JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900

K031346 · Jomed, Inc. · OBJ · Jun 23, 2003 · Cardiovascular

Device Facts

• Record ID: K031346
• Device Name: JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
• Applicant: Jomed, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Jun 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology, such as lesion geometry in 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 adjunt to conventional angiographic procedures to provide an image of the vessel lumen and wall structures, during device (e.g. stent) placement, and/or other percutaneous vascular procedures.

Device Story

Catheter-tip ultrasound device; introduces percutaneously or via surgical cutdown into vascular system; tracks over 0.014" guide wire. Linear array ultrasonic transducer at distal tip produces real-time cross-sectional images of coronary and peripheral vessels. Used exclusively with In-Vision™ Imaging System. Physician operates device during vascular procedures to visualize vessel lumen and wall structures; aids in stent placement and assessment of vascular morphology. Provides real-time visual feedback to clinician to guide interventional decisions and improve procedural outcomes.

Clinical Evidence

Bench testing only. Performance data includes risk analysis and biocompatibility testing per ISO 10993-1. Results met predetermined acceptance criteria and were found comparable to the predicate device.

Technological Characteristics

2.9F intravascular ultrasound imaging catheter; linear array ultrasonic transducer; 0.014" guide wire compatible. Materials include modified backing material and microcable bundle. Connectivity limited to In-Vision™ Imaging System. Sterilization method not specified. Software algorithm class not specified.

Indications for Use

Indicated for evaluation of vascular morphology and lesion geometry in coronary and peripheral vasculature; adjunct to angiography for imaging vessel lumen and wall structures during percutaneous procedures (e.g., stent placement). Not indicated for cerebral vessels.

Regulatory Classification

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.

Predicate Devices

• Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter (K000820)

Submission Summary (Full Text)

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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.<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 | JUN 2 3 2003 |
| Contact person: | Lorry W. Huffman<br>Regulatory Affairs Manager | |
| Phone number:<br>Facsimile number: | [phone]<br>[phone] | |
| Device Name: | JOVUS Eagle Eye™ Intravascular Ultrasound Imaging Catheter<br>(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:

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.

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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.

# 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 [phone]. 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 [phone] or [phone] 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 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.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.19) OR

Over-the-Counter വട്

DerhTM

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K031344