K Number
K173423
Device Name
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
Manufacturer
Date Cleared
2017-11-17

(16 days)

Product Code
Regulation Number
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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).
More Information

Not Found

No
The device description and performance studies focus on the physical properties and performance of a guide wire, with no mention of AI or ML capabilities.

No.
The device is used to direct a catheter for diagnostic or interventional procedures, not to treat a condition itself.

No
The device, a guide wire, is intended to direct other devices during diagnostic or interventional procedures, not to perform diagnosis itself.

No

The device description clearly outlines a physical guide wire constructed from various materials, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
  • Device Description: The description details the physical construction and function of a guide wire used for navigating the vascular system. It does not mention any components or processes related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Providing diagnostic information based on the analysis of these specimens
    • Reagents, calibrators, or controls used in laboratory testing

Therefore, the MRWire Guide Wire is a medical device used for interventional and diagnostic procedures within the body, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

DQX

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI, X-Ray

Anatomical Site

vasculatory system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

The following tests were performed:

  • 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, 3.a of FDA Guidance, In-house Standard)
  • Bending Module (EN ISO 14125:2011)
  • Torque strength (3.b of FDA Guidance, In-house Standard)
  • Torqueability (3.c of FDA Guidance, In-house Standard)
  • Tip flexibility (3.d of Guidance, In-house Standard)
  • Catheter compatibility (3.e of FDA Guidance, In-house Standard)
  • Particulate evaluation (USP , AAMI TIR42 (2010))
  • MRI Compatibility (FDA Guidance)
  • Product dimension (In-house Standard)
  • U-Turn Test (In-house Standard)
  • Simulated Use Test (In-house Standard)
  • Usability Scoring Test (In-house Standard)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160594

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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);

1

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

2

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 deviceManufacturer510(k)Date
----------------------------------------------

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MRWire Guide WireNano4Imaging GmbHK16059411/22/2016
-----------------------------------------------------------

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 in
technological
characteristics | Benchmark Test | Difference/comments
Predicate Device |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | PTFE heat shrink tube
instead of Pebax® outer
extrusion at the outside | • Simulated Use Test | No differences in the Simulated Use Test. |
| | | • Flexing and Bending
Resistance | 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 increased
compared 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 core
diameter has decreased
from 0.52 mm to
0.50 mm mm to make the
surface suitable for PTFE
extrusion | • 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 the
intended use. |
| | | • Bending Module Test
(shaft) | Shaft stiffness is in the same order of magnitude. |
| | | • Torquability Test | The torqueability of the subject device is slightly increased
compared to the predicate. |
| | | • Torque Strength Test | 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 in the U-turn test. |
| | | • Usability Scoring Test | No difference in usability. |
| 3 | Tip is preformed instead
of grinding, no need for
Pebax® 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 the
intended use. |

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| Modification | Differences in
technological
characteristics | Benchmark Test | Difference/comments
Predicate Device |
|--------------|----------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | • Radiopacity Testing | Both have radiopaque elements in the tip. |
| | | • Torquability Test | The torqueability of the subject device is slightly increased
compared to the predicate. |
| | | • Tip Flexibility Test | The tip flexibility of the subject devices is comparable to the
predicate. |
| | | • Torque Strength Test | 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. |
| | | • 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

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).

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
---------------------------------------------------
PartSpecification
Diameter of Guide Wire0.035"
Length of Guide Wire180 cm
Distal tip shape processingPreshaped
Tip ConfigurationStraight, Angled
Tip length40 mm
Outer sleeve materialPTFE
MRI and X-ray visibilityStraight 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 LabelingMR 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 DevicePredicate
CharacteristicsMRWire Guide WireMRWire
CV-G-18035S and CV-G-18035ACV18035S and CV18035A
510(k) numberK173423K160594
Trade nameMRWire Guide WireMRWire Guide Wire
ModelsCV-G-18035S (FG-02175-006A) and
CV-G-18035A (FG-02175-007A)CV18035S (FG-02175-006) and
CV18035A (FG-02175-007)
Indications for useThe MRWire Guide Wire is intended to direct a
catheter to the desired anatomical location in the
vasculatory system
during diagnostic or interventional procedures.The MRWire Guide Wire is intended to direct a
catheter to the desired anatomical location in the
vasculatory system
during diagnostic or interventional procedures.
Principle of operationManual operationManual operation
Diameter0.035"0.035"
Effective lengths180 cm180
Distal shape configurationAngled, straightAngled, 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 Life6 months6 months
MRI compatibilityYesYes
MRI visibilityDiscrete markersDiscrete markers
X-ray visibilityYesYes
CharacteristicsSubject Device
MRWire Guide Wire
CV-G-18035S and CV-G-18035APredicate
MRWire
CV18035S and CV18035A
MaterialGlass fibers, aramid fibers and PTFEGlass fibers, aramid fibers and Pebax
CoatingNoNo

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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 ItemReference
SurfaceSec. 4.3 of ISO 11070: 2014
RadiodetectabilitySec. 4.5 of ISO 11070: 2014, ASTM F640-12
Fracture TestSec. 8.4 of ISO 11070: 2014
Flexing TestSec. 8.5 of ISO 11070: 2014
Peak Tensile Force of guidewireSec. 8.6 of ISO 11070: 2014
Bending ModuleEN 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 ItemReference
Peak Tensile Force of guidewire3.a of FDA Guidancea
In-house Standard
Torque strength3.b of FDA Guidancea
In-house Standard
Torqueability3.c of FDA Guidancea
In-house Standard
Tip flexibility3.d of Guidancea
In-house Standard
Catheter compatibilty3.e of FDA Guidancea
In-house Standard
Particulate evaluationUSP , AAMI TIR42 (2010)
MRI CompatibilityFDA Guidanceb
Product dimensionIn-house Standard
U-Turn TestIn-house Standard
Simulated Use TestIn-house Standard
Usability Scoring TestIn-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 (