(28 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical catheter, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is intended to guide and support a guidewire, allow for guidewire exchanges, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents, not to treat a disease or condition.
No
The device is a support catheter intended to guide and support a guidewire, allow for guidewire exchanges, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. While it can deliver diagnostic contrast agents, its primary function is not to diagnose, but rather to facilitate other procedures.
No
The device description clearly details a physical catheter with various material components (elastomer, stainless steel braided mesh, radiopaque markers, hydrophilic coating) and physical characteristics (working lengths, compatibility with guidewires and sheaths, angled distal tip). The performance studies also focus on physical bench testing of the catheter's properties. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the peripheral vascular system to guide and support a guidewire, facilitate exchanges, and deliver solutions or contrast agents. This is an in vivo application, meaning it's used inside a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- 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 specifically designed to perform tests on samples taken from the body, not to be inserted into the body for therapeutic or diagnostic procedures within the body itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
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)
To demonstrate substantial equivalence of the proposed TrailBlazerTM Angled Support Catheter to the predicate devices, bench testing was performed:
- Dimensional Verification
- Simulated Use
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
510(k) Summary
TrailBlazer™ Angled Support Catheter
| 510(k) Summary | This 510(k) Summary is being submitted per the requirements of
21 C.F.R § 807.92. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Medtronic Vascular, Inc. |
| Submitter | Medtronic Vascular, Inc. (formerly d.b.a ev3 Inc.)
3033 Campus Drive
Plymouth, MN 55441
Tel: 763-398-7000
Fax: 763-591-3248 |
| Contact Person | David Robertson
Senior Regulatory Affairs Specialist |
| Date Prepared | August 12, 2016 |
| Device Trade Name | TrailBlazer™ Angled Support Catheter |
| Device Common
Name | 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, 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. |
| Performance data | To demonstrate substantial equivalence of the proposed |
| | TrailBlazerTM Angled Support Catheter to the predicate devices, |
| | bench testing was performed: |
4
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 ●
5
| • | 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).