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510(k) Data Aggregation
(55 days)
The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM, is a sterile, single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two paddle magnetic sensors, two distal shaft ring electrodes, two shaft magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an insertion tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is intended to be used with the EnSiteTM X EP System and other accessories, including the connecting cable and commercially available irrigation pumps.
This document is a 510(k) summary for the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™. It states that the device is substantially equivalent to a predicate device and includes a summary of non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria alongside specific quantitative device performance metrics. Instead, it states:
| Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Bench design verification activities were performed and met their respective acceptance criteria. | Testing included dimensional, visual, mechanical integrity, simulated use, electrical, packaging, and shelf-life testing to assess substantial equivalence. Additionally, biocompatibility testing was conducted per the voluntary consensus standards under ISO 10993 and met all the biocompatibility endpoints for a medical device category for an external communicating medical device with limited (≤24 hour) circulating blood contact. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench design verification activities" and "biocompatibility testing." These are typically conducted in a lab environment using manufactured samples of the device.
- Sample Size for Test Set: Not explicitly stated in terms of number of devices or data points, but implies standard engineering and biocompatibility test sample sizes.
- Data Provenance: The tests are "bench design verification activities" and "biocompatibility testing." This typically refers to retrospective testing on manufactured devices, not prospective clinical studies with human or animal subjects. The origin is likely the manufacturer (Abbott Medical, Plymouth, MN, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Bench and biocompatibility testing typically rely on standardized protocols and measurements, rather than expert consensus on "ground truth" in the way clinical studies might.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials involving human interpretation of data, which is not the type of testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states "Non-Clinical Testing Summary" and focuses on bench and biocompatibility tests. It does not mention any clinical studies, MRMC studies, or human reader performance.
6. Standalone (Algorithm Only) Performance Study
No. The device is a physical catheter, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical testing would be the physical and chemical specifications and performance standards outlined in the design and verification protocols for the device components and overall system, as well as the established safety criteria in ISO 10993 for biocompatibility. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
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(59 days)
The NeuTrace EP Mapping System v2.1 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The NeuTrace EP Mapping System v2.1 provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure in the right atrium. The system has no special contraindications.
The NeuTrace EP Mapping System v2.1 (NeuTrace System) is an advanced 3D electroanatomical mapping (EAM) and analysis system capable of:
- Displaying catheter location during electrophysiology mapping procedures
- Displaving 3D images of cardiac structures
- Displaying cardiac activity signals as waveforms (ECGs and EGMs)
- Displaying derived voltage and time metric overlays over cardiac models -. including Peak-to-Peak Voltage, Local Activation Time (LAT), Fractionation, and Minimum dV/dt
The NeuTrace System comprises the following software and hardware components:
- NeuTrace Workstation
- Window field generator
- System control unit
- System interface unit
- Interface switches and connection cables
- NeuTrace Software Application v2.1
- NeuTrace Streaming Application Software v2.0 0
The NeuTrace System is used together with compatible recording systems and compatible catheters listed in the device labeling to perform its intended use to support electrophysiology procedures in the right atrium.
