(83 days)
No
The summary describes a mechanical steerable introducer and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is an Introducer, which is used to introduce other catheters into the body. It does not actively treat a disease or condition itself.
No
Explanation: The Agilis NxT Steerable Introducer is an instrument used to facilitate the introduction of other cardiovascular catheters into the heart. It does not obtain or interpret information about the patient's health status, which would be the function of a diagnostic device.
No
The device description clearly outlines physical components such as a steerable sheath, dilator, guidewire, hemostasis valve, sideport with stopcock, and a handle with a rotating collar. The performance studies also detail testing of physical attributes like shaft length, curve angle, tensile strength, and leak testing. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introducing various cardiovascular catheters into the heart via the venous anatomy." This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a physical introducer sheath, dilator, and guidewire designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are typically reagents, kits, or instruments used for laboratory testing.
Therefore, the Agilis NxT Steerable Introducer is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart via the venous anatomy, including the left side of the heart through the 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 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.
Results include Pass for:
Surface Visual Standard
Usable Shaft Length
Curve Angle
Deflection Durability
Shaft Kink
Curve Retention
Shaft Torque Test
Tip Tensile
Sheath/Dilator
Distal tip inner diameter
Insertion Forces
Radiopacity
3-way Stopcock
Shaft to Hub Tensile
Stopcock to Hub bond
Freedom from Leaks
Luer Taper
Lure Stress Cracking
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.
Packaging:
Sterile barrier package testing meets specifications and performance requirements throughout the lifetime of the product, as labeled.
Performance Testing of Shipping Containers (ASTM D4169-05) - Pass
Visual Inspection (ASTM F1886-98) - Pass
Seal Strength (ASTM F88-00) - Pass
Bubble Leak (ASTM F2096-04) - Pass
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.
Biocompatibility:
Testing demonstrates that the device is biocompatible with Pass results for:
Cytotoxicity
Sensitization
Intracutaneous Reactivity (Irritation)
Systemic Toxicity (acute, includes pyrogenicity)
Chemical Characterization / Gas Chromatography with Mass Spectrometry
Chemical Characterization / Inductively Coupled Plasma (ICP)
Partial Thromboplastin Time - PTT
Pyrogenicity
Hemocompatibility - Hemolysis
Hemocompatibility-Complement Activation System
Hemocompatibility - Thrombosis
Chemical Characterization / Fourier Transform Infrared Spectroscopy (FTIR)
Chemical Characterization / Physicochemical Non-volatile Residue (NVR)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Agilis NxT Steerable Introducer (K081645, K061363)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
- · 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 with | |
| Mass Spectrometry | Pass |
| Chemical Characterization / | |
| Inductively Coupled Plasma | |
| (ICP) | Pass |
| Partial Thromboplastin Time |
- PTT | Pass |
| Biological Test | Result
S |
| Pyrogenicity | Pass |
| Hemocompatibility -
Hemolysis | Pass |
| Hemocompatibility-
Complement Activation
System | Pass |
| Hemocompatibility -
Thrombosis | Pass |
| Chemical Characterization /
Fourier Transform Infrared
Spectroscopy (FTIR) | Pass |
| Chemical Characterization /
Physicochemical Non-volatile
Residue (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.
3
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
4
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
5
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 |