(398 days)
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No
The description focuses on the physical characteristics and function of a diagnostic catheter for electrogram recording, with no mention of AI or ML capabilities.
No
The device is described as a "diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials," and its intended use is for "electrogram recording... during diagnostic electrophysiology studies." It is also explicitly stated that "The Pathfinder is not indicated for pacing or ablation."
Yes
The "Intended Use / Indications for Use" states it is "intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies." Additionally, the "Device Description" explicitly calls it a "diagnostic medical device."
No
The device description clearly details a physical catheter with electrodes, working lengths, and a hydrophilic coating, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Cardima Pathfinder 1.5F Microcatheter is a device that is inserted into the body (specifically the coronary venous system) to record electrical signals directly from the heart tissue. It does not examine specimens outside of the body.
Therefore, based on the intended use and device description, the Cardima Pathfinder 1.5F Microcatheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardima Pathfinder® 1.5F Mapping Catheter 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 Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Cardima Pathfinder® 1.5F Mapping Catheter 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 catheter is available with 4, 1mm long electrodes spaced either 2mm or 2-6-2mm apart providing for a total electrode recording length of 10-14 mm. The working outer diameter is 1.5F and will be available with working lengths of 135cm and 170cm. The Pathfinder is not indicated for pacing or ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
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
venous system of the heart, coronary venous system
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)
Safety and effectiveness were evaluated through biocompatibility testing and animal studies. Biocompatibility testing was conducted on final sterilized Pathfinder product per ISO 10993-1 and shown to be acceptable for all categories. Reliability testing was conducted on sterilized product per "Electrode Recording Catheter Preliminary Guidance, March 1995". The tests were used to assess the mechanical and electrical properties of both the catheter and the connector cable and found to be acceptable for use.
Animal studies were conducted to evaluate the maneuverability of the Pathfinder 1.5F catheter positioned in the coronary sinus and veins. The catheter was shown to be easily positioned into selected coronary veins including the anterior interventricular, middle cardiac, posterolateral, lateral and anterolateral veins without difficulty, and signals were of good quality and adequate for clinical applications. Effusion of dye outside the coronary venous system was not evident, nor was there pericardial effusion found on gross examination of the heart. Some procedural complications noted most likely attributable to the guiding catheter included slight endothelial injury with consequent thrombus formation in one case. Some small subepicardial hemorrhage was found around the proximal middle cardiac vein in 2 dogs, and the coronary sinus area in 2 dogs. These complications are not considered to be clinically significant.
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.
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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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§ 870.1220 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).
0
Trade Name:
Cardima Pathfinder 1.5F Mapping Microcatheter
Manufacturer:
Cardima, Inc. 47266 Benicia Street Fremont, CA 94538-7330 Contact: Jack P. Douglas, Ph.D. 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 Pathfinder® 1.5F Mapping Catheter 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 catheter is available with 4, 1mm long electrodes spaced either 2mm or 2-6-2mm apart providing for a total electrode recording length of 10-14 mm. The working outer diameter is 1.5F and will be available with working lengths of 135cm and 170cm. The Pathfinder is not indicated for pacing or ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
Sterilization, Packaging and Pyrogenicity:
The Pathfinder 1.5F Mapping Catheter is packaged individually in a polyethylene protective coil. Each coll is in turn placed in a clear, blue tinted tray and a translucent-white Tyvek lid that is heat sealed to the outside of the tray . This sealed tray is placed within a standard Tyvek/polyester-polyethylene pouch which is also heat sealed. All product is sterilized using gamma radiation.
Substantial Equivalence:
The Pathfinder 1.5F Mapping Catheter is a modified version of Cardima's 2.5F Pathfinder electrode recording catheter. Establishment of equivalence was based on similarities of labeling, design, materials, and physical characteristics as evaluated by physical bench testing and biocompatibility. The primary design modification involves a change of outer diameter from 2.5F to 1.5F.
Summary of Safety and Effectiveness:
Safety and effectiveness were evaluated through biocompatibility testing and animal studies. Biocompatibility testing was conducted on final sterilized Pathfinder product per ISO 10993-1 and shown to be acceptable for all categories. Reliability testing was conducted on sterilized product per "Electrode Recording Catheter Preliminary Guidance, March 1995". The tests were used to assess the mechanical and electrical properties of both the catheter and the connector cable and found to be acceptable for use.
Animal studies were conducted to evaluate the maneuverability of the Pathfinder 1.5F catheter positioned in the coronary sinus and veins. The catheter was shown to be easily positioned into selected coronary veins including the anterior interventricular, middle cardiac, posterolateral, lateral and anterolateral veins without difficulty, and signals were of good quality and adequate for clinical applications. Effusion of dye outside the coronary venous system was not evident, nor was there pericardial effusion found on gross examination of the heart. Some procedural complications noted most likely attributable to the guiding catheter included slight endothelial injury with consequent thrombus formation in one case. Some small subepicardial hemorrhage was found around the proximal middle cardiac vein in 2 dogs, and the coronary sinus area in 2 dogs. These complications are not considered to be clinically significant.
1
Image /page/1/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUL -
Jack P. Douglas, Ph.D. Director of Requlatory Affairs Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, CA 94538-7330
Re: K971975 Cardima Pathfinder™ 1.5F Mapping Microcatheter Requlatory Class: II (two) Product Code: DRF Dated: April 7, 1998 Received: April 8, 1998
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 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements 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 requlations.
2
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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Page _________________________________________________________________________________________________________________________________________________________________________ of
K971975 / 510(k) Number (if known):
Device Name: Cardima Pathfinder 1.5F Mapping Microcatheter TM
Indications For Use:
The Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Cardi voscular, Respiratory, and Neurological Dev
510(k) Number K971975
Image /page/3/Picture/9 description: The image shows the words "Prescription Use" and "(Per 21 CFR 801.109)". The words are written in a clear, legible font. There is a line going through the words "Prescription Use".
OR
Over-The-Counter Use
(Optional Format 1-2-96)
000007