(266 days)
No
The summary describes a physical guide wire and its materials, intended use, and performance in non-clinical and clinical studies. There is no mention of software, algorithms, or any form of artificial intelligence or machine learning.
No
The device is a guide wire used to direct catheters for diagnostic or interventional procedures, not to treat a disease or condition itself.
No
The device, MRWire Guide Wire, is intended to direct a catheter for diagnostic or interventional procedures, but it does not perform the diagnosis itself. Its function is to facilitate the placement of other diagnostic or interventional devices.
No
The device description clearly details a physical guide wire constructed from glass fibers, polymers, and aramid fiber, with a physical tip containing BaSO4 for X-Ray visibility. This is a hardware device, not software only.
Based on the provided information, the MRWire Guide Wire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- MRWire Function: The MRWire Guide Wire is a physical tool used within the patient's body to facilitate the placement of other devices (catheters) during diagnostic or interventional procedures. It does not analyze or test biological specimens.
- Intended Use: The intended use clearly states it's for directing a catheter within the vascular system.
- Device Description: The description focuses on the physical construction and properties of the guide wire for navigation and visibility within the body.
Therefore, the MRWire Guide Wire falls under the category of a medical device used for interventional procedures, 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.
Contraindications: The MRWire Guide Wire is not intended for coronary or cerebral vasculature.
Product codes
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. 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).
MRI Safety Information
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, X-Ray
Anatomical Site
vasculatory system. Not intended for coronary or cerebral vasculature. Specific mention of aortic arch, vena cava, common carotid, right atrium, right ventricle, pulmonary artery.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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.
1
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
2
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) |
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."
3
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 | Terumo | ||
| Corporation | K863138 | 11/20/1986 |
D. Classification
Class II 21 CFR § 870.1330, Product code: DQX Division of Cardiovascular Devices
4
E. 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).
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.
5
H. Comparison of Technological Characteristics
| Part | MRWire | Radifocus Guide Wire
M cleared under
K863138 |
|---------------------------|--------------------|----------------------------------------------------|
| Principle of
operation | 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, J
shaped |
| 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 •
6
- . 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.