(33 days)
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.
The subject device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and is steerable. These catheters have an outer diameter of 5F to 7F, a length ranging from 85 to 125 cm, with 4-20 platinum/iridium, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.
Here's a breakdown of the acceptance criteria and study information for the SterilMed Reprocessed Deflectable Electrophysiology Diagnostic Catheters, based on the provided text:
Important Note: This document (K051220) is a 510(k) summary for a reprocessed device. 510(k)s primarily focus on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or specific performance metrics against clinical acceptance criteria as would be typical for a de novo device or a significantly modified device. Therefore, the "acceptance criteria" here are geared towards demonstrating the reprocessed device is as safe and effective as the original, not establishing new clinical performance benchmarks. The study described focuses on functional and safety aspects, not clinical performance with human readers or standalone AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly) | Reported Device Performance |
|---|---|---|
| Functional Characteristics | Appropriate functional performance after reprocessing (e.g., steerability, electrical conductivity, tip deflection, electrode integrity) | "Representative samples... underwent design testing to demonstrate appropriate functional characteristics." |
| Biocompatibility | Compatibility of device materials after reprocessing (no new patient risks from materials) | "Biocompatibility testing to demonstrate compatibility of the device materials." |
| Manufacturing Process Quality | Visual integrity and functional performance of all individual reprocessed units | "The manufacturing process includes visual and functional testing of all products produced." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Representative samples of reprocessed deflectable electrophysiology diagnostic catheters" were used. A specific number is not provided in this summary.
- Data Provenance: Not explicitly stated, but given it's a reprocessed device, the testing would involve commercially available used devices that then undergo the reprocessing cycle. The testing itself would be prospective in nature relative to the reprocessing process. The country of origin for the data is implicitly the United States, as the filing is with the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable / Not Provided. This type of information is generally relevant for studies involving subjective assessments (e.g., image interpretation) where expert consensus establishes a "ground truth." For functional and biocompatibility testing of a medical device like a catheter, the "ground truth" is defined by objective engineering specifications and scientific testing methods, not by expert interpretation in the same way. The individuals conducting the testing would be qualified engineers, technicians, and scientists.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human interpreters or reviewers to establish a consensus ground truth. As mentioned above, the testing here is objective functional and biocompatibility testing, not interpretative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted nor is it applicable to this device. This device is a reprocessed electrophysiology catheter, which is a physical medical instrument. MRMC studies are typically performed for diagnostic imaging devices or AI algorithms that assist human interpretation. There is no "human reader" involved in the "interpretation" of a catheter's function in the way an MRMC study evaluates.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone performance study for an algorithm was not conducted nor is it applicable. This device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
- The ground truth for the functional testing was based on engineering specifications and performance parameters expected of a new, equivalent electrophysiology diagnostic catheter.
- The ground truth for biocompatibility was based on established biocompatibility standards and tests (e.g., ISO 10993 series) for medical device materials.
- The ground truth for manufacturing process quality was based on internal quality control specifications for visual and functional attributes.
8. Sample Size for the Training Set
- Not Applicable. This document describes a reprocessed medical device, not an AI or machine learning model that would require a "training set." The focus is on verifying the physical device's performance after reprocessing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to this submission.
§ 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).