(227 days)
No
The summary describes a mechanical introducer system with a modified valve design and material. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies are focused on functional testing of the mechanical components.
No
The device is an introducer system used to deliver other devices, not to directly treat a medical condition.
No
The device description clearly states its purpose is to introduce catheters and other intravascular devices, and its functional testing focuses on mechanical performance. There is no mention of it acquiring, processing, or interpreting data for diagnostic purposes.
No
The device description clearly describes a physical, valved tear-away introducer system made of materials and constructed using manufacturing processes. It also details functional testing on the physical device. 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:
- Intended Use: The intended use is to introduce catheters and other intravascular devices into the peripheral vasculature for percutaneous procedures. This is a direct medical intervention on a patient's body.
- Device Description: The device is a valved tear-away introducer, which is a tool used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Product codes
DYB
Device Description
The finished device is a valved tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed using identical processes and material with the exception of the subject device was modified to add a new valve design and material. The performance characteristics to the current marketed predicate device are unchanged and are consistent with other legally marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional testing on un-aged and 4 year aged product was conducted to verify that the modified Galt VTI® Valved Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- Dilator lock Test
- Cap Retention Test
- Pressure Leak Test
- Vacuum Leak Test
- Prolonged Insertion Test
- Valve Separation Test
- Insertion / Extraction Test
Additionally the modified Galt VTI® Valved Tearaway Introducer was adopted into the existing ethylene oxide sterilization cycle for the Galt VTI® Valved Tearaway Introducer Sheath cleared under K112389.
Biocompatibility testing was provided in K112398. The devices tested under K112398 included identical raw materials and package configuration and materials utilized in the Galt VTI® Valved Tearaway Introducer with the exception of the new valve design. Additional biocompatibility testing that includes the material utilized to manufacture new valve design was performed and is included in this 510(k) submission.
Packaging shelf life testing was provided in K112398.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three stylized human profiles facing to the right, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, TX 75041 US
Re: K140028
Trade/Device Name: VTI Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 10, 2014 Received: July 14, 2014
Dear Mr. David Derrick.
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. 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 vour 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 statutes and regulations administered by other Federal agencies. You must comply
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(K) number (if known):_ K140028
Device Name:_
Indications for Use:
The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Prescription Use_ X (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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| Date Prepared: | January 02, 2014 | |
|---|---|---|
| Device Name: | VTI® Valved Tear Away Introducer | |
| Device Model Number: | TBD | |
| Classification Name: | Catheter Introducer (DYB), | |
| 21 CFR 870.1340 | ||
| Device Classification: | Class II (Cardiovascular) | |
| Predicate Device: | Galt VTI® Valved Tearaway Introducer Sheath, K112398 | |
| 6F-16F | ||
| Manufacturer: | Galt Medical | |
| 2220 Merritt Drive | ||
| Garland, TX 75041 | ||
| Establishment | ||
| Registration Number: | 1649395 | |
| Official Contact: | David Derrick | |
| Director of Quality and Regulatory Affairs | ||
| Galt Medical Corporation | ||
| 2220 Merritt Dr. | ||
| Garland, TX 75041 | ||
| Phone: 214-778-1306 | ||
| Fax: 972-271-4706 | ||
| dderrick@galtmedical.com |
Intended Use: The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Device Description: The finished device is a valved tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed using identical processes and material with the exception of the subject device was modified to add a new valve design and material. The performance characteristics to the current marketed predicate device are unchanged and are consistent with other legally marketed devices.
Comparison of Technological Characteristics: The Galt VTI® Valved Tearaway Introducer is substantially equivalent to the unmodified predicate in construction, materials, and device performance.
4
| Subject device | Predicate Device | |
|---|---|---|
| Mfr. / Product | Galt VTI® Valved Tearaway Introducer | |
| with Modified Valve | Galt VTI® Valved Tearaway Introducer | |
| 510(k) Number | NA | K112398 |
| Device | ||
| Classification | 870.1340 | 870.1340 |
| Product Code | DYB | DYB |
| Intended use | The introducer system is intended for use | |
| in percutaneous procedures to introduce | ||
| catheters and other intravascular devices | ||
| into the peripheral vasculature. | The introducer system is intended for use | |
| in percutaneous procedures to introduce | ||
| catheters and other intravascular devices | ||
| into the peripheral vasculature | ||
| Design | Tear-away introducer with winged sheath | |
| hub and locking dilator including an | ||
| integral valve to reduce leakage and air | ||
| embolism during device exchanges | Tear-away introducer with winged sheath | |
| hub and locking dilator including an | ||
| integral valve to reduce leakage and air | ||
| embolism during device exchanges | ||
| Color | Gray cannula with color coded hub | |
| Shape | Cylindrical cannula with winged hub | |
| Sizes | 13cm, and 23cm lengths, sizes 6F - 16F |
Use Type: The Galt VTI® Valved Tearaway Introducer is a single patient use, disposable device.
Summary of Non-Clinical Data Submitted: Functional testing on un-aged and 4 year aged product was conducted to verify that the modified Galt VTI® Valved Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:
- I Dilator lock Test
- 미 Cap Retention Test
- Pressure Leak Test
- ! Vacuum Leak Test
- 미 Prolonged Insertion Test
- Valve Separation Test
- 트 Insertion / Extraction Test
Additionally the modified Galt VTI® Valved Tearaway Introducer was adopted into the existing ethylene oxide sterilization cycle for the Galt VTI® Valved Tearaway Introducer Sheath cleared under K112389.
Biocompatibility testing was provided in K112398. The devices tested under K112398 included identical raw materials and package configuration and materials utilized in the Galt VTI® Valved Tearaway Introducer with the exception of the new valve design. Additional biocompatibility testing that includes the material utilized to manufacture new valve design was performed and is included in this 510(k) submission.
Packaging shelf life testing was provided in K112398.
5
Conclusion: It has been shown in this 510(k) submission that the differences between the modified Galt VTI® Valved Tearaway Introducer and the predicate device do not raise any questions regarding safety and effectiveness. The modified Galt VTI® Valved Tearaway Introducer as designed and manufactured is determined to be substantially equivalent to the referenced predicate device.
End of Section