Medtronic Confida Brecker Guidewire

K181001 · Medtronic Core Valve, LLC · DQX · May 3, 2018 · Cardiovascular

Device Facts

• Record ID: K181001
• Device Name: Medtronic Confida Brecker Guidewire
• Applicant: Medtronic Core Valve, LLC
• Product Code: DQX · Cardiovascular
• Decision Date: May 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Guidewire used by physicians trained in percutaneous, intravascular techniques to introduce and position catheters during diagnostic and interventional procedures, including TAVI. Device consists of stainless steel wire with preformed 360° curved distal tip and PTFE coating. Used in clinical settings; provides mechanical support for catheter placement. Benefits include facilitating access to heart chambers during minimally invasive procedures. Subject device represents a modification to the predicate involving a change from a Chromium VI-containing PTFE coating to a Chromium VI-free PTFE coating.

Clinical Evidence

Bench testing only. Evaluations included PTFE coating adhesion, ISO cytotoxicity, sensitization, intracutaneous study, pyrogenicity, acute systemic toxicity, in vivo thromboresistance, in vitro hemolysis (modified ASTM), and SC5b-9 complement activation. All tests met acceptance criteria.

Technological Characteristics

Stainless steel wire, 0.035" diameter, 260cm length. Preformed 360° curved distal tip. Chromium VI-free PTFE coating for lubricity. Single-use, sterile (Ethylene Oxide, SAL 10^-6). External communicating device, limited contact (<24 hours).

Indications for Use

Indicated for use to introduce and position catheters during diagnostic and interventional procedures within the heart chambers, 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 ConfidaTM Brecker Guidewire (K150465)

Submission Summary (Full Text)

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May 3, 2018

Medtronic Core Valve LLC % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K181001

Trade/Device Name: Medtronic ConfidaTM Brecker Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: April 12, 2018 Received: April 16, 2018

Dear Mr. Job:

We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Nicole G. Ibrahim -S

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)

#### K181001

Device Name Medtronic Confida™ Brecker Guidewire

Indications for Use (Describe)

The Medtronic Confida™ 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 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5.0 510(k) Summary

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: | March 30, 2018 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic CoreValve LLC<br>1851 E Deere Ave<br>Santa Ana, CA 92705<br>USA<br>Establishment Registration NO. 2025587 |
| Contact Person: | Gerardine Drummond<br>Senior Regulatory Affairs Specialist<br>Medtronic Ireland<br>Parkmore Business Park West<br>Galway, Ireland<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Subject Device Name: | Medtronic ConfidaTM Brecker Guidewire |
| Model Number: | GWBC30 |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
| Predicate Device(s): | Medtronic ConfidaTM Brecker Guidewire (K150465 cleared<br>August 03, 2015) |
| Device Description: | The Medtronic ConfidaTM 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<br>ConfidaTM Brecker Guidewire (model number GWBC30) is<br>available in one size and is comprised of a stainless steel wire,<br>0.035" in diameter, and 260cm in length. The distal end of the<br>Medtronic ConfidaTM Brecker Guidewire is comprised of a<br>preformed 360° curved tip. The Medtronic ConfidaTM Brecker<br>Guidewire is an external communicating device having limited<br>contact (<24 hours) with circulating blood. The Medtronic<br>ConfidaTM Brecker Guidewire has a polytetrafluoroethylene<br>(PTFE) coating applied to the entire length of the device in<br>order to aid in lubricity.<br>The Medtronic ConfidaTM Brecker Guidewire is a patient<br>contacting, single use only device and not intended for re-use<br>or re-sterilization. The device is intended to be used only by<br>physicians trained in percutaneous, intravascular techniques<br>and procedures. The Medtronic ConfidaTM Brecker Guidewire<br>is sterilized via Ethylene Oxide to a Sterility Assurance Level<br>(SAL) of 10-6.<br>The purpose of this 510(k) is to notify FDA of a change to the<br>PTFE coating applied to the core wire section of the ConfidaTM<br>Brecker Guidewire. The change is to replace the existing low<br>Chromium VI PTFE coating with Chromium VI free PTFE<br>coating. |
| Statement of<br>Intended Use: | The Medtronic ConfidaTM Brecker Guidewire is intended to<br>facilitate the placement of devices during diagnostic and<br>interventional procedures. |
| Statement of Indications<br>for Use: | The Medtronic ConfidaTM 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 ConfidaTM Brecker CurveTM Guidewire<br>is contraindicated for patients presenting with an<br>intolerance to anticoagulation therapy and<br>unheparinized patients. The guidewire is<br>contraindicated for use in the coronary arteries and in<br>the cerebrovasculature. |
| Comparison to<br>Predicate device: | The Medtronic ConfidaTM Brecker Guidewire is identical to<br>the predicate device for the following characteristics:<br>• Intended use<br>• Indications for use<br>• Contraindications<br>• Target population<br>• Fundamental scientific technology, including design<br>• Operating principle<br>• Packaging materials<br>• Shelf life<br>• Sterility assurance level and method of sterilization |
| Summary of Non-<br>Clinical Data | In order to demonstrate substantial equivalence of the subject<br>device, the Medtronic ConfidaTM Brecker Guidewire, to the<br>predicate device, the following non-clinical evaluations were<br>performed:<br>• PTFE Coating Adhesion Test (Coating Integrity)<br>• ISO Cytotoxicity Study<br>• ISO Maximization Sensitization Study<br>• ISO Intracutaneous Study<br>• ISO/USP Pyrogen Study Material Mediated<br>• ISO Acute Systematic Toxicity Study<br>• In Vivo Thromboresistance<br>• In Vitro Hemolysis Study (Modified ASTM –<br>Extraction Method)<br>• SC5b-9 Compliment Activation<br>All testing met the specified acceptance criteria |
| Conclusion: | Based on the information above, the subject device, the<br>Medtronic ConfidaTM Brecker Guidewire, is substantially<br>equivalent in intended use, performance, and fundamental<br>scientific technology to the predicate device, the<br>Medtronic ConfidaTM Brecker Guidewire (K150465). |

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