(180 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a steerable introducer, with no mention of AI or ML capabilities.
No
Explanation: This device is an introducer sheath used to facilitate the placement of other cardiovascular catheters. It does not provide any therapeutic effect itself.
No
Explanation: The device is an introducer sheath used to guide cardiovascular catheters into the heart. Its function is to facilitate the placement of other devices, not to diagnose medical conditions by providing diagnostic information or images.
No
The device description clearly outlines physical components such as a steerable sheath, plastic dilator, stainless steel guidewire, hemostasis valve, sideport, and handle, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Agilis™ NxT Steerable Introducer is a device used to introduce other catheters directly into the heart. It is a tool used during a medical procedure performed inside the body (in vivo).
- Intended Use: The intended use clearly states it's for "introducing various cardiovascular catheters into the heart." This is a procedural tool, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components and how it functions to facilitate catheter insertion and manipulation within the heart. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the Agilis™ NxT Steerable Introducer is a medical device used for a procedural purpose within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DYB
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 8.5F asymmetrical bi-directional steerable introducer with a large 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Heart, 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
Bench testing of the Agilis TM NxT Steerable Introducer was performed to verify the device modification. Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use.
Key Metrics
Not Found
Predicate Device(s)
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
DEC 0 9 2008
510(k) Summary As required by 21 CFR 807.92(c)
510(k) Number:
Date Prepared:
June 11, 2008
Submitter Information:
Submitter's Name/ Address:
Contact Person:
St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126 Establishment Registration Number: 2182269
Mac McKeen Director, Regulatory Affairs 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:
AgilisTM NxT Steerable Introducer (K061363)
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 8.5F asymmetrical bi-directional steerable introducer with a large 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 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.
1
Indications for Use:
The Agilis "M 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 No NxT Steerable Introducer has the same intended use and fundamental The rights - NY P Stockers in Cases not the canological 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 TM NxT Steerable Introducer was performed to verify the device modification. Results of the testing demonstrate that the Agilis™ 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.
2
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 tail. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical Atrial Fibrillation Division c/o Mr. Mac McKeen Director of Regulatory Affairs 14901 Deveau Place Minnetonka, MN 55345
DEC - 9
K081645 Re:
Trade/Device Name: Agilis™ NxT Steerable Introducer Common Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: November 7, 2008 Received: November 10, 2008
Dear Mr. McKeen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as sualed in the excirement date of the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-11-11, 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 r ou may, disrelere, maines 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 or any 1 outlar statuated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
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) 276-0210. 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,
K/w/
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):
14681645
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 (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-Off)
Doveroular
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