The Glidewire GT-R is intended 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 subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called Glidewire GT-R. It focuses on demonstrating substantial equivalence to an existing predicate device rather than proving novel performance characteristics through a clinical trial or a deep-dive AI performance study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop performance study.

Here's why and what the document does provide:

Device Type: The Glidewire GT-R is a physical medical device (a catheter guide wire), not a software device or an AI algorithm.
Purpose of 510(k): The 510(k) submission aims to show that the new device (Glidewire GT-R) is substantially equivalent to a legally marketed predicate device (Glidewire GT). This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
Testing Focus: The "performance testing" described (Section H, Table 3) is engineering performance testing (e.g., Tensile Strength, Torqueability, Lubricity, Kink Resistance, Radiopacity). These tests ensure the physical properties and functionality of the guidewire itself meet established physical and mechanical standards and are comparable to the predicate.
No AI/Human Reader Study: Since this is a physical guidewire, there is no AI component, and thus no multi-reader multi-case (MRMC) study, human reader improvement, standalone algorithm performance, or ground truth establishment (expert consensus, pathology, outcomes data) as would be relevant for an AI diagnostic device.
"Acceptance Criteria" in this context: The acceptance criteria here refer to the passing thresholds for the physical performance tests listed in Table 3 (e.g., a certain minimum tensile strength, a maximum friction coefficient for lubricity). The document states, "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide the specific numerical acceptance criteria for each test or detailed results beyond this summary statement.

To directly answer your request based on the provided text, while noting the different context:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly detailed as numerical values in the document. The document states "Performance testing met the predetermined acceptance criteria."
Reported Device Performance: The document provides a summary statement that the device met these criteria, but no specific quantitative results for each test item listed in Table 3.

Test Item	Acceptance Criteria	Reported Device Performance
Dimensional Verification	(Not specified, but assumed to be within manufacturing tolerances for guidewire dimensions.)	"met the predetermined acceptance criteria"
Visual Inspection	(Not specified, e.g., no defects, smooth coating.)	"met the predetermined acceptance criteria"
Simulated Use	(Not specified, e.g., successful navigation through a simulated vessel model without kinking or breaking.)	"met the predetermined acceptance criteria"
Tensile Strength	(Not specified, but would be a minimum force required to break/yield.)	"met the predetermined acceptance criteria"
Tip Pull	(Not specified, e.g., a minimum force to separate the tip.)	"met the predetermined acceptance criteria"
Torque Strength	(Not specified, e.g., a minimum torque before a permanent twist.)	"met the predetermined acceptance criteria"
Torqueability	(Not specified, e.g., the ability to transmit torque from the proximal to distal end smoothly.)	"met the predetermined acceptance criteria"
Lubricity and Coating Integrity	(Not specified, e.g., a coefficient of friction, or visual assessment after use.)	"met the predetermined acceptance criteria"
Particulate Evaluation	(Not specified, e.g., maximum number/size of particulates released.)	"met the predetermined acceptance criteria"
Kink Resistance	(Not specified, e.g., ability to resist kinking at certain bend radii.)	"met the predetermined acceptance criteria"
Tip Flexibility	(Not specified, e.g., ability to bend to a certain radius and return.)	"met the predetermined acceptance criteria"
Radiopacity	(Not specified, e.g., visibility under fluoroscopy to a certain standard.)	"met the predetermined acceptance criteria"
Shaping Test	(Not specified, for shapeable types, ability to hold a formed shape.)	"met the predetermined acceptance criteria"
Shape Retention	(Not specified, for shapeable types, ability to retain shape after use.)	"met the predetermined acceptance criteria"
Corrosion resistance	(Not specified, e.g., no signs of corrosion after exposure to specific solutions.)	"met the predetermined acceptance criteria"

Sample sizes used for the test set and the data provenance:
- The document does not specify the sample sizes (number of guidewires) used for each performance test.
- Data Provenance: The tests were conducted internally by Terumo Corporation (Ashitaka Factory, Japan and Terumo Medical Corporation, NJ, USA) on their manufactured devices. The data is prospective, generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, and the "ground truth" is determined by engineering measurements against pre-defined specifications, not by expert consensus on clinical images/data.
Adjudication method for the test set: Not applicable for engineering performance tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.
The type of ground truth used: For the physical performance tests, the "ground truth" is based on engineering specifications and recognized industry standards (e.g., ISO, internal company standards). The predicate device and reference devices informed the establishment of these acceptance criteria.
The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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August 21, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Terumo Corporation Qing Liu Regulatory Affairs Specialist 265 Davidson Ave Suite 320 Somerset, New Jersey 08873

Re: K240859

Trade/Device Name: Glidewire GT-R Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 28, 2024 Received: March 28, 2024

Dear Qing Liu:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Samuel G. Raben -S

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240859

Device Name Glidewire GT-R

Indications for Use (Describe)

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.

