The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

Device Description

The RADIFOCUS® Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft. The soft tip is approximately 0.5~~1.5 mm long on the 4Fr. Optitorque Catheter. It is approximately 1.0~~2.5mm long on the 5 and 6Fr. Optitorque Catheters.

AI/ML Overview

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The device documentation does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the performance of the RADIFOCUS® Optitorque Angiographic Catheter is substantially equivalent to the predicate device (Angiographic Catheter, K863137/A) based on a series of verification tests. This "substantial equivalence" acts as the overarching acceptance criterion. The performance is reported in the context of demonstrating this equivalence.

Performance Test Category	Predicate Device Specification (K863137/A)	RADIFOCUS® Optitorque Performance	Acceptance Criteria (Implicit)
Physical Dimensions	5 – 8 Fr. (Available Sizes), 500 – 1300 mm (Catheter Length)	4 – 6 Fr. (Available Sizes), 650 – 1200 mm (Catheter Length)	Demonstrated suitability for angiographic procedures; differences raise no new safety/effectiveness issues.
Maximum Injection Pressure	5, 6 Fr.: 1000 psi; 7 Fr.: 800 psi; 8 Fr.: 700 psi	4 Fr.: 750 psi; 5, 6 Fr.: 1000 psi	Meets or exceeds pressure capabilities for intended sizes; differences raise no new safety/effectiveness issues.
Material Composition	Polyurethane polyamide elastomer with barium sulfate	Polyurethane polyamide elastomer with barium sulfate (with stainless steel mesh)	Differences in materials raise no new issues of safety and effectiveness.
Mechanical Performance	Not explicitly listed, but inherent in predicate clearance	Tensile strength (shaft, hub, soft tip), Rigidity, Torque Transmission, Flow Rate, Tip Flexibility	Demonstrated substantial equivalence to predicate device.
Delivery of Therapeutic Agents	Not explicitly listed, but inherent in predicate clearance	Demonstrated successful delivery	Demonstrated substantial equivalence to predicate device.
Biocompatibility	Tested per relevant standards	Tested per ISO-10993	Biocompatible for blood-contacting materials with limited contact (≤24 hrs).
Risk Analysis	Not explicitly listed, but inherent in predicate clearance	Conducted	No new issues of safety and effectiveness identified.
Safety & Effectiveness	Established in predicate clearance	Manufacturing controls verified, biocompatibility demonstrated, risk analysis performed	Substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to predicate device, with no new safety or effectiveness issues.

2. Sample Size for Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of patient data or clinical trials. The performance verification refers to engineering tests and material characterization performed on the device itself. Therefore, sample sizes would relate to the number of catheters or components subjected to these physical and chemical tests. The document does not provide these specific sample sizes.

Data Provenance: The data provenance is internal to the manufacturer (Terumo Medical Corporation) as these are verification tests performed on the device by the company. There is no mention of country of origin for external data, retrospective or prospective studies involving patients.

3. Number of Experts and Qualifications for Establishing Ground Truth for Test Set

Not applicable for this type of device and study. The "ground truth" for the engineering and material tests would be the established scientific principles, consensus standards (e.g., ISO-10993 for biocompatibility), and the performance characteristics of the predicate device (K863137/A). This doesn't involve expert medical review of a patient-derived test set to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication. The verification tests are objective measurements against defined criteria or internal specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device submission (510(k)) for an angiographic catheter, not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

6. Standalone (Algorithm Only) Performance Study

No. This submission is for a physical medical device (catheter), not an algorithm or software. Therefore, a standalone algorithm performance study was not conducted.

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is based on:

Engineering specifications and test methodologies: For mechanical properties like tensile strength, rigidity, torque transmission, flow rate, and tip flexibility.
Biocompatibility standards: Specifically, ISO-10993 for the biological evaluation of medical devices.
Performance of the legally marketed predicate device (K863137/A): The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness profile of the predicate device.

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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AUG 10 1999

K992051

SUMMARY AND CERTIFICATION II.

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

A. Device Name

RADIFOCUS® Optitorque Proprietary Name:

Classification Name: Angiographic Catheter

Common Name: Angiographic Catheter

B. Intended Use

The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

Note: This is the same intended use as the RADIFOCUS® Angiographic Catheter, K863137/A.

C. Device Description

D. Substantial Equivalence

The RADIFOCUS® Optitorque Angiographic Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the cleared RADIFOCUS® Angiographic Catheter, (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975).

E. Principle Of Operation / Technology

The RADIFOCUS® Optitorque Angiographic Catheter is operated manually or by a manual process.

F. Design / Materials

Differences in materials between the RADIFOCUS® Optitorque Angiographic Catheter and the RADIFOCUS® Angiographic Catheter, K863137/A, raise no new issues of safety and effectiveness.

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G. Specifications

	Optitorque AngiographicCatheter	Angiographic Catheter,K863137/A
Available Sizes	4 - 6 Fr.	5 – 8 Fr.
Catheter Length	650 - 1200 mm	500 – 1300 mm
Maximum InjectionPressure	4 Fr.: 750 psi5, 6 Fr.: 1000 psi--	--5, 6 Fr.: 1000 psi7 Fr.: 800 psi8 Fr.: 700 psi

H. Performance

The following verification tests were performed to demonstrate the substantial equivalence of the Optitorque Angiographic Catheter to the Angiographic Catheter, K863137/A.

Tensile strength on the shaft, hub and soft tip .
Rigidity .
Maximum Pressure Test ●
Torque Transmission Test .
Flow Rate Test .
. Tip Flexibility Test
Delivery of Therapeutic Agents .
Biocompatability Tests .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the Optitorque Angiographic Catheter is substantially equivalent to the performance of the Angiographic Catheter, cleared under K863137/A.

l. Additional Safety Information

・..

Manufacturing controls include visual, functional (which including dimensional), chemical, biological and sterility tests.

The Optitorque Angiographic Catheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hrs). The device's blood contacting materials were tested 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". Results of the testing demonstrate that the blood contacting materials are biocompatible.

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J. Conclusion

The RADIFOCUS® Optitorque Angiographic Catheter is substantially equivalent in intended use, design, technology / principles of operation, materials and performance to the RADIFOCUS® Angiographic Catheter (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975). Differences between the devices do not raise any significant issues of safety or effectiveness. . . - -

Date Prepared:	June 17, 1999
Prepared By:	Yuk-Ting LewisSenior Regulatory Specialist
Prepared For:	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone: (410) 392-7213 or (410) 392-7231Fax: (410) 398-6079

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 10 1999

Ms. Yuk-Ting Lewis Senior Requlatory Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re : K992051

RADIFOCUS® Optitorque™ Angiographic Catheter Trade Name: Requlatory Class: II Product Code: DQO Dated: July 12, 1999 Received: July 13, 1999

Dear Ms. Lewis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Ms. Yuk-Ting Lewis

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Note: This is the same intended use as the unmodified device, K863137/A

510(k) Number (if known):

RADIFOCUS® Optitorque™ Angiographic Catheter Device Name:

Indications For Use:

The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

Ohtyr M. for Callahan.

ring Off Fascilla: Respiratory, 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).