(28 days)
The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The TrailBlazer™ angled support catheter is an over-the-wire (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath. The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.
The provided text describes the 510(k) summary for the Medtronic TrailBlazer™ Angled Support Catheter (K162384). This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and does not contain information about clinical studies involving human patients or ground truth established by medical experts for diagnostic performance.
Therefore, many of the requested elements related to clinical study design, sample sizes for test and training sets, expert involvement, and comparative effectiveness (MRMC) cannot be answered from the provided text.
Here's an overview of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed to demonstrate substantial equivalence. It does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test in a table format. Instead, it generally states "All testing was performed in accordance with recognized standards. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
However, the types of tests conducted can be considered the acceptance criteria categories:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Verification | Performed |
| Simulated Use | Performed |
| Catheter Bond Strength | Performed |
| Tip Pull Test | Performed |
| Flexibility and Kink Test | Performed |
| Torque Strength and Rotational Control | Performed |
| Radiopacity | Performed |
| Catheter Body Burst | Performed |
| Coating Integrity, and Particulate Evaluation | Performed |
| Contrast Media Flow rate | Performed |
| Packaging and Shelf Life | Performed |
| Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, hemolysis, thromboresistance, complement activation, partial thromboplastin time, platelet and leukocyte counts, mutagenicity, lymphoma and micronucleus) | Performed |
2. Sample size used for the test set and the data provenance
The document describes bench testing, not a clinical study with a test set of patient data. Therefore, this information is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this was a bench study, not a study requiring expert ground truth for diagnostic performance assessment.
4. Adjudication method for the test set
Not applicable as this was a bench study.
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, not an AI-assisted diagnostic tool, and the studies were bench tests, not MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the physical and functional aspects of the catheter in isolation, which were assessed through the listed bench tests.
7. The type of ground truth used
For the bench tests, the "ground truth" was defined by recognized standards and specifications for medical devices. For example, a bond strength test would have a specified minimum acceptable force, and the outcome of the test (e.g., whether the bond held) would be compared against that standard.
8. The sample size for the training set
Not applicable. This device is a physical medical device where performance characteristics are often established through engineering design and testing against specifications, rather than machine learning training sets.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Medtronic Vascular, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K162384
Trade/Device Name: TrailBlazer Angled Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 12, 2016 Received: August 25, 2016
Dear Mr. Job:
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 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education 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,
Brian D. Pullin -S
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) K162384
Device Name TrailBlazer™ Angled Support Catheter
Indications for Use (Describe)
The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
TrailBlazer™ Angled Support Catheter
| 510(k) Summary | This 510(k) Summary is being submitted per the requirements of21 C.F.R § 807.92. |
|---|---|
| Applicant | Medtronic Vascular, Inc. |
| Submitter | Medtronic Vascular, Inc. (formerly d.b.a ev3 Inc.)3033 Campus DrivePlymouth, MN 55441Tel: 763-398-7000Fax: 763-591-3248 |
| Contact Person | David RobertsonSenior Regulatory Affairs Specialist |
| Date Prepared | August 12, 2016 |
| Device Trade Name | TrailBlazer™ Angled Support Catheter |
| Device CommonName | Catheter, Support |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250), Product Code DQY |
| Classification Panel | Cardiovascular |
| Predicate Devices | ev3 TrailBlazer™ Support Catheter (K092299)Cook Medical CXI® Support Catheter (K122796) |
| Indication for Use | The TrailBlazer angled support catheters are percutaneous, singlelumen catheters designed for use in the peripheral vascular system.The TrailBlazer angled support catheters are intended to guide andsupport a guide wire during access of the vasculature, to allow forguide wire exchanges and provide a conduit for the delivery ofsaline solutions or diagnostic contrast agents. |
| Performance data | To demonstrate substantial equivalence of the proposed |
| TrailBlazerTM Angled Support Catheter to the predicate devices, | |
| bench testing was performed: |
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The TrailBlazer™ angled support catheter is an over-the-wire Device Description (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath.
The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.
The TrailBlazer™ angled support catheter has the following Technological Characteristics similarities to the predicate TrailBlazer and the Cook Medical CXI devices:
- Similar fundamental scientific technology
- Similar operating principle ●
- Similar flow rate ●
- Similar crossing profiles ●
- Similar catheter lengths ●
The primary predicate TrailBlazer support catheter (straight tip) design has been modified to include an angled tip that improves guide wire directional control during access of the vasculature. The TrailBlazer angled support catheter is constructed with a multi layered stainless steel braided shaft design similar to the secondary predicate Cook Medical CXI support catheter design, intended to increase torque control at the distal tip.
- Dimensional Verification ●
- Simulated Use ●
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| • | Catheter Bond Strength |
|---|---|
| • | Tip Pull Test |
| • | Flexibility and Kink Test |
| • | Torque Strength and Rotational Control |
| • | Radiopacity |
| • | Catheter Body Burst |
| • | Coating Integrity, and Particulate Evaluation |
| • | Contrast Media Flow rate |
| • | Packaging and Shelf Life |
| • | Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, hemolysis, thromboresistance, complement activation, partial thromboplastin time, platelet and leukocyte counts, mutagenicity, lymphoma and micronucleus) |
All testing was performed in accordance with recognized standards.
Results from this testing provide assurance that the proposed device
has been designed and tested to assure conformance to the
requirements for its intended use.
Conclusion
Based on the intended use, technological characteristics, and
performance testing, Medtronic believes the TrailBlazer™ Angled
Support Catheter is substantially equivalent to the ev3
TrailBlazer™ Support Catheter (K092299) and Cook Medical
CXI® Support Catheter (K122796).
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).