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510(K) SUMMARY

Glidewire GT-R K240859

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

Prepared by: Qing Liu
Regulatory Affairs Specialist
Terumo Medical Corporation
Tel. (908) 842-9016
Fax (410) 398-6079

Prepared for: Owner/Operator

Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo Japan 151-0072 Owner/Operator Number: 8010026

Manufacturer and Sterilization Facility (Applicant)

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 9681834

Contact Person: Qing Liu

Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (908) 842-9016 Fax (410) 398-6079 E-mail: kyo.ryu@terumomedical.com

Date prepared: March 28, 2024

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

Proprietary Name:	Glidewire GT-R
Common Name:	Guide Wire
Classification Name:	Catheter Guide Wire
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:

Predicate Device: K170417-Glidewire GT, manufactured by Ashitaka Factory of Terumo Corporation.

Reference Devices:

. K111498- Fathom 14 Steerable Guidewire manufactured by Boston Scientific Corporation
. K111485- Fathom 16 Steerable Guidewire manufactured by Boston Scientific Corporation
K964611- Transend manufactured by Boston Scientific Corporation .

D. REASON FOR 510(k) SUBMISSION

This traditional 510(k) for Glidewire GT-R is being submitted for a new device for the purposes of establishing substantial equivalence to a legally marketed predicate device. The specification differences are the addition of a 220 cm Guide wire and a change in the individual packaging material.

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

Principle of Operation Technology

The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process.

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Design/Construction

The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length.

Materials

The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

Table 1 provides details on the materials used in the construction of Glidewire GT-R.

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No.	Raw Material	Patient Contact
1	Nickel-Titanium alloy	Non-contact
2	Gold	Non-contact
3	Polyurethane	Direct
4	Tungsten	Direct
5	Hydrophilic polymer	Direct
6	Polyvinyl chloride	Direct
7	Acrylic resin	Non-contact
8	Polyvinyl chloride	Non-contact
9	Polyethylene	Indirect
10	Colorant	Indirect
11	Polypropylene	Non-contact
12	Polypropylene	Indirect
13	Colorant	Indirect
14	Polyethylene	Indirect
15	Styrene-ethylene-butylene-styrene block copolymer	Indirect
16	Polypropylene	Non-contact
17	Polyacetal	Non-contact
18	Stainless steel	Non-contact
19	Epoxy resin	Non-contact
20	Polypropylene	Non-contact
	Polypropylene	Non-contact
	Polyacetal	Non-contact

Table 1: List of Materials

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Specifications

Diameter of Wire:	0.016", 0.018"
Length of Wire:	180cm, 220cm
Distal Shape Processing Type	Preshaped, Shapeable
Tip Configuration:	Straight, Angled (45°, 90°), Double Angled
Accessory Device:	Guide Wire Inserter, Torque Device, Mandrel*
	*: Mandrel is only included with the Shapeable type.

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

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

Glidewire GT-R, the subject of this Traditional 510(k), is substantially equivalent in its Intended Use /Indications for Use , Technological Characteristics to the predicate, Glidewire GT (K170417), manufactured by Ashitaka Factory of Terumo Corporation.

In addition to the above-listed primary predicate, Terumo has identified the following reference devices. These are market leading devices with the same intended use and basic design as the subject device. Since these devices are frequently used in clinical practice, Terumo deemed it appropriate to use them as references when establishing the acceptance criteria for performance testing.

. K111498- Fathom 14 Steerable Guidewire manufactured by Boston Scientific Corporation
. K111485- Fathom 16 Steerable Guidewire manufactured by Boston Scientific Corporation
K964611- Transend manufactured by Boston Scientific Corporation

The comparison of the technological characteristics is summarized in Table 2.

