Medtronic [ProVia™ and Intuition™] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

Medtronic [Zinger™] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [Zinger™] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Device Description

Medtronic PTCA Guidewires are steerable guidewires that are used during the Percutaneous Coronary Intervention (PCI) to reach a lesion or vessel segment by serving as a guide for other diagnostic or interventional devices in the coronary and peripheral vasculature. The guidewires may also be used to reach and cross a target lesion within the coronary and peripheral vasculature excluding the cerebral vasculature. Once the tip of the guidewires arrive at a target destination within the vasculature, it acts as a guide that larger catheter can rapidly follow for easier delivery to the treatment site in the coronary and peripheral vasculature.

Medtronic Guidewires consist of a corewire covered with spring coils and terminated in a variable tip design to impart varied characteristic to the distal section of the wire, such as tip stiffness. Medtronic guidewires are coated to impart sufficient lubricity to reach and cross target lesions. There are marker bands on few Medtronic Guidewires to help in gauging guidewire position in the vasculature.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Medtronic PTCA Guidewires (Cougar™, Zinger™, Thunder™, ProVia™, and Intuition™) based on the provided K140695 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Coating Integrity	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Particulate evaluation	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Outer Diameter Measurement	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Biocompatibility	ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.	Performed and demonstrated that the modified PTCA Guidewires are safe, effective, and perform as well or better than the predicate device. No new safety or effectiveness concerns were raised.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes nonclinical data (bench tests and biocompatibility tests). There is no "test set" in the context of clinical data for human or animal subjects mentioned for this 510(k) submission.

Sample Size: Not specified for each individual bench test. The document states "The following bench tests were performed..."
Data Provenance: Not applicable as these are bench tests, not clinical data involving geographical origin. The tests were performed to demonstrate substantial equivalence in accordance with FDA guidance.
Retrospective/Prospective: Not applicable for bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for the bench tests would refer to established engineering and material science standards and measurement techniques, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable for bench testing. Adjudication typically refers to resolving discrepancies in expert interpretations of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical investigation has been performed on the modified device." Therefore, no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This submission is for physical medical devices (guidewires), not an algorithm or AI.

7. The Type of Ground Truth Used

For the nonclinical (bench) tests, the "ground truth" would be established by:

Established scientific principles, engineering standards, and validated measurement methods for properties like coating integrity, particulate evaluation, and outer diameter.
The ISO 10993-1: 2009 standard for biocompatibility, which provides a framework for evaluating biological responses to medical devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or machine learning for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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JUN 1 2 2014

K140695 510(k) Summary Page 1 of 3

Traditional 510(k) Summary

Submitter:

ﻟﺤﺴﺮ

Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923, USA

Contact Person:

Nisarg Shah Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923 USA Phone: (978)-739-6632 Fax: (978)-750-8204 Email: nisarg.g.shah(@medtronic.com

Date Prepared:

June 6, 2014

Trade Name:

Cougar™ Guidewires Zinger™ Guidewires
Thunder™ Guidewires ProVia™ Guidewires Intuition™ Guidewires

Common Name:

PTCA Guidewire

Classification Name:

Catheter guide wire Class II per 21 CFR §870.1330, Product Code DOX.

Predicate Device:

The following commercialized Medtronic PTCA Guidewires were used as predicate devices in the 510(k) submission:

1. K091582 (ProVia 3, 6, 9 and Intuition)
1. K100470 (ProVia 12)
1. K970466 (Thunder)
1. K983927 (Zinger)
1. K032899 (Cougar)

Device Description : Medtronic PTCA Guidewires are steerable guidewires that are used during the Percutaneous Coronary Intervention (PCI) to reach a lesion or vessel segment by serving as a guide for other diagnostic or interventional devices in the coronary and

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K140695 510(k) Summary Page 2 of 3

peripheral vasculature. The guidewires may also be used to reach and cross a target lesion within the coronary and peripheral vasculature excluding the cerebral vasculature. Once the tip of the guidewires arrive at a target destination within the vasculature, it acts as a guide that larger catheter can rapidly follow for easier delivery to the treatment site in the coronary and peripheral vasculature.

Statement of Intended Use:

Medtronic ProVia™ and Intuition™ Guidewires:

Thunder™ Guidewires:

Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

Zinger™ Guidewires:

Cougar™ Guidewires:

Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Summary of Technological Characteristics: Medtronic Guidewires consist of a corewire covered with spring coils and terminated in a variable tip design to impart varied characteristic to the distal section of the wire, such as tip stiffness. Medtronic guidewires are coated to impart sufficient lubricity to reach and cross target lesions. There are

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K140695 510(k) Summary Page 3 of 3

marker bands on few Medtronic Guidewires to help in gauging guidewire position in the vasculature. The technological characteristics of the Medtronic PTCA Guidewires are identical to the predicate devices legally marketed by Medtronic.

Summary of Nonclinical Data:

The device performance/ bench tests and biocompatibility tests were conducted in accordance to the relevant FDA guidance to demonstrate substantial equivalence to the legally marketed predicate devices.

Performance/ Bench Testing: The following bench tests were performed to demonstrate the substantial equivalence to the predicate PTCA Guidewires:

i. Coating Integrity
ii. Particulate evaluation
iii. Outer Diameter Measurement.

Biocompatibility Testing: Pursuant to the ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process; the biocompatibility testing for the modified PTCA Guidewires.

No new safety or effectiveness concerns were raised during the testing on the modified device. The performance testing along with biocompatibility testing demonstrated that the modified PTCA Guidewires is safe, effective and performs as well or better than the predicate device.

No clinical investigation has been performed on the modified device.

Conclusion from Data:

Summary of

Clinical Data:

Medtronic Vascular has demonstrated that the modified PTCA Guidewires are substantially equivalent to the legally marketed predicate devices based on its intended use and technological characteristics.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2014

Medtronic Vascular Inc. % Nisarg Shah, Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923 US

Re: K140695

Trade/Device Name: Cougar™ Guidewires, Zinger™ Guidewires, Thunder™ Guidewires, ProVia™ Guidewires, Intuition™ Guidewires Regulation Number: -21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: April 3, 2014 Received: April 4, 2014

Dear Mr. Shah.

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.

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Page 2 - Mr. Nisarg Shah

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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M. Lellem

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): K140695

Device Name: Medtronic PTCA Guidewires (Cougar™, Zinger™, Thunder™, ProVia™ and Intuition™).

Indications for Use:

Medtronic ProVia™ and Intuition™ Guidewires:

Thunder™ Guidewires:

Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

Zinger™ Guidewires:

Cougar™ Guidewires:

Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 OF

M. A. Hillman

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.