AGILIS ES STEERABLE INTRODUCER

K103083 · St Jude Medical · DYB · Apr 8, 2011 · Cardiovascular

Device Facts

• Record ID: K103083
• Device Name: AGILIS ES STEERABLE INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Agilis™ ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.

Device Story

Agilis ES Steerable Introducer is a catheter delivery system for cardiac anatomy. Components include 8.5F steerable sheath, 8.5F dilator, and 0.032" guidewire. Sheath features three platinum/iridium electrodes for visualization on EnSite System, intracardiac signal recording, and cardiac stimulation. Handle includes rotating collar for bi-directional tip deflection (>180° clockwise, >90° counterclockwise). Sideport with three-way stopcock allows aspiration, fluid infusion, blood sampling, and pressure monitoring. Distal vent holes minimize cavitation; radiopaque tip marker aids fluoroscopic visualization. Used in clinical electrophysiology settings by physicians to position catheters; provides stable access to cardiac chambers. Benefits include flexible positioning and integrated diagnostic/stimulation capabilities.

Clinical Evidence

No clinical testing performed. Safety and performance supported by bench testing (sterilization, shelf life, biocompatibility, electrical isolation, impedance, leakage current, deflection durability, bond tensile testing) and a GLP animal study evaluating safety and ability to meet intended use.

Technological Characteristics

8.5F steerable sheath with polymer shaft; three 1mm platinum/iridium electrodes. Bi-directional deflection mechanism (rotary-type). Includes hemostasis valve and sideport. Sterilized via EtO (SAL 10-6). Compatible with EnSite System for visualization.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart, including the left side via the interatrial septum, and for recording intracardiac signals or cardiac stimulation during electrophysiology studies.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• St. Jude Medical Agilis™ NxT Steerable Introducer (K061363/K081645)
• St. Jude Medical CPS® Luminary Bi-Deflectable Catheter with Lumen (K052575)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Summary As required by 21 CFR 807.92(c)

APR - 8 2011

# ·510(k) Number: ≥103083

## Date Prepared:

February 15, 2011

#### Submitter Information:

| Submitter's Name/ | St. Jude Medical<br>14901 DeVeau Place<br>Minnetonka, MN 55345-2126 | |
|-------------------|---------------------------------------------------------------------|--|
| Address: | | |
| Contact Person: | Laura Moen-Ftacek | |

Laura Moen-Ftacek Sr. Regulatory Affairs Specialist Tel: [phone] Fax: [phone] [e-mail]

#### Device Information:

| Trade Name: | Agilis™ ES Steerable Introducer |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Catheter Introducer/Electrode Recording Catheter |
| Classification Name: | Catheter Introducer/Electrode Recording Catheter |
| Class: | Class II, 21 CFR 870.1340, Product Code DYB<br>Class II, 21 CFR 870.1220, Product Code DRF |

#### Predicate Device:

St. Jude Medical AgilisTM NxT Steerable Introducer, Catheter Introducer (K061363/K081645)

St. Jude Medical CPS® Luminary Bi-Deflectable Catheter with Lumen (K052575)

#### Device Description:

The St. Jude Medical Agilis ES Steerable Introducer consists of a 94cm, 8.5F dilator, a 180cm, 0.032" guidewire; and a 71cm (usable length), 8.5F steerable sheath. It is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer constructed of a polymer shaft that incorporates three platinum/iridium electrodes, the primary use of which is visualization on the EnSite™ System. The electrodes may also be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise > 180° and counterclockwise > 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

{1}------------------------------------------------

### Indications for Use:

نه

The Agilis ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.

### Comparison to Predicate Devices:

The Agilis ES Steerable Introducer indication for use is similar to those of the predicate devices. The intended use of the subject device is the same as the predicate devices. In addition, the Agilis ES Steerable Introducer utilizes many of the same materials, design principles and fundamental scientific technology.

| Device<br>Characteristic | Subject Device:<br>Agilis ES Steerable<br>Introducer | Agilis NxT Steerable<br>Introducer<br>K061363/ K081645 | CPS Luminary Catheter<br>K052575 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Agilis ES Steerable<br>Introducer is indicated<br>when introducing<br>various cardiovascular<br>catheters into the heart,<br>including the left side<br>of the heart through the<br>interatrial septum. The<br>Introducer may be used<br>for recording<br>intracardiac signals and<br>for cardiac stimulation<br>during<br>electrophysiology<br>studies. | The Agilis NxT<br>Steerable Introducer is<br>indicated when<br>introducing various<br>cardiovascular<br>catheters into the<br>heart, including the<br>left side of the heart<br>through the interatrial<br>septum. | The CPS Luminary<br>Bideflectable Catheter with<br>Lumen is indicated to provide a<br>pathway for delivery and<br>support of transvenous devices<br>and fluids to the coronary sinus<br>and coronary vasculature of the<br>heart. The CPS Luminary<br>Bideflectable Catheter with<br>Lumen can also be used in the<br>evaluation of a variety of cardiac<br>arrhythmias from endocardial<br>and intravascular sites when<br>minimizing blood loss is<br>essential. |
| Intended Use | Mapping/Pacing/<br>Catheter Delivery<br>System | Catheter Delivery<br>System | Mapping/Pacing/<br>Catheter Delivery System |
| Handle | Rotary-type<br>Deflection | Rotary-type Deflection | Paddle-type Deflection |
| Shaft French<br>Size | 8.5 | 8.5 | 7 |
| Shaft Usable<br>Length | 71cm | 71cm | 80cm |
| Shaft Curl at<br>Distal Tip | Small, Medium, and<br>Large Curl | Small, Medium, and<br>Large Curl | Large and X-Large Curl |
| Shaft<br>Deflection | Bi-directional<br>(180°/90°) | Bi-directional<br>(180°/90°) | Bi-directional<br>(small curve/<br>designated curl) |
| Electrodes | Three (3) 1mm<br>platinum/iridium<br>electrodes | N/A | Two (2) 1mm platinum<br>electrodes |
| Dilator French<br>Size | 8.5 | 8.5 | N/A |
| Dilator Length | 94cm | 94cm | N/A |

