The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Device Description

The Radifocus Glidewire is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Radifocus Glidewire". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD), as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and standalone performance, does not directly apply to this document.

The document describes performance testing for a physical medical device (a guide wire) to ensure it meets established engineering and material standards and demonstrates substantial equivalence to a predicate device. It does not involve AI or software development that would require an AI-specific validation study as outlined in your prompt.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided:

Why the requested information for AI/SaMD is not applicable/available:

No AI or Software Component: The Radifocus Glidewire is a physical guide wire. There is no mention of any AI algorithm, software, or digital health component.
No "Acceptance Criteria" for AI Performance: The "acceptance criteria" discussed in the document relate to physical properties and performance tests of the guide wire (e.g., surface, radiodetectability, fracture test, tensile force, torque strength, biocompatibility, sterilization). These are not AI performance metrics like sensitivity, specificity, AUC, or F-measure.
No "Ground Truth" for AI/Imaging Data: Since there's no AI interpreting images or patient data, there's no need for establishing ground truth through expert consensus, pathology, or outcomes data, nor for training/test sets sourced from specific countries or collection methodologies (retrospective/prospective).
No "Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study": This type of study is relevant for evaluating human reader performance with and without AI assistance in interpreting diagnostic images. It's not applicable to a physical guide wire.
No "Standalone (Algorithm Only) Performance": This refers to the performance of an AI algorithm in isolation. It's not relevant here.
No "Sample Sizes for Training/Test Sets" or "Adjudication Methods" for AI: These concepts are tied to machine learning model development and validation, which is absent from this submission.

What the document does provide regarding "acceptance criteria" and "proof":

The document details the non-clinical tests performed to demonstrate the device's performance and substantial equivalence to the predicate device.

A table of acceptance criteria and the reported device performance:

The document provides tables of performance tests based on ISO standards and FDA guidance documents, stating that all samples tested met the standard applicable to each test, and the subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. It doesn't provide specific numerical values for each test result, but rather a statement of compliance.

Test	Standard / Acceptance Criteria (Implicitly Met)	Reported Device Performance
ISO 11070:2014-based Tests:
Surface	Section 4.3 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
Radiodetectability	Section 4.5 of ISO 11070:2014 & ASTM F640-12	Met the standard applicable to the test. Only non-aged sample was tested.
Fracture Test	Section 8.4 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
Flexing Test	Section 8.5 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
Peak Tensile Force of Guidewire (ISO)	Section 8.6 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
FDA Guidance & In-house Standard-based Tests:
Peak Tensile Force of Guidewire (FDA/In-house)	3.a of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Torque Strength	3.b of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Torqueability	3.c of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Tip Flexibility	3.d of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Sliding Resistance/Coating Integrity	3.e of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Particulate Evaluation	VIII.A.13 of Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010; USP<788>; In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Product Dimension	In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
Biocompatibility	ISO 10993-1:2009 (Externally Communicating Devices, Circulating blood, Limited Contact < 24 hrs)	Materials are the same as the predicate device (K863138), which has a demonstrated history of safe and effective use. Concluded as biocompatible for its intended use.
Sterilization	ISO 11135:2014 for Ethylene Oxide sterilization (min. SAL of 10-6)	Validated in accordance with ISO 11135:2014 to provide SAL of 10-6.
Shelf-Life	Not explicitly stated standard, but tests performed on non-aged and accelerated aged samples	Performance ensured throughout the labeled shelf life (24 months).

Sample sizes used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. It mentions "samples" and "accelerated aged samples" but no specific numbers. Data provenance is implied to be internal testing by the manufacturer (Terumo Corporation) based on recognized standards (ISO, ASTM, FDA guidance) and in-house standards. This is for physical device performance, not clinical data or imaging data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as there is no "ground truth" related to AI or diagnostic interpretation. The "truth" here is compliance with engineering specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in consensus building for ground truth in AI/imaging studies.
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 is for evaluating diagnostic performance of AI-assisted human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device is the established engineering and material standards and the performance of the predicate device.
The sample size for the training set:
Not applicable. There is no training set as no AI model is being developed.
How the ground truth for the training set was established:
Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 16, 2015

Terumo Medical Corporation % Phebe Varghese Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset, NJ 08873

Re: K152740

Trade/Device Name: Radifocus Glidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 23, 2015 Received: September 23, 2015

Dear Ms. Varghese:

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.

