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 and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "MRWire Guide Wire." This section outlines the device, its modifications from a predicate device, and the non-clinical tests performed to demonstrate its substantial equivalence and safety.

Here's an analysis of the provided text in relation to the requested information:

Key Takeaway: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this submission. Therefore, much of the requested information regarding human-in-the-loop performance, expert ground truth, and patient-data-driven studies is not applicable to this specific submission.

However, I can extract information related to the physical performance testing of the device for manufacturing and safety purposes.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily focuses on a comparison to a predicate device and adherence to established standards and in-house criteria for physical and material properties. The "acceptance criteria" here refer to the device meeting or surpassing the performance of the predicate device and complying with relevant ISO standards and FDA guidance documents.

Here's a table summarizing the modifications and the performance outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence for these specific changes:

Modification Feature	Technological Difference	Benchmark Test	Acceptance Criteria (Performance vs. Predicate)	Reported Device Performance / Outcome
Modification 1:	PTFE heat shrink tube instead of Pebax® outer extrusion	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Flexing and Bending Resistance	No differences expected compared to predicate.	No differences in Flexing and Bending Resistance Test.
		Biocompatibility Testing	Device should be free from biological risks under applied conditions (per ISO 10993-1).	Under the applied conditions, the device is free from biological risks. (Evaluated through extended biocompatibility testing for new blood-contacting materials).
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Particulate Testing	No generation of particles.	Both (subject and predicate) generate no particles.
		U-Turn Test	No differences expected compared to predicate.	No differences in the U-turn test.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
Modification 2:	Glass fiber core diameter decreased (0.52mm to 0.50mm) for PTFE extrusion	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Fracture Test	No differences expected compared to predicate.	No differences in the Fracture Test.
		Tensile Strength Test	Comparable or improved tensile strength compared to predicate to withstand normal tensile loading.	The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use.
		Bending Module Test (shaft)	Shaft stiffness in the same order of magnitude as predicate.	Shaft stiffness is in the same order of magnitude.
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Torque Strength Test	Comparable or improved torque strength compared to predicate to withstand normal rotational loading.	The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use.
		U-Turn Test	No differences expected compared to predicate.	No differences in the U-turn test.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
Modification 3:	Tip is preformed instead of grinding, no need for Pebax® tip extrusions	Simulated Use Test	No differences expected compared to predicate.	No differences in the Simulated Use Test.
		Tensile Strength Test	Comparable or improved tensile strength compared to predicate.	The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use.
		Radiopacity Testing	Both should have radiopaque elements in the tip.	Both have radiopaque elements in the tip.
		Torquability Test	Comparable or improved torquability compared to predicate.	The torqueability of the subject device is slightly increased compared to the predicate.
		Tip Flexibility Test	Tip flexibility comparable to predicate.	The tip flexibility of the subject devices is comparable to the predicate.
		Torque Strength Test	Comparable or improved torque strength compared to predicate.	The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use.
		Usability Scoring Test	No difference in usability expected compared to predicate.	No difference in usability.
		MRI Compatibility	No difference in MRI labeling.	No difference in MRI labelling. (MR Conditional status; Max temp rise < 0.6 °C after 15 min; image artifact extends ~8mm from device at 3T).
Overall (General)	Compliance with standards and guidance	Various Performance Tests	Conform to recognized consensus ISO standards, FDA guidance documents, or in-house standards; substantially equivalent to predicate device for its shelf life; no new issues of safety and effectiveness.	Performance testing demonstrated that the MRWire Guide Wire conformed to the recognized consensus ISO standards, FDA guidance documents or in-house standards, is substantially equivalent to the predicate device for its shelf life. No new risks identified from risk analysis.
	Biocompatibility	Biocompatibility Testing	Free from biological hazards under applied conditions based on ISO 10993-1.	Evaluated by extended biocompatibility testing in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Showed that under the applied conditions, the device is free from biological hazards.
	Sterilization	Sterilization Validation	Achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135: 2014.	Device adopted into an existing sterilization cycle validated in accordance with ISO 11135: 2014, to provide a SAL of 10-6.
	Risk Analysis	Risk Assessment	No new risks identified in accordance with ISO 14971: 2007.	A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, and no new risks were identified.

