(207 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe features typically associated with AI/ML in medical devices like image processing or complex data analysis beyond basic signal recording and direction determination.
No
The device is intended to aid in the determination and analysis of abnormal heart activity and the possible location of the wavefront's source, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as aiding in the "determination and analysis of abnormal heart activity," specifically "the direction of the cardiac wavefront and the possible location of the wavefront's source," which are diagnostic functions.
No
The device description explicitly states it is used "in conjunction with a 5-electrode catheter," which is a hardware component. Therefore, it is not a software-only medical device.
Based on the provided information, the CATHEFFECTS Desai VectorCath™ Mapping System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device is used "in conjunction with a 5-electrode catheter to record endocardial potentials." This indicates the device is used directly on the patient's heart (endocardial) to measure electrical signals.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the body. The device is interacting with the body directly.
Therefore, the CATHEFFECTS Desai VectorCath™ Mapping System is a medical device used for in vivo (within the living body) measurement and analysis, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
Product codes
DQK
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
Heart / endocardial
Indicated Patient Age Range
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Intended User / Care Setting
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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
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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.)
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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.
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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.
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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)
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§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Mr. Shawn Fojtik Chief Operating Officer CathEffects, L.L.C. 1100 Melody Lane, Suite 108 Roseville, CA 95678
Re: K012089
Trade Name: Desai VectorCath Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer. Regulatory Class: II (two) Product Code: DQK Dated: October 17, 2001 Received: November 5, 2001
Dear Mr. Fojtik:
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.
1
Page 2 - Mr. Shawn Fojtik
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 or any 1 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
K. Don Miller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Desai VectorCath™ Mapping System
- The CATHEFFECTS Desai VectorCath™ Mapping System is intended Indications For Use: to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use /
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012089
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