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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,

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

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Indications for Use

510(k) Number (if known) K152740

Device Name Radifocus Glidewire®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

A. SUBMITTER INFORMATION (807.92(a)(1))

Prepared by:	Phebe Varghese
	Regulatory Affairs Specialist
	Terumo Medical Corporation
	Tel. (732) 412-4166
	Fax (732) 302-4905

Prepared for:	Owner/Operator
	Terumo Corporation
	44-1, 2-Chome, Hatagaya,
	Shibuya-Ku, Tokyo, Japan 151-0072
	Registration Number: 801 002 6

Manufacturer and Sterilization Facility

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho, Fujinomiya, Shizuoka, Japan 418-0015 Registration No: 968 183 4

Contact Person: Phebe Varghese Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (732) 412-4166 Fax (732) 302-4905 E-mail: phebe.varghese@terumomedical.com

Date prepared: November 10, 2015

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	Radifocus Glidewire®
Common Name:	Guide wire
Classification Name:	Wire, Guide, Catheter
Classification Panel:	Cardiovascular
Regulation:	21 CFR 870.1330
Product Code:	DQX
Classification:	Class II

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device to which substantial equivalence is claimed is:

K863138 Terumo Radifocus Guide Wire, manufactured by Ashitaka Factory . of Terumo Corporation
. Additional reference device: K151471 - Terumo Radifocus Glidewire Endoscopic Wire

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Radifocus Glidewire, manufactured by Ashitaka Factory of Terumo Corporation, is to extend the product size range to include 260, 300, 350, 400, and 450cm lengths.

E. DEVICE DESCRIPTION (807.92(a)(4))

Principle of Operation Technology

The Radifocus Glidewire is operated manually or by manual process.

Design/Construction

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wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.

Materials

The materials for the Radifocus Glidewire are provided in the table below.

Part	Raw Material
Guide wire	Core wire	Nickel-Titanium alloy
	First coating*	Polyurethane containing TungstenTungstenPolyurethane
	Second coating*Hydro gelUnder coat	Hydrophilic polymer(Half-ester methyl vinyl ether-maleic anhydride copolymer)Polyvinyl chloride
Guide wire inserter	Polyethylene

Table 5.1: Radifocus Glidewire Materials (All Wire Lengths)

Blood contacting material

Specifications

The specifications for the Radifocus Glidewire are provided in the table below.

Part	Specification
Diameter of Wire	0.035"
Length of Wire	260, 300, 350, 400, and 450cm
Distal Tip Shape	Straight, Angled
Accessory Device	Guide wire inserter

Table 5.2: Radifocus Glidewire Specifications

F. INDICATIONS FOR USE (807.92(a)(5))

Note: The intended use is identical to the predicate device, Terumo Radifocus Guide

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Wire (K863138).

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The Radifocus Glidewire, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the Terumo Radifocus Guide Wire, cleared under K863138, manufactured by Ashitaka Factory of Terumo Corporation.

This device is also identical to the Radifocus Glidwire Endoscopic Wire (K151471) device and differs only in indication for use.

A comparison of the technological characteristics is summarized on the table below.

DeviceCharacteristic	New Device: Radifocus Glidewire	Predicate: Terumo RadifocusGuide Wire (K863138)
Manufacturer	Ashitaka Factory of Terumo Corporation	Same
Indication for Use	The Glidewire is designed to direct acatheter to the desired anatomical locationin the peripheral vasculature duringdiagnostic or interventional procedures.This device is not intended forneurovascular or coronary interventions.	The Glidewire is designed todirect a catheter to the desiredanatomical location duringdiagnostic or interventionalprocedures.
Operation Principle	Manual	Same
Design/Construction	Fully hydrophilic guide wire	Same
Materials	Guidewire	• Core wire:◦ Nickel-Titanium alloy• First Coating:◦ Polyurethane containing Tungsten■ Tungsten■ Polyurethane• Second Coating:◦ Hydro gel■ Hydrophilic polymer◦ Under coat■ Polyvinyl chloride	Same