Here's a breakdown of the specific points requested, based on the provided text:

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

(Provided above in detail)

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

Sample Size: The document does not specify the precise sample sizes (N-values) used for each non-clinical test (e.g., how many guide wires were tested for tensile strength or torquability). It mentions "MRWire Guide Wire Samples" for performance testing.
Data Provenance:
- Country of Origin: Not explicitly stated for the testing location or data collection, but the manufacturer is Nano4Imaging GmbH, located in Aachen, Germany.
- Retrospective or Prospective: This distinction is not applicable as these are non-clinical, controlled laboratory performance tests on manufactured devices, not studies involving patient data or clinical observation. The tests were performed on "non-aged and accelerated-aged MRWire Guide Wire Samples" to evaluate performance throughout the labeled shelf life.

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. This device is a physical guide wire, and the testing described is non-clinical performance and material testing (e.g., tensile strength, flexibility, torquability, biocompatibility, MRI compatibility based on physical properties). There is no "ground truth" established by clinical experts in the context of diagnostic interpretation, as this is not an AI/imaging diagnostic device requiring human evaluation of outputs. The "experts" would be the engineers, scientists, and technicians conducting the physical tests and analyzing the results against engineering specifications and regulatory standards.

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

Not Applicable. As explained in point 3, this is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where multiple human readers disagree on a diagnosis or finding, and an independent expert or panel resolves the discrepancy to establish a "ground truth." This is not relevant for testing a physical device's mechanical or material properties.

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

No. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, no MRMC study was performed, and this device is not an AI diagnostic tool designed to assist human readers.

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

Not Applicable. This is a physical medical device (guide wire), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is irrelevant here.

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

Not Applicable in the traditional sense of clinical data. For this device, the "ground truth" for its performance and safety is established by:
- Engineering specifications: The design parameters and expected performance characteristics of the guide wire.
- Predicate device performance: The previously cleared device serving as a benchmark.
- Consensus standards: ISO 11070:2014, ASTM F640-12, EN ISO 14125:2011, ISO 10993-1:2009, ISO 11135:2014, ISO 14971:2007.
- FDA guidance documents: "Coronary and Cerebrovascular Guidewire Guidance, January 1995" and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014."
- In-house standards: Developed by Nano4Imaging GmbH to ensure specific performance metrics.
The "ground truth" is that the device meets or exceeds the performance of the predicate and complies with all relevant safety and performance standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a physical device being evaluated through non-clinical performance testing, not an AI/machine learning model that learns from data.

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

Not Applicable. (See point 8).

Summary

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November 17, 2017

Nano4Imaging GmbH % Ms. Judith Harrington Consultant G&L Scientific 9 Highland Ave Derry, New Hampshire 03038

Re: K173423

Trade/Device Name: MR Wire Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 4, 2017 Received: November 1, 2017

Dear Ms. Harrington:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ms. Judith Harrington

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,

Kenneth J. Cavanaugh -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) MR Wire Guide Wire

Device Name K173423

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K173423 Page 1 of 8

1. Special 510(k) Summary

1.1. Submitters Information (807.92(a)(1))

Prepared for:	Owner/Operator
	Nano4Imaging GmbH
	Zentrum F\u00fcr 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:
	11/14/2017

1.2. Device Name (807.92(a)(2))

Device Trade Name:	MRWire Guide Wire
Device Common Name:	Guide Wire
Classification Name:	Wire, Guide, Catheter
Classification Pannel:	Cardiovascular
Regulation:	21 CFR 870.1330
Product Code:	DQX
Classification:	Class II

1.3. Predicate Device (807.92(a)(3))

The legally marketed device to which substantial equivalency is claimed is:

Predicate device	Manufacturer	510(k)	Date
------------------	--------------	--------	------

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MRWire Guide Wire	Nano4Imaging GmbH	K160594	11/22/2016
-------------------	-------------------	---------	------------

1.4. Reason for Special 510(k) Submission

The purpose of this special 510(k) submission is establishing substantial equivalency to a legally marketed device as a result of a technical modification in the new design. The technological differences between the predicate cleared under K160594 and the subject device are listed in the table below. Based on the Risk Analysis, the following Design Control Activities were identified.

