(146 days)
No
The description explicitly states the device is operated through a manual process and there is no mention of AI, ML, or any related technologies.
No
The device is intended to direct a catheter for diagnostic or interventional procedures, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section states that the device is intended to direct a catheter "during diagnostic or interventional procedures." This indicates it plays a role in diagnostic procedures.
No
The device description explicitly states it is a physical guidewire constructed from materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This describes a device used within the body for procedural guidance, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description focuses on the physical characteristics and construction of a guidewire, which is a tool used in medical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural guidance within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
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 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: 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. Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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).
1
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
2
Indications for Use
510(k) Number (if known) K240859
Device Name Glidewire GT-R
Indications for Use (Describe)
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.
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)
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3
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
4
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.
5
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.
6
| 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
7
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))
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.
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.
8
| Device
Characteristics | Subject Device:
Glidewire GT-R | Predicate Device:
Glidewire GT (K170417) | Reference Device #1:
Fathom"-14 Steerable
Guidewire (K111498) | Reference Device #2:
Fathom"-16 Steerable
Guidewire (K111485) | Reference Device #3:
Transend (K964611) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ashitaka Factory of
Terumo Corporation | Same | Boston Scientific
Corporation | Boston Scientific
Corporation | Boston Scientific
Corporation |
| Intended Use
/Indications for Use | 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. | The Glidewire® GT 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. | The FATHOM-14
Steerable Guidewire is
intended for general
intravascular use in the
peripheral vasculature. It
can be used to
selectively introduce
and position catheters
and other interventional
devices within the
peripheral vasculature.
This device should be
used only by physicians
trained in percutaneous,
intravascular techniques
and procedures. | The FATHOM-16
Steerable Guidewire is
intended for general
intravascular use in the
peripheral vasculature. It
can be used to
selectively introduce
and position catheters
and other interventional
devices within the
peripheral vasculature.
This device should be
used only by physicians
trained in percutaneous,
intravascular techniques
and procedures. | The Transend Guidewire
is intended for general
intravascular use,
including the peripheral
vasculature. The wire
can be torqued to
facilitate the selective
placement of diagnostic
or therapeutic catheters. |
| Operation Principle | Manual | Same | Same | Same | Same |
| Design/
Construction | Fully hydrophilic Guide
Wire | Same | Hydrophilic distal
portion ; proximal
portion is PTFE. | Hydrophilic distal
portion ; proximal
portion is PTFE. | Hydrophilic distal
portion ; proximal
portion is PTFE. |
| Materials | · Nickel-Titanium alloy
•Gold
• Tungsten
• Polyurethane
• Hydrophilic polymer
•Polyvinyl chloride
• Acrylic resin
· Polyvinyl chloride | Same | Information not publicly
available. | Information not publicly
available. | Information not publicly
available. |
| 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" |
9
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°), Double
Angled, Large curve) | · Tip configuration:
Straight and Angled | · Tip configuration:
Straight and Angled | · Tip configuration:
Straight |
| | · Distal shape processing
type: Preshaped,
Shapeable | · Distal shape processing
type: Same | · Distal shape processing
type: Shapeable | · Distal shape processing
type: Shapeable | · Distal shape processing
type: Shapeable |
| | · Individual package:
Polyester-polyethylene
lamination film and
Polyethylene | · Individual package:
Polyester-polyethylene
lamination 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 |
10
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 (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.