AGILLS PF DELIVERY SYSTEM

K111943 · St. Jude Medical, Cardiac Rhythm Management Divisi · DYB · Sep 29, 2011 · Cardiovascular

Device Facts

• Record ID: K111943
• Device Name: AGILLS PF DELIVERY SYSTEM
• Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Agilis™ PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

Device Story

The Agilis™ PF Introducer System is a steerable catheter introducer used to access the pericardial space via a subxiphoid approach. The system includes a deflectable 13 French introducer, dilator, guidewire, obturator, and 17Ga Tuohy needle. The introducer features a handle-controlled deflection mechanism (up to 90° clockwise/counterclockwise) and a hemostasis valve to minimize air entry. Used in clinical settings by trained physicians under fluoroscopic guidance, the device acts as a conduit for delivering diagnostic or therapeutic instruments into the pericardial space. The radiopaque tip marker assists in visualization. By providing a stable, steerable access point, the device facilitates electrophysiology procedures while minimizing procedural risks associated with subxiphoid access.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

13 French deflectable introducer system; includes dilator, guidewire, obturator, and 17Ga Tuohy needle. Features a hemostasis valve, sideport with three-way stopcock, and handle-actuated deflection mechanism (up to 90°). Radiopaque tip marker for fluoroscopic visualization. Sterile, single-use, ethylene oxide sterilized.

Indications for Use

Indicated for accessing the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies. Contraindicated in patients with congenital absence of the pericardium or absence of a free pericardial space.

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 (G402049)
• St. Jude Medical Fast Cath Introducer (13F Obturator)

Submission Summary (Full Text)

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# K 111943

# Section 5- 510(k) Summary

| Submitter : | St Jude Medical, CRMD<br>15900 Valley View Court<br>Sylmar, CA 91324<br>Establishment Registration Number: 2017865 | SEP 2 9 2011 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person : | Geena George<br>Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] | |
| Date Prepared : | September 27, 2011 | |
| Trade Name : | St Jude Medical Agilis™ PF Introducer System and accessories | |
| Classification : | Class II – 21 CFR 870.1340<br>Catheter Introducer | |
| Product Code : | DYB | |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical<br>Device | |
| | St Jude Medical Agilis NxT Steerable Introducer - G402049 and 17<br>Gauge Tuohy Needle | |
| | St. Jude Medical Fast Cath Introducer<br>(Predicate Device – 13F Obturator) | |
| Device Description : | The St. Jude Medical Agilis™ PF Introducer System consisting of a<br>introducer, guidewire, 17Ga Tuohy needle, dilator and obturator is<br>intended to be used to facilitate delivery of SJM devices into the<br>pericardial space for diagnostic and therapeutic purposes | |
| Intended Use: | The Agilis™ PF Introducer System is intended to access the epicardial<br>surface of the heart via a subxiphoid approach to facilitate<br>electrophysiology studies. | |
| Comparison to<br>Predicate Devices | The St Jude Medical Agilis™ PF Introducer system has a similar<br>intended use and the same fundamental scientific technology as the<br>predicate device. All technological characteristics of the Agilis™ PF<br>Introducer system are substantially equivalent to the predicate device<br>including packaging, biocompatibility, sterilization, and labeling. Where | |

·

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differences exist between the proposed device and the predicate device performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device.

St Jude Medical considers the Agilis™ PF Introducer system to be Conclusion : equivalent to the predicate device listed above. This conclusion is based upon the device similarities in design, technological characteristics, principles of operation,materials and indications for use.

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#### Introduction

#### English

The following Instructions for Use describe the contents of the St. Jude Medical Agilis™ PF Introducer System and their application in accessing the pericardial space.

