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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., |
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