The Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.

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.

AI/ML Overview

Here's an analysis of the Cardima Pathfinder 1.5F Mapping Microcatheter's acceptance criteria and the study used to demonstrate its safety and effectiveness, based on the provided text:

Acceptance Criteria and Device Performance for Cardima Pathfinder 1.5F Mapping Microcatheter

The provided document describes the predicate device equivalence rather than a detailed list of acceptance criteria from a specific clinical trial with performance metrics. The safety and effectiveness evaluation for this device was primarily based on biocompatibility testing and animal studies, as it is a modified version (smaller outer diameter) of an already approved device. The "acceptance criteria" can therefore be inferred from the successful completion of these tests and the demonstration of substantial equivalence.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 for all categories.	Accepted for all categories per ISO 10993-1.
Reliability (Mechanical/Electrical)	Compliance with "Electrode Recording Catheter Preliminary Guidance, March 1995" for mechanical and electrical properties.	Mechanical and electrical properties found to be acceptable for use.
Maneuverability in vivo	Ability to be easily positioned into selected coronary veins.	Catheter was shown to be easily positioned into selected coronary veins (anterior interventricular, middle cardiac, posterolateral, lateral and anterolateral veins) without difficulty.
Signal Quality (Electrogram)	Production of good quality electrogram signals adequate for clinical applications.	Signals were of good quality and adequate for clinical applications.
Absence of Adverse Events (Major)	No evidence of dye effusion outside coronary venous system; no pericardial effusion.	Effusion of dye outside the coronary venous system was not evident, nor was there pericardial effusion found on gross examination of the heart.
Absence of Adverse Events (Minor)	Minor complications, if present, should not be clinically significant.	Some minor complications were noted (slight endothelial injury with thrombus in one case, small subepicardial hemorrhage in 2 dogs), but these were not considered to be clinically significant.

Study Details:

Given the nature of the submission (510(k) for a modified device), the "study" demonstrating performance is primarily preclinical (animal study) and bench testing, rather than a full-scale human clinical trial with extensive statistical and expert-driven ground truth establishment.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "animal studies" and "2 dogs" for specific findings, but doesn't provide a precise total sample size for the animal study. It's safe to assume a small number of animals, typical for preclinical studies of this nature.
- Data Provenance: The study was (presumably) conducted by the manufacturer, Cardima, Inc., and is a preclinical, prospective animal study. The country of origin for the data is not specified, but would likely be the United States, given the manufacturer's location and FDA submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for evaluating the animal study results. This type of preclinical study would typically involve veterinary professionals, potentially electrophysiologists or cardiologists for interpreting signal quality, and pathologists for gross and microscopic examination of tissues.
Adjudication method for the test set:
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1). Decisions on clinical significance of findings and signal quality would have been made by the researchers conducting the animal study, likely through consensus or standard veterinary/medical practice.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was NOT done. This type of study typically involves multiple human readers evaluating medical images or data, often with and without AI assistance, and comparing their performance. The provided document concerns a physical medical device (catheter) and preclinical testing, not an AI or imaging diagnostic tool. Therefore, effects of human readers improving with AI assistance are not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical mapping microcatheter, not an algorithm or AI system. Its performance is inherent in its physical and electrical characteristics and its ability to acquire signals in vivo.
The type of ground truth used:
- Animal study observations, physiological measurements, and gross/histopathological findings.
  - Maneuverability: Direct observation during the procedure.
  - Signal Quality: Electrogram recordings and interpretation.
  - Adverse Events: Direct observation of tissue, dye, and pericardial effusions during necropsy/examination.
  - Biocompatibility: Laboratory analysis of biological response to materials.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense. The design and modifications were likely based on engineering principles and experience with the predicate device.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

{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:

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".

Over-The-Counter Use

(Optional Format 1-2-96)

000007

Regulation Number and Section

§ 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).