(9 days)
Not Found
No
The summary describes a standard angiography catheter for contrast delivery and does not mention any AI/ML components or functionalities.
No.
The device's intended use is to deliver contrast medium for diagnostic imaging (angiography), not to treat a disease or condition.
No
The device is described as an angiography catheter intended for the delivery of radiopaque contrast medium. While this medium aids in diagnostic imaging, the device itself is a delivery tool, not a device that directly performs diagnosis or interprets images.
No
The device description clearly outlines physical components made of Polyamide and Polyurethane materials, indicating it is a hardware 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 is "for the delivery of radiopaque contrast medium to selected sites in the vasculature." This describes a device used in vivo (within the body) for a diagnostic imaging procedure (angiography).
- Device Description: The description details a catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
IVDs are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to facilitate an imaging procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Cordis Tempo Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
Product codes
DQO
Device Description
The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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MAY 2 6 jggg
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Attachment 4
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Cordis Tempo™ Angiography Catheters
Common/Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Cordis Tempo™ Angiography Catheters (K973401) |
| 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 Tempo Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
The device description of Cordis Tempo Angiography Catheters is as follows:
The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038". |
| Biocompatibility | All materials used in the Tempo Angiographic Catheters are biocompatible. |
| Summary of
Substantial
Equivalence | The Cordis Tempo™ Angiography Catheters (40 to 125 cm length) are substantially equivalent to the previously cleared Cordis Tempo Catheters (65 to 125 cm length). |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1999
Ariel MacTavish, RAC Sr. Requlatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
K991673 Re :
4F Tempo™ Angiography Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: May 14, 1999 Received: May 17, 1999
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 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). 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 (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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
2
Page 2 - Ms. Ariel MacTavish
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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical 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 | Tempo TM Angiography Catheter |
| Indications for Use | Cordis Tempo TM Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ohiton Smith Ar TC
Divisi and N 510(k)
Prescription Use __
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_