ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

K121006 · St Jude Medical · MTD · May 3, 2012 · Cardiovascular

Device Facts

• Record ID: K121006
• Device Name: ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
• Applicant: St Jude Medical
• Product Code: MTD · Cardiovascular
• Decision Date: May 3, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The EnSite Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters).

Device Story

EnSite Array Multi-Electrode Diagnostic Catheter is a 9 French, single-use, percutaneous catheter designed for right atrial deployment. It features a distal balloon/braid multi-electrode array (MEA) and three ring electrodes; pigtail tip minimizes endocardial trauma. Device does not require direct endocardial contact for signal detection. Used exclusively with the EnSite System; the system utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms detected by the MEA. The catheter facilitates mapping of complex arrhythmias where conventional linear catheters may be insufficient. Clinicians use the system to visualize cardiac electrical activity, aiding in the identification and diagnosis of complex arrhythmias, potentially improving procedural outcomes for patients.

Clinical Evidence

No clinical testing was submitted, referenced, or relied upon for this determination. Bench testing was performed to verify design modifications and confirm compliance with product specifications and biocompatibility standards.

Technological Characteristics

9 French percutaneous catheter; coaxial design with polyurethane outer sheath; distal balloon/braid multi-electrode array (MEA) and three ring electrodes; pigtail tip. Biocompatibility per ISO 10993-1. Operates as part of the EnSite System for non-contact intracardiac electrogram detection and reconstruction.

Indications for Use

Indicated for patients with complex arrhythmias in the right atrium that are difficult to identify using conventional linear mapping catheters.

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

• EnSite Array Multi-Electrode Diagnostic Catheter (K983456)

Submission Summary (Full Text)

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K 121006

| 510(k) Summary | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Date Prepared: | April 2, 2012 |
| Submitter Information: | |
| Manufacturer<br>Name/Address: | St. Jude Medical - Atrial Fibrillation Division<br>One St. Jude Medical Drive<br>St. Paul, MN 55117<br>Establishment Registration Number: 2184149 |
| Submitter Name/Address: | St. Jude Medical - Atrial Fibrillation Division<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 3005188751 |
| Contact Person: | Nicole Marwick<br>Sr. Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Information: | |
| Trade Name: | EnSite Array Multi-Electrode Diagnostic Catheter |
| Common Name: | Electrode Recording Catheter |
| Classification Name: | Electrode Recording Catheter |
| Classification: | Class II, 21 CFR 870.1220, Product Code DRF |
| Predicate Device(s): | EnSite Array Multi-Electrode Diagnostic Catheter (K983456) |
| Device Description: | The EnSite Array Multi-electrode Diagnostic Catheter (EnSite<br>Array Catheter) is a single use, 9 French, percutaneous catheter.<br>The EnSite Array Catheter is designed for use only with the<br>EnSite System and for deployment in the right atrium. The<br>proximal end contains the patient cable electrical connector, an<br>inflation port for the distal balloon/braid multi-electrode array<br>(MEA), luer port compatible with a 0.035" guidewire, and a push<br>shaft to facilitate expansion and deployment of the MEA. The<br>shaft is a coaxial design with a polyurethane outer sheath. At the<br>distal end in addition to the MEA, there are three ring electrodes;<br>one distal and two proximal mounted at specific locations to the |
| 510(k) Summary | |
| | MEA. The tip of the catheter is a pigtail shape to minimize<br>trauma to the endocardium. |
| | The EnSite Array Catheter does not require direct contact with<br>the endocardium for the detection of intracardiac electrograms.<br>The EnSite System connected to the EnSite Array Catheter<br>utilizes proprietary software algorithms to reconstruct and display<br>right atrial endocardiograms detected by the EnSite Array<br>Catheters' MEA. |
| Intended Use/Indications<br>for Use: | The EnSite Array Multi-Electrode Diagnostic Catheter, when<br>used with the EnSite System, is intended to be used in the right<br>atrium of patients with complex arrhythmias that may be difficult<br>to identify using conventional mapping systems alone (i.e. linear<br>mapping catheters). |
| Comparison to Predicate<br>Devices: | The modified EnSite Array Multi-Electrode Diagnostic Catheter<br>has the same intended use and fundamental scientific technology<br>as the predicate device. All technological characteristics of the<br>modified EnSite Array Multi-Electrode Diagnostic Catheter are<br>substantially equivalent to the predicate device including<br>packaging, biocompatibility, sterilization, and labeling. Through<br>biocompatibility testing and material change evaluation it was<br>demonstrated that the design modifications do not adversely<br>affect the safety and effectiveness. |
| Summary on Non-Clinical<br>Testing: | An evaluation of the modified EnSite Array Multi-Electrode<br>Diagnostic Catheter was performed to verify the device<br>modifications. It was concluded that the modified EnSite Array<br>Multi-Electrode Diagnostic Catheter design meets the product<br>specification and intended use. Biocompatibility was confirmed<br>in accordance with ISO 10993-1. |
| Summary of Clinical<br>Testing: | This section is not applicable for this submission. No clinical<br>testing was submitted, referenced or relied upon for a<br>determination of substantial equivalence. |
| Statement of Equivalence: | The modified St. Jude Medical EnSite Array Multi-Electrode<br>Diagnostic Catheter has the same intended use and technological<br>characteristics as the predicate device. Based on the results of the<br>biocompatibility testing per ISO 10993-1 St. Jude Medical's<br>modified EnSite Array Multi-Electrode Diagnostic Catheter has<br>been shown to be substantially equivalent to the predicate. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers. The symbol is rendered in black and white.

## Public Health Service

3 2012

MAY

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

St. Jude Medical c/o Ms. Nicole Marwick Senior Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345

Re: K121006 Trade/Device Name: EnSite Array Multi-Electrode Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two) Product Code: MTD Dated: April 2, 2012 Received: April 3, 2012

Dear Ms. Marwick:

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. 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.

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Page 2 - Ms. Nicole Marwick

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zubkerman, 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

K121006 510(K) Number (if known):

Device Name: EnSite Array Multi-Electrode Diagnostic Catheter

Indications for Use:

The EnSite Array Multi-Electrode Diagnostic Catheter, when used with the EnSite System, is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters).

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sigh-Off) Division of Cardiovascular Devices 1121 006 510(k) Number__