Please read these instructions thoroughly before using the Agilis PF Introducer System or any of its components to help reduce the potential risks and complications associated with subxiphoid procedures.

| Model | Description |
|------------|------------------------------------------|
| DS2D001-25 | Agilis PF Introducer System, Small Curl |
| DS2D001-35 | |
| DS2D003-25 | Agilis PF Introducer System, Medium Curl |
| DS2D003-35 | |

## Agilis™ PF Introducer System Description

The Agilis™ PF Introducer System consists of the following components: Deflectable introducer, 13 French

-
- Dilator
- · Guidewire
- Obturator
- 17Ga Tuohy Needle

The deflectable introducer is fitted with a hemostasis valve to minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. A handle equipped with a deflection control mechanism deflects the tip up to 90° both clockwise and counterclockwise. The introducer features a radiopaque tip marker to improve fluoroscopic visualization.

## Indications

The Agilis™ PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate earchase of the liefe for the prood sites - place in program studies.

#### Contraindications

- · Congenital absence of the pericardium
- · Absence of a free pericardial space

#### Warnings

- · Do not alter the introducer system in any way.
- Single-use disposable medical device. Do not resterilize and/or reuse this introducer system as adverse patient reactions may result since thorough cleaning of biological and foreign material is not possible.
- Ensure that the patient's hemodynamic parameters are acceptable prior to advancing the dilator or any other component. Continue hemodynamic monitoring throughout the procedure.
- Perform operations such as aspiration, component removal, and introducer exchanges slowly to minimize the potential for creating a vacuum in the introducer.
- Hypercoagulative conditions/anticoagulation should not be present on piven until enicardial access has been obtained.
- Only those physicians who are specially trained in subxiphoid access should use this introducer system.
- During insertion, avoid creating excessive bends in the introducer or other components.
- Use flugroscopy to verify the position of the introducer and other . components and to assist guiding the devices through the patient anatomy.

## Precautions

- Inspect all components before use. Do not use if the package or items in the kit appear to be damaged or defective.
- Contents are sterile if package is unopened and undamaged
- The French size specified on the dilator and obturator hubs indicates the outer diameter of these components. This should match the French size of the Agilis™ PF introducer (as specified on the label). Do not attempt to insert into the introducer any device that has a distal tip or body size larger than the introducer size indicated.
- Ensure that the notch on needle stylet and the corresponding slot on the needle hub face upwards during insertion. This helps ensure that the
needle tip is curved in the upwards direction during insertion. This in turn reduces the risk of accidental myocardial perforation flaceration during needle insertion

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- Do not attempt to use a guidewire larger than the maximum diameter specified on the package label.
- Prior to inserting the introducer into the patient, pre-assemble the deflectable introducer and dilator.
- The Agilis PF Introducer hemostasis valve cap is designed to interlock only with the supplied dilators and obturators. Misuse may result in complications.
- Do not remove dilator or introducer rapidly. Damage to the backbleed valve . may occur.
- Do not deflect the introducer when the dilator has been inserted. .
- If resistance is met when advancing or withdrawing the guidewire or introducer, determine the cause and correct the problem before continuing with this procedure.

#### Note

Do not use the introducer as an abdominal cavity puncture tool.

- . Aspiration and fluid infusion (such as saline flush) should be carried out only through the sideport.
- . This system should only be used with equipment that complies with international safety standards.
- Always straighten the introducer tip before inserting or removing this . introducer from the patient. Prior to removing the introducer, verify that the tip is straight by viewing the tip on fluoroscopy.
- Dispose of this introducer system according to standard hospital procedures
- . Individual patient anatomy and physician technique may require procedural variations.
- . Store in a cool, dry, dark place.

## Potential Complications

As with any catheterization procedure, potential complications include, but are not firnited to:

- · Thromboembolism
- Air embolism
- · Local and systemic infection
- Bleeding or hematorna at puncture site
- Perforation (e.g., diaphragm, liver, lung and vessels)
- Thrombus formation
- Epicardial irritation
- Perforation of the heart chambers leading to cardiac tamponade
- Pericarditis
- Hemopericardium
- Esophageal injury
- Coronary artery injury
- Abdominal bleeding
- Pneumopericardium
- Atrial fibrillation (AF)
- · Ventricular tachycardia (VT) requiring cardioversion
- · Ventricular fibrillation (VF)
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l

#### How Supplied

The St. Jude Medical Agilis™ PF Introducer System is supplied sterile, for single use only, provided the package is unopened and undamaged.

