(133 days)
The Reprocessed Viking Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
The Reprocessed Viking Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing. The catheter has an insulated polymer shaft with platinum electrodes located along the distal section of the shaft.
This document is a 510(k) premarket notification for Reprocessed Viking Diagnostic Electrophysiology Catheters (K162251) by Innovative Health, LLC. It focuses on demonstrating substantial equivalence to a predicate device, not on the performance of a novel AI/ML algorithm. Therefore, many of the requested details related to AI/ML device studies are not applicable to this submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this reprocessed device are based on demonstrating that it performs as safely and effectively as the original, legally marketed predicate device. The study performed is a series of bench and laboratory tests to ensure the reprocessed device meets the original design specifications and safety standards.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | (Not explicitly detailed in this summary) | Meets established biocompatibility standards. |
| Cleaning Validation | (Not explicitly detailed in this summary) | Demonstrates effective removal of visible soil and decontamination. |
| Sterilization Validation | (Not explicitly detailed in this summary) | Demonstrates effective sterilization. |
| Functional Testing | - Visual Inspection |
- Dimensional Verification
- Electrical Continuity and Resistance
- Simulated Use
- Mechanical Characteristics | Meets original device specifications and performance. |
| Electrical Safety Testing| - Dielectric and Current Leakage | Meets electrical safety standards. |
| Packaging Validation | (Not explicitly detailed in this summary) | Demonstrates maintenance of sterility and integrity until use. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size for each test conducted. It states that "Bench and laboratory testing was conducted."
- Data Provenance: The tests were conducted internally by Innovative Health, LLC, as part of their reprocessing validation. This is a prospective testing environment to validate their reprocessing procedures. There is no indication of country of origin for data; it's assumed to be within the US where Innovative Health operates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the submission is for a reprocessed medical device, not an AI/ML device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for this device lies in its physical, electrical, and functional properties meeting specifications.
4. Adjudication method for the test set
Not applicable. The testing described involves objective measurements and validation against established standards for medical devices, rather than subjective expert 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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's safety and effectiveness is based on:
- Established medical device standards (e.g., for biocompatibility, sterility, electrical safety).
- The original design specifications and performance characteristics of the predicate device (C.R. Bard, Inc. Viking Diagnostic Electrode Catheter K971265).
- Objective measurements obtained from functional, dimensional, and electrical testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore no "training set" in the context of machine learning was used.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm in 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).