(6 days)
Not Found
Not Found
No
The summary describes a standard catheter sheath introducer with no mention of AI or ML components or functionalities.
No
Explanation: This device is an introducer sheath used for percutaneous introduction of intravascular devices, not for therapeutic purposes. Its function is to facilitate access rather than provide treatment.
No
Explanation: The device is described as an introducer for percutaneous introduction of intravascular devices in arterial and venous procedures, indicating it is an access tool rather than a device used to diagnose a medical condition.
No
The device description clearly outlines physical components (introducer, mini-guidewire, vessel dilator) made of various materials, indicating it is a hardware 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 the device is for "percutaneous introduction of intravascular devices" in arterial and venous procedures. This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The description details a physical device (catheter sheath introducer, guidewire, dilator) used to access blood vessels. This is consistent with a medical device used in a procedure, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural – facilitating access to the vascular system.
N/A
Intended Use / Indications for Use
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 11 French
• 3 - 120 cm length
• .035" - .038' mini guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis Brite Tip Catheter Sheath Introducer
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows a handwritten number, "1984500". The numbers are written in a slightly messy, cursive style. The numbers are all connected, and the overall appearance is somewhat faded.
Attachment 4
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Cordis Brite Tip Catheter Sheath Introducer
Common/Classification Name: Catheter Introducer System |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Cordis Brite Tip Catheter Sheath Introducer |
| Classification | Class II. |
| Performance
Standards | Performance standards have not been established by the FDA under section 514 of
the Food, Drug and Cosmetic Act. |
| Intended Use
and Device
Description | Cordis Catheter Sheath Introducers are intended for use in arterial and venous
procedures requiring percutaneous introduction of intravascular devices.
The device description of the Brite Tip CSI is as follows.
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The
introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a
high density polyethylene body, and polyurethane sideport extension. The
radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 11 French
• 3 - 120 cm length
• .035" - .038' mini guidewire |
| Biocompatibility | All materials used in the Brite Tip CSI's are biocompatible. |
| Summary of
Substantial
Equivalence | The Brite Tip CSI's are substantially equivalent to the previously cleared Brite Tip
CSI's. |
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely a heading or title, possibly indicating the name of an organization or department.
Image /page/1/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three lines that resemble a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Ms. Ariel MacTavish Sr. Requlatory Affairs Associates Cordis Corporation 14420 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K984500 Cordis Brite Tip Catheter Sheath Introducer System Trade Name: Requlatory Class: II Product Code: DYB Dated: December 14, 1998 Received: December 17, 1998
Dear Ms. MacTavish:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation
2
Page 2 - Ms. Ariel MacTavish
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Allelshan
Thomas J. Callal Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Brite Tip Catheter Sheath Introducer |
| Indications for Use | Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tu A. Ra-
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Hygysod 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_