The indications for use of the IRL VasoScan™ intravascular ultrasound catheter are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA).
The indications for use of the IRL VasoScan™ intravascular ultrasound imaging system are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The IRL VasoScan™ intravascular ultrasound catheter is for use only with the IRL VasoScan™ intravascular ultrasound imaging system.

Device Description

The outer body of the IRL VasoScan™ intravascular ultrasound catheter is manufactured from Vestamid 12. The transducer consists of a 64-element array, supported on a polyimide film. The IRL VasoScan™ intravascular ultrasound catheter has a usable length of 1350mm and is designed to provide high quality intra-arterial ultrasound images of the coronary arteries. The IRL VasoScan™ intravascular ultrasound catheter is designed to be combined with conventional coronary angiography for the purposes of diagnosis, assistance with the choice of therapeutic modalities and assessment of the immediate outcome of such treatment.

AI/ML Overview

The provided text is a 510(k) summary for the IRL VasoScan™ intravascular ultrasound catheter, which is a submission to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance results in the format requested.

Therefore, the information required for the requested table and study details regarding acceptance criteria and performance of the device is not present in the provided text.

The document states that "Qualification testing covering biocompatibility, mechanical strength, electrical safety and imaging has been performed and has proved that, when used according to the instructions provided, the IRL VasoScan™ intravascular ultrasound catheter will operate as intended." However, it does not provide specific acceptance criteria or the results of these tests in a quantifiable manner.

Here's an assessment based on the available information:

A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document generally states that "All testing was supportive of the claims (i.e. indications for use)," but no specific performance metrics or acceptance thresholds are given.
Sample size used for the test set and the data provenance:
This information is not provided. The document mentions "Qualification testing" and "Biocompatibility tests" but does not detail sample sizes or the nature (e.g., human, animal, in vitro) or origin of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing mentioned is for the device's physical and functional properties, not diagnostic accuracy requiring expert interpretation of results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As above, the testing described does not involve a diagnostic test where adjudication would typically be relevant.
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:
This information is not provided. The device is an intravascular ultrasound catheter, which is a diagnostic imaging tool itself, not an AI-assisted diagnostic system. Therefore, an MRMC study with AI assistance is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is a physical catheter that generates images for human interpretation, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in terms of ground truth for diagnostic accuracy, as the testing described focuses on the device's functional integrity. The ground truth for biocompatibility would be standard biological assays, mechanical strength would be engineering standards, etc., but these are not detailed.
The sample size for the training set:
This information is not provided. The document describes a medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
This information is not provided. Not applicable for this type of device.

In summary, the provided text describes a 510(k) submission for an intravascular ultrasound catheter, focusing on its functional description, intended use, and substantial equivalence to a predicate device based on general qualification testing. It does not contain the detailed performance study information with acceptance criteria that would typically be found for a diagnostic accuracy claim or an AI/software as a medical device (SaMD) submission.

Summary

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982208

AUG 27 1999

Submitter

Intravascular Research Limited 3A Centaur Business Park Grant Way Isleworth Middlesex TW7 5QD United Kingdom

Telephone Number: 01144 181 232 8012

Facsimile Number: 01144 181 232 8823

Contact Person: Martin Rothman, M. D., Chief Executive Officer

Date summary was prepared: 06.19.98

Name(s) of the device

Proprietary (Trade) Name: IRL VasoScan™ intravascular ultrasound catheter

Common or Usual Name: Diagnostic ultrasound transducer

ldentification of predicate device(s)

EndoSonics Visions Five-64 3.5F Solid State Intravascular Ultrasound Catheter

EndoSonics Corporation 3078 B Prospect Park Drive Rancho Cordova, CA 95670

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Description of the device

Qualification testing covering biocompatibility, mechanical strength, electrical safety and imaging has been performed and has proved that, when used according to the instructions provided, the IRL VasoScan™ intravascular ultrasound catheter will operate as intended. Every IRL VasoScan™ intravascular ultrasound catheter is final tested to ensure conformance to product specification prior to sterilization and subsequent shipment.

Intended Use

When using the catheter, the following procedure is followed:

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The catheter is carefully removed from the package. The outer surface is washed with sterile water and the circular proximal catheter connector is attached to the catheter interface module. The catheter is introduced into the coronary artery using the vascular entry technique of choice through a guide catheter with an internal diameter of at least 0.074in using a 0.014in guide wire. The catheter is then advanced to the area of interest and the intravascular coronary ultrasound imaging carried out.

Comparison of device characteristics to predicate

A comparison was made between the physical and performance characteristics of the IRL VasoScan™ intravascular ultrasound catheter and the physical and performance characteristics of a legally marketed product. This analysis revealed that the IRL VasoScan™ intravascular ultrasound catheters are substantially equivalent to that predicate product.

Non clinical testing

Biocompatibility tests were carried out on the IRL VasoScan™ intravascular ultrasound catheter, including cytotoxicity, hemolysis and coagulation. Validation of the sterilization cycle used was also undertaken. All testing was supportive of the claims (i.e. indications for use).

Conclusion

In conclusion, the basis for substantial equivalence between the IRL VasoScan™ intravascular ultrasound catheter and the legally marketed predicate product is that the products are predominately similar and that the difference between the products does not raise new issues of safety and effectiveness.

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Based upon the information provided herein, it is our conclusion that the IRL VasoScan™ intravascular ultrasound catheter is substantially equivalent to the EndonSonics Visions Five 64 3.5F Solid State Intravascular Ultrasound Catheter.

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Image /page/4/Picture/1 description: The image contains the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Intravascular Research Limited c/o Louise C. Myers 14808 N.E. 66th Street Redmond, WA 98052

K982208 Re: IRL VasoScan™ Intravascular Ultrasound Catheter Regulatory Class: II Product Code: ITX Dated: June 1, 1999 Received: June 4, 1999

Dear Ms. Myers:

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 aqainst misbranding and adulteration.

This determination of substantial equivalence applies to the following transducer intended for use with the Vasoscan™ Intravascular Ultrasound Catheter as described in your premarket notification:

Transducer Model Number 2.9 Fr, 30 MHz

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any

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Page 2 - Ms. Louise C. Myers

obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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INDICATIONS FOR USE

510(k) Number

K982208.

Device Name

IRL VasoScan™ intravascular ultrasound imaging system.

Indications for Use

The indications for use of the IRL VasoScan™ intravascular ultrasound imaging system are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The IRL VasoScan™ intravascular ultrasound catheter is for use only with the IRL VasoScan™ intravascular ultrasound imaging system.

Contraindications

Whenever possible, the clinician should eliminate or minimize factors that increase risk. These include hypokalemia or other reversible causes of ventricular irritability, digitalis toxicity, febrile illness, decompensated heart failure, severe hypertension and significant anaemia.

The device is not indicated for use in the cerebral arteries or for uses other than those indicated above.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)
Over the Counter Use 0

V. DeWitt Miller

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.