubing isintended to be used with an airor CO2 source and/ or pumpalong with a sterile water sourceto supply air or CO2 and sterilewater to an gastrointestinalendoscope during endoscopicprocedures | The Vacutore® Air/Water Bottle Tubingis to connect an air/CO2 source, asterile water source (water bottle), andan endoscope to supply air/CO2 andwater during gastrointestinalendoscopic procedures. This device isintended to be used for not more than24 hours. It is a 24-hour multi-patientuse device | SubstantialEquivalent |
| Environment ofUse | Hospital and or clinics | Hospital and or clinics | Identical |
| Material | Methyl methacrylate-acrylonitrile-butadiene-styrenecopolymer, Polycarbonate,Polyethylene, PolyvinylChloride, ThermoplasticElastomer | Polyvinyl Chloride, Silicone,Polyoxymethylene,Polycarbonate, AcrylonitrileButadiene Styrene | SubstantialEquivalent |
| Packaging | Each model packed separatelyin a seal pouched | Each model packed separately ina seal pouched | Identical |
{6}------------------------------------------------
| Manufacturingmethod | Injection moulding andextrusion | Injection moulding and extrusion | SubstantialEquivalent |
|---|---|---|---|
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | One year | SubstantialEquivalent |
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 | SubstantialEquivalence |
|---|---|---|---|
| Device name | FUJIFILM Water Tank | Vacutore® Air/Water BottleTubing | 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 |
| RegulationName | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | No | Yes | SubstantialEquivalent* |
| Compatibility | FUJIFILM 700 system scopes | Fujifilm 700 series endoscope | SubstantialEquivalent |
| Indications forUse | The Water Tank Model WT-603is intended for use incombination with FUJIFILM 700system scopes to deliver air andwater through the endoscopeunder the management of aphysician in medical facilities.Do not use this product for anyother purpose. | The Vacutore® Air/Water BottleTubing is to connect an air/CO2source, a sterile water source(water bottle), and an endoscope tosupply air/CO2 and water duringgastrointestinalendoscopicprocedures. This device is intended tobe used for not more than 24 hours. Itis a 24-hour multi-patient use device. | SubstantialEquivalent |
| Environment ofUse | Hospital and or clinics | Hospital and or clinics | Identical |
| Material | Silicone Rubber, Poly (4-methyl-1-pentene) | Polyvinyl Chloride, Silicone,Polyoxymethylene,Polycarbonate, AcrylonitrileButadiene Styrene | SubstantialEquivalent |
| Packaging | Each model packed in a PE bagwith a carton box | Each model packed separately ina seal pouch | SubstantialEquivalent |
| Manufacturingmethod | Injection moulding | Injection moulding and extrusion | SubstantialEquivalent |
| Sterilization | Supplied non-sterileSterilized in a daily basis | EO gas | SubstantialEquivalent* |
| Shelf Life | One year | One year | Identical |
| Specification | Predicate Device | Proposed Device | SubstantialEquivalence |
| Device name | Endo SmartCap™ CO2 SourceTubing | Vacutore® CO2 Source Tubingwith 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 |
| RegulationName | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | No | No | Identical |
| Indications forUse | ENDO SMARTCAP™ CO2Source Tubing with Luer Input isintended to be used with a CO2insufflator along withENDOSMARTCAP™ IrrigationTubingor ENDOGATOR™ HybridIrrigation Tubing to supply CO2 toa GI endoscope during GIendoscopic procedures | The Vacutore® CO2 Source Tubingwith Luer Connector is intended tobe used with a carbon dioxide (CO2)source with the purposeof supplying CO2 to theendoscope during endoscopicprocedures. This device is intendedto be used for not more than 24hours. It is a 24-hour multi-patientuse device. | SubstantialEquivalent |
| Environment ofUse | Hospital and or clinics | Hospital and or clinics | Identical |
| Material | Polycarbonate, PolyvinylChloride, high impactpolystyrene, Polyethyleneterephthalate,polytetrafluoroethylene | Polyvinyl Chloride,polypropylene, Polycarbonate,polytetrafluorethylene, | SubstantialEquivalent |
| Packaging | Each model packed separately ina PE bag | Each model packed separately ina seal pouched | Identical |
| Manufacturingmethod | Injection moulding | Injection moulding | SubstantialEquivalent |
| Shelf Life | Three years | Three years | SubstantialEquivalent |
{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.
§ 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.