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.

AI/ML Overview

The provided text describes a 510(k) summary for the TrailBlazer™ Support Catheter. It focuses on demonstrating substantial equivalence to predicate devices through bench testing. The information required for all sections of your request (1-9) about acceptance criteria and a study proving a device meets those criteria is not explicitly available in the provided document, as it pertains to AI/algorithm performance studies.

However, I can extract information regarding the device's performance assessment based on the provided text's scope, which is primarily about bench testing for substantial equivalence, rather than clinical acceptance criteria or AI study data.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way one would define them for an AI medical device (e.g., target sensitivity, specificity). Instead, it relies on "bench testing" to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially that it performed comparably in these bench tests.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Conformance to requirements for intended use	"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."
Similar fundamental scientific technology	Met
Similar operating principle	Met
Similar flow rate	Met
Similar crossing profiles	Met
Similar catheter lengths	Met

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers only to "Bench testing." There is no mention of a "test set" in the context of patient data or algorithm evaluation. Data provenance is not applicable as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a medical device clearance based on substantial equivalence and bench testing, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the context of an algorithm or diagnostic 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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" would be engineering specifications and standards for catheter performance (e.g., flow rate measurements, material strength tests, dimensional accuracy, etc.), implicitly established by standard engineering practices.

8. The sample size for the training set

Not applicable. There is no training set for an AI/algorithm involved.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned in the context of an AI device.

Summary of what is present in the document:

The TrailBlazer™ Support Catheter received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices: Spectranetics Quick-Cross™ Support2 Catheters (K072750) and Vascular Solutions Minnie™ Support Catheter (K082337). This equivalence was established through bench testing, which assessed similarities in:

Fundamental scientific technology
Operating principle
Flow rate
Crossing profiles
Catheter lengths

The document does not detail the specific parameters or results of the bench tests beyond stating that they provided assurance of conformance to intended use requirements and demonstrated similarities to predicate devices. It is a traditional medical device clearance, not involving AI or machine learning algorithms, and therefore discussions of test sets, ground truth, experts, or training sets in the context of AI are not present.

Summary

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AUG 0 7 2009

510(k) Summary

TrailBlazer™ Support Catheter

510(k) Summary	This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R §807.92.
Applicant	ev3 Inc.
Submitter	ev3 Inc.9600 54th Ave. NPlymouth, MN 55442Tel: 763-398-7000Fax: 763-591-3248
Contact Person	David RobertsonRegulatory Affairs Associate
Date Prepared	July 16, 2009
Device Trade Name	TrailBlazer™ Support Catheter
Device CommonName	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 lumencatheters designed for use in the peripheral vascular system.TrailBlazer™ Support Catheters are intended to guide and support aguide wire during access of the vasculature, allow for wireexchanges and provide a conduit for the delivery of saline solutionsor diagnostic contrast agents.
Device Description	The TrailBlazer™ Support Catheter is an over-the-wire (OTW)single lumen catheter with an atraumatic tapered tip. The cathetersystem 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 radiopaquemarkers that aid in positioning the catheter. The distal 40 cmportion of the catheter has a hydrophilic coating. The manifoldprovides a proximal lumen which transitions to the catheter shaftand terminates at the distal tip. This lumen is used to pass thecatheter 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 7000ev3 Europe SAS • 106/108 rue La Boétie • 75008 Paris, France • PH +33 156 88 59 10ev3 Neurovascular • 9775 Toledo Way • Irvine, CA 92618 • PH +1 949-887-3700www.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.

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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:

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

Regulation Number and Section

§ 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).