(9 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter) and its intended use and construction. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are bench testing, not related to algorithmic performance.
No
The device is used to guide other devices and deliver solutions, it does not directly treat a condition.
No
The device is a support catheter for guiding guidewires, allowing wire exchanges, and delivering saline or diagnostic contrast agents. While it can deliver diagnostic contrast agents, its primary function is not to diagnose but to facilitate other procedures.
No
The device description clearly describes a physical catheter with a lumen, tip, shaft, radiopaque markers, and hydrophilic coating. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- TrailBlazer™ Function: The description clearly states the TrailBlazer™ Support Catheter is a device used within the peripheral vascular system to guide and support a guidewire, allow for wire exchanges, and deliver solutions. This is an in vivo (within the body) procedure.
The device's function is to facilitate a medical procedure within the body, not to perform diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for 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™ Support Catheter is an over-the-wire (OTW) single lumen catheter with an atraumatic tapered tip. The catheter system is offered in 9 models that are 0.014", 0.018", and 0.035" guidewire compatible and have working lengths of 65 cm, 90 cm, 135 cm, 150 cm. The distal catheter shaft has three radiopaque markers that aid in positioning the catheter. The distal 40 cm portion of the catheter has a hydrophilic coating. The manifold provides a proximal lumen which transitions to the catheter shaft and terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. All models are 5 Fr compatible.
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)
Bench testing was performed to support a determination of substantial equivalence. 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
AUG 0 7 2009
510(k) Summary
TrailBlazer™ Support Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R §
807.92. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.
9600 54th Ave. N
Plymouth, MN 55442
Tel: 763-398-7000
Fax: 763-591-3248 |
| Contact Person | David Robertson
Regulatory Affairs Associate |
| Date Prepared | July 16, 2009 |
| Device Trade Name | TrailBlazer™ Support Catheter |
| Device Common
Name | Catheter, Support |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250), Product Code DQY |
| Classification Panel | Cardiovascular |
| Predicate Devices | Spectranetics Quick-Cross™ Support2 Catheters (K072750)
Vascular Solutions Minnie™ Support Catheter (K082337) |
| Intended use | TrailBlazer™ Support Catheters are percutaneous, single lumen
catheters designed for use in the peripheral vascular system.
TrailBlazer™ Support Catheters are intended to guide and support a
guide wire during access of the vasculature, allow for wire
exchanges and provide a conduit for the delivery of saline solutions
or diagnostic contrast agents. |
| Device Description | The TrailBlazer™ Support Catheter is an over-the-wire (OTW)
single lumen catheter with an atraumatic tapered tip. The catheter
system is offered in 9 models that are 0.014", 0.018", and 0.035"
guidewire compatible and have working lengths of 65 cm, 90 cm,
135 cm, 150 cm. The distal catheter shaft has three radiopaque
markers that aid in positioning the catheter. The distal 40 cm
portion of the catheter has a hydrophilic coating. The manifold
provides a proximal lumen which transitions to the catheter shaft
and terminates at the distal tip. This lumen is used to pass the
catheter over a guidewire. All models are 5 Fr compatible. |
| ev3 Corporate World Headquarters / Peripheral Vascular • 9600 54th Avenue North • Plymouth, MN 55442 • PH +1 763 398 7000
ev3 Europe SAS • 106/108 rue La Boétie • 75008 Paris, France • PH +33 156 88 59 10
ev3 Neurovascular • 9775 Toledo Way • Irvine, CA 92618 • PH +1 949-887-3700
www.ev3.net | |
| Performance data | Bench testing was performed to support a determination of substantial equivalence. 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. |
| Summary of Substantial Equivalence | The TrailBlazerTM Support Catheter has the following similarities to the predicate devices: Similar fundamental scientific technology Similar operating principle Similar flow rate Similar crossing profiles Similar catheter lengths |
| Conclusion | Based on the similar indications for use, technological characteristics, and performance testing, ev3 believes the TrailBlazerTM Support Catheter is substantially equivalent to the Spectranetics Quick-Cross Support Catheter (K072750) and Vascular Solutions Minnie Support Catheter (K082337). |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 0 7 2009
ev3 Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313
Re: K092299
Trade/Device Name: Trailblazer Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: July 27, 2009 Received: July 31, 2009
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.
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.
3
Page 2 - Mr. Mark Job
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Dina R. Kirchner
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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Page 1 of 1
Indications for Use Statement
510(k) Number (if known):_K 0 9 22 99
Device Name: TrailBlazer™ Support Catheter
Indications for Use:
TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Duna D. V. Auner
ign-Off)
Cardiovascular Devices
510(k) Number K092249