(28 days)
The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
The Cordis Webster REF-STAR External Reference Patch is indicated for the use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.
The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.
The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.
The provided document describes a 510(k) summary for the REF-STAR External Reference Patch. It is a submission for substantial equivalence to a predicate device, not a study proving a novel device meets specific acceptance criteria in a clinical setting with human subjects. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes "Verification testing" to confirm the device's characteristics against a predicate. It does not list specific numerical acceptance criteria or performance metrics directly from the testing. The statement is broad, indicating the new device's technological characteristics are the same as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Structural Integrity | Verified (compared to Predicate Device) |
| Electrical Integrity | Verified (compared to Predicate Device) |
| Adhesive Durability | Verified (compared to Predicate Device) |
| Technological Characteristics | Same as Predicate Device |
| Intended Use | Provides reference location with CARTO and NOGA systems for catheter tip location and electrogram information. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It refers to "Verification testing" but doesn't elaborate on the methodology or data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a regulatory filing for a device, not a study involving expert-established ground truth. The device's function is purely technical in providing a reference location.
4. Adjudication method for the test set
Not applicable. This does not involve adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This device is a passive external reference patch, not an AI or diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a hardware component. Its performance is inherent to its physical and electrical properties when integrated into the CARTO and NOGA systems. It does not have an "algorithm only" mode.
7. The type of ground truth used
"Verification testing" was conducted against the "Predicate Device." The ground truth for proving the new device's performance is essentially the established performance and characteristics of the existing, legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
§ 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).