(18 days)
The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.
The Apeel™ CS Plus Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port with 3-way Stopcock, Guidewire, Syringe, Needle, and 2 Valve Bypass Tools. The introducer kits are provided sterile, and are intended for single-use only.
The provided document, K051096, is a Special 510(k) for a device modification of the Apeel™ CS Plus Catheter Delivery System. This type of submission is for device modifications, not for validating new AI algorithms or diagnostic tools. As such, the document does not contain any information related to acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.
The submission focuses on establishing substantial equivalence to a predicate device (Apeel CS Catheter Delivery System) and a reference device (Spyglass Angiographic Catheter) for a modified medical device. The "support of the substantial equivalence" section explicitly states: "St. Jude Medical considers the Apeel CS Plus Catheter Delivery System to be substantially equivalent to the predicate and referenced devices."
Therefore, I cannot provide the requested information for an AI/diagnostic device based on this document. The sections you asked for are not applicable to the content of this 510(k) submission.
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MAY 1 7 2005
Special 510(k): Device Modification
510(k) Summary (As required by 21 CFR 807.92)
A. Submitter Information
| Submitter's Name: | St. Jude Medical |
|---|---|
| Address: | 14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | (952) 351-1453 |
| Contact Person: | Mike Burnside |
| Date Submission Prepared: | 28-April-2005 |
B. Device Information
| Trade Name: | Apeel™ CS Plus Catheter Delivery System |
|---|---|
| Common or Usual Name: | Percutaneous Catheter Introducer |
| Classification Name: | Percutaneous Catheter Introducer(per 21 CFR Part 870.1340) |
| Device Classification: | Class II (per 21 CFR Part 870.1340)Panel - Cardiovascular |
| Predicate Device:Reference Device: | Apeel CS Catheter Delivery SystemSpyglass Angiographic Catheter |
| Device Description: | The Apeel™ CS Plus Catheter Delivery Systemincludes a Peelable Introducer Sheath, Dilator,Cannulator, Detachable Hemostasis Valve with SidePort with 3-way Stopcock, Guidewire, Syringe,Needle, and 2 Valve Bypass Tools. The introducerkits are provided sterile, and are intended for single-use only. |
| Intended Use: | The Apeel CS Plus Catheter Delivery System isintended to provide vascular access including thecoronary sinus and serve as a conduit for thedelivery and support of other devices whereminimizing blood loss is essential. |
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C. Comparison of Required Technological Characteristics
All technological characteristics of the Apeel™ CS Plus Catheter Delivery System are substantially equivalent to the predicate and referenced devices including product design, packaging, sterilization, and labeling.
D. Support of the Substantial Equivalence
St. Jude Medical considers the Apeel CS Plus Catheter Delivery System to be substantially equivalent to the predicate and referenced devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2005
Mr. Mike Burnside Senior Regulatory Affairs Specialist St. Jude Medical 14900 Minnetonka Ind. Rd. Minnetonka, MN 55345
K051096 Re:
Trade/Device Name: Apeel™ CS Plus Catheter Delivery System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: April 28, 2005 Received: April 29, 2005
Dear Mr. Burnside:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reach 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.
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 comply 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. Mike Burnside
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. product railation only to begin marketing your device as described in your Section 510(k) rms retet 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmerman for
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): _Ko51694
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Apeel CS Plus Catherer Delivery System is intended to provide vascular
System in the same and serve as a conduit for the delivery an The Apeel CS Plus Catheter Denvery system is mondus as promotive for the delivery and
access including the coronary sinis wiring hood loss is essential. access including the coronaly since and ber. C of the best is essential.
support of other devices where minimizing blood loss is essential.
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)
Blummenstiel
Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
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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).