METRICATH SYSTEM

K042685 · Angiometrx, Inc. · DQO · Nov 18, 2004 · Cardiovascular

Device Facts

• Record ID: K042685
• Device Name: METRICATH SYSTEM
• Applicant: Angiometrx, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended 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, renal, iliac and femoral arteries. The 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 artery.

Device Story

Metricath System functions as adjunct to conventional angiography; provides real-time arterial lumen measurements. Device consists of balloon catheter; used by physicians during percutaneous, transluminal interventional procedures. Catheter inserted into coronary, renal, iliac, or femoral arteries; balloon inflated to measure lumen cross-sectional area and diameter. Output displayed for clinician to assist in procedural decision-making; aids in assessing vessel dimensions prior to or during interventions. Benefits include precise anatomical sizing to guide stent selection or procedural planning.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Diagnostic intravascular catheter system; balloon-based measurement principle. Intended for coronary, renal, iliac, and femoral artery use. Class II device (21 CFR 870.1200).

Indications for Use

Indicated for patients undergoing percutaneous, transluminal interventional procedures requiring arterial lumen measurements (cross-sectional area and diameter) in coronary, renal, iliac, and femoral arteries, specifically proximal to lesions or within stented sections.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Angiometrix Inc. c/o Mr. Tim Verspagen Regulatory Affairs Manager 107-1099 8th Avenue West Vancouver. BC Canada V6H 103

Re: K042685 Metricath System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: September 27, 2004 Received: September 29, 2004

Dear Mr. Verspagen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat nave been receasined in quire approval of a premarket approval application (PMA). alle Costience Act (11ct) that as not require appear al controls provisions of the Act. The I ou may, merclore, mailer of the Act include requirements for annual registration, listing of general controls provider and prohibitions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is blubsition (600 a00 m) ols. Existing major regulations affecting your device can may be subject to back as a success 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 (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,

Duna R. Va. Aanes

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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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## Indications for Use

510(k) Number (if known): K042685

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, renal, iliac and femoral arteries. The 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 artery.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma P. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

010(K) Number_K0426 85

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