Modification	Differences intechnologicalcharacteristics	Benchmark Test	Difference/commentsPredicate Device
1	PTFE heat shrink tubeinstead of Pebax® outerextrusion at the outside	• Simulated Use Test	No differences in the Simulated Use Test.
		• Flexing and BendingResistance	No differences in Flexing and Bending Resistance Test.
		• Biocompatibility Testing	Under the applied conditions the device is from biological risks.
		• Torquability Test	The torqueability of the subject device is slightly increasedcompared to the predicate.
		• Particulate Testing	Both generate no particles.
		• U-Turn Test	No differences in the U-turn test.
		• Usability Scoring Test	No difference in usability.
2	The glass fiber corediameter has decreasedfrom 0.52 mm to0.50 mm mm to make thesurface suitable for PTFEextrusion	• Simulated Use Test	No differences in the Simulated Use Test.
		• Fracture Test	No differences in the Fracture Test.
		• Tensile Strength Test	The tensile strength is slightly higher than the predicate device,making it better to withstand normal tensile loading for theintended use.
		• Bending Module Test(shaft)	Shaft stiffness is in the same order of magnitude.
		• Torquability Test	The torqueability of the subject device is slightly increasedcompared to the predicate.
		• Torque Strength Test	The torque Strength of the subject device is increasedcompared to the predicate making it better to withstandnormal rotational loading for the Intended use.
		• U-Turn Test	No differences in the U-turn test.
		• Usability Scoring Test	No difference in usability.
3	Tip is preformed insteadof grinding, no need forPebax® tip extrusions	• Simulated Use Test	No differences in the Simulated Use Test.
		• Tensile Strength Test	The tensile strength is slightly higher than the predicate device,making it better to withstand normal tensile loading for theintended use.

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Modification	Differences intechnologicalcharacteristics	Benchmark Test	Difference/commentsPredicate Device
		• Radiopacity Testing	Both have radiopaque elements in the tip.
		• Torquability Test	The torqueability of the subject device is slightly increasedcompared to the predicate.
		• Tip Flexibility Test	The tip flexibility of the subject devices is comparable to thepredicate.
		• Torque Strength Test	The torque Strength of the subject device is increasedcompared to the predicate making it better to withstandnormal rotational loading for the Intended use.
		• Usability Scoring Test	No difference in usability.
		• MRI Compatibility	No difference in MRI labelling.

1.5. Device Description

Principle of Operation Technology

The MRWire Guide Wire is operated by manual process.

Design/Construction

MRI Safety Information

Image /page/5/Picture/8 description: The image shows a black triangle with the letters "MR" in bold black font in the center. The triangle is outlined in black and has a white background. The letters "MR" are stacked on top of each other.

Non-clinical testing has demonstrated the MRWire Guide Wire is MRConditional.

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 Tsystems
Maximum spatial field gradient of 1800 Gauss/cm (18.0 T/m) for 3.0 Tsystems
. Maximum MR system reported, whole body averaged specific absorptionrate (SAR) of 4.0 W/kg (First Level Operating Mode at 1.5T)
. Maximum MR system reported, whole body averaged specific absorptionrate (SAR) of 4.0 W/kg (First Level Operating Mode at 3.0T)

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Under the scan conditions defined above, MRWire Guide Wire is expected to produce a maximum temperature rise of less than 0.6 °C 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.

Specifications

The specifications for MRWire Guide Wire are provided in the table below.

Table 1.1: MRWire Guide Wire Specifications
---------------------------------------------	--	--	--

Part	Specification
Diameter of Guide Wire	0.035"
Length of Guide Wire	180 cm
Distal tip shape processing	Preshaped
Tip Configuration	Straight, Angled
Tip length	40 mm
Outer sleeve material	PTFE
MRI and X-ray visibility	Straight tip:
	Passive markers at discrete positions 0, 2, 4 cm from the tip
	Angled tip:
	Passive markers at discrete positions 0, 2, 4 cm from the tip
MRI Labeling	MR Conditional

1.6. Indications For Use (807.92(a)(5))

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.

1.7. Substantial Equivalence Comparison (807.92(a)(6))

The MRWire Guide Wire, subject of this special 510(k) is substantially equivalent in intended/indications for use, technology /principle of operation, and performance to the MRWire Guide Wire manufactured by Nano4Imaging GmbH.

A comparison of the technological characteristics is summarized on the table below.

