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).

Device Description

The Medtronic Confida™ Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic Confida™ Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic Confida™ Brecker Guidewire is an external communicating device having limited (<24 hours) with circulating blood. The Medtronic Confida™ Brecker Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity. The Medtronic Confida™ Brecker Guidewire is a patient contacting, single use only device and not intended for re-use or re-sterilization. The device is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures. The Medtronic Confida™ Brecker Guidewire is sterilized via Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6.

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K150465). It describes the device and its intended use, and compares it to a predicate device (K132623). The document focuses on establishing substantial equivalence through non-clinical testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for each test or detailed quantitative performance data in a table format. Instead, it lists the non-clinical evaluations performed and concludes that the subject device "performs as well as the legally marketed predicate device."

Without specific acceptance criteria metrics and detailed performance results from the provided text, a table like the one requested cannot be accurately generated.

However, the types of non-clinical evaluations performed are listed, suggesting that the criteria for acceptance would be satisfactory outcomes for these tests compared to the predicate device's expected performance or established safety standards.

Inferred Information for a Hypothetical Table:

Test Name	Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
PTFE Coating Adhesion (Coating Integrity)	Satisfactory coating adhesion and integrity.	Performed "as well as the legally marketed predicate device," implying satisfactory coating integrity.
ISO Cytotoxicity Study	No cytotoxic effects.	Performed "as well as the legally marketed predicate device," implying no cytotoxic effects.
ISO Maximization Sensitization Study	No sensitization potential.	Performed "as well as the legally marketed predicate device," implying no sensitization potential.
ISO Intracutaneous Study	No intracutaneous irritation.	Performed "as well as the legally marketed predicate device," implying no intracutaneous irritation.
ISO/USP Pyrogen Study Material Mediated	No pyrogenic response.	Performed "as well as the legally marketed predicate device," implying no pyrogenic response.
ISO Acute Systematic Toxicity Study	No acute systemic toxicity.	Performed "as well as the legally marketed predicate device," implying no acute systemic toxicity.
In Vivo Thromboresistance	Acceptable thromboresistance.	Performed "as well as the legally marketed predicate device," implying acceptable thromboresistance.
In Vitro Hemolysis Study	Acceptable level of hemolysis.	Performed "as well as the legally marketed predicate device," implying an acceptable level of hemolysis.
C3a Compliment Activation	Acceptable level of C3a complement activation.	Performed "as well as the legally marketed predicate device," implying acceptable C3a complement activation.
SC5b-9 Compliment Activation	Acceptable level of SC5b-9 complement activation.	Performed "as well as the legally marketed predicate device," implying acceptable SC5b-9 complement activation.
Overall Conclusion	Demonstrates substantial equivalence to predicate device.	"The result of the non-clinical testing demonstrate the subject device... performs as well as the legally marketed predicate device..."

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

Sample Size for Test Set: The document does not specify the sample sizes used for each of the non-clinical tests. These typically involve a certain number of samples of the device or its materials subjected to the various assays.
Data Provenance: Not explicitly stated as retrospective or prospective, or location of data origin (e.g., country). Non-clinical bench and lab testing often does not fit neatly into "retrospective" or "prospective" as clinical studies do. The testing was conducted by Medtronic CoreValve, LLC.

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

This section is not applicable to the provided document. The submission is for a medical device (guidewire) and relies on non-clinical (bench and biocompatibility) testing, not on interpretation of diagnostic images or clinical data by human experts. Therefore, "ground truth" in the context of expert consensus (as asked for in the prompt) is not relevant here.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically used in clinical studies or studies involving multiple human readers for diagnostic interpretation. It is not applicable to the non-clinical evaluations listed for this guidewire. These tests have defined laboratory protocols and pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size.

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging modalities, especially with human readers, which is not the subject of this 510(k) submission.

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

No, a "standalone algorithm performance" study was not done. The device is a physical medical guidewire, not an algorithm or AI software, so this type of study is not relevant.

7. The type of ground truth used

The "ground truth" for the non-clinical evaluations would be defined by the standardized protocols and reference methods used for each test (e.g., ISO standards for biocompatibility, material testing standards). For example, for cytotoxicity, the "ground truth" is determined by established cell viability assays against negative and positive controls. For coating adhesion, it would be based on validated physical testing methods. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

This question is not applicable. The device is a physical guidewire, not an AI/ML algorithm. Therefore, there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

Summary

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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 (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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)

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, LLC1851 E. Deere Ave.Santa Ana, CA 92705U.S.A.Establishment Registration No. 2025587
Contact Person:	Matthew LobeckRegulatory Affairs SpecialistMedtronic Heart ValvesPhone: (763) 514-9515Fax: (763) 514-9521Email: matthew.lobeck@medtronic.com
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; clearedDecember 19, 2013)
Device Description:	The Medtronic Confida™ Brecker Guidewire was developedfor use in diagnostic and interventional procedures includingtranscatheter aortic valve implantation (TAVI) procedures forthe treatment of aortic valve disease. The Medtronic ConfidaTMBrecker Guidewire (model number GWBC30) is available inone size and is comprised of a stainless steel wire, 0.035" indiameter, and 260cm in length. The distal end of the MedtronicConfida™ Brecker Guidewire is comprised of a preformed 360°curved tip.

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	The Medtronic Confida™ Brecker Guidewire is an externalcommunicating device having limited (<24 hours) withcirculating blood. The Medtronic Confida™ Brecker Guidewirehas a polytetrafluoroethylene (PTFE) coating applied to theentire length of the device in order to aid in lubricity.
	The Medtronic Confida™ Brecker Guidewire is a patientcontacting, single use only device and not intended for re-use orre-sterilization. The device is intended to be used only byphysicians trained in percutaneous, intravascular techniques andprocedures. The Medtronic Confida™ Brecker Guidewire issterilized via Ethylene Oxide to a Sterility Assurance Level(SAL) of 10-6.
Statement ofIntended Use:	The Medtronic Confida™ Brecker Guidewire is intended tofacilitate the placement of devices during diagnostic andinterventional procedures.
Statement ofIndications for Use:	The Medtronic Confida™ Brecker Guidewire is intended foruse to introduce and position catheters during diagnostic andinterventional procedures within the chambers of the heart,including transcatheter aortic valve implantation (TAVI).
Contraindications:	The Medtronic Confida™ Brecker Guidewire is contraindicatedfor patients presenting with an intolerance to anticoagulationtherapy and unheparinized patients.
	The guidewire is contraindicated for use in the coronary arteriesand in the cerebrovasculature.
Comparisonto Predicate Devices:	The Medtronic Confida™ Brecker Guidewire is identical to thepredicate device for the following characteristics: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 ofNon-Clinical Data:	In order to demonstrate substantial equivalence of the subjectdevice, the Medtronic Confida™ Brecker Guidewire, to thepredicate 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).

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.