The Radifocus® Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Radifocus® Glidewire Advantage (0.014"), structured according to your request.

Please note: The provided document is a 510(k) Summary for a medical device (a guide wire), which focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments. It does not describe a study involving human readers, AI, or advanced clinical outcomes data, as would be typical for an AI/ML-driven diagnostic device. Therefore, several of your requested sections will be answered as "Not applicable" or by indicating that the information is not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for many of these tests were "Test method developed in-house" or based on FDA Guidance documents for similar devices. For biocompatibility, the acceptance criteria are generally to be "Non-cytotoxic," "Non-hemolytic," etc. The document explicitly states that the tests were "performed and passed," indicating adherence to their established criteria. For the in-house developed tests, specific quantitative acceptance criteria are not provided in this summary, but the results indicate successful performance.

Performance Testing for the Radifocus® Glidewire Advantage	Reported Device Performance	Acceptance Criteria
Torque control	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Sliding Friction (hydrophilic coating)	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Sliding Friction (PTFE coating)	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Pushing Resistance at Tip (Tip impact)	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Proximal Shaft Stiffness	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Bend Strength	Passed (implied by "Performance Testing")	Test method developed in-house (specific criteria not detailed)
Tensile Strength	Passed (implied by "Performance Testing")	Coronary and Cerebrovascular Guidewire Guidance - January 1995 (specific criteria not detailed)
Torque Strength	Passed (implied by "Performance Testing")	Coronary and Cerebrovascular Guidewire Guidance - January 1995 (specific criteria not detailed)
Coating Adherence/Integrity	Passed (implied by "Performance Testing")	Coronary and Cerebrovascular Guidewire Guidance - January 1995 (specific criteria not detailed)
Particulate Test	Passed (implied by "Performance Testing")	Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters (specific criteria not detailed)
Cytotoxicity	Non-cytotoxic	Non-cytotoxic (as per ISO 10993-5)
Hemolysis	Non-hemolytic	Non-hemolytic (as per ASTM F756-08)
Thromboresistance	Thromboresistant	Thromboresistant (as per ISO10993-4)
Sensitization	No evidence of causing delayed dermal contact sensitization	No evidence of causing delayed dermal contact sensitization (as per ISO 10993-10)
Acute Systemic Toxicity	No mortality or evidence of systemic toxicity	No mortality or evidence of systemic toxicity (as per ISO 10993-11)
Intracutaneous Reactivity	No evidence of significant irritation or toxicity	No evidence of significant irritation or toxicity (as per ISO 10993-10)
Pyrogen	Non-pyrogenic	Non-pyrogenic (as per ISO 10993-11)
Complement Activation Testing C3a	Not a complement system activator	Not a complement system activator (as per ISO 10993-4)
Complement Activation Testing Sc5b-9	Not a complement system activator	Not a complement system activator (as per ISO 10993-4)
Physicochemical Profile	Meets requirements	Meets requirements (as per USP35<661>)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of wires tested for torque, friction, etc.). It refers to "tests performed" and methods, implying a sufficient number of samples were used to generate statistically meaningful results for each test.
Data Provenance: The tests are described as "bench tests" and "biocompatibility testing." This is laboratory-generated data, not patient data from a specific country or origin in the traditional sense. It's prospective in the sense that the tests were deliberately conducted to assess the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission describes bench and biocompatibility testing, which do not typically involve experts establishing ground truth in the same way clinical studies or image-based diagnostic evaluations do. The "ground truth" for these tests are the established physical/chemical properties or biological reactions according to the specified standards or in-house methods.

4. Adjudication method for the test set

Not applicable. As this involves bench and biocompatibility testing against defined standards, there is no need for expert adjudication. The results are objective measurements or observations interpreted against pre-defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (a guide wire), not an AI-enabled diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for performance testing was based on:

In-house developed test methods and their established specifications.
Relevant FDA Guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance - January 1995," "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters").
International Standards for biocompatibility (e.g., ISO 10993 series, ASTM F756-08, USP35<661>).
Risk analysis performed according to ISO 14971, which helps define acceptance criteria.

8. The sample size for the training set

Not applicable. This refers to a physical medical device submission, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used for this device.

Summary

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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.

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D. Predicate Device

Terumo Corporation, Radifocus® Glidewire Advantage (K063372)

E. Device Description

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® GlidewireAdvantage (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

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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 GuidewireGuidance - January 1995
Torque Strength	Coronary and Cerebrovascular GuidewireGuidance - January 1995
Coating Adherence/Integrity	Coronary and Cerebrovascular GuidewireGuidance - January 1995
Particulate Test	Class II Special Controls GuidanceDocument for Certain PercutaneousTransluminal 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:

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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 causingdelayed dermal contactsensitization.
Acute Systemic Toxicity	ISO 10993-11	No mortality or evidenceof systemic toxicity.
Intracutaneous Reactivity	ISO 10993-10	No evidence of significantirritation or toxicity.
Pyrogen	ISO 10993-11	Non-pyrogenic.
Complement Activation TestingC3a	ISO 10993-4	Not a complement systemactivator
Complement Activation TestingSc5b-9	ISO 10993-4	Not a complement systemactivator
Physicochemical Profile	USP35<661>	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:

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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

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.