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Table 1.2 Summary of Comparative Information

	Subject Device	Predicate
Characteristics	MRWire Guide Wire	MRWire
	CV-G-18035S and CV-G-18035A	CV18035S and CV18035A
510(k) number	K173423	K160594
Trade name	MRWire Guide Wire	MRWire Guide Wire
Models	CV-G-18035S (FG-02175-006A) andCV-G-18035A (FG-02175-007A)	CV18035S (FG-02175-006) andCV18035A (FG-02175-007)
Indications for use	The MRWire Guide Wire is intended to direct acatheter to the desired anatomical location in thevasculatory systemduring diagnostic or interventional procedures.	The MRWire Guide Wire is intended to direct acatheter to the desired anatomical location in thevasculatory systemduring diagnostic or interventional procedures.
Principle of operation	Manual operation	Manual operation
Diameter	0.035"	0.035"
Effective lengths	180 cm	180
Distal shape configuration	Angled, straight	Angled, straight
Sterilization method /Sterilization Assurance Level(SAL)	Ethylene oxide (cycle CMI 01 EQ). SAL 10-6.	Ethylene oxide (cycle CMI 01 EQ). SAL 10-6.
Shelf Life	6 months	6 months
MRI compatibility	Yes	Yes
MRI visibility	Discrete markers	Discrete markers
X-ray visibility	Yes	Yes
Characteristics	Subject DeviceMRWire Guide WireCV-G-18035S and CV-G-18035A	PredicateMRWireCV18035S and CV18035A
Material	Glass fibers, aramid fibers and PTFE	Glass fibers, aramid fibers and Pebax
Coating	No	No

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1.8. Non Clinical Tests (807.92(b)(1))

Performance

Performance testing was conducted to evaluate the performance of the MRWire Guide Wire throughout the labeled shelf life, verify conformity to applicable standards and demonstrate substantial equivalence to the predicate devices. With the exception of the Radiopacity test, biocompatibility and the sterilization the following performance tests were performed on non-aged and accelerated-aged MRWire Guide Wire Samples. However, the particulate test and the Usability test were performed only on accelerated aged samples tested met the applicable acceptance criteria, and no new issues of safety and effectiveness were raised by the testing performed.

Test Item	Reference
Surface	Sec. 4.3 of ISO 11070: 2014
Radiodetectability	Sec. 4.5 of ISO 11070: 2014, ASTM F640-12
Fracture Test	Sec. 8.4 of ISO 11070: 2014
Flexing Test	Sec. 8.5 of ISO 11070: 2014
Peak Tensile Force of guidewire	Sec. 8.6 of ISO 11070: 2014
Bending Module	EN ISO 14125:2011

Table 1.3: Performance Testing per ISO Standard/ASTM

Additionally, performance testing other than that recommended in the above ISO standard was performed on the device in accordance with FDA guidance documents and/or in-house standards. The subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents, as shown in the table below.

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Test Item	Reference
Peak Tensile Force of guidewire	3.a of FDA GuidanceaIn-house Standard
Torque strength	3.b of FDA GuidanceaIn-house Standard
Torqueability	3.c of FDA GuidanceaIn-house Standard
Tip flexibility	3.d of GuidanceaIn-house Standard
Catheter compatibilty	3.e of FDA GuidanceaIn-house Standard
Particulate evaluation	USP <788>, AAMI TIR42 (2010)
MRI Compatibility	FDA Guidanceb
Product dimension	In-house Standard
U-Turn Test	In-house Standard
Simulated Use Test	In-house Standard
Usability Scoring Test	In-house Standard

Table 5.4: Performance Testing per FDA Guidance Documents and/or In-house Standard

a) Coronary and Cerebrovascular Guidewire Guidance, January 1995

b) Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014

Performance testing demonstrated that the MRWire Guide Wire conformed to the recognized consensus ISO standards, FDA guidance documents or in-house standards, is substantially equivalent to the predicate device for its shelf life.

Biocompatibility

In accordance with ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, the MRWire Guide Wire is classified as an Externally Communicating Devices, Circulating blood, Limited Contact (<24 hrs). This is the same classification as the predicate MRWire Guide Wire (K160594) which is intended for vascular use.

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All the new blood contacting materials from the subject device were evaluated by extended biocompatibility testing in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. Per ISO 10993-1 showed that under the applied conditions, the device is free from biologicalhazards.

Sterilization

The device was adopted into an existing sterilization cycle that was validated in accordance with ISO 11135: 2014, Sterilization of health-care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6

Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, Medical devices-Application of risk management to medical devices, and no new risks were identified.

1.9. Clinical Tests (807.92(b)(2))

This 510(k) does not include data from clinical tests.

1.10. Conclusion (807.92(b)(3))

In summary, MRWire Guide Wire, subject of this special 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, and performance to the predicate device MRWire Guide Wire cleared under K160594. There are no significant differences that raise any new issues of safety and effectiveness.

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.