(56 days)
Not Found
No
The device description and performance studies focus on the physical components and fluid/gas delivery functions of tubing for endoscopic procedures, with no mention of AI or ML.
No
The device's intended use is to supply air/CO2 and water during gastrointestinal endoscopic procedures, which are supportive functions for the procedure rather than direct therapeutic intervention.
No.
The device is described as tubing to supply gasses and fluids to an endoscope, which is an accessory used during procedures, not for diagnosis itself. Its purpose is to facilitate endoscopic procedures by providing irrigation and CO2 insufflation, not to provide diagnostic information.
No
The device description clearly outlines physical components (tubing, luer connector) and their intended use in connecting physical sources (air/CO2, water bottle) to an endoscope. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device (Vacutore Air/Water Bottle Tubing and CO2 Source Tubing) is used to supply air/CO2 and water during an endoscopic procedure. It is a piece of equipment used to facilitate the procedure itself, not to analyze a sample taken from the patient.
- Intended Use: The intended use clearly states its purpose is to supply air/CO2 and water during gastrointestinal endoscopic procedures. This is a procedural aid, not a diagnostic test.
- Device Description: The description details the physical components and how they connect to an endoscope and external sources (water bottle, CO2 insufflator). It does not mention any analysis of biological samples.
The device is a medical device used in a clinical setting, but its function is to support the endoscopic procedure, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes
OCX, FCX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing was performed to support substantial equivalence. The following testing were performed on GA Health samples from initial production lots, including sterilization:
Vacutore® Air/Water Bottle Tubing Performance Tests: Assembling Integrity, Endoscope Compatibility, Compatibility with Bottle, Two-Way Valve Integrity, Flow Clamp Test, Air Flow Test, Water Flow Test, 24-hour use test.
Vacutore® CO2 Source Tubing with Luer Connector Performance Tests: Assembling Integrity, Compatibility with CO2 Insufflator, Compatibility with air/water bottle tubing, CO2 delivery test, Water delivery test, Air leak test, Water backflow test.
Sterilization: Vacutore® Air/Water Bottle Tubing is sold in sterile package with a validated EO sterilization cycle (SAL of 10-6). EO residuals are below maximum levels defined in ANSI/AAMI/ISO 10993-7:2008. Vacutore® CO2 Source Tubing with Luer Connector is supplied as non-sterile.
Shelf Life: Vacutore® Air/Water Bottle Tubing has a one (1) year shelf life. Vacutore® CO2 Source Tubing with Luer Connector has a three (3) year shelf life. Accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test, and sterility tests were conducted on packaging by an CNAS accredited laboratory.
Biocompatibility: Tested per FDA guideline "Use of International Standard ISO 10993-1," including Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin sensitization, and Irritation. The air/water bottle tubing and CO2 source tubing are classified as surface devices 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.
Simulated Use Testing: Conducted on subject devices, implying sufficient backflow prevention with intended devices and verifying 24-hour multi-patient use.
Clinical Testing was not necessary to support substantial equivalence.
Key results: Based on the technological characteristics and overall performance of the devices in bench testing, it is believed 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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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) |
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3
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
| Submitter's Name: | 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.