AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

K081645 · St Jude Medical · DYB · Dec 9, 2008 · Cardiovascular

Device Facts

• Record ID: K081645
• Device Name: AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Story

The Agilis NxT Steerable Introducer is an 8.5F asymmetrical bi-directional steerable sheath used by physicians to introduce cardiovascular catheters into the heart, including the left side via the interatrial septum. The device includes a steerable sheath, plastic dilator, and stainless steel guidewire. The handle features a rotating collar to deflect the distal tip 90° counterclockwise and 180° clockwise. A proximal hemostasis valve minimizes blood loss, and a sideport with a three-way stopcock allows for fluid infusion, blood sampling, and pressure monitoring. The sheath is radiopaque for fluoroscopic visualization. The device is used in a clinical setting to facilitate catheter placement, aiding in cardiovascular procedures.

Clinical Evidence

Bench testing only. Performance testing verified that the device design meets product specifications and intended use following modifications.

Technological Characteristics

8.5F asymmetrical bi-directional steerable introducer; 71 cm length; stainless steel guidewire; radiopaque sheath material; hemostasis valve; sideport with three-way stopcock; mechanical deflection mechanism via handle-mounted rotating collar.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart, including the left side via the interatrial septum.

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

• Agilis™ NxT Steerable Introducer (K061363)

Submission Summary (Full Text)

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DEC 0 9 2008

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

# 510(k) Number:

K081445

Date Prepared:

June 11, 2008

#### Submitter Information:

Submitter's Name/ Address:

Contact Person:

St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126 Establishment Registration Number: 2182269

Mac McKeen Director, Regulatory Affairs Tel: [phone] Fax: [phone] [e-mail]

#### Device Information:

Trade Name: Common Name: Classification Name: Class:

AgilisTM NxT Steerable Introducer Catheter Introducer Introducer, Catheter Class II, 21 CFR 870.1340, Product Code DYB

#### Predicate Device:

AgilisTM NxT Steerable Introducer (K061363)

#### Device Description:

The Agilis NxT Steerable Introducer consists of a steerable sheath, plastic dilator and stainless steel guidewire, which is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

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#### Indications for Use:

The Agilis "M NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

#### Comparison to Predicate Devices:

The Agilis No NxT Steerable Introducer has the same intended use and fundamental The rights - NY P Stockers in Cases not the canological characteristics of the Agilis™ NxT Steerable Introducer are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling. Where dimensional differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness

#### Summary of Non-Clinical Testing:

Bench testing of the Agilis TM NxT Steerable Introducer was performed to verify the device modification. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use.

### Statement of Equivalence:

The St. Jude Medical Agilis™ NxT Steerable Introducer has the same indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, SJM's Agilis™ NxT Steerable Introducer has been shown to be substantially equivalent.

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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 stylized eagle with three stripes forming its wing and tail. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical Atrial Fibrillation Division c/o Mr. Mac McKeen Director of Regulatory Affairs 14901 Deveau Place Minnetonka, MN 55345

DEC - 9

K081645 Re:

Trade/Device Name: Agilis™ NxT Steerable Introducer Common Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: November 7, 2008 Received: November 10, 2008

Dear Mr. McKeen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as sualed in the excirement date of the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-11-11, 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 r ou may, disrelere, maines 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 such 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 or any 1 outlar statuated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

K/w/

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

510(K) Number (if known):

14681645

Device Name: Agilis™ NxT Steerable Introducer

Indications for Use:

The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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