(227 days)
The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
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.
The provided text is related to a medical device's 510(k) submission, specifically for the Galt Medical Corp. VTI Valved Tearaway Introducer. This document outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device, focusing on functional testing rather than clinical study results involving human readers or AI.
Therefore, many of the requested categories in the prompt regarding AI, human readers, ground truth, and training data are not applicable to this type of document. The information provided is primarily about the physical and functional performance of the device itself.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to "product specifications" and "protocols based on international standards and Galt Medical requirements" but does not explicitly list the specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that the device "met product specifications."
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Meet product specifications based on international standards and Galt Medical requirements for functional testing. | Device met product specifications. Substantially equivalent to predicate device. |
| Maintain structural and functional integrity after aging (4 years). | Device performed equivalently after 4 years of simulated aging. |
| Proper dilator lock function. | Successfully passed Dilator Lock Test. |
| Secure cap retention. | Successfully passed Cap Retention Test. |
| No leakage under pressure. | Successfully passed Pressure Leak Test. |
| No air leakage under vacuum. | Successfully passed Vacuum Leak Test. |
| Ease of insertion and extraction. | Successfully passed Prolonged Insertion Test and Insertion/Extraction Test. |
| Valve integrity (no separation). | Successfully passed Valve Separation Test. |
| Biocompatibility. | Additional biocompatibility testing performed for new valve material, included in submission. Previous biocompatibility (K112398) covers identical raw materials and package configuration with the exception of the new valve design. |
| Sterilization effectiveness. | Adopted into existing ethylene oxide sterilization cycle (K112389). |
| Packaging shelf life. | Previous packaging shelf life testing (K112398) applies. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Functional testing on un-aged and 4 year aged product," implying a set of physical devices were tested.
- Data Provenance: Not specified, but generally, such functional and physical tests are conducted in a controlled laboratory environment by the manufacturer (Galt Medical Corp.) in the US (Garland, TX). The study is retrospective in the sense that the testing has already been completed and the results are being submitted for regulatory review, but it's a prospective test of the device's characteristics against its specifications.
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 its performance is established by standardized functional tests and measurements, not by expert interpretation of data like in an AI or diagnostic study.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, there's no "adjudication" in the sense of resolving discrepancies in expert interpretations. The tests have clear pass/fail criteria based on objective measurements.
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 a catheter introducer, not a diagnostic AI system or a system that assists human readers.
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:
- Physical device measurements and established engineering/performance standards. The "ground truth" is whether the physical device can perform its intended functions (e.g., locking, not leaking, ease of use, biocompatibility) according to predefined specifications and regulatory requirements.
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of this device's functional testing. This is not an AI/machine learning product.
9. How the ground truth for the training set was established:
- Not Applicable. Same as point 8.
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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
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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
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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)
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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, K1123986F-16F | |
| Manufacturer: | Galt Medical2220 Merritt DriveGarland, TX 75041 | |
| Establishment | ||
| Registration Number: | 1649395 | |
| Official Contact: | David DerrickDirector of Quality and Regulatory AffairsGalt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706dderrick@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.
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| Subject device | Predicate Device | |
|---|---|---|
| Mfr. / Product | Galt VTI® Valved Tearaway Introducerwith Modified Valve | Galt VTI® Valved Tearaway Introducer |
| 510(k) Number | NA | K112398 |
| DeviceClassification | 870.1340 | 870.1340 |
| Product Code | DYB | DYB |
| Intended use | The introducer system is intended for usein percutaneous procedures to introducecatheters and other intravascular devicesinto the peripheral vasculature. | The introducer system is intended for usein percutaneous procedures to introducecatheters and other intravascular devicesinto the peripheral vasculature |
| Design | Tear-away introducer with winged sheathhub and locking dilator including anintegral valve to reduce leakage and airembolism during device exchanges | Tear-away introducer with winged sheathhub and locking dilator including anintegral valve to reduce leakage and airembolism 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.
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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
§ 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).