(463 days)
The AcQMap® 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.
The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device.
The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).
The information provided does not contain a typical "device performance" section with specific metrics like sensitivity, specificity, accuracy, or other quantifiable measures that would usually be compared against acceptance criteria in a table format.
This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified AcQMap 3D Imaging and Mapping Catheter (Model 900009) to a predicate AcQMap 3D Imaging and Mapping Catheter (Model 900009) (K201341). The key difference highlighted is the addition of a marker band.
Therefore, the acceptance criteria and study information largely revolve around demonstrating that this minor modification does not negatively impact safety or effectiveness, and that the original device's performance data is still applicable.
Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a modified device demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate and does not raise new issues of safety or effectiveness. Explicit numerical acceptance criteria are not presented for performance in the given text.
| Performance Characteristic | Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|---|
| Overall Safety & Effectiveness | No new or increased safety risks; performance similar to predicate | Demonstrated through nonclinical testing that modified device meets established specifications, and clinical data from original device is applicable. |
| Ultrasound Data Collection | Able to collect ultrasound data for visualizing the selected chamber. | Functional and Compatibility Testing and Accuracy Testing performed; results support intended use. |
| Electrical Impulse Recording | Able to record electrical impulses in patients with complex arrhythmias. | Functional and Compatibility Testing and Accuracy Testing performed; results support intended use. |
| 3D Anatomic Map Creation | Enables creation of 3D anatomic maps that display chamber-wide electrical activation. | Nonclinical testing demonstrates device "does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps." |
| Mechanical Integrity | Meeting mechanical specifications for intended use. | Mechanical Testing performed. |
| Corrosion Resistance | Resisting corrosion during intended use. | Corrosion Testing performed. |
| Electrode Coating Integrity | Acceptable particulate levels for electrode coating. | Electrode Coating Particulate Testing performed. |
| Acoustic Output | Within specified safe limits. | Acoustic Output Testing performed; MI = 0.06, ISTPA.3 = 0.08 (mW/cm²), ISPPA.3 = 1.03. |
| Usability | User interface and handling are acceptable. | Usability Testing performed. |
| Biocompatibility | Biologically safe for patient contact. | Biocompatibility Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance
- For the Modified Device (K210766):
- No new clinical (human patient) test set was described. The submission relies on nonclinical (bench) testing primarily because the modification (marker band) is considered minor and does not affect the core functionality.
- For nonclinical testing, specific sample sizes are not provided for each test but are implied to be sufficient for design verification and validation (e.g., "all necessary bench testing was conducted").
- For the Original AcQMap Catheter (K170819), referenced for clinical data:
- Test Set Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- For the Modified Device (K210766): Not applicable, as no new clinical study requiring expert ground truth establishment for patient data was performed. Nonclinical testing relies on engineering and scientific evaluation.
- For the Original AcQMap Catheter (K170819) clinical study: The text does not specify the number of experts or their qualifications for establishing ground truth in the "DDRAMATIC-SVT" study. It was a clinical study involving patients with "complex arrhythmias," implying diagnosis and assessment by medical professionals, but details are not provided.
4. Adjudication Method for the Test Set
- For the Modified Device (K210766): Not applicable for clinical data. For nonclinical tests, adjudication methods are typically internal quality control and verification processes, but no specific multi-reviewer adjudication method is described.
- For the Original AcQMap Catheter (K170819) clinical study: The text does not specify any adjudication method used in the "DDRAMATIC-SVT" study.
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 MRMC comparative effectiveness study is described. The device is a diagnostic and mapping catheter, not explicitly an AI-assisted interpretation tool in the context of MRMC studies typical for image analysis. The "AI" component is not referenced in this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes a medical device (catheter) that collects data for visualization and recording electrical impulses. It is used with the AcQMap High Resolution Imaging and Mapping System. The performance described relates to the catheter's ability to acquire accurate data for mapping and imaging. It is not an "algorithm-only" performance study in the sense of a standalone AI diagnostic tool. Its function is to provide inputs for human interpretation and system processing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the Modified Device (K210766): For nonclinical testing, the "ground truth" would be established engineering specifications, validated test methods, and industry standards.
- For the Original AcQMap Catheter (K170819) clinical study: The study "DDRAMATIC-SVT" assessed "safety and effectiveness for its intended use" in patients with complex arrhythmias. This implies that clinical outcomes, diagnostic accuracy in identifying arrhythmias, and safety endpoints defined in the study protocol would form the "ground truth" or primary endpoints. Specific details are not provided.
8. The Sample Size for the Training Set
- The provided document describes a device (catheter) and references a clinical study for its safety and effectiveness. It does not mention any "training set" in the context of machine learning or AI algorithm development. The device's functionality is based on its physical design, sensors, and the underlying system's processing capabilities, not typically on a machine learning training dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as no training set for a machine learning algorithm is discussed in this document.
§ 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).