(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML technologies.
No.
The device is a guidewire used to direct catheters for diagnostic or interventional procedures, not to provide therapy itself.
No
The device is described as a guidewire to direct a catheter during diagnostic or interventional procedures, but it does not perform a diagnostic function itself. It is an accessory to aid in the delivery of other instruments.
No
The device description clearly outlines physical components like a core wire, coatings, packaging, and an inserter, indicating it is a hardware device.
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 during diagnostic or interventional procedures." This describes a device used within the body to facilitate a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical wire with coatings and a holder, designed for insertion into the body. This aligns with an invasive medical device, not an IVD which typically involves reagents, test strips, or analytical instruments for sample analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely procedural and mechanical.
N/A
Intended Use / Indications for Use
The Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
Product codes
DQX
Device Description
The Radifocus Glidewire Advantage consists of a Nickel Titanium alloy core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in many configurations such as straight, J shaped, and angled. The wire is package in a plastic holder contained within a pouch. A guide wire inserter is contained within the pouch to assist with the insertion of the wire into a needle or catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Radifocus Glidewire Advantage) to the unmodified device (Radifocus Guide Wire).
- Ease of removal from holder
- Torque control
- Sliding friction
- Tip impact
- Proximal shaft stiffness
- Bend strength
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Therefore the performance of the modified Radifocus Glidewire Advantage is substantially equivalent to the performance of the predicate device the Radifocus Guide Wire which was cleared under K863138.
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.
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SECTION II. 510(K) SUMMARY
A. Device Name
JAN 1 9 2007
| Proprietary Name | Radifocus® Glidewire® Advantage |
|---|---|
| Classification Name | Wire, Guide, Catheter |
| Common Name | Guide Wire |
B. Intended Use
The Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
Note: This is the same intended use as the predicate device - Radifocus Guide Wire K863138
C. Device Description
The Radifocus Glidewire Advantage consists of a Nickel Titanium alloy core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in many configurations such as straight, J shaped, and angled. The wire is package in a plastic holder contained within a pouch. A guide wire inserter is contained within the pouch to assist with the insertion of the wire into a needle or catheter.
D. Principle Of Operation / Technology
The Radifocus Glidewire Advantage is operated manually or by a manual process.
E. Design / Materials
Differences in materials between the modified device and the predicate device the Radifocus Guide Wire cleared under K863138 raise no new issues of safety and effectiveness.
1
F. Specifications
| Part | Modified Radifocus® Glidewire® Advantage | Radifocus® Guide Wire cleared under K863138 |
|---|---|---|
| Diameter of Wire | 0.018"-0.038" | 0.018"-0.038" |
| Length of Wire | 150-300 cm | 30-300 cm |
| Shapes of Wire | Angled, straight, J shaped | Angled, straight, J shaped |
| Accessory Devices | Guide wire inserter | Guide wire inserter |
2
G. Performance
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Radifocus Glidewire Advantage) to the unmodified device (Radifocus Guide Wire).
- Ease of removal from holder �
- Torque control .
- Sliding friction .
- Tip impact .
- Proximal shaft stiffness ●
- Bend strength ●
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Therefore the performance of the modified Radifocus Glidewire Advantage is substantially equivalent to the performance of the predicate device the Radifocus Guide Wire which was cleared under K863138.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The guide wire is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994, Medical Devices – Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 1056.
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H. Substantial Equivalence
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The modified Radifocus Glidewire Advantage is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Radifocus Guide Wire, cleared under K863138. Differences between the two devices do not raise any significant issues of safety or effectiveness.
I. Submitter Information
| Prepared By: | Mr. Mark Unterreiner
Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
Phone: (410) 392-7213
Fax: (410) 398-6079
Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | November 8, 2006 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921
JAN 1 9 2007
Re: K063372
Radifocus® Guidewire® Advantage Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II (two) Product Code: DQX Dated: December 20, 2006 Received: December 21, 2006
Dear Mr. Unterreiner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Mark Unterreiner
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna P. Vamer
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): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmara P. Vuhner
(Division Sign-Off) (Division Oigin Olivision Devices
510(x) Number_K063333