(189 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a guidewire designed to direct a catheter, which is an interventional procedure. It does not provide any therapeutic effect on its own.
No
The device is a guidewire designed to direct catheters during diagnostic or interventional procedures; it does not itself perform diagnostic functions. Its purpose is mechanical guidance, not information gathering for diagnosis.
No
The device description clearly states it is a physical guidewire made of Nickel Titanium alloy with various coatings and a radiopaque spring coil, packaged with a guide wire inserter. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This describes a device used within the body for procedural guidance, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details the physical components of a guidewire used in medical procedures, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Radifocus® Glidewire Advantage is a medical device used for guiding catheters within the body, which falls under the category of interventional or diagnostic devices used in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The Radifocus® Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Radifocus® Glidewire Advantage (0.014") 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 an angled configuration. The Radifocus® Glidewire Advantage (0.014") diameter wire contains a distal radiopaque spring coil. The wire is package in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package 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
peripheral vasculature
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 bench tests were performed to verify that the subject device is substantially equivalent to the predicate device and that there are no new issues regarding the safety and effectiveness of the device:
Performance Testing for the Radifocus® Glidewire Advantage
- Verification Test: Torque control, Test Method: Test method developed in-house
- Verification Test: Sliding Friction (hydrophilic coating), Test Method: Test method developed in-house
- Verification Test: Sliding Friction (PTFE coating), Test Method: Test method developed in-house
- Verification Test: Pushing Resistance at Tip (Tip impact), Test Method: Test method developed in-house
- Verification Test: Proximal Shaft Stiffness, Test Method: Test method developed in-house
- Verification Test: Bend Strength, Test Method: Test method developed in-house
- Verification Test: Tensile Strength, Test Method: Coronary and Cerebrovascular Guidewire Guidance - January 1995
- Verification Test: Torque Strength, Test Method: Coronary and Cerebrovascular Guidewire Guidance - January 1995
- Verification Test: Coating Adherence/Integrity, Test Method: Coronary and Cerebrovascular Guidewire Guidance - January 1995
- Verification Test: Particulate Test, Test Method: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters
Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process." The Radifocus® Glidewire Advantage is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24h). The specific tests performed and passed were as follows:
- Test: Cytotoxicity, Test Method: ISO 10993-5, Result: Non-cytotoxic
- Test: Hemolysis, Test Method: ASTM F756-08, Result: Non-hemolytic.
- Test: Thromboresistance, Test Method: ISO10993-4, Result: Thromboresistant
- Test: Sensitization, Test Method: ISO 10993-10, Result: No evidence of causing delayed dermal contact sensitization.
- Test: Acute Systemic Toxicity, Test Method: ISO 10993-11, Result: No mortality or evidence of systemic toxicity.
- Test: Intracutaneous Reactivity, Test Method: ISO 10993-10, Result: No evidence of significant irritation or toxicity.
- Test: Pyrogen, Test Method: ISO 10993-11, Result: Non-pyrogenic.
- Test: Complement Activation Testing C3a, Test Method: ISO 10993-4, Result: Not a complement system activator
- Test: Complement Activation Testing Sc5b-9, Test Method: ISO 10993-4, Result: Not a complement system activator
- Test: Physicochemical Profile, Test Method: USP35, Result: Meets requirements
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.
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.
0
510(k) Summary
MAR 0 1 2013
Radifocus® Glidewire Advantage (0.014")
January 24, 2013
A. General Information
Applicant:
Terumo Corporation, Tokyo, Japan 44-1, 2-chome Hatagaya Shibuya-ku Tokyo 151-0072 Japan Registration No: 801 002 6
Official Correspondent:
Stacy Abbatiello Kluesner, M.S., RAC Sr. Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873 Phone: (908) 302-4900 ext: 4273 Fax: (732) 302-4905 Email: stacy.kluesner@terumomedical.com
B. Device Nume
Proprietary Name: Classification Name: Common Name: Regulation Number: Regulatory Description: Regulatory Class: Review Panel: Product Code:
Radifocus® Glidewire Advantage (0.014") Wire, Guide, Catheter Guide Wire 21 CFR 870.1330 Catheter guide wire II Cardiovascular DQX
C. Intended Use
The Radifocus® Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
1
D. Predicate Device
Terumo Corporation, Radifocus® Glidewire Advantage (K063372)
E. Device Description
The Radifocus® Glidewire Advantage (0.014") 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 an angled configuration. The Radifocus® Glidewire Advantage (0.014") diameter wire contains a distal radiopaque spring coil. The wire is package in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.