## Recommended Patient Screening

Patients with the following pre-existing conditions may not be suitable for this procedure:

- · Congenital absence of the pericardium
- Epicardial surface fat pad on the epicardium surface >5 mm
- · Constrictive and adhesive pericarditis (large percentage of adhesion).
- · Active infection

#### Note

Ensure that the patient has been appropriately treated for infections and does not have any active infections, prior to undergoing this procedure.

- Previous cardiac surgery
- · Myocardial infarction
-

#### Note

- These ore-existing conditions may inhibit access to areas of the epicardium due to pericardial fibrosis. Special care should be used when performing pericardial access procedures in these patients.
- · Hemodynamic instability
- · Unstable angina

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- Recent cerebral vascular accident (CVA)
- Presence of acute cardiac thrombus
- Acute conditions, such as electrolyte abnormality, acute ischemia, and drug toxicity.
- · Cardiac defibrillator epicardial galch. l

#### Procedural Considerations

The following are among the procedural considerations that should be examined prior to use of the introducer system. They are designed to better prepare the clinician for potential complications associated with the subxiphoid technique and pericardial anatomy in general, such as air emboli.

- · Prior to catheterization, the patient's clotting system should be evaluated. Use anticoagulant as training and experience may dictate.
- Subxiphoid procedures should be performed prily in facilities appropriately . equipped and staffed to perform such procedures. Laboratory capabilities should include, but are not limited to:
- Intracardiac pressure monitoring -
- Systemic pressure monitaring -
- Pericardiocentesis
- . Surgical backup
- Appropriate monitoring of vital signs throughout the procedure -
- Familiarity with contrast media injection and management of untoward reactions to contrast media

Note

- Excessive contrast may reduce visibility under fluoroscopy.
## Pericardial Access

Use the Agilis™ PF Introducer system to gain access to the pericardial space
with a subxiphoid procedure. This serves as a conduit during delivery of St. Jude Medical devices.

- Use fluoroscopic guidance to gain access to the pericardial space.
- 1 . Create a subxiphoid incision that sufficiently allows introducer access and maneuverability.
- 2. Use the Tuohy needle to gain access to the pericardial space. Par;s inte needle above the level of the diapbragm rather than traversing through the diaohragm so that the infra-al>doctural viscera and subdiaphraematic blood vessels may be avoided. Use a left lateral fluoroscopic view to idenbly ine precise location of the draphragun.
- 3. To confirm entry into the pericardial space, inject small amounts of con-ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
- 4. Insert the guidewire into the Tuohy needle
- 5. Advance the guidewire into the pericardial space. Passage of the quideains into the pericantial space is bast confirmed using a fluoroscopic Left-Antenor-Oblique (LAO) projection,
- Remove the Tuohy needle while retaining the guidewire in place. 6.
- 7. Flush the introducer and the dilator with sterile saline.
- 8. If the introducer tip is already deflected, use the deflection control mechanism to straighten the lip. This mechanism is located on the introduce handle.
- 9. Insert the dilator into the introducer and lock the dilator into the hemostasis cap
- 10. Place the dilator over the guidewire. Advance the introducer and dilator into the pericardial space.
- 11. Remove the dilator and guidewire from the introducer.
- 12. Insert the obturator into the introducer and lock the obturator into the hemostasis cap.
- 13. With the obturator in place, maneuver the introducer and deflect the introducer tip to access the desired location.
- 14. Remove the obturator and if required, carefully adjust the introducer position for subsequent cardiac diagnostic and/or therapeutic device delivery.
- 15. Always straighten the introducer tip before removing the introducer from the patient. When the device is inside the patient, verify the tip position using fluoroscopy prior to removing the introducer system.