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DeviceCharacteristics	Subject Device:Glidewire GT-R	Predicate Device:Glidewire GT (K170417)	Reference Device #1:Fathom"-14 SteerableGuidewire (K111498)	Reference Device #2:Fathom"-16 SteerableGuidewire (K111485)	Reference Device #3:Transend (K964611)
Manufacturer	Ashitaka Factory ofTerumo Corporation	Same	Boston ScientificCorporation	Boston ScientificCorporation	Boston ScientificCorporation
Intended Use/Indications for Use	The Glidewire GT-R isintended to direct acatheter to the desiredanatomical location inthe peripheralvasculature duringdiagnostic orinterventionalprocedures. This deviceis not intended forneurovascular orcoronary interventions.	The Glidewire® GT isdesigned to direct a catheterto the desired anatomicallocation in the peripheralvasculature duringdiagnostic or interventionalprocedures. This device isnot intended forneurovascular or coronaryinterventions.	The FATHOM-14Steerable Guidewire isintended for generalintravascular use in theperipheral vasculature. Itcan be used toselectively introduceand position cathetersand other interventionaldevices within theperipheral vasculature.This device should beused only by physicianstrained in percutaneous,intravascular techniquesand procedures.	The FATHOM-16Steerable Guidewire isintended for generalintravascular use in theperipheral vasculature. Itcan be used toselectively introduceand position cathetersand other interventionaldevices within theperipheral vasculature.This device should beused only by physicianstrained in percutaneous,intravascular techniquesand procedures.	The Transend Guidewireis intended for generalintravascular use,including the peripheralvasculature. The wirecan be torqued tofacilitate the selectiveplacement of diagnosticor therapeutic catheters.
Operation Principle	Manual	Same	Same	Same	Same
Design/Construction	Fully hydrophilic GuideWire	Same	Hydrophilic distalportion ; proximalportion is PTFE.	Hydrophilic distalportion ; proximalportion is PTFE.	Hydrophilic distalportion ; proximalportion is PTFE.
Materials	· Nickel-Titanium alloy•Gold• Tungsten• Polyurethane• Hydrophilic polymer•Polyvinyl chloride• Acrylic resin· Polyvinyl chloride	Same	Information not publiclyavailable.	Information not publiclyavailable.	Information not publiclyavailable.
Specifications	· O.D.: 0.016", 0.018"	· O.D .: 0.014", 0.016",0.018"	· O.D .: 0.014"	· O.D .: 0.016"	· O.D .: 0.014", 0.018"

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Terumo Corporation Traditional 510(k) – Glidewire GT-R 510(k) Summary

	· Lengths: 180cm,220cm	· Lengths: 180cm, 200cm	· Lengths: 200cm,300cm,	· Lengths: 140cm,180cm, 200cm, 215cm,	· Lengths: 135cm,165cm, 190cm
	· Tip configuration:Straight and Angled(Angled (45°, 90°),Double Angled)	· Tip configuration:Straight and Angled(Angled (45°, 90°), DoubleAngled, Large curve)	· Tip configuration:Straight and Angled	· Tip configuration:Straight and Angled	· Tip configuration:Straight
	· Distal shape processingtype: Preshaped,Shapeable	· Distal shape processingtype: Same	· Distal shape processingtype: Shapeable	· Distal shape processingtype: Shapeable	· Distal shape processingtype: Shapeable
	· Individual package:Polyester-polyethylenelamination film andPolyethylene	· Individual package:Polyester-polyethylenelamination film and Paper	unknown	unknown	unknown
Package Material	· Unit box:Coated cardboard· Shipping carton:Corrugated cardboard	· Unit box:Same· Shipping carton:Same
Sterilization	Ethylene oxide	Same	Same	Same	Same
Shelf life	24 months	Same	unknown	unknown	unknown

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

Performance Testing

Performance testing was conducted to ensure the safety and effectiveness of Glidewire GT-R throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. Except for the Radio-detectability and Simulated Use tests, which were only performed on non-aged samples, the following performance tests were conducted on both non-aged and accelerated aged samples. Table 3 provides a list of performance tests that were performed on Glidewire GT-R.

Test Item
Dimensional Verification
Visual Inspection
Simulated Use
Tensile Strength
Tip Pull
Torque Strength
Torqueability
Lubricity and Coating Integrity
Particulate Evaluation
Kink Resistance
Tip Flexibility
Radiopacity
Shaping Test
Shape Retention
Corrosion resistance

Table 3: Summary of Performance Testing

Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.

Biocompatibility

In accordance with ISO 10993-1, Glidewire GT-R is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). The

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finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. The Table 4 below provides a list of biocompatibility tests conducted on Glidewire GT-R.

Non-aged, sterile, whole device
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Systemic Toxicity (Acute)
Pyrogenicity
Hemolysis (Direct and Indirect)
Complement Activation (SC5b-9)
In vivo Thrombogenicity
Genotoxicity (Mouse Lymphoma Mutagenesis)
Genotoxicity (Bacterial Reverse Mutation)
Physicochemical
FT-IR
Accelerated-aged (2 years), sterile, whole device
Cytotoxicity
Hemolysis (Direct and Indirect)
Physicochemical
FT-IR

Table 4: Summary of ISO 10993 Biocompatibility Testing

Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.

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Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014/Amd 1:2018, Sterilization of Health Care Products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.

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, Glidewire GT-R, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K170417 - Glidewire GT, manufactured by Ashitaka Factory of Terumo Corporation.

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.