JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Description

The JOVUS Eagle Eye™ F/X catheters contain a catheter-tip ultrasound device that applies ultrasound energy dir ctly into the interior vessel wall of the patient to obtain an image of the vessel. This device is not currently indicated for use in cerebral vessels. The JOVUS Eagle Eye F/X catheter accommodates a 0.014" guide wire.

The JOVUS Eagle Eye™ F/X catheter utilizes an integral guide wire lumen in which the catheter tracks over the guide wire at the distal tip. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip.

The JOVUS Eagle Eye™ F/% catheter is introduced percutaneously or via surgical cutdown into the vascular sy:tem. A linear array ultrasonic transducer situated circumferentially near the tip of the catheter produces real time cross-sectional images of coronary and peripheral vessels.

The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.

AI/ML Overview

The provided document is a 510(k) summary for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, seeking substantial equivalence to a predicate device. It's important to note that this type of submission typically focuses on comparison to a predicate device and does not involve the kind of detailed clinical study data often seen for novel devices that require extensive performance data to establish their safety and effectiveness.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance.

The key statement regarding performance is:
"Applicable testing is being performed in accordance with the Master Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results will be found to be comparable to those of the predicate device, Avanar™ F/X 2.9F Iritravascular Ultrasound Imaging Catheter. The new backing material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."

Therefore, the implicit acceptance criterion for overall device performance is "comparable to the predicate device."

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Device performance comparable to the predicate device (Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter).	Test results are found to be comparable to the predicate device.
Biocompatibility of new backing material meets predetermined acceptance criteria (ISO 10993-1).	The new backing material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.
Functionality in conjunction with In-Vision™ Imaging System.	The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. (This implies it functions correctly with the specified system).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of clinical performance evaluation directly. The evaluation focuses on engineering and biocompatibility testing. There is no mention of patient data (retrospective or prospective) or country of origin for such data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document does not describe a clinical study involving a test set that requires expert-established ground truth for image interpretation or diagnosis. The testing mentioned is primarily related to device performance, manufacturing, and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in the document. The submission focuses on device modifications and substantial equivalence, not a comparative clinical trial with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The device is an intravascular ultrasound catheter, which is a physical diagnostic tool operated by a human, not an AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility testing, the ground truth used was established by compliance with ISO 10993-1, a recognized international standard for biological evaluation of medical devices.

For the claim of "comparable" device performance, the ground truth is implicitly the performance of the predicate device, Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, as measured through engineering and functional testing. No pathology, expert consensus, or outcomes data is mentioned as ground truth.

8. The Sample Size for the Training Set

This is not applicable. The document describes a medical device, not a machine learning or artificial intelligence system that requires a "training set."

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

This is not applicable for the same reason as point 8.

Summary

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JOMED INC. April 21, 2003

510 (K) Summary JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter

Dave Prepared:	April 15, 2003
Submitted by:	JOMED Inc.2870 Kilgore Rd.Rancho Cordova, CA 95670	JUN 2 3 2003
Contact person:	Lorry W. HuffmanRegulatory Affairs Manager
Phone number:Facsimile number:	(916) 638-9404(916) 638-8112
Device Name:	JOVUS Eagle Eye™ Intravascular Ultrasound Imaging Catheter(Eagle Eye™ IVUS Catheter)

Classification name:		Class
•	870.1200 Diagnostic Intravascular catheter	II
•	892.1560 Ultrasonic pulsed echo imaging system	II

Predicate Device:

The JOMED Inc. JOVUS Ear:le Eye™ F/X 2.9F Intravascular Ultrasound (IVUS) Imaging Diagnostic Catheter is substantially equivalent to the Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter cleared under K000820 on June 5, 2000.

Device Description:

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The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.

Intended Use:

JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology, such as lesion grometry in blood vessels of the coronary and peripheral vasculature by providing a cr ss-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunt to conventional angiographic procedures to provide an image of the vessel lumen and wall structures, during devic< (e.g. stent) placement, and/or other percutaneous vascular procedures.

Device Technological Characteristics and Comparison to Predicate Device:

The modified device, JOVUS: Eagle Eye™ F/X catheter, was developed utilizing a higher performance material in the e ectrical contact area and improved manufacturing processes to achieve improved catheter performance. The JOVUS Eagle Eye™ 2.9F Intravascular Ultrasound Imaging Catheter utilizes the same fundamental scientific technologies and has the same intended use as that of the predicate device. Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter.

The scanner, hub, and conner tor assembly have been slightly modified as listed below:

· The backing material changed.

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. The bump shart has been changed from black to teal in order to match new corporate ider tity colors
. The microcable bundle configuration has been modified for improved electrical performance.
. Tolerances have been added to the catheter dimensions to provide a more realistic inspection parameter.

Performance Data:

Applicable testing is being performed in accordance with the Master Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results will be found to be comparable to those of the predicate device, Avanar™ F/X 2.9F Iritravascular Ultrasound Imaging Catheter. The new backing material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.

Conclusion:

JOVUS Eagle Eye™ F/X 2.91; Intravascular Ultrasound Imaging Catheter has the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate device, Avanar™ F.X 2.9F Intravascular Ultrasound Imaging Catheter cleared under K000820 on June 5, 2000. The performance data and a declaration of conformity with design controls support a determination of substantial equivalence of the modified device, JOVUS Eagle Eye™ Intravascular Ultrasound Imaging Catheter, to the predicate device, Avanar™ F/X 2.9F Ir.travascular Ultrasound Imaging Catheter.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2003

Jomed Inc. c/o Ms. Lorry W. Huffman Regulatory Affairs Manager 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K031346

Trade Name: JOVUS Eagle Eye™ Intravascular Ultrasound Imaging Catheter (Eagle Eye 100 IVUS Catheter) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: June 10, 2003 Received: June 12, 2003

Dear Ms. Huffman:

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 (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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lorry W. Huffman

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Vele Tuh
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031346 510(k) Number (if known):

Device Name:

Indications for Use:

JOMED INC.

JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

(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 801.19) OR

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K031344

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).