Note

- If required, remove air by closing the hemostasis valve and withdrawing air through the three-way stopcock.
## Available Accessories

Additional accessories available for use with the St. Jude Medical Agilis™ PF Introducer System include:

- Agilis™ PF Introducer Accessory Kit (0.032°, 100cm guidewire, 13Fr.
Dilator, 13Fr. Obturator and 17Ga. Tuohy Needle)

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# Symbols

Image /page/5/Picture/2 description: The image shows two rows of symbols and text. The top row contains two symbols: one depicting a house with a sun shining above it, and another of an umbrella with raindrops falling. The bottom row contains the word "STERILE" in bold, followed by the letters "EO".

Store in a cool, dark, dry place

Sterilized using ethylene oxide

Consult instructions for use

2

Do not reuse

Image /page/5/Picture/31 description: The image shows a simple black and white drawing of an open book. The book is slightly angled, revealing a portion of its pages. A lowercase letter 'i' is prominently displayed on the visible page of the book.

Image /page/5/Picture/8 description: The image shows a black and white drawing of an hourglass. The hourglass is upright, with the top bulb larger than the bottom bulb. The top bulb is filled with sand, and the sand is flowing through the narrow neck of the hourglass into the bottom bulb. The hourglass is a symbol of time, and the image suggests that time is passing.

Do not use if package is damaged

Image /page/5/Picture/10 description: The image shows a series of black shapes against a white background. The shapes appear to be arranged horizontally, with the leftmost shapes resembling triangles or arrowheads. The rightmost shape is a tall rectangle. The shapes are solid black, creating a stark contrast with the white background.

Manufacturer

Use by

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Lot number

Image /page/5/Figure/16 description: The image shows a rectangular box divided into two sections. The left section contains the text "EC" in bold, black font. The right section contains the text "REP" in bold, black font.

LOT

Authorized representative in the
European Community

Temperature limitations

Prescription only

Inner diameter

Outer diameter

Image /page/5/Picture/19 description: The image shows a symbol that is commonly associated with prescriptions in the medical field. The symbol consists of the letter 'R' with a line through its leg, often referred to as 'Rx'. Below the 'Rx' symbol, the word 'ONLY' is printed in capital letters. The presence of this symbol indicates that the medication or treatment is only available with a valid prescription from a licensed healthcare professional.

Image /page/5/Picture/20 description: The image shows a circle with a horizontal line inside. The horizontal line has an arrow pointing to the left on the left side and an arrow pointing to the right on the right side. The arrows are pointing in opposite directions.

Image /page/5/Picture/21 description: The image shows two circles, one white and one black. Each circle has two arrows pointing towards it from different directions. The arrows are positioned on opposite sides of each circle, suggesting a force or movement directed towards the center of each circle. The contrast between the white and black circles highlights the difference in their fill color.

Image /page/5/Picture/23 description: The image contains the words "Inner and outer diameters". The text is in a simple sans-serif font. The background is a plain white color. The text is left-aligned.

outer diameters

Agilis™ PF Introducer System

Manufacturing date

ਹੈ ਕਿ ਇੱਕ ਸੰਸੀ ਨਾ

Hereby, **[illegible]** declares that this device is in compliance with the essential requirements and other relevant provisions of the Directives.

Lot number

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

#### Public Health Service

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

St. Jude Medical, CRM c/o Ms. Geena George Associate Regulatory Submission Specialist 15900 Vallev View Court Sylmar. CA 91342

SEP 2 9 2011

Re: K111943

Trade/Device Name: Agilis™ PF Introducer System Regulatory Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II (two) Product Code: 74 DYB Dated: September 19. 2011 Received: September 20. 2011

Dear Ms. George:

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. 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

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Page 2 – Ms. Geena George

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 331-542 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.html 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/ReportalProblem/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/Undustry/default.htm.

Sincerely yours.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. 10, 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): K111943

Device Name: St Jude Medical Agilis™ PF Introducer System and accessories

Indications for Use: The Agilis™ PF Introducer System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate 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) | |
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ision Slan-Division of Cardiovascular Devices

**510(k) Number** K111943