(269 days)
Medtronic Cascade® Angiographic Catheter, USCI® Angiographic Catheter
Not Found
No
The summary describes a physical catheter used for delivering contrast and measuring pressure, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used for diagnostic purposes (delivering radiopaque media and making pressure measurements), not for treating a disease or condition.
No
The device is used for delivering radiopaque media and making pressure measurements, which are procedures for obtaining information (diagnostic), but the device itself is a catheter used for delivery and measurement, not a diagnostic device that interprets or processes data to make a diagnosis.
No
The device description clearly states it is a physical catheter with varying diameters and tip configurations, indicating it is a hardware device.
Based on the provided information, the Medtronic® Angiographic Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states the catheter is used for "delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system." This is an in vivo procedure, meaning it is performed inside the living body.
- No Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
Therefore, the Medtronic® Angiographic Catheter is a medical device used for diagnostic and interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
Product codes
DQO
Device Description
The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected coronary sites within the 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
Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Medtronic Cascade® Angiographic Catheter, USCI® Angiographic Catheter
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).
0
Medtronic® Angiographic Catheter
DEC 1 0 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
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- The trade or proprietary name of the device is the Medtronic® Angiographic Catheter. Models offered in this product line include Medtronic® 4F Angiographic Catheter, Medtronic® 5F Angiographic Catheter, Medtronic® 6F Angiographic Catheter and Medtronic® 7F Angiographic Catheter. The classification name is Diagnostic Intravascular Catheter.
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- The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
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- The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
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- All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic® Angiographic Catheters.
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- Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use. The line of angiographic catheters is considered to be substantially equivalent to the following devices:
- . Medtronic Cascade® Angiographic Catheter
- . USCI® Angiographic Catheter
1
Image /page/1/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 an abstract image of a stylized bird or human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Mr. Mark Chartier Quality Assurance and Regualtory Affairs Manager Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923
Re : K980973 Trade Name: Medtronic® Angiographic Catheter Regulatory Class: II Product Code: DQO Dated: September 11, 1998 Received: September 14, 1998
Dear Mr. Chartier:
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 Regulation (QS) for Medical Devices: General requlation (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 obliqation
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Page 2 - Mr. Mark Chartier
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. Callehan
Thomas J. Callahe Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | To be assigned by FDA |
|---|---|
| Device Name: | Medtronic® Angiographic Catheter |
| Indications for Use: | The Medtronic® Angiographic Catheter is designed to be |
| used for delivering radiopaque media and making pressure | |
| measurements in selected coronary sites within the vascular | |
| system. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ice Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device x 510(k) Number _
Prescription Use
(21 CFR 801.109)
Over-The-Counter Use OR
(Per 21 CFR 801.109)
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