(214 days)
The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to localize aberrant conduction pathways and to test for the susceptability of the cardiac chambers to arrhythmias.
The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is reinforced with a stainless steel braid to enhance torque control and allow easier maneuverability and has a soft tip to reduce the potential for vessel trauma during placement of the catheter. The tip of the catheter is fitted with up to ten platinum electrodes. No new electrode geometries are introduced. Catheters with various curve styles are also available to meet anatomical constraints as well as physician preference and technique.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:
The provided document describes a 510(k) premarket notification for an electrode recording catheter. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "study" described in the document are focused on showing that the new device performs similarly and is as safe and effective as the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Strength of each bond (tip electrode/tubing, shaft/tip tubing, connector/shaft) | Tensile testing demonstrated functional integrity. |
| Resistance to rotation until failure (tip electrode fixed) | Demonstrated functional integrity. | |
| Electrical Performance | Recording capabilities | Demonstrated functional integrity and performance characteristics. |
| Pacing capabilities | Demonstrated functional integrity and performance characteristics. | |
| Torque Performance | Torque performance testing | Demonstrated functional integrity and performance characteristics. |
| Biocompatibility | Compliance with Tripartite and ISO Guidelines for Medical Devices | Materials suitable for short-term, human intravascular use. |
| Sterilization | Ethylene oxide gas residuals compliance | Monitored for compliance to maximum releasable limits; no detrimental effects. |
| Bacterial endotoxin levels compliance | Monitored for compliance to maximum releasable limits; no detrimental effects. | |
| Overall Equivalence | Substantial equivalence to predicate devices (ELECATH's Investigator and DAIG's Response) in design and performance. | Demonstrated through comparative characteristics (Table 1) and functional testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes used for the mechanical, electrical, and torque performance tests. It refers to "testing" and "bench top models" without numerical specifics for the devices tested. For biocompatibility, it states "All testing was performed on sterilized samples" but again, no number is given.
- Data Provenance: The data appears to be prospective as it describes tests conducted on the proposed device. The source is Boston Scientific Corporation's internal testing. There is no mention of country of origin for the data; it's implicit to be from the manufacturer's testing facilities (likely in the USA, given the address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. This type of information (experts establishing ground truth) is typically relevant for studies involving human interpretation or clinical endpoints (e.g., diagnostic imaging studies). For a device like an electrode recording catheter, ground truth for performance characteristics is established through engineering and biomaterial testing against predefined technical specifications and standards, not through expert consensus in the clinical sense.
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, adjudication methods like 2+1 or 3+1 consensus are used when human interpretation or clinical outcomes require agreement among experts. The performance testing described (tensile strength, electrical recording, etc.) relies on instrumental measurements and objective criteria, not subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not mentioned and would not be relevant for this type of device submission. MRMC studies are used to evaluate the impact of a new diagnostic aid (like AI software) on human reader performance in interpreting medical images. This submission is for a physical medical device (catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is also not applicable. This is a physical medical device, not an algorithm or software device.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance is based on engineering specifications, established industry standards (e.g., for biocompatibility via Tripartite and ISO Guidelines), and functional testing results. For the comparative aspect, the ground truth is the established performance and design of the predicate devices. The claim is "functional integrity and performance characteristics that were substantially equivalent and acceptable."
8. The Sample Size for the Training Set:
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set." It is a physical medical device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As above, no training set for an algorithm is involved.
In summary, the provided document focuses on demonstrating the substantial equivalence of a new electrode recording catheter to existing predicate devices through comprehensive engineering, electrical, and biocompatibility testing. The "acceptance criteria" are implied by the stated performance characteristics and the assertion that these characteristics are "substantially equivalent and acceptable" given the predicate devices' established safety and effectiveness.
§ 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).