(12 days)
The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunctions with a pressure interface module during catheterisation laboratory procedures 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.
Not Found
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 specific acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (CD Leycom Pressure/Volume Catheter) which primarily establishes substantial equivalence to a predicate device for marketing purposes. It does not contain details of performance studies, sample sizes, ground truth establishment, or expert evaluations.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS) in the USA. The logo features the department's name encircling a stylized eagle symbol. The eagle is depicted with three overlapping profiles, creating a sense of depth and movement. The overall design is simple and professional, reflecting the organization's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
CD Levcom BV c/o Dr. T. Lopes Regulatory Affairs Argonstraat 116 2718 SP Zoetermeer The Netherlands
Re: K030524
Trade/Device Name: 7 Fr Pressure/Volume Catheter with Lumen Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: February 11, 2003 Received: February 19, 2003
Dear Dr. Lopes:
This letter corrects our substantially equivalent letter of March 3, 2003.
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 (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 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 - Dr. Lopes
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 continue 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 (240) 276-4008. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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 Enclosure
INDICATIONS
KO30524 -KOSSO20 510(k) Number: Device Name: CD Leycom Pressure/Volume Catheters
Indications For Use:
The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunctions with a pressure interface module during catheterisation laboratory procedures 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.
Moffett Mayn for BDE
510(k) number K030524
§ 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).