(84 days)
K863138, K913074B, K925852A
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML technologies.
Yes
The device is used to facilitate the placement of balloon dilatation catheters for therapeutic procedures like percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), which are therapeutic interventions.
No
The device is used to facilitate the placement of balloon dilatation catheters for PTCA and PTA, which are interventional procedures, not diagnostic ones.
No
The device description clearly outlines physical components like wires, coatings, and coils, and the performance studies focus on physical characteristics like tensile strength and flexibility, indicating it is a hardware device.
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 "facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA)." This describes a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical wire with specific materials, lengths, diameters, and features designed for navigating within blood vessels. This is consistent with a medical device used in a procedure, not a device used to test samples outside the body.
- 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 used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used during a medical procedure on the patient.
N/A
Intended Use / Indications for Use
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters The platinum coil wire, 300cm length, is used exclusively for exchange respectively. purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary
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)
The following tests were performed demonstrating the substantial equivalence of the Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil submitted in this 510(k) to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.
- Tensile Strength Test
- Torque Transmission Test
- Torque Failure Test
- Memory Retention Test
- Flexibility Test
- Radiopacity Test
- Pushing Resistence Test
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.
K863138, K913074B, K925852A
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
JUL 9 1996
Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string is "K961445". The characters are written in a bold, black font, and they appear to be on a white background. The characters are slightly uneven and have a handwritten appearance.
SECTION II Summary and Certification
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
RADIFOCUS® Glidewire® for coronary use with platinum (or Proprietary Device Name: gold) coil* *These wires may also be called by a proprietary name of just CROSSWIRE®.
Classification Name: Wire, Guide, Catheter
INTENDED USE
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Note: This is the same intended use as the Terumo Coronary Guide Wires cleared under 510(k) K953533.
DESCRIPTION
ﻣﻌﻤﯿﺴﻪ
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters The platinum coil wire, 300cm length, is used exclusively for exchange respectively. purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.
1
SECTION II Summary and Certification
SUBSTANTIAL EQUIVALENCE
The Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.
PRINCIPLE OF OPERATION/TECHNOLOGY
The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are operated manually or by a manual process.
DESIGN/MATERIALS
| Parts | Terumo PTCA Wire | Cleared Terumo PTCA Wire
K953533 |
|-------------------|--------------------------------------------------|--------------------------------------------------|
| Wire | Nickel-Titanium core coated
with polyurethane | Nickel-Titanium core coated
with polyurethane |
| Core Wire | Single Taper | Single Taper |
| Radiopaque Marker | Platinum or Gold | Platinum or Gold |
| Radiopaque Length | 3-3.5cm | 2cm |
| Exterior Coating | Hydrogel | Hydrogel |
| SPECIFICATIONS | | |
| Parts | Terumo PTCAWire | Cleared Terumo PTCA Wire
K953533 |
| Wire diameter | .014, .016, .018 | .014, .016, .018 |
| Wire length | 180cm & 300cm | 180cm & 300cm |
| Tip configuration | Straight | Straight |
2
PERFORMANCE
The Terumo PTCA guide wires (represented in this submission) tested are substantially equivalent to the cleared Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil K953533. The Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability. For all other physical characteristics the Terumo PTCA guide wires represented in this submission were found to be equivalent to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.
The following tests were performed demonstrating the substantial equivalence of the Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil submitted in this 510(k) to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533.
- · Tensile Strength Test
- · Torque Transmission Test
- · Torque Failure Test
- · Memory Retention Test
- · Flexibility Test
ﻟﻌﻤﻠﻴﺔ
- · Radiopacity Test
- · Pushing Resistence Test
PLEASE NOTE: A coating Adherence Strength Test and Coating Flake Test (SEM) was not performed again for purposes of this submission as none of the coating features of the Terumo PTCA guide wires represented in this submission are different from the cleared Terumo PTCA guide wires K953533.
ADDITIONAL SAFETY INFORMATION
Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.
Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).
Manufacturing control test methods include: functional, extraction and sterility tests.
3
SECTION II Summary and Certification
Blood contacting materials were tested in accordance with the tests recommended in the Tripartite Biocompatibility Guidance for Medical Devices for biocompatibility testing of a device classified as Externally Communicating Devices, Blood Path Direct, Short-term (5 minutes-29 days). These tests were also in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Prolonged (24 hours-30 days) contact duration). The blood contacting materials were found to be biocompatible.
The expiration dating for the RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil will be 24 months. This dating period is adopted from legally marketed Terumo guide wires cleared under K863138, K913074B and K925852A. The sterilization process and packaging materials are the same for these products. Verification testing of aged product consists of package permeability, sterility and shelf life functional testing.
CONCLUSION
ﻤﺴﻌﺪ
The Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
- Date Prepared April 11, 1996 Prepared by Keith M. Smith Submissions Specialist Regulatory Affairs Prepared for Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Phone (410) 392-7375 or (410) 392-7231 Fax (410) 398-6079