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 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 11F asymmetrical bi-directional steerable introducer with a small and medium 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 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

AI/ML Overview

This 510(k) summary (K083402) describes a medical device, the Agilis™ NxT Steerable Introducer Catheter, which is a Class II device (21 CFR 870.1340, Product Code DYB) for introducing cardiovascular catheters into the heart. The regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer, K061363) rather than defining specific acceptance criteria and providing a detailed study report with performance metrics.

Therefore, the requested information elements related to device acceptance criteria and a study proving those criteria are largely not applicable in the context of this 510(k) submission as it is presented. This type of submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

However, I can extract what is provided and explain why other sections are not present in this document.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary of Information Provided in the 510(k) Document:

This 510(k) submission for the Agilis™ NxT Steerable Introducer Catheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Agilis™ NxT Steerable Introducer, K061363). The core argument is that the new device has the same intended use and fundamental scientific technology as the predicate and that testing confirmed its design meets product specifications and intended use, implying equivalence to the predicate's performance. Specific quantitative acceptance criteria with corresponding device performance metrics for novel functionalities are not explicitly detailed in this summary.

The "acceptance criteria" and "device performance" in this context are implicitly tied to demonstrating that the modifications made to the predicate device do not negatively impact its safety and effectiveness, and that the device performs as expected for its intended use, comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Safety and Effectiveness Equivalence: Demonstrated substantial equivalence to the predicate device in terms of safety and effectiveness.	"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 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 and Statement of Equivalence sections)
Design Meeting Product Specifications: Device design meets its established product specifications for its intended use.	"Bench testing of the Agilis NxT Steerable Introducer was performed to verify the device modifications. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use." (Summary of Non-Clinical Testing section)
Functional Performance (e.g., Steerability, Blood Loss, Visualization): The device functions as described, including 90° counterclockwise and 180° clockwise deflection, minimization of blood loss, and radiopaque visualization.	While specific quantitative performance metrics (e.g., precise deflection angles under load, quantified blood loss rates, visibility scores) are not provided in this summary, the device description outlines these functional characteristics. The "bench testing" mentioned in the non-clinical summary would have implicitly verified these functions to meet internal design specifications that ensure equivalence to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated in this 510(k) summary. The "bench testing" performed would have involved a sample of manufactured devices.
Data Provenance: Not explicitly stated. Bench testing is typically conducted internally by the manufacturer. It is not clinical data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. This submission describes a physical medical device, not an AI/software device requiring "ground truth" established by human experts for a test set in the same manner. The "ground truth" for a device like this is its performance against engineering specifications and its functional behavior in a simulated environment, typically evaluated by engineers and quality control personnel.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is not an AI/software device requiring a human-expert adjudication method for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical medical device submission, not an AI/software device requiring MRMC studies to assess human reader improvement with AI assistance. The evaluation is focused on the device's physical and functional properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Functional Performance Benchmarks. For a physical device, the "ground truth" is typically defined by:
- Design Specifications: Quantitative and qualitative requirements established during the device's design phase.
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device to which the new device is compared for substantial equivalence.
- Industry Standards: Relevant ISO or ASTM standards that might apply to introducer catheters (though not explicitly mentioned for this specific testing).
- Bench Test Results: Direct measurements and observations of the device's physical properties and functional behavior (e.g., deflection angles, material strength, flow rates).

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of a physical medical device submission unless it refers to process validation or manufacturing controls, which are not detailed in this 510(k) summary. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, there is no "training set" or "ground truth for a training set" as typically understood in AI/software device submissions.

Summary

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

510(k) Number: K683402

Date Prepared:

November 17, 2008

DEC 1 5 2008

Submitter Information:

Submitter's Name/ Address:

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

Contact Person:

Mac McKeen Director, Regulatory Management Tel: 952-351-1544 Fax: 952-930-9481 mmckeen@sjm.com

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:

Agilis™M NxT Steerable Introducer (K061363)

Device Description:

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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.

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 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 No NXT Steerable Introducer was performed to verify the device modifications. Results of the testing demonstrate that the Agilis™M 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 a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA". The eagle is oriented towards the right, and the text is arranged around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. Mac McKeen Director, Regulatory Management 14901 DeVeau Place Minnetonka, MN 55345-2126

DEC 1 5 2008

Re: K083402

Trade/Device Name: Agilis™ NxT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: November 17: 2008 Received: November 18, 2008

Dear Mr. McKeen:

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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Mr. Mac McKeen

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely gours,

Bram D. Zuckerman, M.D.

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): K083402

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 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)

Division Sign City ular Device " 23407

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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).