Reprocessed PentaRay Nav eco High-Density Mapping Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. June 23, 2021 Sterilmed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Parkway N, Suite 2 Plymouth, Minnesota 55446 Re: K201806 Trade/Device Name: Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: NLG Dated: Mav 20, 2021 Received: May 21, 2021 Dear Jan Flegeau: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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Sincerely, Aneesh Deoras Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | Device Name | Biosense<br>Webster<br>Model Numbers | Sterilmed<br>Model Numbers | Description | |----------------------------------------------------------------------------|--------------------------------------|----------------------------|----------------------------------------| | Reprocessed<br>PENTARAY®<br>NAV eco<br>High-Density<br>Mapping<br>Catheter | D128207 | RD128207 | 7Fr, F Curve, 4-4-4 mm spacing, 115 cm | | | D128208 | RD128208 | 7Fr, F Curve, 2-6-2 mm spacing, 115 cm | | | D128210 | RD128210 | 7Fr, D Curve, 4-4-4 mm spacing, 115 cm | | | D128211 | RD128211 | 7Fr, D Curve, 2-6-2 mm spacing, 115 cm | The following device models are included in the scope of this 510(k) submission: {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201806 Device Name Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter Indications for Use (Describe) 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 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(K) SUMMARY This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. | Date Prepared: | June 21, 2021 | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Submitter and<br>Manufacturer: | Sterilmed, Inc.<br>5010 Cheshire Parkway N, Suite 2<br>Plymouth, MN 55446<br>www.sterilmed.com | | | Manufacturing<br>Facility Address: | 11400 73rd Avenue<br>North Maple Grove<br>MN 55369 | | | Official<br>Correspondent: | Jan Flegeau<br>Associate Director, Regulatory Affairs<br>Sterilmed, Inc.<br>Tel: 786-575-5903<br>Email: jflegeau@its.jnj.com | | | Trade Name: | Reprocessed PENTARAY® NAV eco High-Density Mapping<br>Catheter | | | Regulation Name: | Catheter, Intracardiac Mapping, High-Density, Reprocessed | | | Common Name: | Deflectable Tip Electrophysiology Catheter-Diagnostic | | | Device Classification: | II | | | Product Code | NLG | | | Predicate Device: | PENTARAY® NAV eco High-Density Mapping Catheter<br>(Biosense Webster K123837) | | | Device Description: | The Reprocessed PENTARAY® NAV eco High-Density<br>Mapping Catheter is designed to facilitate electrophysiological<br>mapping of the heart with the CARTO® 3 EP Navigation<br>System. It is designed for deployment in a heart chamber<br>through an 8 Fr guiding sheath. This deflectable catheter<br>consists of multiple 3 Fr spines on the distal tip, each spine<br>having multiple platinum electrodes that are used for<br>stimulation and recording. A magnetic location sensor<br>embedded in the deflectable tip transmits location information<br>to the CARTO® 3 EP Navigation System. The catheter has two<br>electrodes on the deflectable tip to provide for visualization of<br>the tip when used with the CARTO® 3 EP Navigation System.<br>Pushing forward on the catheter thumb knob deflects the tip;<br>pulling back on the thumb knob straightens the tip. This<br>catheter includes an irrigation lumen for connection to a source<br>of continuous drip anticoagulant fluid. | | | | | | | Model Numbers | RD128207 | 7Fr, F Curve, 4-4-4 mm spacing, 115 cm | | | RD128208 | 7Fr, F Curve, 2-6-2 mm spacing, 115 cm | | | RD128210 | 7Fr, D Curve, 4-4-4 mm spacing, 115 cm | | | RD128211 | 7Fr, D Curve, 2-6-2 mm spacing, 115 cm | | Indications For Use: | The Reprocessed PENTARAY® NAV eco High-Density<br>Mapping Catheter is indicated for multiple electrode<br>electrophysiological mapping of cardiac structures in the heart,<br>i.e., recording or stimulation only. This catheter is intended to<br>obtain electrograms in the atrial and ventricular regions of the<br>heart. The Reprocessed PENTARAY® NAV eco High-Density<br>Mapping Catheter provides location information when used<br>with compatible CARTO® 3 EP Navigation Systems. This<br>catheter is not compatible with CARTO® 3 EP Navigation<br>Systems prior to Version 3.x. | | | Technological<br>Characteristics: | The Reprocessed PENTARAY® NAV eco High-Density<br>Mapping Catheter family is a 7 Fr, multi-electrode<br>electrophysiological mapping catheter designed for diagnostic<br>electrogram mapping and pacing in all chambers (atria and<br>ventricles) of the heart.<br>The catheters have five flexible spines, each with four ring<br>electrodes for a total of 20 electrodes. There are two different<br>electrode spacing configurations (4-4-4 or 2-6-2mm) and two<br>different curves (F or D) in order to accommodate different<br>clinical situations. The tip of the shaft houses a Magnetic<br>Location Sensor that provides magnetic location information<br>when used with the CARTO® 3 EP Navigation System. In<br>addition to the 20 spine electrodes, two additional Ring<br>Electrodes are located near the tip of the shaft for a total of 22<br>ring electrodes that provide location information via Advanced<br>Catheter Location (ACL) technology when used with the<br>CARTO® 3 EP Navigation System. | | | Functional and Safety<br>Testing: | Representative samples of reprocessed devices were tested to<br>demonstrate appropriate functional characteristics. Process<br>validation testing was performed to validate cleaning and<br>sterilization as well as device packaging. In addition, the<br>manufacturing process includes visual and validated functional<br>testing of all products produced.<br>The PENTARAY® NAV eco High-Density Mapping Catheter<br> | | | | | | | Summary of<br>Non-Clinical Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning<br>validation, sterilization verification, ethylene oxide residual<br>testing (ISO 10993-7), packaging validation (ASTM D4169,<br>ASTM F88, ASTM F2096), and shelf-life validation (ASTM<br>1980-07). In addition, validation of functional performance<br>(bench testing) was performed through simulated use, visual<br>inspection, and fatigue testing. Testing performed:<br>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 Performance testing demonstrates that the Reprocessed<br>PENTARAY® NAV eco High-Density Mapping Catheter<br>performs as originally intended.<br>In addition, the device was tested for biocompatibility<br>per ISO 10993-1 for external communicating device,<br>short duration contact with circulating blood (<24 hours).<br>Biocompatibility testing included:<br>Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Hemocompatibility Thrombogenicity Pyrogenicity | | | Conclusion: | Sterilmed conducted performance testing for the Reprocessed<br>PENTARAY® NAV eco High-Density Mapping Catheter<br>against the OEM predicate device, the PENTARAY® NAV<br>eco High-Density Mapping Catheter (K123837). Results<br>demonstrated substantial equivalence to the predicate device.<br>Sterilmed therefore concludes that the Reprocessed<br>PENTARAY® NAV eco High-Density Mapping Catheter is<br>substantially equivalent to the predicate device, the<br>PENTARAY® NAV eco High-Density Mapping Catheter. | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------