(21 days)
The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.
The St. Jude Medical Agilis™ NxT Stecrable Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counter-clockwise ≥ 90°15 The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
This document, K083083, is a 510(k) summary for the Agilis™ NxT Steerable Introducer Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the St. Jude Medical Agilis™ NxT Steerable Introducer (K061363).
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Agilis™ NxT Steerable Introducer. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Performance | Meets product specifications and performance requirements (as determined by bench testing). | "Results of the testing demonstrate that the Agilis™ NxT Stecrable Introducer meets product specifications and performance requirements." |
| Material Equivalence | Utilizes many of the same materials as the predicate device. | "The Agilis™ NxT Steerable Introducer (40cm) utilizes many of the same materials..." |
| Design Principles | Follows similar design principles as the predicate device. | "...and design principles..." |
| Fundamental Technology | Fundamental scientific technology remains unchanged from the predicate device. | "...and the fundamental scientific technology of the device remain unchanged." |
| Indications for Use | The indications for use are either identical or fall within a broader statement of the predicate. | "The Agilis™ NxT Steerable Introducer (40cm) has an Indication for Use statement that is included in the broader Indications for Use statement of the predicate Agilis™ NxT Steerable Introducer." |
Note: The acceptance criteria are largely implied by the statement of "substantial equivalence" and the general successful outcome of non-clinical testing. Specific numerical or threshold-based performance metrics are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" which typically involves testing a sample size of devices, but the specific number is not provided.
- Data Provenance: The testing appears to be non-clinical bench testing, meaning it was conducted in a laboratory setting, not with human or animal subjects. Details on the geographic origin are not mentioned, but it would typically be internal testing by the manufacturer (St. Jude Medical). It is retrospective in the sense that the test results confirm the design choices made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not available in the provided document. The study described is a non-clinical bench test. "Ground truth" in the context of expert review typically refers to clinical studies where human experts (e.g., radiologists, pathologists) interpret data (e.g., images, case files) to establish a correct diagnosis or outcome. For bench testing of a medical device like an introducer catheter, the "ground truth" is typically defined by engineering specifications, physical measurements, and established testing standards, not by expert human review in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not available. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers in clinical studies to establish a consensus ground truth. Since this study is a non-clinical bench test validating device performance against specifications, such a method would not be used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this document. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to evaluate the performance of human readers with and without AI assistance. This document describes the substantial equivalence of a physical medical device (an introducer catheter) based on bench testing.
Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable and not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this concept is not applicable to the device described. A "standalone" performance evaluation refers to the performance of an algorithm or AI model without human intervention. The Agilis™ NxT Steerable Introducer is a physical medical device. Its performance is evaluated through engineering tests, not as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this study would be derived from:
- Engineering Specifications: Pre-defined performance parameters and design requirements for the introducer catheter.
- Physical Measurements and Standards: Data obtained from bench tests (e.g., material strength, deflection angles, hemostasis valve integrity, flow rates) are compared against established industry standards, design tolerances, and the performance characteristics of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and therefore not available. A "training set" is used for machine learning algorithms. The Agilis™ NxT Steerable Introducer is a physical medical device, not an AI algorithm. Its development and validation are based on engineering design, manufacturing processes, and physical testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no "training set" in the context of this device.
{0}------------------------------------------------
510(k) Summary As required by 21 CFR 807.92(c)
s required by 21 CFR 807.92(c)
NOV - 6 2008
510(k) Number:
Date Prepared:
October 3, 2008
Submitter Information:
Submitter's Name/ Address:
St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126
Contact Person:
Laura Moen-Ftacek Regulatory Affairs Specialist Tel: 952-351-1453 Fax: 952-930-9481 Imoen-ftacek@sjm.com
Device Information:
Trade Name: Common Name: Classification Name: Class:
Agilis™ NxT Steerable Introducer Catheter Introducer Introducer, Catheter Class II, 21 CFR 870.1340, Product Code DYB
Predicate Device:
St. Jude Medical Agilis™ NxT Steerable Introducer, Catheter Introducer (K061363)
Device Description:
The St. Jude Medical Agilis™ NxT Stecrable Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer if fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counter-clockwise ≥ 90°15 The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
Indications for Use:
The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.
{1}------------------------------------------------
Comparison to Predicate Devices:
The Agilis™ NxT Steerable Introducer (40cm) has an Indication for Use statement that is included in the broader Indications for Use statement of the predicate Agilis™ NxT Steerable Introducer. The Agilis™ NxT Steerable Introducer (40cm) utilizes many of the same materials and design principles and the fumdamental scientific technology of the device remain unchanged,
Summary of Non-Clinical Testing:
Bench testing of the Agilis™ NxT Stecrable Introducer was performed to support substantial equivalence. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer meets product specifications and performance requirements.
Statement of Equivalence:
The Agilis™ NxT Steerable Introducer has similar 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 6 2008
St. Jude Medical c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K083083
Agilis NXT Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 15, 2008 Received: October 16, 2008
Dear Mr. Job:
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. T o 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 moy publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIDA 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 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 yours.
Dma R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(K) Number (if known):
Device Name: AgilisTM NxT Steerable Introducer
Indications for Use:
The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart.
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)
oning & la misses
Page 1 of 1
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_KO8308 3
§ 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).