AGILIS NXT STEERABLE INTRODUCER

K110450 · St Jude Medical · DYB · May 10, 2011 · Cardiovascular

Device Facts

• Record ID: K110450
• Device Name: AGILIS NXT STEERABLE INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: May 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.

Device Story

8.5F asymmetrical bi-directional steerable introducer; 82 cm length; includes steerable sheath, dilator, and guidewire. Sheath features radiopaque material for fluoroscopic visualization; proximal hemostasis valve; sideport with three-way stopcock for aspiration, infusion, sampling, and pressure monitoring. Handle includes rotating collar for 90° counterclockwise and 180° clockwise distal tip deflection. Used by physicians in clinical settings to provide a guide/platform for introducing diagnostic and therapeutic cardiovascular catheters into the heart via venous anatomy. Benefits include facilitated catheter navigation and placement within the heart, including transseptal access.

Clinical Evidence

No clinical or animal testing conducted. Substantial equivalence supported by bench testing, including mechanical performance (deflection durability, torque, tensile strength, kink resistance), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), and packaging/sterilization validation.

Technological Characteristics

8.5F asymmetrical bi-directional steerable introducer; 82 cm length. Materials include radiopaque components for fluoroscopic visualization. Features hemostasis valve and three-way stopcock. Sterilized via Ethylene Oxide (EtO). Mechanical deflection mechanism via handle-actuated rotating collar. Packaging validated per ASTM D4169-05, F1886-98, F88-00, and F2096-04.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the heart via venous anatomy, including access to the left side of the heart through 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 (K081645, K061363)

Submission Summary (Full Text)

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K110450

# Section 5 - 510(k) Summary

MAY 1 0 2011

| Submitter: | St. Jude Medical |
|----------------------|----------------------------------------------------|
| | 14901 DeVeau Place |
| | Minnetonka, MN 55345 |
| | Establishment Registration Number: 3005188751 |
| Contact Person: | Wendy Pinor |
| | Sr. Regulatory Affairs Specialist |
| | Phone [phone] |
| | Fax [phone] |
| Date Prepared: | February 15, 2011 |
| Common Name: | Catheter Introducer |
| Trade Name: | 82cm Agilis NxT™ Steerable Introducer |
| Classification: | Class II - 21 CFR 870.1340 |
| | Catheter Introducer |
| Panel: | Cardiovascular |
| Product Code: | DYB |
| Predicate Device(s): | Agilis NxT Steerable Introducer (K081645, K061363) |

#### Device Description

The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, 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 82 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 quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The 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.

A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

# Comparison to Predicate Devices

The Agilis™ NxT Steerable Introducer has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the Agilis™ NxT Steerable Introducer are substantially equivalent to the predicate device

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including packaging, biocompatibility, sterilization, and labeling. Where dimensional differences exist between the subject device and the predicate device, performance testing demonstrates that these differences do not adversely affect safety and effectiveness. The introducer acts as a functioning guide/platform for introduction of other diagnostic and therapeutic devices.

# Intended Use

The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the interatrial septum.

# Testing

# Bench Testing

The Use and Design FMEAs were used in evaluating the need for performance and design verification testing due to the modifications made to the predicate Agilis NxT device. Testing performed demonstrates that the device meets all product specifications and performance requirements.

| Test | Result |
|---------------------------|--------|
| Surface Visual Standard | Pass |
| Usable Shaft Length | Pass |
| Curve Angle | Pass |
| Deflection Durability | Pass |
| Shaft Kink | Pass |
| Curve Retention | Pass |
| Shaft Torque Test | Pass |
| Tip Tensile | Pass |
| Sheath/Dilator | Pass |
| Test | Result |
| Distal tip inner diameter | Pass |
| Insertion Forces | Pass |
| Radiopacity | Pass |
| 3-way Stopcock | Pass |
| Shaft to Hub Tensile | Pass |
| Stopcock to Hub bond | Pass |
| Freedom from Leaks | Pass |
| Luer Taper | Pass |
| Lure Stress Cracking | Pass |

## Sterilization

Based on results of EtO residual, lethality, natural product sterility, bacteriostasis and fungistasis testing, bioburden and LAL testing, it has been determined that the 82 cm Agilis NxT Steerable Introducer meets all applicable specifications.

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# Packaging:

Sterile barrier package testing meets specifications and performance requirements throughout the lifetime of the product, as labeled.

The following package testing was performed

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- · Performance Testing of Shipping Containers (ASTM D4169-05)
- · Visual Inspection (ASTM F1886-98)
- · Seal Strength (ASTM F88-00)
- · Bubble Leak (ASTM F2096-04)

There were no failures reported for any of the tests. The testing demonstrates that the Agilis NxT packaging will maintain its integrity and provide a sufficient barrier to ensure the sterile barrier will not be breached.

Product shelf life testing demonstrates that the device meets product specifications and performance requirements throughout the lifetime of the product, as labeled.

| Biological Test | Result |
|----------------------------------------------------------------------------------|-------------|
| | s |
| Cytotoxicity | Pass |
| Sensitization | Pass |
| Intracutaneous Reactivity<br>(Irritation) | Pass |
| Systemic Toxicity (acute,<br>includes pyrogenicity) | Pass |
| Chemical Characterization /<br>Gas Chromatography with<br>Mass Spectrometry | Pass |
| Chemical Characterization /<br>Inductively Coupled Plasma<br>(ICP) | Pass |
| Partial Thromboplastin Time<br>- PTT | Pass |
| Biological Test | Result<br>S |
| Pyrogenicity | Pass |
| Hemocompatibility -<br>Hemolysis | Pass |
| Hemocompatibility-<br>Complement Activation<br>System | Pass |
| Hemocompatibility -<br>Thrombosis | Pass |
| Chemical Characterization /<br>Fourier Transform Infrared<br>Spectroscopy (FTIR) | Pass |
| Chemical Characterization /<br>Physicochemical Non-volatile<br>Residue (NVR) | Pass |

#### Biocompatibility

Testing demonstrates that the device is biocompatible.

## Pre-Clinical and Clinical Testing

No animal or human testing was conducted on the 82 cm Agilis NxT Introducer.

Testing of the 82 cm Agilis NxT Steerable demonstrates that the 82 cm Agilis NxT Steerable Introducer design meets product specifications and intended use.

# Conclusion

St. Jude Medical considers the 82 cm Agilis NxT Steerable Introducer to be equivalent to or substantially similar to the predicate device listed above. This conclusion is based upon the devices' similarities in design, technological characteristics, principles of operation, materials, and intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - 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: K110450

Trade/Device Name: 82cm Agilis NxT™ Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2011 Received: February 16, 2011

Dear Ms. Pinor:

This letter corrects our substantially equivalent letter of May 10, 2011.

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.

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

JUN 1 5 2015

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Page 2 - Ms. Wendy Pinor

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education 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. Zuckerman -S

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

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# Indications for Use

510(k) Number (if known): _ K | 0450

Device Name:

82cm Agilis NxT™ Steerable Introducer

# Indications for Use:

The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|----------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K110 450 |