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K Number
K031599
Device Name
CD LEYCOM PRESSURE/VOLUME CATHETERS
Manufacturer
CD LEYCOM BV
Date Cleared
2003-12-09

(202 days)

Product Code
DQO,DRO,DXO
Regulation Number
870.1200
Type
Special
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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 Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, stating that the CD Leycom 4 Fr Pressure/Volume Catheter has been found substantially equivalent to legally marketed predicate devices.

The letter discusses:

  • The device's trade name, regulation number, regulation name, regulatory class, and product code.
  • The date of receipt and review of the premarket notification.
  • The FDA's determination of substantial equivalence.
  • General controls provisions of the Act that the device must comply with.
  • Contact information for specific advice and general information.
  • The intended indications for use, stating that the catheters are "intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired."

However, it does not contain specific details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size or ground truth establishment for a training set.

The document is primarily a regulatory clearance notification and does not include the technical study details requested.

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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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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)

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).