(18 days)
Apeel CS Catheter Delivery System
Spyglass Angiographic Catheter
No
The summary describes a mechanical catheter delivery system and does not mention any AI or ML components or functions.
No
The device is a delivery system for other devices and provides vascular access; it does not directly treat a medical condition.
No
The device description states it is a "Catheter Delivery System" intended to "provide vascular access...and serve as a conduit for the delivery and support of other devices." This indicates it is a tool for delivering other medical devices or providing access, rather than a device designed to identify or diagnose a condition.
No
The device description explicitly lists multiple hardware components (Peelable Introducer Sheath, Dilator, Cannulator, etc.) and is described as a "Catheter Delivery System," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices". This describes a device used in vivo (within the body) for a medical procedure, not for testing samples in vitro (outside the body).
- Device Description: The components listed (catheter, sheath, dilator, guidewire, etc.) are all instruments used for accessing and navigating within the vascular system. These are typical components of devices used for interventional procedures, not for diagnostic testing of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate access and delivery within the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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.
Product codes
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Apeel CS Catheter Delivery System
Reference Device(s)
Spyglass Angiographic Catheter
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
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 Place |
| Minnetonka, 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 System |
| Spyglass Angiographic Catheter | |
| Device Description: | 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. | |
| Intended Use: | 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. |
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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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