Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

Device Description

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.

The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."

Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:

Acceptance Criterion (Type of Test)	Reported Device Performance
Mechanical Performance:
Dimensional Verification	Met applicable design and performance requirements
Visual Inspection	Met applicable design and performance requirements
Tensile Strength (Proximal & Distal Bond)	Met applicable design and performance requirements
Torque Strength	Met applicable design and performance requirements
Lubricity/Pinch Force	Met applicable design and performance requirements
Kink Resistance	Met applicable design and performance requirements
Tip Flexibility/Spiral Tip Compression	Met applicable design and performance requirements
Flex Test	Met applicable design and performance requirements
Fracture Test	Met applicable design and performance requirements
Three-Point Bend Test	Met applicable design and performance requirements
Material/Biocompatibility:
Coating Integrity	Met applicable design and performance requirements
Corrosion Resistance	Met applicable design and performance requirements
Particulate Evaluation & Chemical Characterization	Met applicable design and performance requirements
Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity)	Compliant with ISO 10993-1 requirements
Sterility/Packaging:
Sterilization Validation	Compliant with ISO 11135 requirements
Packaging Design Verification Testing	Compliant with ISO 11607 requirements
Durability:
Shelf Life Testing	Met applicable design and performance requirements
Simulated Use:
Simulated Use/Compatibility	Met applicable design and performance requirements
Radiopacity	Met applicable design and performance requirements

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
- Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.
Adjudication method for the test set:
- N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.
The type of ground truth used:
- The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.
The sample size for the training set:
- N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- N/A. As there is no training set for a physical device, this question is not applicable.

Summary

FDA 510(k) Clearance Letter - Medtronic Stedi Extra Support Guidewire

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 13, 2025

Medtronic Inc
Hillary Barasa
Principal Regulatory Affairs Specialist
710 Medtronic Parkway
Minneapolis, Minnesota 55432

Re: K250075
Trade/Device Name: Medtronic Stedi Extra Support Guidewire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: DQX
Dated: January 10, 2025
Received: January 10, 2025

Dear Hillary Barasa:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

June 13, 2025

Medtronic Inc
Hillary Barasa
Principal Regulatory Affairs Specialist
710 Medtronic Parkway
Minneapolis, Minnesota 55432

Dear Hillary Barasa:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250075 - Hillary Barasa Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250075 - Hillary Barasa Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LYDIA S. GLAW -S
Digitally signed by LYDIA S. GLAW -S
Date: 2025.06.13 13:49:17 -04'00'

Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250075

Device Name: Medtronic Stedi Extra Support Guidewire

Indications for Use (Describe):
Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) Summary K250075

Date Prepared: Jan 10, 2025

Applicant: Medtronic Inc
710 Medtronic Parkway
Minneapolis, MN 55432
USA
Establish Registration Number: 2112641

Contact Person: Hillary Barasa
Principal Regulatory Affairs Specialist
Email: hillary.s.barasa@medtronic.com

Nisarg Shah (Alternate)
Senior Manager, Regulatory Affairs
Email: nisarg.g.shah@medtronic.com

Trade Name: Medtronic Stedi™ Extra Support Guidewire
Common Name: Guidewire
Classification Name: Wire, Guide, Catheter
Classification: Class II
Regulation Number: 21 CFR 870.1330
Product Code: DQX

Name of Predicate Device: Medtronic Confida Brecker Guidewire (K181001)
Name of Reference Devices: Cook Lunderquist Extra Stiff Wire Guidewire (K220137)

Page 1 of 4

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Device Description:

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

Indications for Use:

Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

Comparison of Technological Characteristics with the Predicate Device:

The Stedi Guidewire has the same indication for use and principles of operation as the legally marketed Medtronic Confida Brecker Guidewire (K181001). In addition, the functional characteristics of the Stedi Guidewire are substantially equivalent to the Medtronic Confida Brecker Guidewire, with similar materials, dimensions, and method of construction. The design modifications to the new device include differences in coil shape, dimensional characteristics (i.e., tip sizes, proximal wire diameter, wire length), coating process, bonding type, and material used on the proximal joint. The performance and safety testing have shown that these modifications have not raised any new questions of safety or efficacy, and the device continues to meet its intended use.

Summary of Performance Data

The determination of substantial equivalence includes an assessment of non-clinical (bench) performance testing. This testing was performed in order to demonstrate that the Stedi Extra Support Guidewire met applicable design and performance requirements and to support a determination of substantial equivalence. The following testing was conducted according to established procedures and samples were analyzed according to predetermined acceptance criteria. FDA guidance Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019) was utilized.

Design Verification and Validation Testing
Dimensional Verification
Visual Inspection
Simulated Use/Compatibility
Tensile Strength of Proximal Bond and Distal Bond
Torque Strength

Page 2 of 4

Page 7

Coating Integrity
Particulate Evaluation and Chemical Characterization
Lubricity/Pinch Force
Corrosion Resistance
Kink Resistance
Tip Flexibility/Spiral Tip Compression
Radiopacity
Flex Test
Fracture Test
Three-Point Bend Test
Sterilization Validation per requirements of ISO 11135
Biocompatibility Testing per the requirements of ISO 10993-1
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation
- Thrombogenicity
Packaging Design Verification Testing per requirements of ISO 11607
Shelf Life Testing

Page 3 of 4

Page 8

Conclusion:

The Stedi™ Extra Support Guidewire met all design input requirements based on the intended use and supports conclusion that the Stedi™ Extra Support Guidewire does not raise new questions of safety and effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device Medtronic Confida™ Brecker Guidewire (K181001).

Page 4 of 4

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.