(70 days)
Not Found
Not Found
No
The summary describes a physical catheter for delivering contrast medium and does not mention any software, algorithms, or AI/ML capabilities.
No
The device delivers contrast medium, which is用于诊断而非治疗的。
No
The device is used to deliver contrast medium, which aids in imaging for diagnosis, but the catheter itself is an interventional tool for delivery, not a diagnostic tool that produces diagnostic information.
No
The device description clearly states it is a physical catheter made of polyamide and polyurethane materials, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Cordis TempoTM 4 Angiography Catheter is designed to deliver contrast medium into the vascular system. This is an invasive procedure performed inside the body.
- Intended Use: The intended use clearly states it's for delivering contrast medium to selected sites in the vascular system. This is a therapeutic or diagnostic procedure performed directly on the patient, not on a specimen.
The information provided describes a device used for a medical procedure performed in vivo (within a living organism), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
The Cordis Tempo™ 4 Angiography Catheters are designed for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Cordis Tempo™ 4 Angiography catheter is a single lumen catheter consisting of polyamide and polyurethane materials with a proximal strain relief and hub. The catheters are available in various lengths and tip configurations and accept guidewires with diameters of 0.035" or 0.038" depending on the configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Tempo™ 4 Angiography Catheters per ISO 10993-1.
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 4F Infinity™ Angiography Catheter
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
§ 870.1200 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).
0
00-00009
Ka973401
Summary Of Safety And Effectiveness
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14 - 18
Status
| General
| Provisions | The name of the device is: NOV 18 1997 | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Cordis Tempo™ 4 Angiography Catheter | Diagnostic Intravascular | |
| Catheter and Percutaneous | ||
| Catheter | ||
| Predicate | ||
| Device | The name of the predicate device is: | |
| • Cordis 4F Infinity™ Angiography Catheter | ||
| Classification | The FDA has classified angiography catheters as Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under Section | |
| 514 of the Food, Drug, and Cosmetic Act. | ||
| Indications for | ||
| Use | The Cordis Tempo™ 4 Angiography Catheters are designed for the delivery | |
| of radiopaque contrast medium to selected sites in the vascular system. | ||
| Device | ||
| Description | The Cordis Tempo™ 4 Angiography catheter is a single lumen catheter | |
| consisting of polyamide and polyurethane materials with a proximal strain | ||
| relief and hub. The catheters are available in various lengths and tip | ||
| configurations and accept guidewires with diameters of 0.035" or 0.038" | ||
| depending on the configuration. | ||
| Continued on next page |
PREMARKET NOTIFICATION Cordis Corporation
Tempo™ 4 Angiography Catheter
1
ՌՈ-ՈՌՈ | Օ
Summary Of Safety And Effectiveness, Continued
| Biocompatibility | All appropriate Biocompatibility tests were successfully performed on the
materials used for the Cordis Tempo™ 4 Angiography Catheters per ISO
10993-1. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | The Cordis Tempo™ 4 Angiography Catheter is similar in design,
construction, indication for use and performance characteristics to other
commercially available angiography catheters. |
' Any statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suuites." 42 Fed. Reg. 42,520, et seg. (1977).
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font. The words are stacked on top of each other, with "Public" and "Health" on the top line and "Service" on the bottom line.
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Ms. Jacqueline Zimovan Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700
Re : K973401 Tempo™ Angiography Catheter Requlatory Class: II (two) Product Code: DQO Dated: September 8, 1997 Received: September 9 1997
Dear Ms. Zimiovan:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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.
3
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) 594-4648. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
| 510(K) Number (if known): [To be assigned by the FDA] | |
|---|---|
| Device Name: | Tempo TM 4 Angiography Catheter |
| Indications for Use: | The Cordis TempoTM 4 Angiography Catheter is designed to |
| deliver radiopaque contrast medium to selected sites in the vascular | |
| system. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Tara A. Ry
(Division Sign-Off)
Division of Cardiovascular Respiratory, and Neurological Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use _
PREMARKET NOTIFICATION
D
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Cordis Corporation Tempo™ 4 Angiography Catheter