(242 days)
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Not Found
No
The 510(k) summary describes a diagnostic mapping catheter for sensing electrical potentials and pacing in the heart. There is no mention of AI, ML, image processing, or any computational analysis of the collected data that would suggest the use of these technologies. The performance studies focus on biocompatibility, reliability, and animal studies evaluating maneuverability and signal quality, not algorithmic performance.
No
The document states that the device is a "diagnostic medical device" and is "contraindicated for ablation," which is a therapeutic procedure. Its primary functions are "electrogram recording and pacing during diagnostic electrophysiology studies."
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the Pathfinder® 3mm Mapping Catheter is a "diagnostic medical device." It is designed for "sensing of electrical potentials in the heart" and "electrogram recording" for "diagnostic electrophysiology studies."
No
The device description clearly details a physical catheter with electrodes, a specific diameter, and usable lengths, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "localized unipolar or bipolar sensing of electrical potentials in the heart" and "pacing during diagnostic electrophysiology studies." This involves directly interacting with the patient's body to record electrical signals and deliver electrical pulses.
- Device Description: The device is a catheter designed to be inserted into the heart.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform tests on samples outside the body.
The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device that is used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The Pathfinder is also indicated for pacing. It is contraindicated for ablation.
The Cardima Pathfinder 3mm catheter is intended for electrogram recording and pacing during diagnostic electrophysiology studies.
Product codes (comma separated list FDA assigned to the subject device)
74DRF
Device Description
The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The catheter is available with 4 or 8, 3mm long electrodes spaced 2mm apart providing for a total electrode recording length of 4cm. The working outer diameter of the catheter is 3.3F and will be available with useable lengths of 100cm and 135cm. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
The Pathfinder 3mm Mapping Catheter is packaged individually in a polyethylene protective coil. Each coil 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, coronary sinus, right atrium and right ventricle
Indicated Patient Age Range
Not Found
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 3 mm catheter positioned in the coronary sinus, right atrium and right ventricle. The catheter could be positioned into the coronary sinus, right atrium and right ventricle without significant difficulty, and signals were of good quality and adequate for clinical applications. Pacing was easily achieved at clinically-relevant thresholds. During one study, coronary sinus thrombosis occurred in one animal, believed to result from manipulation of the guiding catheter. Otherwise, this procedure was found to be safe without injury to the animals.
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.
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
§ 870.1220 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
Summary of Safety and Effectiveness
Trade Name:
NOV - 4 1997
Cardima Pathfinder 3mm 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® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The catheter is available with 4 or 8, 3mm long electrodes spaced 2mm apart providing for a total electrode recording length of 4cm. The working outer diameter of the catheter is 3.3F and will be available with useable lengths of 100cm and 135cm. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
Sterilization, Packaging and Pyrogenicity:
The Pathfinder 3mm Mapping Catheter is packaged individually in a polyethylene protective coil. Each coil 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 3mm 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. Design modifications include a longer electrode length and a larger outer diameter size.
1
K970853
p2/2
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 3 mm catheter positioned in the coronary sinus, right atrium and right ventricle. The catheter could be positioned into the coronary sinus, right atrium and right ventricle without significant difficulty, and signals were of good quality and adequate for clinical applications. Pacing was easily achieved at clinically-relevant thresholds. During one study, coronary sinus thrombosis occurred in one animal, believed to result from manipulation of the guiding catheter. Otherwise, this procedure was found to be safe without injury to the animals.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV - 4 1997
Jack P. Douglas, Ph.D. Regulatory Affairs Manager Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, California 94539-1372
K970853 Re: Cardima Pathfinder 3mm Mapping Microcatheter™ Trade Name: Regulatory Class: II Product Code: 74DRF Dated: August 5, 1997 Received: August 7, 1997
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, Drug, 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
3
Page 2 - Jack P. Douglas, Ph.D.
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 requlation (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, "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 at (301) 443-6597.
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 Radiological Health
Enclosure
4
| 5 1 0(k) Number (if.known): | K970853 |
|---|---|
| ----------------------------- | --------- |
Device Name:
.
Cardima Pathfinder 3mm Mapping Microcatheter
2014/08/
Indications For Use: . * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
The Cardima Pathfinder 3mm catheter is intended for electrogram recording and pacing 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) | Dan Talli |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K970853 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------------------------------ | ---------------------------------------------------------- | ---- | ---------------------- | ------------------------------------------------------------------ |
(Optional Format 1-2-96)
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