(83 days)
The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.
The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 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 quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.
This document describes the acceptance criteria and the study for the 82cm Agilis NxT™ Steerable Introducer.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface Visual Standard | Pass | Pass |
| Usable Shaft Length | Pass | Pass |
| Curve Angle | Pass | Pass |
| Deflection Durability | Pass | Pass |
| Shaft Kink | Pass | Pass |
| Curve Retention | Pass | Pass |
| Shaft Torque Test | Pass | Pass |
| Tip Tensile | Pass | Pass |
| Sheath/Dilator | Pass | Pass |
| Distal tip inner diameter | Pass | Pass |
| Insertion Forces | Pass | Pass |
| Radiopacity | Pass | Pass |
| 3-way Stopcock | Pass | Pass |
| Shaft to Hub Tensile | Pass | Pass |
| Stopcock to Hub bond | Pass | Pass |
| Freedom from Leaks | Pass | Pass |
| Luer Taper | Pass | Pass |
| Lure Stress Cracking | Pass | Pass |
| Sterilization | ||
| EtO residuals | Meets specifications | Pass |
| Lethality | Meets specifications | Pass |
| Natural product sterility | Meets specifications | Pass |
| Bacteriostasis | Meets specifications | Pass |
| Fungistasis | Meets specifications | Pass |
| Bioburden | Meets specifications | Pass |
| LAL testing | Meets specifications | Pass |
| Packaging | ||
| Performance Testing of Shipping Containers (ASTM D4169-05) | Maintain integrity and sterile barrier | No failures reported |
| Visual Inspection (ASTM F1886-98) | Maintain integrity and sterile barrier | No failures reported |
| Seal Strength (ASTM F88-00) | Maintain integrity and sterile barrier | No failures reported |
| Bubble Leak (ASTM F2096-04) | Maintain integrity and sterile barrier | No failures reported |
| Product shelf life testing | Meets specifications | Pass |
| Biocompatibility | ||
| Cytotoxicity | Pass | Pass |
| Sensitization | Pass | Pass |
| Intracutaneous Reactivity (Irritation) | Pass | Pass |
| Systemic Toxicity (acute, includes pyrogenicity) | Pass | Pass |
| Chemical Characterization / Gas Chromatography with Mass Spectrometry | Pass | Pass |
| Chemical Characterization / Inductively Coupled Plasma (ICP) | Pass | Pass |
| Partial Thromboplastin Time - PTT | Pass | Pass |
| Pyrogenicity | Pass | Pass |
| Hemocompatibility - Hemolysis | Pass | Pass |
| Hemocompatibility - Complement Activation System | Pass | Pass |
| Hemocompatibility - Thrombosis | Pass | Pass |
| Chemical Characterization / Fourier Transform Infrared Spectroscopy (FTIR) | Pass | Pass |
| Chemical Characterization / Physicochemical Non-volatile Residue (NVR) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing for the device, not a human clinical trial involving a "test set" of patients or data in the typical sense for evaluating diagnostic accuracy or clinical outcomes. The "test set" here refers to the actual devices or components tested.
- Sample Size: The specific sample size for each individual bench test (e.g., how many devices underwent a Shaft Kink test) is not explicitly stated in the provided text. The results are simply reported as "Pass."
- Data Provenance: The tests are conducted by the manufacturer, St. Jude Medical, which implies internal testing. The data provenance is retrospective in the sense that these tests were performed on manufactured devices to verify their specifications. The country of origin of the data is implicitly the manufacturing or testing location of St. Jude Medical, likely the United States (Minnetonka, MN, as listed for the submitter).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation is based on bench testing of device specifications, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies, particularly for interpreting diagnostic images or clinical endpoints where multiple experts might disagree. Bench tests have objective Pass/Fail criteria based on predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study assesses the impact of a device (like an AI algorithm) on human reader performance, which is not relevant for a steerable introducer device's bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an electro-mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is the defined product specifications and performance requirements. For example, the "Curve Angle" test would have a specific angle tolerance as its ground truth, and the device either meets it ("Pass") or fails to. For biocompatibility tests, the ground truth is established by standards (e.g., ISO 10993) and the biological response observed meets the defined acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/ML algorithm. The device design and materials are based on engineering principles and previous predicate devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as above.
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Section 5 - 510(k) Summary
MAY 1 0 2011
| Submitter: | St. Jude Medical |
|---|---|
| 14901 DeVeau Place | |
| Minnetonka, MN 55345 | |
| Establishment Registration Number: 3005188751 | |
| Contact Person: | Wendy Pinor |
| Sr. Regulatory Affairs Specialist | |
| Phone (651) 756-5223 | |
| Fax (952) 930-9481 | |
| Date Prepared: | February 15, 2011 |
| Common Name: | Catheter Introducer |
| Trade Name: | 82cm Agilis NxT™ Steerable Introducer |
| Classification: | Class II - 21 CFR 870.1340 |
| Catheter Introducer | |
| Panel: | Cardiovascular |
| Product Code: | DYB |
| Predicate Device(s): | Agilis NxT Steerable Introducer (K081645, K061363) |
Device Description
The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 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 quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.
