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 ConfidaTM 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 ConfidaTM Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic ConfidaTM Brecker Guidewire is an external communicating device having limited contact (<24 hours) with circulating blood. The Medtronic ConfidaTM Brecker Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity. The Medtronic ConfidaTM 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 ConfidaTM Brecker Guidewire is sterilized via Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. The purpose of this 510(k) is to notify FDA of a change to the PTFE coating applied to the core wire section of the ConfidaTM Brecker Guidewire. The change is to replace the existing low Chromium VI PTFE coating with Chromium VI free PTFE coating.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K181001), indicating its substantial equivalence to a predicate device. The purpose of this 510(k) is to notify the FDA of a change to the PTFE coating on the core wire section from a low Chromium VI PTFE coating to a Chromium VI-free PTFE coating.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
PTFE Coating Adhesion Test (Coating Integrity)	(Implicitly, the coating must remain integral and adhere properly to the guidewire under simulated use conditions)	All testing met the specified acceptance criteria
ISO Cytotoxicity Study	(Implicitly, the device must not exhibit cytotoxic effects)	All testing met the specified acceptance criteria
ISO Maximization Sensitization Study	(Implicitly, the device must not cause sensitization)	All testing met the specified acceptance criteria
ISO Intracutaneous Study	(Implicitly, the device must not cause intracutaneous irritation)	All testing met the specified acceptance criteria
ISO/USP Pyrogen Study Material Mediated	(Implicitly, the device must not cause a pyrogenic reaction)	All testing met the specified acceptance criteria
ISO Acute Systematic Toxicity Study	(Implicitly, the device must not cause acute systemic toxicity)	All testing met the specified acceptance criteria
In Vivo Thromboresistance	(Implicitly, the device must demonstrate resistance to thrombus formation in vivo)	All testing met the specified acceptance criteria
In Vitro Hemolysis Study (Modified ASTM – Extraction Method)	(Implicitly, the device must not cause significant hemolysis in vitro)	All testing met the specified acceptance criteria
SC5b-9 Complement Activation	(Implicitly, the device must not cause significant complement activation)	All testing met the specified acceptance criteria

Note: The document states "All testing met the specified acceptance criteria," indicating successful compliance without explicitly detailing the specific quantitative or qualitative criteria for each test in this summary.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of guidewires tested for coating adhesion, number of animals for in vivo studies, or cell cultures for in vitro tests).

The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective, beyond the fact that they are non-clinical evaluations performed to demonstrate substantial equivalence.

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

This is a technical device evaluation rather than a study involving expert human interpretation or ground truth establishment in a clinical context (e.g., imaging interpretation). Therefore, information regarding "number of experts," "qualifications of experts," or "ground truth for the test set" as typically understood in AI/clinical studies is not applicable to this submission content. The "ground truth" here is the adherence to established scientific and regulatory safety and performance standards for medical devices, validated through the non-clinical tests listed.

4. Adjudication Method for the Test Set

As mentioned above, this is a non-clinical device evaluation. Therefore, an "adjudication method" in the context of expert consensus (e.g., 2+1, 3+1 for clinical interpretations) is not applicable. The "adjudication" is inherent in the laboratory testing and comparison against pre-defined acceptance criteria for each specific test.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. The current submission is for a physical medical device (guidewire) and focuses on its material and performance characteristics through non-clinical testing.

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

This query is pertinent to AI algorithms. The Medtronic Confida™ Brecker Guidewire is a physical medical device, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is standalone in the sense that its physical properties and biocompatibility are tested directly.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device evaluation is established by validated non-clinical test methodologies and their pre-defined acceptance criteria, which are based on recognized standards (e.g., ISO, USP, ASTM) for biocompatibility and material performance of medical devices. The success of each test (e.g., passing a cytotoxicity assay) serves as its own ground truth for compliance.

8. The Sample Size for the Training Set

This submission pertains to a physical medical device and its non-clinical evaluation, not an AI algorithm requiring a training set. Therefore, the concept of "sample size for the training set" is not applicable.

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

As this document does not concern an AI algorithm, the question of "how the ground truth for the training set was established" is not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 LLC1851 E Deere AveSanta Ana, CA 92705USAEstablishment Registration NO. 2025587
Contact Person:	Gerardine DrummondSenior Regulatory Affairs SpecialistMedtronic IrelandParkmore Business Park WestGalway, IrelandPhone: (+353-91)-708914Fax: (+353-91)-708672Email: Gerardine.drummond@medtronic.com
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 clearedAugust 03, 2015)
Device Description:	The Medtronic ConfidaTM Brecker Guidewire was developedfor use in diagnostic and interventional procedures includingtranscatheter aortic valve implantation (TAVI) procedures forthe treatment of aortic valve disease. The MedtronicConfidaTM Brecker Guidewire (model number GWBC30) isavailable in one size and is comprised of a stainless steel wire,0.035" in diameter, and 260cm in length. The distal end of theMedtronic ConfidaTM Brecker Guidewire is comprised of apreformed 360° curved tip. The Medtronic ConfidaTM BreckerGuidewire is an external communicating device having limitedcontact (<24 hours) with circulating blood. The MedtronicConfidaTM Brecker Guidewire has a polytetrafluoroethylene(PTFE) coating applied to the entire length of the device inorder to aid in lubricity.The Medtronic ConfidaTM Brecker Guidewire is a patientcontacting, single use only device and not intended for re-useor re-sterilization. The device is intended to be used only byphysicians trained in percutaneous, intravascular techniquesand procedures. The Medtronic ConfidaTM Brecker Guidewireis sterilized via Ethylene Oxide to a Sterility Assurance Level(SAL) of 10-6.The purpose of this 510(k) is to notify FDA of a change to thePTFE coating applied to the core wire section of the ConfidaTMBrecker Guidewire. The change is to replace the existing lowChromium VI PTFE coating with Chromium VI free PTFEcoating.
Statement ofIntended Use:	The Medtronic ConfidaTM Brecker Guidewire is intended tofacilitate the placement of devices during diagnostic andinterventional procedures.
Statement of Indicationsfor Use:	The Medtronic ConfidaTM 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 ConfidaTM Brecker CurveTM Guidewireis contraindicated for patients presenting with anintolerance to anticoagulation therapy andunheparinized patients. The guidewire iscontraindicated for use in the coronary arteries and inthe cerebrovasculature.
Comparison toPredicate device:	The Medtronic ConfidaTM Brecker Guidewire is identical tothe predicate 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 of Non-Clinical Data	In order to demonstrate substantial equivalence of the subjectdevice, the Medtronic ConfidaTM Brecker Guidewire, to thepredicate device, the following non-clinical evaluations wereperformed:• 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)• SC5b-9 Compliment ActivationAll testing met the specified acceptance criteria
Conclusion:	Based on the information above, the subject device, theMedtronic ConfidaTM Brecker Guidewire, is substantiallyequivalent in intended use, performance, and fundamentalscientific technology to the predicate device, theMedtronic ConfidaTM Brecker Guidewire (K150465).

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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.