(122 days)
Not Found
No
The 510(k) summary describes a mechanical catheter introducer and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is an introducer used to facilitate the placement of other catheters. It is not designed to perform a therapeutic function itself.
No
The device is described as an introducer for various cardiovascular catheters, designed to facilitate their positioning and minimize blood loss. Its function is to assist in the introduction and exchange of other catheters, rather than to diagnose medical conditions itself. It does not provide information about a patient's health status.
No
The device description clearly outlines physical components such as a dilator, guidewire, steerable sheath, hemostasis valve, sideport with stopcock, distal vent holes, and a radiopaque tip marker. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for introducing cardiovascular catheters into the heart. This is a procedure performed on the patient's body, not on a sample of the patient's body outside of the body.
- Device Description: The device components (dilator, guidewire, steerable sheath, hemostasis valve, sideport) are all designed for direct interaction with the patient's circulatory system during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to test samples in vitro (in glass, or outside the body) to diagnose diseases or conditions.
Therefore, the St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SJM Agilis™ Steerable Catheter 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™ Steerable Catheter 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 is 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. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary (As required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | St. Jude Medical, Daig Division, Inc. |
|---|---|
| Address: | 14901 DeVeau Place |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | (952) 351-1496 |
| Fax Number: | (952) 930 - 9481 |
| Contact Person: | Jennifer Nevison |
| Date Submission Prepared: | September 24, 2004 |
B. Device Information
| Trade Name: | Agilis™ Steerable Catheter Introducer |
|---|---|
| Common or Usual Name: | Steerable Transseptal Catheter Introducer |
| Classification Name: | Catheter Introducer (per 21CFR 870.1340) |
| Predicate Devices: | Fast-Cath™ (Two-Piece AMAS) Transseptal & Intra- |
| Cardiac Catheter Introducers (K964518 & K973840) | |
| Device Description: | The Agilis™ Steerable Catheter 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 is 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. The steerable introducer features distal vent | |
| holes to facilitate aspiration and minimize cavitation, | |
| and a radiopaque tip marker to improve fluoroscopic | |
| visualization. The device is provided sterile and is | |
| intended for single-use only. | |
| Intended Use: | The SJM Agilis™ Steerable Catheter Introducer is |
| indicated for introducing various cardiovascular | |
| catheters into the heart, including the left side of the | |
| heart through the interatrial septum. |
C. Comparison of Required Technological Characteristics
All technological characteristics of the Agilis™ Steerable Catheter Introducer are substantially equivalent to the predicate devices including product design, packaging, sterilization, and labeling. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness.
1
Support of the Substantial Equivalence D.
St. Jude Medical, Daig Division, Inc. considers the Agilis™ Steerable Catheter Introducer to be substantially equivalent to the predicate device, Fast-Cath™ (Two-Piece AMAS) Transseptal Intra-Cardiac Catheter Introducer.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the eagle.
JAN 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Glenn Jacques Sr. Regulatory Affairs Specialist St. Jude Medical, Daig Division, Inc. 14901 Deveau Place Minnetonka, MN 55345
K042623 Re:
Ro+2025
Trade/Device Name: Agilis™ Steerable Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: January 11, 2005 Received: January 13, 2005
Dear Mr. Jacques:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarell 9 re(s) pecialized is substantially equivalent (for the indications felerenced above und nave actern legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard the Medical Device Amendments, or to commence provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not requent to the general controls provisions of the Act. The I ou may, therefore, manel are a ct include requirements for annual registration, listing of general controls provided of are tice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back added to begulations, 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 that I D'I has Intacted and regulations administered by other Federal agencies. You must or any I 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
3
Page 2 – Mr. Glenn Jacques
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR 100); (2005) (2005) (21 c. 531, 542 of the Anti-21 CFR 1000-1050, forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Acction 5 product radiation control provisions (Sections 35 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin hiakemily your active of your device to a legally
premarket notification. The FDA finding of substantial equivaleond thus, permits vour d premarket notification. The FDA Imaling of substantial equive 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
rs of the many of the many of 1010 - Alex welesse note the regulation entit If you desire specific advice for your ac not on one on one mote the regulation entitled,
contact the Office of Compliance at (240) 276-0120. ↑ Also, please note the regulati contact the Office of Comphalice at (240) 270 - 1 ion (210) Part 807.97). You may obtain
"Misbranding by reference to premarket no iif cation of Small "Misbranding by relerence to prematici notified in (ce Act from the Division of Small
other general information on your responsibilities under (800) 638-204 other general information on your responsibilities and its toll-lifee mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-limers/support Manufacturers, international and Consumer Assistance articles of to corport/industry/support/index.html.
Sincerely yours,
Dama P. Lochner
J / 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): | K042623 |
|---|---|
| Device Name: | Agilis™ Steerable Catheter Introducer |
Indications for Use:
The St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
__ X ___ Prescription Use
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Jochner
I Dision Sign-Off) ്പങ്ങാന of Cardiovascular Devices
510(K) Number KO(K) Number KO(K) 3 ___________________________________________________________________________________________________________________________________________
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