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
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including packaging, biocompatibility, sterilization, and labeling. Where dimensional differences exist between the subject device and the predicate device, performance testing demonstrates that these differences do not adversely affect safety and effectiveness. The introducer acts as a functioning guide/platform for introduction of other diagnostic and therapeutic devices.
Intended Use
The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the interatrial septum.
Testing
Bench Testing
The Use and Design FMEAs were used in evaluating the need for performance and design verification testing due to the modifications made to the predicate Agilis NxT device. Testing performed demonstrates that the device meets all product specifications and performance requirements.
| Test | Result |
|---|---|
| Surface Visual Standard | Pass |
| Usable Shaft Length | Pass |
| Curve Angle | Pass |
| Deflection Durability | Pass |
| Shaft Kink | Pass |
| Curve Retention | Pass |
| Shaft Torque Test | Pass |
| Tip Tensile | Pass |
| Sheath/Dilator | Pass |
| Test | Result |
| Distal tip inner diameter | Pass |
| Insertion Forces | Pass |
| Radiopacity | Pass |
| 3-way Stopcock | Pass |
| Shaft to Hub Tensile | Pass |
| Stopcock to Hub bond | Pass |
| Freedom from Leaks | Pass |
| Luer Taper | Pass |
| Lure Stress Cracking | Pass |
Sterilization
Based on results of EtO residual, lethality, natural product sterility, bacteriostasis and fungistasis testing, bioburden and LAL testing, it has been determined that the 82 cm Agilis NxT Steerable Introducer meets all applicable specifications.
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Packaging:
Sterile barrier package testing meets specifications and performance requirements throughout the lifetime of the product, as labeled.
The following package testing was performed
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- · Performance Testing of Shipping Containers (ASTM D4169-05)
- · Visual Inspection (ASTM F1886-98)
- · Seal Strength (ASTM F88-00)
- · Bubble Leak (ASTM F2096-04)
There were no failures reported for any of the tests. The testing demonstrates that the Agilis NxT packaging will maintain its integrity and provide a sufficient barrier to ensure the sterile barrier will not be breached.
Product shelf life testing demonstrates that the device meets product specifications and performance requirements throughout the lifetime of the product, as labeled.
| Biological Test | Result |
|---|---|
| s | |
| Cytotoxicity | Pass |
| Sensitization | Pass |
| Intracutaneous Reactivity(Irritation) | Pass |
| Systemic Toxicity (acute,includes pyrogenicity) | Pass |
| Chemical Characterization /Gas Chromatography withMass Spectrometry | Pass |
| Chemical Characterization /Inductively Coupled Plasma(ICP) | Pass |
| Partial Thromboplastin Time- PTT | Pass |
| Biological Test | ResultS |
| Pyrogenicity | Pass |
| Hemocompatibility -Hemolysis | Pass |
| Hemocompatibility-Complement ActivationSystem | Pass |
| Hemocompatibility -Thrombosis | Pass |
| Chemical Characterization /Fourier Transform InfraredSpectroscopy (FTIR) | Pass |
| Chemical Characterization /Physicochemical Non-volatileResidue (NVR) | Pass |
Biocompatibility
Testing demonstrates that the device is biocompatible.
Pre-Clinical and Clinical Testing
No animal or human testing was conducted on the 82 cm Agilis NxT Introducer.
Testing of the 82 cm Agilis NxT Steerable demonstrates that the 82 cm Agilis NxT Steerable Introducer design meets product specifications and intended use.
Conclusion
St. Jude Medical considers the 82 cm Agilis NxT Steerable Introducer to be equivalent to or substantially similar to the predicate device listed above. This conclusion is based upon the devices' similarities in design, technological characteristics, principles of operation, materials, and intended use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Wendy Pinor Sr. Regulatory Affairs Specialist 14901 Deveau Place Minnetonka, MN 55345
Re: K110450
Trade/Device Name: 82cm Agilis NxT™ Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2011 Received: February 16, 2011
Dear Ms. Pinor:
This letter corrects our substantially equivalent letter of May 10, 2011.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 or any Federal statutes and regulations administered by other Federal agencies. You must
JUN 1 5 2015
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Page 2 - Ms. Wendy Pinor
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _ K | 0450
Device Name:
82cm Agilis NxT™ Steerable Introducer
Indications for Use:
The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum
Prescription Use _ × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K110 450 |
§ 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).