(652 days)
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.
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.
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).
§ 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).