Medtronic Confida Brecker Guidewire

K150465 · Medtronic Core Valve, LLC · DQX · Aug 3, 2015 · Cardiovascular

Device Facts

• Record ID: K150465
• Device Name: Medtronic Confida Brecker Guidewire
• Applicant: Medtronic Core Valve, LLC
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

The Medtronic Confida™ Brecker Guidewire is a single-use, stainless steel guidewire (0.035" diameter, 260cm length) featuring a preformed 360° curved distal tip and a PTFE coating for lubricity. It is used by physicians trained in percutaneous, intravascular techniques to introduce and position catheters within heart chambers during diagnostic and interventional procedures, specifically TAVI. The device provides a track for catheter delivery, facilitating the placement of therapeutic devices. It is an external communicating device with limited (<24 hours) contact with circulating blood.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including PTFE coating adhesion, ISO cytotoxicity, sensitization, intracutaneous, pyrogen, acute systemic toxicity, in vivo thromboresistance, in vitro hemolysis (modified ASTM), and complement activation (C3a, SC5b-9) studies.

Technological Characteristics

Stainless steel wire, 0.035" diameter, 260cm length; preformed 360° curved distal tip; PTFE coating for lubricity. Sterilized via Ethylene Oxide (SAL 10^-6). Single-use, patient-contacting device.

Indications for Use

Indicated for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI). Contraindicated for patients with intolerance to anticoagulation therapy, unheparinized patients, and for use in coronary arteries 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 Confida™ Brecker Guidewire (K132623)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.

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

August 3, 2015

Medtronic CoreValve, LLC. Matthew Lobeck Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, California 95403

Re: K150465

Trade/Device Name: Medtronic Confida™ Brecker Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 4, 2015 Received: Mav 6. 2015

Dear Matthew Lobeck:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Bram D. Zuckerman -S

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)

Device Name

Medtronic ConfidaTM Brecker Guidewire

Indications for Use (Describe)

The Medtronic ConfidaTM Brecker 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)

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 C.ER 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subnart C) |

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### 7.0 510(k) Summary in Accordance with 21 CFR § 807.92(c)

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: | July 21, 2015 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic CoreValve, LLC<br>1851 E. Deere Ave.<br>Santa Ana, CA 92705<br>U.S.A.<br>Establishment Registration No. 2025587 |
| Contact Person: | Matthew Lobeck<br>Regulatory Affairs Specialist<br>Medtronic Heart Valves<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Subject Device Name: | Medtronic Confida™ Brecker Guidewire |
| Model Number: | GWBC30 |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
| Predicate Device(s): | Medtronic Confida™ Brecker Guidewire (K132623; cleared<br>December 19, 2013) |
| Device Description: | The Medtronic Confida™ Brecker Guidewire was developed<br>for use in diagnostic and interventional procedures including<br>transcatheter aortic valve implantation (TAVI) procedures for<br>the treatment of aortic valve disease. The Medtronic ConfidaTM<br>Brecker Guidewire (model number GWBC30) is available in<br>one size and is comprised of a stainless steel wire, 0.035" in<br>diameter, and 260cm in length. The distal end of the Medtronic<br>Confida™ Brecker Guidewire is comprised of a preformed 360°<br>curved tip. |

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| | The Medtronic Confida™ Brecker Guidewire is an external<br>communicating device having limited (<24 hours) with<br>circulating blood. The Medtronic Confida™ Brecker Guidewire<br>has a polytetrafluoroethylene (PTFE) coating applied to the<br>entire length of the device in order to aid in lubricity. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Medtronic Confida™ Brecker Guidewire is a patient<br>contacting, single use only device and not intended for re-use or<br>re-sterilization. The device is intended to be used only by<br>physicians trained in percutaneous, intravascular techniques and<br>procedures. The Medtronic Confida™ Brecker Guidewire is<br>sterilized via Ethylene Oxide to a Sterility Assurance Level<br>(SAL) of 10-6. |
| Statement of<br>Intended Use: | The Medtronic Confida™ Brecker Guidewire is intended to<br>facilitate the placement of devices during diagnostic and<br>interventional procedures. |
| Statement of<br>Indications for Use: | The Medtronic Confida™ Brecker Guidewire is intended for<br>use to introduce and position catheters during diagnostic and<br>interventional procedures within the chambers of the heart,<br>including transcatheter aortic valve implantation (TAVI). |
| Contraindications: | The Medtronic Confida™ Brecker Guidewire is contraindicated<br>for patients presenting with an intolerance to anticoagulation<br>therapy and unheparinized patients. |
| | The guidewire is contraindicated for use in the coronary arteries<br>and in the cerebrovasculature. |
| Comparison<br>to Predicate Devices: | The Medtronic Confida™ Brecker Guidewire is identical to the<br>predicate device for the following characteristics:<br>Intended use Indications for use Contraindications Target population Fundamental scientific technology, including design Operating principle Packaging materials Shelf life Sterility assurance level and method of sterilization |
| Summary of<br>Non-Clinical Data: | In order to demonstrate substantial equivalence of the subject<br>device, the Medtronic Confida™ Brecker Guidewire, to the<br>predicate device, the following non-clinical evaluations were |

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performed:

- · PTFE Coating Adhesion Test (Coating Integrity)
- 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)
- · C3a Compliment Activation
- · SC5b-9 Compliment Activation

Conclusion: The result of the non-clinical testing demonstrate the subject device, the Medtronic Confida™ Brecker Guidewire performs as well as the legally marketed predicate device, the Medtronic Confida™ Brecker Guidewire. Therefore, the subject device, the Medtronic Confida™ Brecker Guidewire, is substantially equivalent in intended use, performance, and fundamental scientific technology to the predicate device, the Medtronic Confida" Brecker Guidewire (K132623).