MR Wire Guide Wire Straight, MR Wire Guide Wire Angled

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below. 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. 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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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Nano4Imaging. The logo consists of a blue spiral of dots on the left and the text "Nano4Imaging" on the right. The "4" in "Nano4Imaging" is a lighter shade of blue than the rest of the text. 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 | |------------------|--------------|--------|------| |------------------|--------------|--------|------| {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Nano4Imaging, which is in blue font. To the left of the logo is a blue spiral made of circles. In the upper right corner of the image, it says "Page 2 of 8". | 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 in<br>technological<br>characteristics | Benchmark Test | Difference/comments<br>Predicate Device | |--------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | PTFE heat shrink tube<br>instead of Pebax® outer<br>extrusion at the outside | • Simulated Use Test | No differences in the Simulated Use Test. | | | | • Flexing and Bending<br>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<br>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<br>diameter has decreased<br>from 0.52 mm to<br>0.50 mm mm to make the<br>surface suitable for PTFE<br>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,<br>making it better to withstand normal tensile loading for the<br>intended use. | | | | • Bending Module Test<br>(shaft) | Shaft stiffness is in the same order of magnitude. | | | | • Torquability Test | The torqueability of the subject device is slightly increased<br>compared to the predicate. | | | | • Torque Strength Test | The torque Strength of the subject device is increased<br>compared to the predicate making it better to withstand<br>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<br>of grinding, no need for<br>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,<br>making it better to withstand normal tensile loading for the<br>intended use. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Nano4Imaging, which is a blue spiral of circles on the left and the name of the company in blue on the right. The text "Page 3 of 8" is located in the upper right corner of the image. The logo is simple and modern, and the text indicates that the image is part of a larger document. | Modification | Differences in<br>technological<br>characteristics | Benchmark Test | Difference/comments<br>Predicate Device | |--------------|----------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | • Radiopacity Testing | Both have radiopaque elements in the tip. | | | | • Torquability Test | The torqueability of the subject device is slightly increased<br>compared to the predicate. | | | | • Tip Flexibility Test | The tip flexibility of the subject devices is comparable to the<br>predicate. | | | | • Torque Strength Test | The torque Strength of the subject device is increased<br>compared to the predicate making it better to withstand<br>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) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Nano4Imaging. The logo consists of a blue spiral of circles on the left and the text "Nano4Imaging" in blue and black on the right. The text "Page 4 of 8" is located in the upper right corner of the image. 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Nano4Imaging. The logo consists of a blue spiral of circles on the left and the word "Nano4Imaging" in blue and black on the right. The text "Page 5 of 8" is in the upper right corner of the image. ## 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) and<br>CV-G-18035A (FG-02175-007A) | CV18035S (FG-02175-006) and<br>CV18035A (FG-02175-007) | | Indications for use | The MRWire Guide Wire is intended to direct a<br>catheter to the desired anatomical location in the<br>vasculatory system<br>during diagnostic or interventional procedures. | The MRWire Guide Wire is intended to direct a<br>catheter to the desired anatomical location in the<br>vasculatory system<br>during 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 /<br>Sterilization Assurance Level<br>(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 Device<br>MRWire Guide Wire<br>CV-G-18035S and CV-G-18035A | Predicate<br>MRWire<br>CV18035S and CV18035A | | Material | Glass fibers, aramid fibers and PTFE | Glass fibers, aramid fibers and Pebax | | Coating | No | No | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Nano4Imaging. The logo consists of a spiral of blue circles on the left and the text "Nano4Imaging" in blue on the right. The text "Page 6 of 8" is located in the upper right corner of the image. ## 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. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Nano4Imaging. The logo consists of a spiral of blue circles on the left and the text "Nano4Imaging" on the right. The number 4 in the text is blue, while the rest of the text is dark blue. The text "Page 7 of 8" is in the upper right corner of the image. | Test Item | Reference | |---------------------------------|-------------------------------------------| | Peak Tensile Force of guidewire | 3.a of FDA Guidancea<br>In-house Standard | | Torque strength | 3.b of FDA Guidancea<br>In-house Standard | | Torqueability | 3.c of FDA Guidancea<br>In-house Standard | | Tip flexibility | 3.d of Guidancea<br>In-house Standard | | Catheter compatibilty | 3.e of FDA Guidancea<br>In-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. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Nano4Imaging, which is a company that specializes in imaging technology. The logo features a spiral of blue circles on the left and the company name in bold, dark blue letters on the right. The number 4 in the company name is a lighter blue color. The text "Page 8 of 8" is located in the upper right corner of the image. 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.