{2}------------------------------------------------

| Dilator Tip<br>Configuration | Curved | Curved | N/A |
|------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Guidewire | 0.032", fixed core,<br>PTFE coated, 180cm<br>length with 3mm "J" tip | 0.032", fixed core,<br>PTFE coated, 180cm<br>length with 3mm "J" tip | Compatible w/ 0.014" - 0.035"<br>guidewire (not included) |
| Packaging | PVC tray within a<br>sealed LDPE/Tyvek<br>pouch, placed in an<br>SBS paperboard box | PVC tray within a<br>sealed LDPE/Tyvek<br>pouch, placed in an<br>SBS paperboard box | PETG tray and retainer sealed<br>with a Tyvek lid. Tray/lid placed<br>within an outer PETG/Tyvek<br>tray/lid, placed in an SBS<br>paperboard box |
| Sterilization | EtO<br>SAL 10-6 | EtO<br>SAL 10-6 | EtO<br>SAL 10-6 |

#### Summary of Non-Clinical Testing:

Bench and GLP Animal testing of the Agilis ES Steerable Introducer were performed to support Results of the testing demonstrate that the Agilis ES Steerable substantial equivalence. Introducer meets product specifications and performance requirements.

The following testing, performed or leveraged, has successfully been completed:

Testing performed on the subject device:

- Sterilization Testing t
- . Shelf Life

.

- Biocompatibility Chemical Characterization .
- Performance Bench:
- Visual
- 트 Dimensional
- Electrode spacing ■
- 트 Electrode ring/Pebax transition
- . Deflection Angle
- l Electrical
- Isolation and Continuity .
- . Impedance
- Leakage Current
- Functional 트
- Leak Test ■
- Deflection Durability ■
- Shaft Kink
- Insertion/Withdrawal with Short Sheath .
- . Shaft Torque Transmission
- Luer Lock
- Connector Compatibility ■
- Bond Tensile Testing 미
- Connector Bond ●
- . Hub to Mounting Shaft
- Hub to Shaft Bond .
- Tip/Reflow Bond .

{3}------------------------------------------------

- GLP Animal Study Assessment of the device safety performance and � demonstration of the ability to met its intended use.
Testing leverage from the predicate devices:

- Shelf Life .
- . Packaging
- . Biocompatibility
- Performance Bench: .
- 트 Visual
- . Dimensional
- . Usable Length
- . Inner and Outer Diameter
- 트 Sheath Tip Holes
- . Functional
- Insertion Force 트
- l Radiopacity
- 트 Hemostasis Seal Leak Test
- I Insertion/Withdrawal with Dilator and Needle
- I Corrosion Resistance
- Connector Compatibility 트
- 트 Bond Tensile Testing
- . Stopcock to Hub
- I Dilator Dimensional Testing
- I Guidewire Dimensional Testing

Clinical Testing: The Agilis ES Steerable Introducer has equivalent clinical performance to the predicate devices. A GLP animal study was conducted to evaluate the subject device for its safety performance and ability to meet its intended use. No clinical testing was required.

#### Statement of Equivalence:

The Agilis ES Steerable Introducer has similar indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided in the pre-market notification, SJM's Agilis ES Steerable Introducer has been shown to be substantially equivalent.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

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

St. Jude Medical c/o Ms. Laura Moen-Ftacek Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345-2126

APR - 8 2011

Re: K103083

Trade/Device Name: Agilis™ ES Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 24. 2011 Received: March 25, 2011

Dear Ms. Moen-Ftacek:

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.

{5}------------------------------------------------

Page 2 – Ms. Laura Moen-Ftacek

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 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.

R. Vance

E
L

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

Enclosure

{6}------------------------------------------------

## INDICATIONS FOR USE

510(K) Number (if known):

Device Name: Agilis™ ES Steerable Introducer

Indications for Use:

The Agilis™ ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.

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)

Duna R. Vclmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K103083_________________________________________________________________________________________________________________________________________________________

Page 1 of 1