Medtronic, Inc. · Class II · Cleared Dec 5, 2024
| K-number | K243435 |
| Device name | Magnetic Localization Patch Kit (AFR-00021) |
| Applicant | Medtronic, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Dec 5, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The Affera Integrated Mapping System is a computerized diagnostic system for catheter-based cardiac electrophysiological mapping that displays catheter location in real time and cardiac electrical maps. The Magnetic Localization Patch Kit is an accessory consisting of two surface patches placed on the patient's skin to provide reference points for electromagnetic-based tracking during EP procedures.
The subject device uses magnetic localization (electromagnetic-based tracking only), whereas the predicate supported both electromagnetic and impedance-based tracking. The subject device includes only 2 patches (Anterior and Posterior, 50mm × 40mm each) compared to the predicate's 6 patches (100mm × 65mm each), since Left, Right, Superior, and Inferior patches are unnecessary for electromagnetic-only tracking.
Not stated in this summary. The document references design verification testing, design validation, pre-clinical animal testing, biocompatibility testing, and packaging validation but does not cite specific ISO, IEC, or ASTM standards by name.
The subject and predicate devices share the same intended use (catheter-based electrophysiological mapping) and both support electromagnetic-based tracking with similar Anterior and Posterior patches. The removal of impedance-based capability and the elimination of Left, Right, Superior, and Inferior patches do not raise different questions of safety or effectiveness because these patches are not needed for electromagnetic-only operation. All performance testing met acceptance criteria, demonstrating the subject device performs as intended without introducing new safety concerns.
View the full FDA submission: accessdata.fda.gov