(202 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML, and the device description is not available.
No
Explanation: The device is described as being for "quantitative assessment of Left Ventricular function," which is a diagnostic purpose, not a therapeutic one. It provides measurements to help understand the heart's function, but it does not treat a disease or condition.
Yes
Explanation: The device is intended for the "quantitative assessment of Left Ventricular function," which is a diagnostic purpose to evaluate the state or function of an organ.
No
The device description is not found, but the intended use explicitly mentions "Pressure, Volume and Pressure-Volume catheters" and a "pressure interface module," which are hardware components. The software (CFL 512) is used with these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used during catheterization to assess Left Ventricular function. This is a procedure performed in vivo (within the living body).
- Anatomical Site: The device is used within the Left Ventricular, which is an internal anatomical site.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment based on in vitro analysis.
The device appears to be a medical device used for direct physiological measurement within the body during a clinical procedure.
N/A
Intended Use / 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.
Product codes
DQO, DXO, DRQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Left Ventricular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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)