The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

Device Description

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.

Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

AI/ML Overview

The provided document is a 510(k) summary for the MRWire Guide Wire. It details the device, its intended use, and a comparison with a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI algorithm or human readers for diagnostic performance. Therefore, many of the requested fields, particularly those related to AI model evaluation, ground truth establishment, expert consensus, and MRMC studies, cannot be directly addressed from this document.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests, implying certain acceptance criteria were met for each, but it does not quantitatively define these criteria or provide specific numerical results for each test. Instead, it offers a qualitative statement of substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Proximal shaft stiffness meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Bend strength meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Tensile Strength meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Torque Strength meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Torqueability meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Tip Flexibility meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Catheter Compatibility meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Dimensional Verification meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Biocompatibility meets standard	Testing confirmed performance is substantially equivalent to predicate device.
MR Compatibility (see detailed conditions below)	MR Conditional: Safely scanned in a 1.5 or 3.0 T MR system with specific gradient and SAR limits. Max temperature rise < 0.6°C after 15 mins. Image artifact extends ~8mm from wire with gradient echo pulse sequence and 3T MRI.
Packaging Testing meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Shelf life Testing meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Sterilization Testing meets standard	Testing confirmed performance is substantially equivalent to predicate device.
Preclinical performance (ability to direct catheter)	Both straight and angled tip MRWire Guide Wires can be inserted and maneuvered to different target sites (e.g., aortic arch, vena cava) with no difficulties in swine. MR imaging was optimal, and the MR Wire was well visible without causing changes in vital parameters.
Clinical performance (ability to direct catheter)	Wires can be safely and effectively maneuvered in the MRI suite to reach intended target sites (e.g., right atrium, right ventricle, pulmonary artery, aortic arch) in interplay with catheters of ≥ 5F in patients with congenital heart disease.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Preclinical: Swine model, unspecified sample size. Data provenance: Department of Cardiology (Johns Hopkins Division of Medicine), USA (implied as Johns Hopkins is in the US). Prospective testing.
Clinical: Patients with congenital heart disease, unspecified sample size. Data provenance: German Heart Centre in Munich (Germany). Prospective (ongoing Post-Market Clinical Follow-up study).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes device performance testing, not an AI algorithm requiring expert-established ground truth for diagnostic accuracy. The "ground truth" here is the physical performance and safety of the device itself, observed by researchers and clinicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI diagnostic study.

5. 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

Not applicable. This is a medical device clearance document, not an AI performance study.

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

Not applicable. There is no AI algorithm discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device can be considered:

Physical measurements (e.g., tensile strength, dimensions) compared against design specifications and industry standards.
Direct observation of device maneuverability and visibility during preclinical (swine) and clinical use.
Physiological stability of subjects during preclinical testing.
Safety and effectiveness observations in clinical use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm study. There is no training set mentioned.

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

Not applicable. There is no training set or AI algorithm discussed.

Summary

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

November 22, 2016

Nano4Imaging GmbH Mr. Christoph R. Manegold CEO Pauwelsstrasse 17 52074 Aachen Germany

Re: K160594

Trade/Device Name: MRWire Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 12, 2016 Received: October 17, 2016

Dear Mr. Manegold:

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 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.

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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,

Brian D. Pullin -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) K160594

Device Name MR Wire Guide Wire

Indications for Use (Describe)

The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

Contraindications: The MRWire Guide Wire is not intended for coronary or cerebral vasculature.

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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510(k) Summary

Submitters, name/contact details A.

Nano4Imaging GmbH Zentrum Für Biomedizintechnik Pauwelsstrasse 17 52074 Aachen, Germany +49 241 5656 28 261

Contact Details:

Christoph R. Manegold (CEO) Phone: +49 (0) 241 56528261 / +49 (0) 171 770 4392 Email: cm@nano4imaging.com

Prepared By: Sjef Cremers, Ph.D. Senior Scientist Date of preparation: 11/15/2016

B. Device Name

Device Common Name: Guide Wire
Device Trade Name:	MRWire Guide Wire
Classification Name:	Wire, Guide, Catheter

C. Predicate device

Predicate device	Manufacturer	510(k)	Date
Radifocus® Guidewire M	TerumoCorporation	K863138	11/20/1986

D. Classification

Class II 21 CFR § 870.1330, Product code: DQX Division of Cardiovascular Devices

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E. Device Description

Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

MRI Safety Information

Image /page/4/Picture/4 description: The image shows a white triangle with a black border. Inside the triangle, there are the letters "MR" in bold black font. The letters are centered within the triangle.

Non-clinical testing has demonstrated the MRWire Guide Wire is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5 or 3.0 T .
Maximum spatial field gradient of 3600 Gauss/cm (36.0 T/m) for 1.5 T systems .
Maximum spatial field gradient of 1800 Gauss/cm (18.0 T/m) for 3.0 T systems .
. Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 1.5 T)
. Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 3.0 T)

Under the scan conditions defined above. MRWire Guide Wire is expected to produce a maximum temperature rise of less than 0.6 ℃ after 15 minutes continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 8 mm from the MRWire Guide Wire when imaged with a gradient echo pulse sequence and a 3 T MRI system.

Intended Use F.

The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

Contraindications:

The MRWire Guide Wire is not intended for coronary or cerebral vasculature.

G. Design/Materials

Differences MRWire Guide wire and the predicate device - Radifocus Guidewire M cleared under K863138 relates to the materials used.

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H. Comparison of Technological Characteristics

Part	MRWire	Radifocus Guide WireM cleared underK863138
Principle ofoperation	Manual operation	Manual operation
Diameter	0.035"	0.018" - 0.038"
Effective lengths	180 cm	150 - 300 cm
Shape of wires	Angled, straight	Angled, straight, Jshaped
MRI compatibility	Conditional	No
MRI visibility	Discrete marker(s)	No
X-ray visibility	Yes only tip	Yes continuous

I. Performance

The following verification tests were performed to demonstrate the substantial equivalence of MRWire Guide Wire to Radifocus Guidewire M

Proximal shaft stiffness .
Bend strength •
Tensile Strength •
Torque Strength
Torqueability
Tip Flexibility •
Catheter Compatibility •
Dimensional Verification •

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. Biocompatibility
MR Compatibility
Packaging Testing
Shelf life Testing
. Sterilization Testing

This testing has confirmed that the performance of MRWire Guide Wire is substantially equivalent to the performance of the predicate device the Radifocus Guidewire M which was cleared under K863138.

J. Preclinical information

Preclinical studies were performed at the Department of Cardiology (Johns Hopkins Division of Medicine) in compliance with applicable requirements in the GLP regulation (21 CFR Part 58), and has shown that both straight and angled tip MRWire Guide Wires can be inserted and maneuvered to different target sites (e.g. aortic arch, vena cava) with no difficulties. Testing was also conducted in the common carotid but some difficulties were noted in this vasculature due to the pig anatomy. MR imaging in swine was optimal and the MR Wire was well visible in all target sites without causing changes in vital parameters.

K. Clinical information

Clinical studies were performed at the German Heart Centre in Munich (Germany) in compliance with European regulations (MEDDEV 2.12-2.) as part of the ongoing Post-Market Clinical Follow-up study in patients with congenital heart disease. The obtained results shows that the wires can be safely and effectively maneuvered in the MRI suite to reach the intended target sites such as right atrium, right ventricle, pulmonary artery and the aortic arch in interplay with catheters of ≥ 5F.

L. Conclusion

The MRWire Guide Wire is substantially equivalent in intended use, design, technology/principles of operations, and performance to the predicate device the Radifocus Guidewire M, cleared under K863138.

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.