(652 days)
Not Found
No
The summary describes a standard diagnostic mapping catheter and does not mention any AI or ML capabilities. The performance studies focus on biocompatibility, mechanical/electrical properties, and animal studies evaluating maneuverability, signal quality, and pacing, which are typical for this type of device. There is no mention of algorithms, data analysis beyond signal recording, or any features that would suggest AI/ML involvement.
No
The device is described as a "diagnostic medical device" and its intended use is for "mapping" and temporarily recording and pacing during the mapping procedure, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Tracer diagnostic mapping device is intended for use in cardiac multations For Ose." Additionally, the "Device Description" section refers to it as a "diagnostic medical device."
No
The device description clearly describes a physical catheter with electrodes, a guide wire channel, and a hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device 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 Tracer diagnostic mapping device is a catheter inserted into the body (specifically the venous system of the heart) to record electrical signals and temporarily pace the heart. This is an in vivo procedure, meaning it is performed within a living organism.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the electrical activity of the heart.
Therefore, the Tracer diagnostic mapping device falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure.
The Tracer diagnostic mapping device is intended for use in cardiac applications. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.
Product codes
DRF
Device Description
The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure. The catheter is designed to accommodate a 0.010" guide wire and is available in five configurations with either 4, 8, or 16 electrodes. Both the 4 and 8 electrode catheters come with either regular spaced electrodes of 5mm or electrode pair spacing of 2-5-2 mm. The 16 electrode catheter is available only with 2-5-2mm pair spacing. The outer diameter of the catheter is 3.2F - 3.3F and will be available with working lengths of 145cm. The outer surface is treated with a hydrophilic coating to enhance lubriciousness. The Tracer is not indicated for ablation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system of the heart, coronary sinus, coronary veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Animal studies were conducted to evaluate the maneuverability and signal quality of the Tracer positioned in the coronary sinus and coronary veins. The Tracer catheter was also evaluated for pacing. The catheter could be positioned into the coronary sinus and distal coronary veins without difficulty. Signals were of good quality and adequate for clinical applications. Ventricular pacing from different pairs of electrodes on the Tracer were conducted on twelve occasions (threshold 0.1 - 1.9 mA @ a pulse width of 2.0 msec.). Coronary sinus angiography post-procedure showed normal venous anatomy without rupture or thrombosis. Effusion of dye outside the coronary venous system was not evident, nor was pericardial effusion found on gross examination of the heart. In two cases small patches of subepicardial hemorrhage were found on post-mortem inspection, and are believed to be clinically insignificant.
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.
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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§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
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Trade Name:
Cardima Tracer Over-the-Wire Mapping Microcatheter
Manufacturer:
Cardima. Inc. 47266 Benicia Street Fremont, CA 94538-7330 Contact: Shelley Trimm Establishment Registration Number: 9007594
Classification Name:
Electrode Recording Catheter (21 CFR 870.1220)
Device Classification:
Class II (21 CFR 870.1220) Panel: Circulatory System Devices Panel, DCRND
Intended Use and Product Description:
The Cardima Tracer Over-the-Wire Mapping Microcatheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The Tracer catheter can also be utilized for temporary epicardial pacing during the mapping procedure. The catheter is designed to accommodate a 0.010" guide wire and is available in five configurations with either 4, 8, or 16 electrodes. Both the 4 and 8 electrode catheters come with either regular spaced electrodes of 5mm or electrode pair spacing of 2-5-2 mm. The 16 electrode catheter is available only with 2-5-2mm pair spacing. The outer diameter of the catheter is 3.2F - 3.3F and will be available with working lengths of 145cm. The outer surface is treated with a hydrophilic coating to enhance lubriciousness. The Tracer is not indicated for ablation.
Sterilization, Packaging and Pyrogenicity:
The Tracer is packaged individually as a coil in a clear, blue tinted polyethylene teraphthlate (PETG) tray which is heat-sealed with a translucent-white Tyvek lid. This sealed tray is placed within a standard Tyvek/polyester-polyethylene pouch which is also heat sealed. Both Tracer and Pathfinder utilize the identical packaging materials and process for gamma sterilization. The design modification to Tracer does not introduce any new or unique challenges to the current validate sterlization process. Given these considerations re-validating the sterilization process used for Tracer was deemed unnecessary.
Substantial Equivalence:
The Tracer Over-the-Wire Mapping Catheter is a modified version of Cardima 2.5F Pathfinder electrode recording catheter (cleared K955802). Establishment of equivalence was based on similarities of labeling, design, materials, and physical characteristics as evaluated by physical bench testing, biocompatibility and animal studies. The primary design modification involves use of an over-the-wire feature and a larger outer diameter. The additional intended for use claim: "can be utilized for temporary pacing", was supported by the animal studies.
Summary of Safety and Effectiveness:
Safety and effectiveness were evaluated through biocompatibility testing and animal studies. The Tracer and the Pathfinder utilize the same materials requiring biocompatibility testing. Therefore, the biocompatibility testing conducted on final sterilized Pathfinder product per ISO 10993-1, which were shown to be acceptable for all categories, was deemed applicable to the Tracer. Reliability testing was conducted on sterilized Tracer product per "Electrode Recording Catheter Preliminary Guidance, March 1995". The tests were used to assess the mechanical and electrical properties of the catheter and found to be acceptable for use.
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Animal studies were conducted to evaluate the maneuverability and signal quality of the Tracer positioned in the coronary sinus and coronary veins. The Tracer catheter was also evaluated for pacing. The catheter could be positioned into the coronary sinus and distal coronary veins without difficulty. Signals were of good quality and adequate for clinical applications. Ventricular pacing from different pairs of electrodes on the Tracer were conducted on twelve occasions (threshold 0.1 - 1.9 mA @ a pulse width of 2.0 msec.). Coronary sinus angiography post-procedure showed normal venous anatomy without rupture or thrombosis. Effusion of dye outside the coronary venous system was not evident, nor was pericardial effusion found on gross examination of the heart. In two cases small patches of subepicardial hemorrhage were found on post-mortem inspection, and are believed to be clinically insignificant.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human profile with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1999
Jack P. Douglas, Ph.D. Director of Regulatory Affairs Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, CA 94538-7330
Re: K972803 Cardima® TRACER™ Over-the-Wire Mapping Microcatheter Regulatory Class: II (two) Product Code: DRF Dated: March 1, 1999 Received: March 2, 1999
Dear Dr. Douglas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
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concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 of of 1 _ Page
510(k) Number (if known):
Tracer Over-the-Wire Mapping Microcatheter_ Device Name:
The Tracer diagnostic mapping device is intended for use in cardiac Indications For Use: multations For Ose. This catheter can be used to temporarily record epicardial electrical signals from the coronary sinus. The Tracer catheter can be used to temporarily pace during the mapping procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for the
Division Sign Off
(Division Sign, Off) Diysion of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K972803
Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use