← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K150631 # St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631) _St Jude Medical · DRF · Apr 1, 2015 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K150631 ## Device Facts - **Applicant:** St Jude Medical - **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md) - **Decision Date:** Apr 1, 2015 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1220 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Intended Use The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. ## Device Story Diagnostic electrophysiology catheter; used for mapping cardiac arrhythmias from endocardial/intravascular sites. MediGuide Enabled version incorporates passive sensor at tip; tracked by MediGuide gMPS system; superimposes 3D catheter tip position onto 2D X-ray images in real-time. Used in clinical electrophysiology labs; operated by physicians. Provides real-time navigation/positioning adjunct to fluoroscopy; reduces radiation exposure by allowing visualization of catheter tip without continuous fluoroscopy. Transmits electrical signals to ECG; assists in diagnostic evaluation of cardiac arrhythmias. ## Clinical Evidence Bench testing only. Historical bench test data for buckle force was evaluated to establish updated specifications. ## Technological Characteristics Flexible electrode catheter; polyurethane insulation/shaft; platinum electrodes. Includes passive sensor for gMPS tracking. Steerable tip via proximal remote control. Compatible with MediGuide gMPS system for real-time navigation. ## Regulatory 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 - St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter ([K101955](/device/K101955.md)) - Livewire™ Electrophysiology Catheter ([K102721](/device/K102721.md)) - Livewire™ Electrophysiology Catheter ([K022380](/device/K022380.md)) - Livewire™ Electrophysiology Catheter ([K913940](/device/K913940.md)) ## Related Devices - [K101955](/device/K101955.md) — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 · St Jude Medical · Oct 15, 2010 - [K151622](/device/K151622.md) — St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter · St Jude Medical · Jul 15, 2015 - [K211438](/device/K211438.md) — OPTRELL Mapping Catheter with TRUEref Technology · Biosense Webster, Inc. · Mar 18, 2022 - [K013083](/device/K013083.md) — CARTO XP EP NAVIGATION SYSTEM · Biosense Webster, Inc. · Nov 21, 2001 - [K160335](/device/K160335.md) — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D · St Jude Medical · Dec 13, 2016 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 1, 2015 St. Jude Medical Harlan Jones Sr. Regulatory Affairs Specialist 14901 De Veau Place Minnetonka, Minnesota 55345-2126 Re: K150631 Trade/Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: March 10, 2015 Received: March 11, 2015 Dear Harlan Jones: We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general controls provisions of the Act. 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 devices are 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 {1}------------------------------------------------ with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Shawn W. Forrest -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): K150631 Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Indications for Use: - The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used with ● evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. - The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with . MediGuide™ Technology to enable real-time tip positioning and navigation. - The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): K150631 Device Name: Livewire™ Steerable Electrophysiology Catheter Indications for Use: St. Jude Medical (SJM™) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {4}------------------------------------------------ # St. Jude Medical – 510(k) Summary | 510(k) Summary | | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K150631 | | Submitter Information: | | | Date Prepared: | 06 March 2015 | | Submitter Name &<br>Address: | St. Jude Medical - Atrial Fibrillation Division<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 3005188751 | | Contact Person: | Harlan Jones<br>Senior Regulatory Affairs Specialist<br>Phone (651) 756-3429<br>Fax (651) 756-3298<br>HJones02@sjm.com | | Device Information: | | | Trade Name: | St. Jude Medical MediGuide Enabled Livewire Steerable<br>Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | St. Jude Medical MediGuide Enabled Livewire Steerable<br>Electrophysiology Catheter (K101955) | | Device Description: | The MediGuide Enabled Livewire Steerable Electrophysiology<br>Catheter is designed to allow electrophysiological mapping at<br>various endocardial and intravascular sites including the inferior<br>vena cava, superior vena cava, pulmonary veins and coronary sinus. | | | The use of the MediGuide Enabled Livewire diagnostic mapping<br>catheter in conjunction with the MediGuide gMPS system allows<br>real-time tip positioning and navigation during routine diagnostic<br>evaluation. | | | When connected to the ECG, the MediGuide Enabled Livewire<br>Catheter will transmit routine electrical signals while the passive<br>sensor at the tip of the catheter is tracked by gMPS and is<br>superimposed on any 2D X-ray image in real time (“Live”)<br>fluoroscopy mode (the actual 3D position of the catheter tip is<br>projected on the real time 2D image). | | Intended Use:<br>(Indications for Use) | The SJM™ Livewire™ Diagnostic Catheter, MediGuide<br>Enabled™ can be used in the evaluation of a variety of cardiac<br>arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is<br>compatible with MediGuide™ Technology to enable real-time | | | tip positioning and navigation. | | | • The MediGuide™ Technology is indicated for use as an adjunct | | | to fluoroscopy. | | Comparison to<br>Predicate Devices | The MediGuide Enabled Livewire Steerable Electrophysiology<br>Catheter that is the subject of this application remains substantially<br>equivalent to the predicate device. The changes made to the buckle<br>force requirement do not alter the fundamental design, packaging,<br>biocompatibility, sterilization or labeling. | | Summary on Non-<br>Clinical Testing | Historical bench test data for buckle force was evaluated to set the<br>proposed buckle force specifications. | | Statement of<br>Equivalence | The MediGuide Enabled Livewire Steerable Electrophysiology<br>Catheter that is the subject of this application has the same<br>indications for use and technological characteristics as the predicate<br>device. Based on this and the data provided in this pre-market<br>notification, the subject device remains substantially equivalent to<br>the predicate device. | | Device Information: | | | Trade Name: | Livewire™ Steerable Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | Livewire™ Electrophysiology Catheter (K102721, K022380,<br>K913940) | | Device Description: | The SJM Livewire™ Steerable Electrophysiology Catheter is a<br>flexible electrode catheter constructed of a polyurethane<br>insulation/shaft and incorporates platinum electrodes. The active tip<br>may be manipulated by a remote means located at the proximal end<br>of the catheter. | | Intended Use:<br>(Indications for Use) | The SJM Livewire™ Steerable Electrophysiology Catheter can be<br>used in the evaluation of a variety of cardiac arrhythmias from<br>endocardial and intravascular sites. | | Comparison to<br>Predicate Devices | The Livewire Steerable Electrophysiology Catheter that is the<br>subject of this application remains substantially equivalent to the<br>predicate device. The changes made to the buckle force requirement<br>do not alter the fundamental design, packaging, biocompatibility,<br>sterilization or labeling. | | Summary on Non-<br>Clinical Testing | Historical bench test data for buckle force was evaluated to set the<br>proposed buckle force specifications. | | Statement of<br>Equivalence | The Livewire Steerable Electrophysiology Catheter that is the<br>subject of this application has the same indications for use and<br>technological characteristics as the predicate device. Based on this<br>and the data provided in this pre-market notification, the subject<br>device remains substantially equivalent to the predicate device. | {5}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K150631](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K150631) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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