METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000

K051042 · Angiometrx, Inc. · LIT · Aug 5, 2005 · Cardiovascular

Device Facts

• Record ID: K051042
• Device Name: METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
• Applicant: Angiometrx, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for: - Balloon dilatation of the stenotic portion of an arterial lesion - Post-delivery expansion of balloon expandable stents - Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.

Device Story

Metricath Gemini-P System is a percutaneous catheter used in renal, iliac, and femoral arteries. Device performs balloon dilatation of stenotic lesions and post-delivery expansion of balloon-expandable stents. System integrates measurement capabilities to determine arterial lumen cross-sectional area and diameter proximal to lesions or within stented sections. Operated by physicians in clinical settings. Provides real-time dimensional data to assist in procedural decision-making during angioplasty or stenting, potentially improving accuracy of vessel sizing and stent placement.

Technological Characteristics

Percutaneous catheter system; Class II; Product Code LIT; 21 CFR 870.1250. System includes balloon dilatation mechanism and integrated measurement functionality for arterial lumen dimensions.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic arterial lesions or post-delivery expansion of balloon-expandable stents in the renal, iliac, and femoral arteries, including measurement of arterial lumen cross-sectional area and diameter.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

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Mr. Tim Verspagen Regulatory Affairs Manager Angiometrx Inc. 1099 8th Avenue West, Suite 107 Vancouver, British Columbia Canada V6H-1C3

K051042 Re: Metricath Gemini-P System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: July 8, 2005 Received: July 10, 2005

Dear Mr. Verspagen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becomined 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 encrosule) to regars actuation the Medical Device Amendments, or to conninered prial to May 20, 1978, the exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (7107 market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controlo provisions 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 If your device is etablined (occare) ols. Existing major regulations affecting your device can thay be subject to suen additional connections, 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 I least of advised that I Drissian that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must of any I cacal success and regaranents, 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. production of the or probegin marketing your device as described in your Section 510(k) I mis icter will anow you'll begin finding of substantial equivalence of your device to a legally premits to the month 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, Connact the Office of Company of Crification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general microal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. bo dines

GA 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): K051042

Device Name: The Metricath Gemini-P System

… 、 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ Indications For Use:

تحت تحت ترتان تيمي

The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:

- Balloon dilatation of the stenotic portion of an arterial lesion �
- Post-delivery expansion of balloon expandable stents .
- Measurement of arterial lumen cross sectional area and diameter proximal to a ● lesion, or within a stented section of artery.

× Prescription Use __ (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)

Dmma R. Vochner

Division Sign-Off)
Division of Cardiovascular Devices

ાંકા Number Kostoday

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