(62 days)
REFSTAR® PLUS with QWIKPATCH® External Reference Patch: The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable: The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.
The provided text describes a 510(k) premarket notification for the REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable. This submission focuses on establishing substantial equivalence to a predicate device, rather than a clinical study proving performance against acceptance criteria in the typical sense of AI/algorithm performance.
Therefore, many of the requested categories are not applicable to this type of submission. However, I will extract the available information and indicate where information is not present.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity (Implicit) | Passed bench testing to validate mechanical integrity. |
| Electrical integrity (Implicit) | Passed bench testing to validate electrical integrity. |
| Performance with CARTO® and NOGA® Systems (Implicit: "provide a reference point for catheter tip location") | Passed bench testing to validate performance with CARTO® and NOGA® Systems. |
| Substantial Equivalence to Predicate Device (Explicit requirement for 510(k) clearance) | Found substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended use, operating principles, fundamental scientific technology, design and performance. |
2. Sample size used for the test set and the data provenance
This section is not applicable. The submission describes "bench testing" for mechanical and electrical integrity and performance with systems. It does not refer to a test set of data derived from patients or human subjects. The provenance of any data used for bench testing is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth for a clinical or AI performance study is not relevant here as it's a device safety and performance validation through bench testing, not a clinical trial or AI algorithm evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There was no clinical test set requiring adjudication.
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
This section is not applicable. This is not an AI device, and no MRMC study was conducted or referenced. The device provides a reference point for catheter tip location within existing navigation systems (CARTO® and NOGA®), rather than AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is an external reference patch and cable, not a standalone algorithm. Its function is to provide an input (reference point) to the CARTO® and NOGA® systems, which are themselves non-fluoroscopic navigation systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable in the context of clinical "ground truth." The "ground truth" for the bench testing would have been established by engineering specifications, calibration standards, and expected performance parameters when integrated with the CARTO® and NOGA® systems.
8. The sample size for the training set
This section is not applicable. This is not an AI/machine learning device, so there is no concept of a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this device.
§ 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).