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510(k) Data Aggregation
(357 days)
Sterilmed Inc. (Johnson and Johnson)
The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter provides location information when used with compatible CARTO™ 3 EP Navigation Systems. This catheter is not compatible with CARTO™ 3 EP Navigation Systems prior to Version 3.x.
The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is designed to facilitate electrophysiological mapping of the heart with the CARTO® 3 EP Navigation System. It is designed for deployment in a heart chamber through an 8 Fr guiding sheath. This deflectable catheter consists of multiple 3 Fr spines on the distal tip, each spine having multiple platinum electrodes that are used for stimulation and recording. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO® 3 EP Navigation System. The catheter has two electrodes on the deflectable tip to provide for visualization of the tip when used with the CARTO® 3 EP Navigation System. Pushing forward on the catheter thumb knob deflects the tip; pulling back on the thumb knob straightens the tip. This catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid.
The provided text describes the 510(k) summary for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter. This document outlines the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are implicitly derived from demonstrating substantial equivalence to the predicate device, the original PENTARAY® NAV eco High-Density Mapping Catheter (Biosense Webster K123837). The tests performed cover various functional, safety, and manufacturing aspects to ensure the reprocessed device performs as intended and is safe for use.
| Acceptance Criteria (Implicitly from substantial equivalence to predicate) | Reported Device Performance |
|---|---|
| Functional Characteristics: | Performance testing demonstrates that the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter performs as originally intended. Specific tests included: Electrical Resistance and Isolation, Electrical Leakage, Leak test, Planarity, Curvature and Spine Spacing, CCS Calibration, Auto ID/EEPROM Reset Verification, Connector Cycling, Tip Stiffness, Tip Side Force, Tip Buckle, Fluid Integrity, Deflection Fatigue, Torsional Strength, Flexation Fatigue, Shaft Rotation Fatigue, Shaft and Connector Bond Strength, Micro Lumen Inspection, Final Rinse and blow out. |
| Cleaning and Sterilization Validation: | Process validation testing was performed to validate cleaning and sterilization. |
| Ethylene Oxide Residual Testing: (to ISO 10993-7 standard) | Testing performed to ISO 10993-7. |
| Packaging Validation: (to ASTM D4169, ASTM F88, ASTM F2096 standards) | Testing performed to ASTM D4169, ASTM F88, ASTM F2096. |
| Shelf-life Validation: (to ASTM 1980-07 standard) | Testing performed to ASTM 1980-07. |
| Biocompatibility: (per ISO 10993-1 for external communicating device, short duration contact with circulating blood ( |
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