F. Technologicul Comparison
The Radifocus® Glidewire Advantage (0.014") is identical to the predicate device in intended use, and is similar in the design specifications. The main difference between the subject device and the predict device is in the wire diameter offered.
| Part | Modified Radifocus®
Glidewire Advantage (0.014") | Predicate Radifocus® Glidewire
Advantage (K063372) |
|------------------|-----------------------------------------------------|-------------------------------------------------------|
| Diameter of Wire | 0.014" | 0.018" - 0.038" |
| Length of Wire | 180, 300 cm | 150-300 cm |
| Shapes of Wire | Angled | Angled, straight, J shaped |
| Accessory | Guide wire inserter | Guide wire inserter |
2
G. Performance Testing
The following bench tests were performed to verify that the subject device is substantially equivalent to the predicate device and that there are no new issues regarding the safety and effectiveness of the device:
| Performance Testing for the Radifocus® Glidewire Advantage | |
|---|---|
| Verification Test | Test Method |
| Torque control | Test method developed in-house |
| Sliding Friction (hydrophilic coating) | Test method developed in-house |
| Sliding Friction (PTFE coating) | Test method developed in-house |
| Pushing Resistance at Tip (Tip impact) | Test method developed in-house |
| Proximal Shaft Stiffness | Test method developed in-house |
| Bend Strength | Test method developed in-house |
| Tensile Strength | Coronary and Cerebrovascular Guidewire |
| Guidance - January 1995 | |
| Torque Strength | Coronary and Cerebrovascular Guidewire |
| Guidance - January 1995 | |
| Coating Adherence/Integrity | Coronary and Cerebrovascular Guidewire |
| Guidance - January 1995 | |
| Particulate Test | Class II Special Controls Guidance |
| Document for Certain Percutaneous | |
| Transluminal Coronary Angioplasty | |
| (PCTA) Catheters |
H. Additional Safety Information
As the device incorporated materials that had not been previously used together on this device, biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process." The Radifocus® Glidewire Advantage is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24h). The specific tests performed and passed were as follows:
3
| Test | Test Method | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Hemolysis | ASTM F756-08 | Non-hemolytic. |
| Thromboresistance | ISO10993-4 | Thromboresistant |
| Sensitization | ISO 10993-10 | No evidence of causing |
| delayed dermal contact | ||
| sensitization. | ||
| Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence |
| of systemic toxicity. | ||
| Intracutaneous Reactivity | ISO 10993-10 | No evidence of significant |
| irritation or toxicity. | ||
| Pyrogen | ISO 10993-11 | Non-pyrogenic. |
| Complement Activation Testing | ||
| C3a | ISO 10993-4 | Not a complement system |
| activator | ||
| Complement Activation Testing | ||
| Sc5b-9 | ISO 10993-4 | Not a complement system |
| activator | ||
| Physicochemical Profile | USP35 | Meets requirements |
Risk Analysis was performed in accordance with established in-house acceptance criteria based on ISO 14971. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-9.
I. Substantial Equivalence
When compared to the predicate device, the modified Radifocus® Glidewire Advantage (0.014") is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate Radifocus® Glidewire Advantage device cleared under K063372. Differences between the two devices do not raise any new concerns regarding the safety and effectiveness of the product:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Terumo Medical Corporation c/o Ms. Stacy Kluesner 265 Davidson Ave, Suite 320 Somerset, New Jersey 08873
Re: K122590
Trade/Device Name: Radifocus Guidewire Advantage Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 30, 2013 Received: February 1, 2013
Dear Ms. Kluesner:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Matthew G莉레illebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K122590
Radifocus® Glidewire Advantage Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Radifocus® Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G. Hillebrenner
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