K Number
K163004
Device Name
Radifocus Glidewire Advantage Track
Date Cleared
2017-01-30

(94 days)

Product Code
Regulation Number
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radifocus Glidewire Advantage Track 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 Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. 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 angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged 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. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.
More Information

No
The description focuses on the physical properties and intended use of a guidewire, with no mention of AI or ML capabilities.

No.
The device is described as a guidewire used to direct a catheter for diagnostic or interventional procedures, not to provide therapy itself.

No
The device is a guidewire used to direct a catheter during diagnostic or interventional procedures, but it does not perform diagnostic functions itself. It is a tool for accessing anatomical locations, not for diagnosing conditions.

No

The device description clearly outlines physical components made of Nickel Titanium alloy, stainless steel, polyurethane, hydrophilic coating, PTFE coating, and a gold coil. It also mentions packaging and a guide wire inserter, indicating it is a physical medical device, not software-only.

Based on the provided information, the Radifocus Glidewire Advantage Track is not an IVD (In Vitro Diagnostic) device.

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 for testing samples outside the body.
  • Device Description: The description details the physical components of a guidewire used for navigating blood vessels. It doesn't mention any components or functions related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing information about a patient's health status, disease, or condition based on sample analysis.
    • Reagents, calibrators, or controls used in laboratory testing.

In summary, the Radifocus Glidewire Advantage Track is a medical device used for guiding catheters within the peripheral vasculature during procedures, which is a function performed in vivo (within the living body), not in vitro (in glass or outside the living body).

N/A

Intended Use / Indications for Use

The Radifocus Glidewire Advantage Track 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.

Product codes

DQX

Device Description

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

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. 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 angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged 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.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

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)

Performance testing was conducted to demonstrate substantial equivalence to the predicate device, to verify conformity to applicable external and internal standards, and verify that aging does not affect the Radifocus Glidewire Advantage Track. All testing met acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K122590, K063372

Reference Device(s)

K033742, K112745, K052339, K122573, K152709

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

January 30, 2017

Terumo Medical Corporation Mr. Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K163004

Trade/Device Name: Radifocus Glidewire Advantage Track Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 25, 2016 Received: November 2, 2016

Dear Mr. Lu:

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,

Fernando Aguel
Fernando Aguel
-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) K163004

Device Name Radifocus Glidewire Advantage Track

Indications for Use (Describe)

The Radifocus Glidewire Advantage Track 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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 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:Liang Lu
Senior Regulatory Affairs Specialist
Terumo Medical Corporation
Tel. (410) 392-7321
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: Liang Lu

Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com

Date prepared: January 23, 2016

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Image /page/4/Picture/1 description: The image shows the Terumo logo. The logo consists of a red angled line above the word "TERUMO" in green. The red line is positioned above and to the left of the word, creating a sense of forward movement.

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

Proprietary Name:Radifocus Glidewire Advantage Track
Common Name:Guide Wire
Classification Name:Wire, Guide, Catheter
Classification Panel:Cardiovascular
Regulation:21CFR870.1330
Product Code:DQX
Classification:Class II

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

The legally marketed device(s) to which substantial equivalence is claimed are:

  • K122590 and K063372 Radifocus Glidewire Advantage manufactured by . Ashitaka Factory of Terumo Corporation.
510(K) No.Competitor's productCompetitor's name
K033742V-18Boston Scientific
K112745V-14Boston Scientific
K052339MiracleASAHI INTECC
K122573CommandAbbott Vascular
K152709SpartacoreAbbott Vascular

The following competitors' devices were used as reference devices:

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Radifocus Glidewire Advantage Track, manufactured by Ashitaka Factory of Terumo Corporation, for the modifications on the previously cleared predicate device (K122590 and K063372) manufactured by the same factory.

The proposed Radifocus Glidewire Advantage Track is identical to the predicate Radifocus Glidewire Advantage (K122590 and K063372) with the exception of the following:

  • . The proximal core wire material of the predicate device (K063372 and K122590 Radifocus Glidewire Advantage) is being modified from NiTi (Nickel Titanium alloy) to Stainless Steel;

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  • . The angle of the angle-shape wire distal tip is being modified from 45° to 35°;
  • . The labeling for the proposed Radifocus Glidewire Advantage Track is being slightly modified

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

Principle of Operation Technology

The Radifocus Glidewire Advantage Track is operated by manual process.

Design/Construction

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

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. 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 angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged 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.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word.

Materials

The materials for the Radifocus Glidewire Advantage Track are provided in Table 1 below.

PartRaw material
Core wire*(Proximal portion from junction)Stainless steel
Core wire*(Distal portion from junction)Nickel-Titanium alloy
First coating*Polyurethane containing tungsten
Second coating on distal portion of wire*
(Hydrophilic polymer)-Hydrophilic polymer
Half-ester methyl vinyl ether-maleic
anhydridecopolymer
-Under coat
Polyvinyl chloride
PTFE spiral
coating on
proximal portion
of wireUnder coating
Top coating*
Spiral coating*Polytetrafluoroethylene (PTFE)
Edge protection
partMetal part*
Solder*Platinum/ Iridium (Pt/Ir)
Tin/Silver (Sn/Ag)
Third coating on edge protection part*
(Hydrophilic polymer)Dimethyle acrylamideglycidyl
methacrylate copolymer
Tip coil markerGold (Au)
Table 1: List of Materials
------------------------------
  • Blood contacting material

Specifications

The specifications for the Radifocus Glidewire Advantage Track are provided in the Table 2 below.

