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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Agilis™ ES Steerable Introducer. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a medical AI/ML device would.

Therefore, many of the requested categories for AI/ML device studies (like sample size, ground truth definition, MRMC studies, training set details) are not applicable to this type of medical device submission.

However, I can extract the information related to the non-clinical testing performed and the general intent of the submission.

Here's a breakdown based on the provided text, indicating "Not Applicable" where the information is not relevant to a traditional medical device like an introducer:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to meeting "product specifications and performance requirements" and demonstrating "substantial equivalence" to predicate devices. Specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are not presented in this summary, as they are not typically required for a Class II non-AI device of this type during a 510(k) submission.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Meets Product Specifications	"Agilis ES Steerable Introducer meets product specifications and performance requirements."
Meets Performance Requirements	"Agilis ES Steerable Introducer meets product specifications and performance requirements."
Demonstrated Safety	"Assessment of the device safety performance..." (GLP Animal Study)
Able to Meet Intended Use	"...demonstration of the ability to meet its intended use." (GLP Animal Study)
Substantial Equivalence to Predicate	"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... SJM's Agilis ES Steerable Introducer has been shown to be substantially equivalent."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a single "test set" in the context of AI/ML. The document refers to "Bench and GLP Animal testing." The number of animals used in the GLP animal study is not specified in this summary.
Data Provenance: The animal study is a GLP (Good Laboratory Practice) study, which implies a controlled, prospective study environment, likely in a laboratory setting or animal research facility. The country of origin is not specified but generally for US FDA submissions, studies are either US-based or comply with international GLP standards acceptable to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical medical device, not an AI/ML system requiring expert-established ground truth on images or data. The evaluation of performance and safety would be conducted by clinicians, veterinarians, and technical staff involved in the GLP animal study and bench testing, based on established protocols and endpoints.

4. Adjudication method for the test set

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance evaluation described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. See point 5.

7. The type of ground truth used

For the GLP Animal Study: The "ground truth" refers to the physiological outcomes, device function within the living system, and safety observations as determined by direct measurement, clinical assessment, and potentially necropsy findings in the animals.
For Bench Testing: The "ground truth" is based on engineered specifications and physical measurements (e.g., dimensional accuracy, deflection angles, electrical properties, leak tests, bond strength), assessed against predetermined thresholds or ranges.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that utilizes a training set. The device design is based on engineering principles and iterative development, not data-driven machine learning.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary of Device Performance (from the document):

The Agilis ES Steerable Introducer underwent both bench and GLP (Good Laboratory Practice) animal testing. The results of these tests demonstrated that the device "meets product specifications and performance requirements." The GLP animal study specifically assessed the device's safety performance and its ability to meet its intended use. The submission concludes that "No clinical testing was required" for this device, and it was found to be substantially equivalent to its predicate devices.

Summary

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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 Medical14901 DeVeau PlaceMinnetonka, 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 DYBClass 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:

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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.

DeviceCharacteristic	Subject Device:Agilis ES SteerableIntroducer	Agilis NxT SteerableIntroducerK061363/ K081645	CPS Luminary CatheterK052575
Indications forUse	The Agilis ES SteerableIntroducer is indicatedwhen introducingvarious cardiovascularcatheters into the heart,including the left sideof the heart through theinteratrial septum. TheIntroducer may be usedfor recordingintracardiac signals andfor cardiac stimulationduringelectrophysiologystudies.	The Agilis NxTSteerable Introducer isindicated whenintroducing variouscardiovascularcatheters into theheart, including theleft side of the heartthrough the interatrialseptum.	The CPS LuminaryBideflectable Catheter withLumen is indicated to provide apathway for delivery andsupport of transvenous devicesand fluids to the coronary sinusand coronary vasculature of theheart. The CPS LuminaryBideflectable Catheter withLumen can also be used in theevaluation of a variety of cardiacarrhythmias from endocardialand intravascular sites whenminimizing blood loss isessential.
Intended Use	Mapping/Pacing/Catheter DeliverySystem	Catheter DeliverySystem	Mapping/Pacing/Catheter Delivery System
Handle	Rotary-typeDeflection	Rotary-type Deflection	Paddle-type Deflection
Shaft FrenchSize	8.5	8.5	7
Shaft UsableLength	71cm	71cm	80cm
Shaft Curl atDistal Tip	Small, Medium, andLarge Curl	Small, Medium, andLarge Curl	Large and X-Large Curl
ShaftDeflection	Bi-directional(180°/90°)	Bi-directional(180°/90°)	Bi-directional(small curve/designated curl)
Electrodes	Three (3) 1mmplatinum/iridiumelectrodes	N/A	Two (2) 1mm platinumelectrodes
Dilator FrenchSize	8.5	8.5	N/A
Dilator Length	94cm	94cm	N/A

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Dilator TipConfiguration	Curved	Curved	N/A
Guidewire	0.032", fixed core,PTFE coated, 180cmlength with 3mm "J" tip	0.032", fixed core,PTFE coated, 180cmlength with 3mm "J" tip	Compatible w/ 0.014" - 0.035"guidewire (not included)
Packaging	PVC tray within asealed LDPE/Tyvekpouch, placed in anSBS paperboard box	PVC tray within asealed LDPE/Tyvekpouch, placed in anSBS paperboard box	PETG tray and retainer sealedwith a Tyvek lid. Tray/lid placedwithin an outer PETG/Tyvektray/lid, placed in an SBSpaperboard box
Sterilization	EtOSAL 10-6	EtOSAL 10-6	EtOSAL 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 .

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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.

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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.

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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

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INDICATIONS FOR USE

510(K) Number (if known):

Device Name: Agilis™ ES Steerable Introducer

Indications for Use:

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

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).