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.

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.

AI/ML Overview

The provided text describes a submission for a medical device (Cardima Pathfinder 3mm Mapping Microcatheter) for 510(k) clearance, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is not a study proving the device meets acceptance criteria as typically found in an AI/ML context with performance metrics like sensitivity/specificity.

Instead, this document focuses on demonstrating substantial equivalence to an existing device and assessing safety and effectiveness through different types of testing common for physical medical devices. Therefore, many of the requested categories (e.g., AI performance metrics, readers, training sets, ground truth types) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Biocompatibility	Acceptable per ISO 10993-1 categories using final sterilized product.	Confirms the material used is safe for contact with biological tissue.
Reliability (Mechanical & Electrical)	Acceptable for use based on "Electrode Recording Catheter Preliminary Guidance, March 1995" using sterilized product.	Ensures the device's physical and electrical properties are suitable for its intended function.
Maneuverability	Catheter could be positioned into coronary sinus, right atrium, and right ventricle without significant difficulty.	Assesses the ease of navigation within the heart.
Signal Quality	Signals were of good quality and adequate for clinical applications.	Confirms the ability to accurately record electrical potentials.
Pacing Capability	Pacing was easily achieved at clinically-relevant thresholds.	Verifies its secondary function of pacing is effective.
Safety (Animal Study)	No injury to animals, except for one instance of coronary sinus thrombosis in one animal, attributed to guiding catheter manipulation. Procedure found to be safe.	Assesses adverse events during use in a living organism.

2. Sample Size Used for the Test Set and Data Provenance

Animal Studies: The text mentions "animal studies" and "one animal" where thrombosis occurred, implying a small number of animals were part of the study. The exact number of animals in the study is not specified.
Data Provenance: The studies were conducted by the manufacturer, Cardima, Inc. They are prospective animal studies and laboratory bench testing. The country of origin is implicitly the USA (manufacturer is in Fremont, CA, and submission is to FDA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable (N/A) in the context of this device. The evaluations were primarily objective measurements (biocompatibility, electrical/mechanical tests) and direct observation by researchers/veterinarians during animal studies. There's no mention of expert consensus for interpreting complex data like images, which would require multiple human experts to establish "ground truth."

4. Adjudication Method for the Test Set

N/A. As above, expert adjudication for a "test set" in the AI/ML sense is not relevant for this type of device submission. Direct measurements and observations were the basis of evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

For Biocompatibility: Laboratory test results against ISO 10993-1 standards (e.g., cytotoxicity tests, irritation tests).
For Reliability: Laboratory measurements and physical inspections against specified performance criteria (e.g., electrical impedance, mechanical strength, flexibility).
For Animal Study (Maneuverability, Signal Quality, Pacing, Safety): Direct observation of catheter performance, physiological signal analysis, and post-procedure examination of animal welfare/injury by the researchers/veterinarians conducting the study. This aligns more with outcomes data (direct observation of device function and biological response) rather than expert consensus on a subjective measure or pathology (though pathology might be part of post-mortem analysis, it's not explicitly detailed here as the primary ground truth).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

N/A. As there is no training set for an AI/ML model, this question is not applicable.

Summary

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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.

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K970853
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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.

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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

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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

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5 1 0(k) Number (if.known):	K970853
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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
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(Optional Format 1-2-96)

ﯿ :

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).