PartSpecification
Diameter of Wire0.014 and 0.018"
Length of Wire180 and 300 cm*
Shapes of Wire (distal tip)Angled (Tip angle 35°)
  • tolerance: ± 20 mm

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

The Radifocus Glidewire Advantage Track 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.

Note: The indications for use are identical to the predicate device, Radifocus Glidewire Advantage (K122590 and K063372).

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

The Radifocus Glidewire Advantage Track, subject of this traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

  • Predicate Device: K063372 and K122590 Radifocus Glidewire Advantage, . manufactured by Ashitaka Factory of Terumo Corporation.
    A comparison of the technological characteristics is summarized in Table 3 below.

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| Table 3:
Comparison of
Device
Characteristics | New Device:
Radifocus Glidewire Advantage Track | Predicate Device:
Radifocus Glidewire
Advantage (K063372) | Predicate Device:
Radifocus Glidewire
Advantage (K122590) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ashitaka Factory of Terumo Corp. | Same | Same |
| Intended
Use/Indication
for
Use | 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. | Same | Same |
| Operation Principle | Manual | Same | Same |
| Design/
Construction | The Radifocus Glidewire Advantage
Track consists of a Nickel Titanium alloy
(distal) and stainless steel (proximal) 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 angled configuration.
The wire contains a distal radiopaque
gold coil.

The wire is packed in a plastic holder
contained within an individual package. A
guide wire inserter is contained within the
individual package to assist with the | The Radifocus Glidewire
Advantage consists of a
Nickel Titanium alloy core
wire

Same (the distal radiopaque
gold coil is for the 0.018"
only). | The Radifocus Glidewire
Advantage consists of a
Nickel Titanium alloy core
wire.

Same |
| | | Same unless mentioned below: | Same as K063372 unless mentioned below: |
| Materials | Core wire (Proximal portion from junction): Stainless steel (Distal portion from junction): Nickel-Titanium alloy First coating: Polyurethane containing tungsten Second coating on distal portion of wire (Hydrophilic polymer): Half-ester methyl vinyl ether-maleic anhydridecopolymer Under coat: Polyvinyl chloride PTFE spiral coating on proximal portion of wire: Polytetrafluoroethylene (PTFE) Edge protection part Metal part: Platinum/ Iridium (Pt/Ir) Solder: Tin/Silver (Sn/Ag) Third coating on edge protection part (Hydrophilic polymer): Dimethyle acrylamideglycidyl methacrylate copolymer Tip coil marker: Gold (Au) available for 0.014" and 0.018" | Core wire: Nickel-Titanium alloy First coating: Polyurethane containing tungsten Tip coil marker: Gold (Au) only available for 0.018" | Tip coil marker: Gold (Au) only available for 0.014" |
| Package | Individual package on which the product label and the peel-off labels are attached 1 unit per package | Same | Same |
| Specifications | Diameter of Wire: 0.014 and 0.018" Length of Wire: 180 and 300 cm

  • tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 35°) Accessory Devices: Guide wire inserter | Diameter of Wire: 0.018 - 0.038" Length of Wire: 150 - 300 cm
  • tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°), straight, J shaped Accessory Devices: Guide wire inserter | Diameter of Wire: 0.014" Length of Wire: 180 and 300 cm
  • tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°) Accessory Devices: Guide wire inserter |
    | Sterilization | Ethylene oxide | Same | Same |
    | Shelf Life | 24 months | Same | Same |

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

Performance Testing

Performance testing was conducted to demonstrate substantial equivalence to the predicate device, to verify conformity to applicable external and internal standards, and verify that aging does not affect the Radifocus Glidewire Advantage Track. All testing met acceptance criteria. Table 4 below provides a list of the performance tests that were performed on the proposed Radifocus Glidewire Advantage Track.

TestStandard
SurfaceISO 11070: 2014 Section 4.3
Corrosion resistanceISO 11070: 2014 Section 4.4
Radio-detectabilityISO 11070: 2014 Section 4.5
Size designationISO 11070: 2014 Section 8.2
Fracture testISO 11070: 2014 Section 8.4
Flexing testISO 11070: 2014 Section 8.5
Peak tensile force of guidewireISO 11070: 2014 Section 8.6
Torque strengthFDA Guidance
In-house Standard
Torqueability
(Torque control)FDA Guidance
In-house Standard
Tip Flexibility
(Tip impact)FDA Guidance
In-house Standard
Coating Adherence
/IntegrityFDA Guidance
In-house Standard
Particulate testFDA Guidance
In-house Standard
Ease of removing from the holderIn-house Standard
Sliding friction
(hydrophilic coating portion)In-house Standard
Sliding friction
(PTFE coating portion)In-house Standard
Proximal shaft stiffnessIn-house Standard

Table 4: Summary of Performance Testing

The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria. Based on the results of the performance testing, the proposed Radifocus Glidewire Advantage Track is substantially equivalent to the predicate.

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Biocompatibility

In accordance with ISO 10993-1, the Radifocus Glidewire Advantage Track is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (