Who is the manufacturer of Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Sterilmed Inc. (Johnson and Johnson) filed the 510(k) submission for Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806).

What is the FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

MTD. It is classified under 21 CFR 870.1220 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

PENTARAY® NAV eco High-Density Mapping Catheter (K123837).

Who can help prepare an FDA 510(k) submission like Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

K201806 · Sterilmed Inc. (Johnson and Johnson) · MTD · Jun 23, 2021 · Cardiovascular

Device Facts

Record ID	K201806
Device Name	Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Applicant	Sterilmed Inc. (Johnson and Johnson)
Product Code	MTD · Cardiovascular
Decision Date	Jun 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

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.

Device Story

Deflectable, multi-electrode mapping catheter; used for electrophysiological mapping and pacing in cardiac chambers. Input: electrical signals from heart tissue via 20 platinum electrodes on 5 flexible spines; magnetic location data from embedded sensor. Operation: physician inserts catheter through 8 Fr guiding sheath; thumb knob controls tip deflection/straightening; irrigation lumen connects to anticoagulant fluid source. Output: electrograms and location data transmitted to CARTO™ 3 EP Navigation System. Healthcare provider uses system visualization to guide mapping and clinical decision-making for cardiac arrhythmias. Benefits: enables high-density mapping of cardiac structures.

Clinical Evidence

No clinical data. Bench testing only. Validation included cleaning/sterilization verification, biocompatibility (ISO 10993-1), and functional performance testing (simulated use, fatigue, electrical leakage, tip stiffness, deflection, torsional strength, and bond strength).

Technological Characteristics

7 Fr, 115 cm deflectable catheter. 5 flexible spines with 20 ring electrodes (4-4-4 or 2-6-2 mm spacing) plus 2 tip electrodes for ACL technology. Magnetic location sensor. Materials: platinum electrodes. Connectivity: compatible with CARTO™ 3 EP Navigation System. Sterilization: ethylene oxide.

Indications for Use

Indicated for multiple electrode electrophysiological mapping (recording or stimulation) of cardiac structures in atrial and ventricular regions. For use with compatible CARTO™ 3 EP Navigation Systems (Version 3.x or later).

Regulatory Classification

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.

Predicate Devices

PENTARAY® NAV eco High-Density Mapping Catheter (K123837)

Related Devices

K211438 — OPTRELL Mapping Catheter with TRUEref Technology · Biosense Webster, Inc. · Mar 18, 2022
K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009) · Medtronic · Aug 7, 2024
K201750 — Pentaray Nav eco High-Density Mapping Catheter · Biosense Webster, Inc. · Aug 6, 2020
K193237 — Carto Octaray Mapping Catheter with Trueref Technology · Biosense Webster, Inc. · Jul 31, 2020
K211219 — LASSOSTAR NAV Circular Mapping Catheter · Biosense Webster, Inc. · Jan 26, 2022

Submission Summary (Full Text)

{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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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 Webster Model Numbers | Sterilmed Model Numbers | Description | |----------------------------------------------------------------------------|--------------------------------------|----------------------------|----------------------------------------| | Reprocessed PENTARAY® NAV eco High-Density Mapping 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;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ 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 Manufacturer: | Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 www.sterilmed.com | | | Manufacturing Facility Address: | 11400 73rd Avenue North Maple Grove MN 55369 | | | Official Correspondent: | Jan Flegeau Associate Director, Regulatory Affairs Sterilmed, Inc. Tel: 786-575-5903 Email: jflegeau@its.jnj.com | | | Trade Name: | Reprocessed PENTARAY® NAV eco High-Density Mapping 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 (Biosense Webster K123837) | | | Device Description: | 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. | | | | | | | 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 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. | | | Technological Characteristics: | The Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter family is a 7 Fr, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram mapping and pacing in all chambers (atria and ventricles) of the heart. The catheters have five flexible spines, each with four ring electrodes for a total of 20 electrodes. There are two different electrode spacing configurations (4-4-4 or 2-6-2mm) and two different curves (F or D) in order to accommodate different clinical situations. The tip of the shaft houses a Magnetic Location Sensor that provides magnetic location information when used with the CARTO® 3 EP Navigation System. In addition to the 20 spine electrodes, two additional Ring Electrodes are located near the tip of the shaft for a total of 22 ring electrodes that provide location information via Advanced Catheter Location (ACL) technology when used with the CARTO® 3 EP Navigation System. | | | Functional and Safety Testing: | Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate cleaning and sterilization as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced. The PENTARAY® NAV eco High-Density Mapping Catheter | | | | | | | Summary of Non-Clinical Tests Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization verification, ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, and fatigue testing. Testing performed: 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 PENTARAY® NAV eco High-Density Mapping Catheter performs as originally intended. In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (<24 hours). Biocompatibility testing included: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Hemocompatibility Thrombogenicity Pyrogenicity | | | Conclusion: | Sterilmed conducted performance testing for the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter against the OEM predicate device, the PENTARAY® NAV eco High-Density Mapping Catheter (K123837). Results demonstrated substantial equivalence to the predicate device. Sterilmed therefore concludes that the Reprocessed PENTARAY® NAV eco High-Density Mapping Catheter is substantially equivalent to the predicate device, the PENTARAY® NAV eco High-Density Mapping Catheter. | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------