(118 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, as shown in Figure II.I. 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 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 and directions of interest within the heart. Refer to Figure 10.1 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 provided text describes modifications to an existing device, the AcQMap 3D Imaging and Mapping Catheter, and asserts its substantial equivalence to a predicate device. It does not contain acceptance criteria or a study directly proving the modified device meets them in the traditional sense of a clinical performance study for AI devices. Instead, it relies on substantial equivalence to the predicate device, which had prior clinical testing.
Therefore, the following information will be extracted or inferred to the best of my ability from the provided document, addressing each of your points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the modified device in the context of clinical effectiveness. Instead, it relies on the predicate device's clinical performance and non-clinical testing for the modified device to demonstrate substantial equivalence.
The "acceptance criteria" for this submission are implicitly that the modified device does not raise new questions of safety or effectiveness compared to the predicate device. The reported performance relies on the predicate device's clinical study and the modified device's non-clinical testing.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Modified Device) |
|---|---|
| Safety: | Biocompatibility: Passed biocompatibility testing, including NAVI testing. |
| Sterilization: Sterilization validation performed (changed from e-beam to EO method). | |
| Mechanical Integrity: Met established specifications through mechanical testing (tensile testing). | |
| Corrosion Resistance: Passed corrosion testing. | |
| Electrode Coating Particulate: Passed electrode coating particulate testing. | |
| Acoustic Output: Maintained identical acoustic output (MI 0.06, ISTPA.3 0.08 mW/cm2, ISPPA.3 1.03) as the predicate, which itself would have been shown to be safe within regulatory limits. | |
| Usability: Usability testing performed. | |
| Effectiveness: | Dimensional Accuracy: Passed dimensional inspection. |
| Functional Performance (Electrical): Passed functional (electrical) and compatibility testing. | |
| Accuracy of Mapping/Imaging: Accuracy testing performed. | |
| Shelf Life & Packaging: Validated. | |
| Clinical Effectiveness: The clinical validation of the original AcQMap 3D Imaging Catheter (K170819) is applicable and demonstrated safety and effectiveness for its intended use in 84 patients based on "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" study. This study demonstrated that the AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use, which is identical to the modified device. | |
| Identical Indications for Use | The indications for use for the modified device are identical to those of the predicate device. |
| No New Questions of Safety/Effectiveness | The non-clinical testing demonstrates that the modified AcQMap 3D Imaging and Mapping Catheter does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
For the modified device, no clinical test set is described. The submission relies on non-clinical (bench) testing.
For the predicate device (clinical testing incorporated by reference):
- 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 Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The document refers to the "DDRAMATIC-SVT" study for the predicate device but does not detail how ground truth was established within that study or the number/qualifications of experts involved. Given it's an invasive medical device for mapping arrhythmias, the "ground truth" would likely involve comparison to established clinical methods and expert interpretation of the complex arrhythmia data, but specifics are absent here.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device (AcQMap 3D Imaging and Mapping Catheter) is an imaging and mapping catheter for collecting ultrasound data and electrical impulses, not an AI-assisted diagnostic or interpretation tool for human readers in the traditional sense of an MRMC study. It collects data that physicians then use. The document does not describe any human-in-the-loop performance evaluation or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an "algorithm only" performance that would typically be seen for AI products. The device itself is designed to function and capture data. The "standalone" performance here refers to the device's ability to "collect ultrasound data for visualizing the selected chamber and recording electrical impulses," which was assessed through non-clinical accuracy and functional testing and clinically by its ability to facilitate identification of complex arrhythmias, as demonstrated by the predicate device's clinical study. The device itself performs the data acquisition, which is then presented to clinicians.
7. The Type of Ground Truth Used
For the predicate device's clinical study (DDRAMATIC-SVT), the document does not explicitly state the type of ground truth used. However, for a device intended to help identify "complex arrhythmias that may be difficult to identify using conventional mapping systems alone," the ground truth would likely involve:
- Clinical Outcomes/Resolution: Efficacy in guiding successful ablation or treatment of arrhythmias.
- Expert Consensus/Diagnosis: Comparison of the mapping system's output to expert electrophysiologist (EP) diagnoses using established clinical practices or other validated mapping techniques.
For the non-clinical testing of the modified device, the "ground truth" would be against engineering specifications and known physical properties and measurements (e.g., dimensional accuracy, electrical performance, acoustic output measurements).
8. The Sample Size for the Training Set
This device is not described as an AI/ML device that requires a training set in the conventional sense. Therefore, information on a "training set" and its size is not applicable/provided.
9. How the Ground Truth for the Training Set was Established
As above, this is not applicable as the device is not presented as an AI/ML product with a training set.
§ 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).