(31 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter for delivering contrast and providing a conduit. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The "Intended Use / Indications for Use" section states "as well as to provide a conduit for various diagnostic and therapeutic procedures." which directly indicates its use in therapeutic applications.
Yes
The device is intended to "deliver contrast medium during angiography" and "provide a conduit for various diagnostic and therapeutic procedures." Angiography is a diagnostic imaging technique, and the catheter's role in facilitating diagnostic procedures directly indicates its function in diagnostics.
No
The device description clearly describes a physical catheter with a shaft, hub, and tip, 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 to deliver contrast medium and provide a conduit for diagnostic and therapeutic procedures within the body (angiography in selected blood vessels). This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the core function of an IVD.
Therefore, the Selector Angiographic Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.
Product codes
Not Found
Device Description
The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present. Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.
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)
The new Selector Angiographic Catheter has been subjected to non-clinical performance testing to provide data supporting the safety and effectiveness of the device. The test protocol included verification of tensile, dynamic pressure testing, flow rate, diameters, and radiopacity. The resultant data demonstrates that the device meets the required performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
PREMARKET NOTIFICATION
VII: 510(K) SUMMARY
| | Manufacturer: | NAMIC USA Corporation
Glens Falls, New York 12801 | MAR 2 9 1996 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------|
| www.rammannen.comment.com
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Contact Person: | Mary Meagher Rubin
Regulatory Affairs Specialist | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | Telephone Number (518) 798-0067
Facsimile Number (518) 798-5475 | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Date Prepared: | February 26, 1996 | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Trade Name: | Selector Angiographic Catheter | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Common Name: | Angiographic Catheter | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-
| Classification Name: | Catheter, Angiographic
Catheter, Cardiovascular
Catheter, Intravascular, Diagnostic | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Predicate Device: | Selector Angiographic Catheter (K922552) | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Intended Use: | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The Selector Angiographic Catheter is intended to deliver contrast medium during
angiography as well as to provide a conduit for various diagnostic and therapeutic
procedures. Selector Angiographic Catheters are intended for single-patient use only. | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Product Description: | | |
| | The Selector Angiographic Catheter consists of a radiopaque shaft with an attached
molded female luer lock hub. The shaft of the catheter includes a flexible section and an
optional soft distal tip. The Selector Angiographic catheter may vary with respect to | | |
| | | length, diameter, curve style, and the number of side holes present. | |
| | Selector Angiographic Catheters can be introduced into the selected blood vessel by
either cutdown or percutaneous entry techniques. | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | Selector™
Angiographic Catheter | NAMIC® USA CORPORATION | Page 4 |
1
VII. 510(K) Summary (Continued).
Comparison to Predicate Device:
The Selector Angiographic Catheter is equivalent to the currently marketed Selector Angiographic Catheter. The proposed new Selector Angiographic Catheter will be offered in a larger French size (diameter) than the currently marketed device.
The Selector Angiographic Catheter is manufactured in the same manner as the predicate device. Packaging and sterilization for the Selector Angiographic Catheter are the same as for other NAMIC devices.
Performance Testing:
The new Selector Angiographic Catheter has been subjected to non-clinical performance testing to provide data supporting the safety and effectiveness of the device. The test protocol included verification of tensile, dynamic pressure testing, flow rate, diameters, and radiopacity. The resultant data demonstrates that the device meets the required performance criteria.
Biocompatibility:
Biocompatibility testing has been performed on the currently marketed Selector Angiographic Catheter (K922552). The material composition of the new Selector Angiographic Catheter is the same as currently marketed NAMIC products.