The Tracer diagnostic mapping device is intended for use in cardiac 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.

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.

AI/ML Overview

The provided text describes the regulatory clearance of the Cardima Tracer Over-the-Wire Mapping Microcatheter. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety and effectiveness testing, but it does not include a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in a way that aligns with a typical AI/software device evaluation.

The information provided is for a physical medical device, not an AI/software product, which typically has quantitative performance metrics for acceptance criteria. As such, I will interpret "acceptance criteria" based on the described safety and effectiveness evaluations for this type of device.

Here's an attempt to answer the request based on the provided text, highlighting where information is not available due to the nature of the device and the provided document:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The Cardima Tracer Over-the-Wire Mapping Microcatheter received clearance based on demonstrating substantial equivalence to a predicate device (Cardima 2.5F Pathfinder electrode recording catheter, K955802) and through safety and effectiveness evaluations. The "acceptance criteria" for this type of device primarily revolve around material compatibility, mechanical/electrical integrity, and biological safety and performance in a relevant physiological environment.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Summary from text)
Substantial Equivalence	Similarities in labeling, design, materials, physical characteristics to predicate device.	"Establishment of equivalence was based on similarities of labeling, design, materials, and physical characteristics as evaluated by physical bench testing, biocompatibility and animal studies."
Biocompatibility	Acceptable biological response to device materials per ISO 10993-1.	"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/Mechanical & Electrical Properties	Acceptable mechanical and electrical integrity under specified conditions.	"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."
Maneuverability (In Vivo)	Catheter can be positioned into target anatomical locations (coronary sinus, distal coronary veins) without difficulty.	"The catheter could be positioned into the coronary sinus and distal coronary veins without difficulty."
Signal Quality (In Vivo)	Signals of good quality and adequate for clinical applications.	"Signals were of good quality and adequate for clinical applications."
Pacing Capability (In Vivo)	Capable of temporary epicardial pacing.	"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.)."
Safety (Tissue Injury)	No or clinically insignificant tissue damage (e.g., rupture, thrombosis, significant hemorrhage, effusion).	"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."
Sterilization	Sterility maintained without introducing new challenges.	"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 validated sterilization process. Given these considerations re-validating the sterilization process used for Tracer was deemed unnecessary."

2. Sample size used for the test set and the data provenance

Animal Studies: The animal study for maneuverability, signal quality, and pacing involved an unspecified number of animals/instances, but pacing was conducted on "twelve occasions". The provenance is not explicitly stated but implies a controlled laboratory setting (likely within the USA). The study appears to be prospective in nature, as it describes the conduct and results of specific tests.
Bench Testing: Sample sizes for reliability and mechanical/electrical property testing are not specified, nor is the provenance, but it would have been conducted in a laboratory setting.
Biocompatibility: The biocompatibility testing was conducted on the Pathfinder predicate device and deemed applicable to the Tracer. The sample size for this original testing is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this physical device evaluation. The "ground truth" was established through objective measurements (e.g., signal recording, pacing threshold measurements, post-mortem examination) and established regulatory standards (e.g., ISO 10993-1, Electrode Recording Catheter Preliminary Guidance).

4. Adjudication method for the test set

Not applicable. The evaluation methods described (bench testing, animal studies, biocompatibility) rely on objective measurements and established protocols rather than expert adjudication of subjective assessments.

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

Not applicable. This is a physical medical device, not an AI/software algorithm. No human reader studies or AI assistance were part of this evaluation.

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

Not applicable. This refers to a physical medical device, not an algorithm.

7. The type of ground truth used

Bench Testing: Physical and electrical measurements.
Biocompatibility: Results against ISO 10993-1 standards for biological response.
Animal Studies: Direct observations during catheter placement, recorded electrical signals, measured pacing thresholds, and macroscopic/microscopic examination of tissues post-mortem. This could be considered outcomes data or pathology in the animal model.

8. The sample size for the training set

Not applicable. This is a physical medical device clearance, not an AI/ML model that requires a training set. The "development" of the device involves engineering and design, validated through the described testing.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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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:

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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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

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).