Here's an analysis of the provided text, extracting information related to the acceptance criteria and the study proving the device meets those criteria:
Device Name: NeuTrace EP Mapping System v.2.1
Product Code: DQK
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a formal "acceptance criteria" table with pre-defined thresholds. Instead, it describes performance metrics that were measured and the results achieved, which implicitly serve as the "met criteria." The "Comments" column indicates whether the observed performance meets or aligns with expectations for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Ground-truth Accuracy | Expected to be low (e.g., < 1mm) and comparable to predicate/reference devices. | Statistically demonstrated as < 1mm | Meets implicit criterion. Demonstrates high accuracy essential for EP mapping systems. |
| Shift | Expected to be low (e.g., < 1mm). | < 1mm | Meets implicit criterion. Indicates stability of localization. |
| Drift | Expected to be low (e.g., < 2mm). | < 2mm | Meets implicit criterion. Indicates stability of localization over time. |
| 3D Geometry Generation | Equivalent generation of 3D geometries compared with the predicate (CARTO 3 System). | Equivalent generation of 3D geometries compared with CARTO 3 System | Demonstrated equivalence to the predicate, indicating comparable functionality for creating anatomical models. |
| Map Generation (Voltage, LAT, Fractionation) | Equivalent performance compared with the reference (EnSite X System) for relevant maps. | Equivalent accuracy and performance compared with EnSite X System (using FlexAbility™ Ablation Cathether, Sensor Enabled™) for peak-to-peak voltage maps, Local Activation Time (LAT) maps, and fractionation maps. | Demonstrated equivalence to the reference device for key electrophysiological maps, ensuring comparable diagnostic information. Note: NeuTrace does not include impedance maps, which were present in reference devices, but this is stated as not required for their intended use. |
| System Performance (Overall) | Meets all specifications and user requirements. Operates as intended for catheter-based cardiac EP procedures. | Passed all testing and met all design specifications and user requirements. | Overall system performance verified through comprehensive testing. |
| Software Verification & Validation | Compliant with software development standards and functional requirements. | Performed | Assures software quality and reliability. |
| Hardware Verification | Meets specifications for shift, drift, and intrinsic time delay. | Includes 4-hour shift and drift testing and intrinsic time delay testing. | Ensures hardware robustness and accurate timing. |
| Cybersecurity Risk Management & Testing | Compliant with cybersecurity standards for medical devices. | Performed | Addresses potential cybersecurity vulnerabilities. |
| EMC/EMI Testing | Compliant with IEC 60601-1 and IEC 60601-1-2 standards. | Performed per IEC 60601-1 and IEC 60601-1-2 | Ensures electromagnetic compatibility and safety. |
| NeuTrace-EnSite accuracy and equivalency testing | Accuracy and performance equivalent to EnSite X System. | Performed; demonstrated equivalent accuracy and performance. | Confirms performance parity with a key reference device. |
| NeuTrace-CARTO geometry and mapping equivalency analyses | Geometry and mapping generation equivalent to CARTO 3 System. | Performed; demonstrated equivalent generation of 3D geometries and maps. | Confirms performance parity with the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (e.g., number of cases, number of data points) used for the bench testing or the GLP animal study. It only states that a GLP animal study was performed.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but a "GLP animal study" implies prospective data collection under Good Laboratory Practice principles. Bench testing is inherently prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document does not provide any information on the number of experts used or their qualifications for establishing ground truth, especially for the animal study.
- The "ground-truth accuracy" results (e.g., < 1mm) suggest that a highly precise physical measurement system was used as the ground truth, rather than human expert interpretation of images or data.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for the test set. Given the context of a 3D electroanatomical mapping system and the nature of the performance metrics (accuracy, shift, drift, geometric equivalence), the ground truth seems to be derived from physical measurements or direct comparisons to established systems/methods rather than interpretations requiring human consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done involving human readers improving with AI vs. without AI assistance.
- This device is an EP mapping system, providing objective electrical and anatomical data, not an AI-assisted diagnostic imaging interpretation tool that would typically undergo MRMC studies. Its function is to provide information for the clinician, not to make a diagnosis or interpretation in place of one.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- The performance data presented (accuracy, shift, drift, geometry, and map generation) are inherently standalone performance of the system's ability to localize and generate data. The system itself generates the maps and measurements; it's not a human-in-the-loop scenario where a human is assisted by AI to perform a task. The NeuTrace system provides the foundational spatial and electrical data directly.
7. Type of Ground Truth Used
- The type of ground truth used appears to be based on highly precise physical measurements and direct comparisons to established, validated predicate/reference systems.
- For accuracy, shift, and drift: Likely precise physical measurement systems (e.g., optical tracking, high-precision fiducial markers) were used in conjunction with the device's own measurements.
- For 3D geometry and map generation: The ground truth was established by direct comparison to the performance of the predicate (CARTO 3 System) and reference (EnSite X System) devices, which are already considered established and validated standards in the field.
8. Sample Size for the Training Set
- The document does not specify any sample size for a training set. This makes sense given that the NeuTrace EP Mapping System v.2.1 is described as an "advanced 3D electroanatomical mapping (EAM) and analysis system" that relies on "Magnetic-based localization" and "derived voltage and time metric overlays." This suggests an algorithmic or physics-based system, rather than a machine learning/AI system that requires a dedicated training set to learn from data.
9. How Ground Truth for the Training Set Was Established
- Since no training set is mentioned (implying a non-ML/AI driven system), there is no information provided on how ground truth for a training set was established.
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