MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE

K132623 · Medtronic · DQX · Dec 19, 2013 · Cardiovascular

Device Facts

• Record ID: K132623
• Device Name: MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
• Applicant: Medtronic
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Medtronic Confida™ Brecker Curve™ Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).

Device Story

Medtronic Confida™ Brecker Curve™ Guidewire is a 0.035-inch diameter, 260 cm long stainless steel guidewire with a PTFE coating. Features a preformed 540° curved distal tip (30 mm width) designed to anchor the distal spring tip during cardiac procedures. Used by physicians in clinical settings to facilitate catheter placement during diagnostic and interventional procedures, specifically TAVI. Device provides mechanical support and positioning for catheters within heart chambers. Benefits include improved stability and anchoring during complex cardiac interventions.

Clinical Evidence

Bench testing only. Evaluations included visual inspection, dimensional verification, mechanical performance (tip tensile, stiffness, loop compression, torque, flexibility), PTFE coating adhesion/simulated use, corrosion resistance, and anchoring. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous, pyrogenicity, acute systemic toxicity, thromboresistance, hemolysis, complement activation). Sterilization validated to SAL 10^-6.

Technological Characteristics

304 stainless steel core; PTFE coating. 0.035-inch diameter; 260 cm length. Distal end features preformed 540° curved tip. Mechanical device; no energy source or software. Sterilized to SAL 10^-6.

Indications for Use

Indicated for introduction and positioning of catheters during diagnostic and interventional procedures within heart chambers, including transcatheter aortic valve implantation (TAVI). Contraindicated for patients with intolerance to anticoagulation therapy, unheparinized patients, and for use in coronary or cerebrovasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medtronic Archer TM Super Stiff Guidewire (K101339)
• Toray TORAYGUIDE™ Guidewire (K042370)

Submission Summary (Full Text)

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K132623

DEC 1 9 2013

#### 510(k) Summary 5.0

As required by the Safe Medical Devices Act of 1990, coded under Section 513, part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

| Date Prepared: | August 21, 2013 |
|-----------------|----------------------------------------|
| Applicant: | Medtronic CoreValve, LLC |
| | 1851 E. Deere Ave. |
| | Santa Ana, CA 92705 |
| | U.S.A. |
| | Establishment Registration No. 2025587 |
| Contact Person: | Monica Hernandez-Soto |
| | Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |

E-mail: [e-mail]

Subject Device Name:

Device Trade Name: Medtronic Confida™ Brecker Curve™ Guidewire

Common Name: Guidewire

Classification Name: Wire, Guide, Catheter

Classification: Class II, 21 CFR 870.1330

Product Code: DQX

Predicate Device(s):

- Medtronic Archer TM Super Stiff Guidewire (K101339, cleared . Aug. 31, 2010), manufactured by Medtronic, Inc.
- Toray TORAYGUIDE™ Guidewire (K042370, cleared Dec. 17, . 2004), manufactured by Toray Industries, Inc.

Device Description: The Medtronic ConfidaTM Brecker Curve™ Guidewire is manufactured of 304 stainless steel and is polytetrafluoroethylene (PTFE) coated, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.035 inches and 260 cm in length. The distal end of the Medtronic Confida TM Brecker Curve™ Guidewire is comprised

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of a preformed curved tip. The loop configuration has a 540° curved tip which is 30 mm in width and aids in anchoring of the distal spring tip during diagnostic and interventional procedures, including TAVI.

## Statement of

Intended Use:

The Medtronic Confida "M Brecker Curve" Guidewire is intended to to facilitate the placement of devices during diagnostic and interventional procedures.

# Statement of

Indications for Use: The Medtronic Confida™ Brecker Curve™ Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart including transcatheter aortic valve implantation (TAVI).

## Comparison of Indications for Use

to Predicate Devices: The Indications for Use of the Medtronic Confida™ Brecker Curve™ Guidewire is within the scope of the Indications for Use of both predicate devices. While the Indications for Use are different between the subject device and the predicate devices, the differences do not raise any new issues of safety and effectiveness of the device or change the intended use of the device.

Contraindications:

The Medtronic Confida™ Brecker Curve™ Guidewire is contraindicated for patients presenting with an intolerance to anticoagulation therapy and unheparinized patients. The Guidewire is contraindicated for use in the coronary arteries and in the cerebrovasculature.

## Comparison of Technological Characteristics

to Predicate Devices: The Medtronic Confidated Brecker Curve™ Guidewire has the following similarities to the predicate devices:

- . Intended use (all predicates)
- Indications for use (all predicates)
- Target population (all predicates) .
- Fundamental scientific technology (all predicates)

· � Curve Response to Questions

ーとして、

Operating principle (all predicates) Packaging materials (all predicates)

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Sterility assurance level and method of sterilization (all predicates) ♥

## Summary of

Non-Clinical Data:

In order to demonstrate substantial equivalence of the subject device, the Medtronic ConfidaTM Brecker Curve™ Guidewire, to the predicate devices, the following non-clinical evaluations were performed:

- . Visual Inspection
- Overall Length .
- Proximal Outer Diameter �
- . Coil Outer Diameter
- Tip Curve Rotation .
- t Tip Curve Outer Diameter
- . Tip Tensile
- . Tip Stiffness
- . Loop Compression
- # Proximal Stiffness
- Coil Length ●
- PTFE Coating Adhesion .
- PTFE Coating, Simulated Clinical Use .
- Corrosion Resistance ●
- Anchoring ●
- Usability for Design Validation .
- Flexibility �
- Torque .

Biocompatibility testing was also performed per the requirements of ISO 10993-1:2009 on the Medtronic Confida™ Brecker Curve™ Guidewire as listed below:

- ISO Cytotoxicity Study .
- ISO Maximization Sensitization Study .
- ISO Intracutaneous Study .
- ISO/USP Pyrogen Study Material Mediated .
- ISO Acute Systematic Toxicity Study .
- In Vivo Thromboresistance
- In Vitro Hemolysis Study (Modified ASTM - Extraction Method)

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- C3a Compliment Activation .
- SC5b-9 Compliment Activation .

Packaging and shelf life testing (product and package) was performed on the Medtronic ConfidaTM Brecker Curve TM Guidewire. In addition, a sterilization validation adoption was performed to ensure the Medtronic Confida™ Brecker Curve™ Guidewire adequately met a Sterility Assurance Level (SAL) of 10 6. The non-clinical evaluations verify the Medtronic Confida™ Brecker Curve™ Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use.

Based on the information above, the Medtronic Confida™ Brecker Curve™ Guidewire is substantially equivalent in intended use performance, and fundamental scientific technology to the predicate devices, the Archer™ Super Stiff
Guidewire (K101339), and Toray TORAYGUIDE™ Guidewire (K042370).

## Conclusion:

.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 19, 2013

Medtronic Ms. Monica Hernandez-Soto Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403

Re: K132623

> Trade/Device Name: Confida Brecker Curve Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: November 15, 2013 Received: November 18, 2013

Dear Ms. Hernandez-Soto:

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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Page 2 - Ms. Monica Hernandez-Soto

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4.0 Indication for Use Statement

510(k) Number (if known): _

K132623 500 |

Device Name:

Medtronic Confida™ Brecker Curve™ Guidewire

## Indication for Use:

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The Medtronic Confida™ Brecker Curve™ Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).

Prescription Use X _ _ AND/OR Over-The Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

M FDA