METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER

K024000 · Angiometrx, Inc. · DQO · Jun 26, 2003 · Cardiovascular

Device Facts

• Record ID: K024000
• Device Name: METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
• Applicant: Angiometrx, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Metricath System is intended for measuring intravascular diameter and cross-sectional area, in the coronary arteries only.

Device Story

Metricath System comprises Metricath 1000 computer console and sterile, disposable Metricath Balloon Catheter. System measures coronary artery lumen diameter and cross-sectional area using low-pressure balloon catheter inserted via standard interventional procedures. Used in clinical settings by physicians during percutaneous transluminal interventional procedures. Provides real-time arterial measurements to assist clinicians in assessing vessel dimensions proximal to lesions or within stented sections. Benefits include precise anatomical sizing to guide interventional decision-making.

Clinical Evidence

System tested in-vivo and found safe and effective. Bench testing included functional and safety testing per IEC 60601-1 and IEC 60601-1-2 for the console, and ISO 10555-1, ISO 10555-4, and ISO 10993 for the catheter. Evaluated characteristics included tensile strength, leakage, burst, kinking, tortuosity, and fatigue.

Technological Characteristics

System consists of a computer console and a low-pressure balloon catheter. Catheter materials evaluated for biocompatibility (ISO 10993) and mechanical integrity (ISO 10555-1/4). Operates as a diagnostic intravascular catheter (21 CFR 870.1200).

Indications for Use

Indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary vasculature in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.

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

• Galaxy Intravascular Ultrasound System (Boston Scientific)
• UltraCross™ 2.9, 30MHz Coronary Imaging Catheter (Boston Scientific)
• Equinox™ Occlusion Balloon Catheter (Micro Therapeutics)
• Amplatzer® Sizing Balloon (AGA Medical)

Submission Summary (Full Text)

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K024000

P1/2

angiometrx inc.

JUN 2 6 zuu3

107-1099 8th Avenue West
Vancovver, BC Canada V6H I C 3
Vancovver, BC Canada V6H I C 3
C fax . [phone] www.angiometrx.com

## Summary of Safety and Effectiveness K024000

| Trade Name | Metricath™ System |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Angiometrx Inc., a division of Medical Ventures Corp.<br>1099 8th Avenue West, Unit 107<br>Vancouver, British Columbia<br>Canada, V6H 1C3<br>Tel: [phone]<br>Fax: [phone]<br>Contact Person: Tim Verspagen, RAC |
| Intended Use | The Metricath™ System is intended for measuring intravascular<br>diameter and cross-sectional area, in the coronary arteries only. |
| Device<br>Description | The Metricath™ System consists of two parts, the Metricath™ 1000<br>computer console, and the sterile, disposable Metricath™ Balloon<br>Catheter. The Metricath™ System measures both artery lumen<br>diameter and cross sectional area using a low-pressure balloon<br>catheter inserted into the artery using standard interventional<br>procedures and techniques. The Metricath™ System is indicated for<br>use in patients who are candidates for percutaneous transluminal<br>interventional procedures to make arterial lumen measurements<br>proximal to a lesion, or within a stented section of an artery. |
| Classification | Classification: Class II<br>Product Code: DQO<br>Classification Name: Diagnostic Intravascular Catheter |
| Predicate<br>Devices | 1. Galaxy Intravascular Ultrasound System (Boston Scientific)<br>2. UltraCross™ 2.9, 30MHz Coronary Imaging Catheter (Boston<br>Scientific)<br>3. Equinox™ Occlusion Balloon Catheter (Micro Therapeutics)<br>4. Amplatzer® Sizing Balloon (AGA Medical) |

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K024000
p.2/2

## The Metricath™ 1000 Console met or exceeded the requirements of Functional & Safety Testing IEC 60601-1 and IEC 60601-1-2 regarding safety of medical electrical equipment. The Metricath™ 1000 Console software has been successfully validated. The Metricath™ Balloon Catheter met or exceeded the requirements of ISO 10555-1 and ISO 10555-4 regarding sterile intravascular (balloon) catheters and ISO 10993 regarding biocompatibility. The following characteristics of the Metricath™ Balloon Catheter were evaluated: tensile strength of catheter bonds; catheter leakage, burst, kinking, tortuosity and fatigue. The Metricath™ System has been tested in-vivo, and found safe and effective for its intended use. The Metricath™ System has been tested and compared to the Conclusion predicate devices, and found to be substantially equivalent with regards to device safety and intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes that suggest movement or flow.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2003

Angiometrx, Inc. c/o Mr. Tim Verspagen Regulatory Affairs Manager 107-1099 8th Avenue West Vancouver, BC V6H 1C3 Canada

Re: K024000

Trade Name: Metricath System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: May 2, 2003 Received: May 6, 2003

Dear Mr. Verspagen:

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 - Mr. Tim Verspagen

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 (OS) 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 vours.

L. Delettu

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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## angiometry

107-1089 Rt. Autoria Views Karssants, BE Canada VEH 110 152441 2530

angiometrx inc.

.angiometrx.com

## Indications for Use Statement

510(k) Number: K024000

Device Name: The Metricath System

Indications for Use:

The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary vasculature. Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

DeVitte

Prescription Use __ X (Per 21 CFR §801.109)

OR Over-The-Counter Use