Table 5.3: Summary of Comparative Information

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DeviceCharacteristic		New Device: Radifocus Glidewire	Predicate: Terumo RadifocusGuide Wire (K863138)
	Guidewireinserter	Polyethylene
Specifications		Diameter: 0.035"	Diameter: 0.018-0.052"
		Lengths: 260, 300, 350, 400, and 450cm	Lengths: 30-300cm
		Shaft configurations: standard and stiff	Same
		Distal tip shape: straight and angled	Same
		Flexible part lengths of the tip: 3 and 5cm	Flexible part lengths of the tip:1, 3, 5 and 8 cm
Package		Individual packageUnit boxShipping carton	Same
Sterilization		Ethylene oxide	Same
Shelf - life		24 months	Same

H. NON CLINICAL TESTS (807.92(b)(1))

Performance

Testing was conducted to ensure the performance of the Radifocus Glidewire throughout the labeled shelf life, verify conformity to the applicable parts of ISO standard and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability1 test, the following performance tests were performed on non-aged and accelerated aged Radifocus Glidewire samples. All samples tested met the standard applicable to each test, and no new issues of safety and effectiveness were raised with the testing performed.

Test	Standard
Surface	Section 4.3 of ISO 11070:2014
Radiodetectability	Section 4.5 of ISO 11070:2014ASTM F640-12
Fracture Test	Section 8.4 of ISO 11070:2014
Flexing Test	Section 8.5 of ISO 11070:2014
Peak Tensile Force of Guidewire	Section 8.6 of ISO 11070:2014

Table 5.4: Performance Testing per ISO Standard

1 Only non-aged sample was tested since there is no change over time on the radiopaque metal material.

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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 Terumo's 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.

Test	Standard
Peak Tensile Force of Guidewire	3.a of Coronary and CerebrovascularGuidewire Guidance, January 1995
Torque Strength	3.b of Coronary and CerebrovascularGuidewire Guidance, January 1995
	In-house Standard
Torqueability	3.c of Coronary and CerebrovascularGuidewire Guidance, January 1995
	In-house Standard
Tip Flexibility	3.d of Coronary and CerebrovascularGuidewire Guidance, January 1995
	In-house Standard
Sliding Resistance/Coating Integrity(Product Appearance)	3.e of Coronary and CerebrovascularGuidewire Guidance, January 1995
	In-house Standard
Particulate Evaluation	VIII.A.13 of Class II Special ControlsGuidance Document for CertainPercutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September8, 2010
	USP<788>
	In-house Standard
Product Dimension	In-house Standard

Table 5.5: Performance Testing per FDA Guidance Documents and/or In-house Standards

Performance testing demonstrated that the Radifocus Glidewire conformed to the recognized consensus ISO standard and FDA guidance documents, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout 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 Radifocus Glidewire is classified as: Externally Communicating Devices, Circulating blood,

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Limited Contact (<24 hrs). This is the same classification as the predicate Terumo Radifocus Guide Wire (K863138).

All the materials from the subject device are the same as the predicate device. The subject and predicate devices have the same intended use/indications for use, body contact, and contact duration classification, based on ISO 10993-1:2009. Additionally, the Terumo Radifocus Guide Wire product line has a demonstrated history of safe and effective use in the clinical setting. Therefore, Terumo concludes that the Radifocus Glidewire is biocompatible for its intended use.

Sterilization

The sterility of the device is assured using a sterilization method 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 it was determined that there were no new issues of safety or effectiveness.

I. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

J. CONCLUSION (807.92(b)(3))

In summary, the Radifocus Glidewire, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device:

K863138 – Terumo Radifocus Guide Wire, manufactured by Ashitaka Factory of Terumo Corporation.

There are no significant differences that raise any new issues of safety and effectiveness.

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.