CD LEYCOM PRESSURE/VOLUME CATHETERS

K031599 · Cd Leycom BV · DQO · Dec 9, 2003 · Cardiovascular

Device Facts

• Record ID: K031599
• Device Name: CD LEYCOM PRESSURE/VOLUME CATHETERS
• Applicant: Cd Leycom BV
• Product Code: DQO · Cardiovascular
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization in the clinical setting where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.

Device Story

CD Leycom 4 Fr Pressure/Volume Catheter functions as diagnostic intravascular catheter; measures pressure and volume within left ventricle. Used in conjunction with CFL 512 system and pressure interface module. Catheter inserted during cardiac catheterization procedures; provides real-time hemodynamic data. Clinicians use output to assess left ventricular function; aids in clinical decision-making regarding cardiac performance and patient management. Benefits include precise, quantitative hemodynamic monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

4 Fr catheter; includes pressure transducer and volume measurement capabilities. Designed for use with CFL 512 signal amplifier and conditioner. Class II device under 21 CFR 870.1200, 870.2870, and 870.2060.

Indications for Use

Indicated for patients undergoing catheterization requiring quantitative assessment of Left Ventricular function. Intended for clinical use by healthcare professionals.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2003

CD Leycom c/o Teresa Lopes, Ph.D. Regulatory Affairs Argonstraat 116 2718 SP Zoetermeer The Netherlands

## Re: K031599

Trade Name: CD Leycom 4 Fr Pressure/Volume Catheter Regulation Number: 21 CFR 870.1200, 870.2870, and 870.2060 Regulation Name: Diagnostic Intravascular Catheter, Catheter Tip Pressure Transducer, and Transducer Signal Amplifier and Signal Conditioner Regulatory Class: Class II (two) Product Code: DQO, DXO, DRQ Dated: November 17, 2003 Received: November 20, 2003

Dear Dr. Lopes:

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 - Teresa Lopes, Ph.D.

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 vours.

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

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## Indications for Use

K031599 510(k) Number (if known):

CD Leycom Pressure/Volume Catheters Device Name:

Indications For Use:

The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization In = 0 f = 1.1 sonjanet.or where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.

See Annex 3 for Instructions for Use

Dma Heule

510(k) N

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)