(122 days)
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.
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.
The provided text is a 510(k) Summary for the Agilis™ Steerable Catheter Introducer. It includes information about the device, its intended use, and a comparison to predicate devices, but it does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies.
The document explicitly states: "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." This indicates that mechanical and biocompatibility testing were performed, but the details of these tests (e.g., acceptance criteria, specific results, sample sizes) are not provided in this summary.
Therefore, I cannot provide the requested information. The 510(k) Summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety and effectiveness considerations, rather than detailing specific performance studies with acceptance criteria as typically found in clinical validation reports or more comprehensive technical documentation.
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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 PlaceMinnetonka, 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 consistsof a dilator, guidewire, and steerable sheath, which isdesigned to provide flexible catheter positioning in thecardiac anatomy. The steerable introducer is fitted witha hemostasis valve to minimize blood loss duringcatheter introduction and/or exchange. A sideport withthree-way stopcock is provided for air or bloodaspiration, fluid infusion, blood sampling and pressuremonitoring. The steerable introducer features distal ventholes to facilitate aspiration and minimize cavitation,and a radiopaque tip marker to improve fluoroscopicvisualization. The device is provided sterile and isintended for single-use only. |
| Intended Use: | The SJM Agilis™ Steerable Catheter Introducer isindicated for introducing various cardiovascularcatheters into the heart, including the left side of theheart 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.
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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.
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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
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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
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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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§ 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).