Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical components of a steerable introducer for cardiovascular procedures. There is no mention of AI/ML in the device description, intended use, or performance studies. The device's function is described in terms of physical manipulation and signal recording, not data analysis or algorithmic decision-making.

Therapeutic

No.
A therapeutic device is one that treats or cures a disease or condition. This device is indicated for introducing catheters, recording intracardiac signals, and cardiac stimulation during electrophysiology studies, which are diagnostic or procedural support functions, not therapeutic treatments.

Diagnostic

Yes

The device is used for "recording intracardiac signals," which is a diagnostic function to assess the heart's electrical activity during electrophysiology studies.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a dilator, guidewire, steerable sheath, polymer shaft with electrodes, hemostasis valve, sideport, handle with a rotating collar, distal vent holes, and a radiopaque tip marker. These are all hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Agilis™ ES Steerable Introducer is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to introduce cardiovascular catheters into the heart and for recording intracardiac signals and cardiac stimulation during electrophysiology studies. This involves direct interaction with the patient's body and physiological processes, not the analysis of samples taken from the body.
Device Description: The device is a physical introducer sheath with electrodes for signal recording and stimulation, a hemostasis valve, and a sideport for fluid management. These are all components used for in vivo procedures (within the living body).
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) outside of the body. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to provide information about a person's health.

Therefore, the Agilis™ ES Steerable Introducer is a medical device used for in vivo procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DYB, DRF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

heart, interatrial septum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Testing performed on the subject device:

Sterilization Testing
Shelf Life
Biocompatibility Chemical Characterization
Performance Bench:
- Visual
- Dimensional
  - Electrode spacing
  - Electrode ring/Pebax transition
  - Deflection Angle
- Electrical
  - Isolation and Continuity
  - Impedance
  - Leakage Current
- Functional
  - Leak Test
  - Deflection Durability
  - Shaft Kink
  - Insertion/Withdrawal with Short Sheath
  - Shaft Torque Transmission
  - Luer Lock
  - Connector Compatibility
  - Bond Tensile Testing
    - Connector Bond
    - Hub to Mounting Shaft
    - Hub to Shaft Bond
    - Tip/Reflow Bond
GLP Animal Study Assessment of the device safety performance and demonstration of the ability to met its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061363/K081645, K052575

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

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
14901 DeVeau Place
Minnetonka, MN 55345-2126 | |
|-------------------|---------------------------------------------------------------------|--|
| Address: | | |
| Contact Person: | Laura Moen-Ftacek | |

Laura Moen-Ftacek Sr. Regulatory Affairs Specialist Tel: 651-756-2957 Fax: 952-930-9481 lmoen-ftacek@sjm.com

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
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:

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

2

| Dilator Tip

Configuration	Curved	Curved	N/A
Guidewire	0.032", fixed core,
PTFE coated, 180cm
length with 3mm "J" tip	0.032", fixed core,
PTFE coated, 180cm
length with 3mm "J" tip	Compatible w/ 0.014" - 0.035"
guidewire (not included)
Packaging	PVC tray within a
sealed LDPE/Tyvek
pouch, placed in an
SBS paperboard box	PVC tray within a
sealed LDPE/Tyvek
pouch, placed in an
SBS paperboard box	PETG tray and retainer sealed
with a Tyvek lid. Tray/lid placed
within an outer PETG/Tyvek
tray/lid, placed in an SBS
paperboard box
Sterilization	EtO
SAL 10-6	EtO
SAL 10-6	EtO
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 (800) 638-2041 or (240) 276-3150 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_________________________________________________________________________________________________________________________________________________________

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