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).

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 respectively. The platinum coil wire, 300cm length, is used exclusively for exchange 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.

AI/ML Overview

The provided document describes a submission for substantial equivalence for a medical device, the RADIFOCUS® Glidewire® for coronary use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

However, I can extract information related to the device's performance testing demonstrating substantial equivalence to a predicate device.

Here's a summary of the performance information provided:

Device: RADIFOCUS® Glidewire® for coronary use with platinum (or gold) coil

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" against numerical targets like those for a novel device. Instead, the performance tests demonstrated equivalence to a predicate device (K953533). The document states:

"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."

"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 Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability." (This is noted as a difference that does not raise new safety/effectiveness concerns).

Characteristic	Acceptance Criteria (Predicate Device K953533 Performance)	Reported Device Performance (RADIFOCUS® Glidewire®)
Tensile Strength	(Implied to be met by predicate)	Substantially Equivalent
Torque Transmission	(Implied to be met by predicate)	Substantially Equivalent
Torque Failure	(Implied to be met by predicate)	Substantially Equivalent
Memory Retention	(Implied to be met by predicate)	Substantially Equivalent
Flexibility	(Implied to be met by predicate)	Substantially Equivalent
Radiopacity	(Implied to be met by predicate)	Substantially Equivalent
Pushing Resistance	(Implied to be met by predicate)	Higher (associated with higher crossability)
Coating Adherence*	(Implied to be met by predicate)	Not re-tested, assumed equivalent
Coating Flake (SEM)*	(Implied to be met by predicate)	Not re-tested, assumed equivalent

*Note: Coating Adherence and Coating Flake tests were not performed for 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."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document only states "The Terumo PTCA guide wires (represented in this submission) tested...".
Data Provenance: Not specified. The tests are physical performance tests of the device itself, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device performance study, not a study requiring expert clinical review or interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No adjudication was explicitly mentioned for mechanical device testing.

5. 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 not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the physical tests (Tensile Strength, Torque Transmission, etc.), the "ground truth" is the measured physical properties of the device relative to the predicate device. There is no biological or clinical "ground truth" as described in the prompt.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; there is no training set mentioned.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set.

Summary

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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

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.

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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 WireK953533
Wire	Nickel-Titanium core coatedwith polyurethane	Nickel-Titanium core coatedwith 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 WireK953533
Wire diameter	.014, .016, .018	.014, .016, .018
Wire length	180cm & 300cm	180cm & 300cm
Tip configuration	Straight	Straight

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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.

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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

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.