ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

K101955 · St Jude Medical · DRF · Oct 15, 2010 · Cardiovascular

Device Facts

• Record ID: K101955
• Device Name: ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The SJM MediGuide Enabled Catheter™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The MediGuide Enabled Catheter™ is used with a compatible gMPS™ system to enable real-time tip positioning and navigation. The MediGuide System is indicated for use as an adjunct to fluoroscopy

Device Story

Steerable electrophysiology catheter for endocardial/intravascular mapping of cardiac arrhythmias. Integrates passive sensor at catheter tip; tracked by external gMPS (gated MediGuide Positioning System). System superimposes real-time 3D catheter tip position onto 2D fluoroscopic images. Operated by physicians in clinical electrophysiology settings. Provides real-time visualization of catheter location relative to anatomy; reduces reliance on continuous fluoroscopy; assists in navigation and diagnostic evaluation. Output displayed on compatible gMPS monitor for clinical decision-making during arrhythmia procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and technological characteristics.

Technological Characteristics

Steerable electrophysiology catheter with integrated passive electromagnetic sensor for tracking. Compatible with gMPS system. Materials and design principles consistent with predicate Livewire catheters. Connectivity via integration with gMPS and ECG monitoring systems.

Indications for Use

Indicated for patients requiring evaluation of cardiac arrhythmias via endocardial and intravascular sites. Used as an adjunct to fluoroscopy for real-time catheter tip positioning and navigation.

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

• St. Jude Medical Livewire Electrophysiology Catheter
• MediGuide Guided Measurement Catheter (GMC)

Submission Summary (Full Text)

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Section 5 – 510(k) Summary

| Submitter: | St. Jude Medical - Atrial Fibrillation Division<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 3005188751 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wendy Pinor<br>Sr. Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] |
| Date Prepared: | July 9, 2010 |
| Trade Name: | St. Jude Medical MediGuide Enabled Livewire Steerable<br>Electrophysiology Catheter |
| Classification: | Class II - 21 CFR 870.1220<br>Electrode recording catheter or electrode recording probe |
| Product Code: | DRF |
| Predicate<br>Device(s): | The subject device is equivalent to the following St. Jude<br>Medical devices:<br>· St. Jude Medical Livewire Electrophysiology Catheter<br>· MediGuide Guided Measurement Catheter (GMC) |
| Device<br>Description: | The MediGuide Enabled Livewire Steerable<br>Electrophysiology Catheter is designed to allow<br>electrophysiological mapping at various endocardial and<br>intravascular sites, including the inferior vena cava,<br>superior vena cava, pulmonary veins and coronary sinus.<br>The use of the MediGuide Enabled Livewire diagnostic<br>mapping catheter in conjunction with the MediGuide<br>gMPS system allows real-time tip positioning and<br>navigation during routine diagnostic evaluation.<br>When connected to the ECG, the MediGuide Enabled<br>Livewire Catheter will transmit routine electrical signals<br>while the passive sensor at the tip of the catheter is<br>tracked by gMPS and is superimposed on any 2D X-ray<br>image in real time ("Live") fluoroscopy mode (the actual 3D<br>position of the catheter tip is projected on the real time 2D<br>image). |
| Intended Use: | The SJM MediGuide Enabled Catheter™ can be used in<br>the evaluation of a variety of cardiac arrhythmias from<br>endocardial and intravascular sites.<br>The MediGuide Enabled Catheter™ is used with a<br>compatible gMPS™ system to enable real-time tip<br>positioning and navigation. |
| | The MediGuide System is indicated for use as an adjunct<br>to fluoroscopy |
| Comparison to<br>Predicate Devices | The MediGuide Enabled Livewire Steerable<br>Electrophysiology Catheter uses similar technology,<br>materials, and design principals as the predicated devices.<br>The dimensional characteristics, indication for use and the<br>fundamental scientific technologies of the predicate<br>devices are also substantially similar. |
| Conclusion: | St. Jude Medical considers the MediGuide Enabled<br>Livewire Steerable Electrophysiology Catheter to be<br>equivalent to or substantially similar to the predicate<br>devices listed above. This conclusion is based upon the<br>devices' similarities in design, technological<br>characteristics, and principles of operation, materials, and<br>indications for use. |

ude Medical St. Jude Medical

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15 2010

OCT

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Ms. Wendy Pinor Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345

Re: K101955

Trade/Device Name: St Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe. Regulatory Class: Class II (two) Product Code: DRF Dated: September 16, 2010 Received: September 17, 2010

Dear Ms. Pinor:

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. 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.

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.

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Page 2 - Ms. Wendy Pinor

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## OCT 1 5 2010

### 510(k) Number (if known): K101955

#### Device Name:

St Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter

#### Indications for Use:

The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The MediGuide Enabled Livewire™ Steerable Electrophysiology Catheter is used with a compatible gMPS™ system to enable real-time tip positioning and navigation.

The MediGuide System 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)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | k101955 |

St. Jude Medical

Page 15of 129 PreMarket Notification for the MediGuide Enabled Livewire Steerable Electrophysiology Catheter

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