(64 days)
Not Found
No
The summary describes a physical catheter and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device delivers therapeutic agents, but it is not a therapeutic device itself. Its primary function is a delivery mechanism.
No
Explanation: The device is intended for the infusion of therapeutic agents or contrast media, which are interventional rather than diagnostic functions. While it uses fluoroscopic visualization, this is for guidance during the interventional procedure, not for diagnosing a condition.
No
The device description clearly describes a physical catheter with a lumen, shaft, luer adapter, coating, and radiopaque marker, indicating it is a hardware medical device.
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 controlled selective infusion of therapeutic agents or contrast media into the vasculature. This is a therapeutic or diagnostic procedure performed in vivo (within the body), not an in vitro (outside the body) test on biological samples.
- Device Description: The device is a catheter designed for insertion into the vasculature. This is a medical device used for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver substances, not to perform a diagnostic test on a sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the distal vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165" lumen) have a secondary marker 3 cm proximal of the distal tip marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-specified
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)
Biocompatibility of the Rebar catheter was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the Rebar catheter when tested as an external communicating, blood contact, short duration device (
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Rebar™ Micro Catheter
Prepared December 2, 1999
| TRADE NAME: | Rebar™ Micro Catheter | ||
|---|---|---|---|
| GENERIC NAME: | Infusion Catheter | CLASSIFICATION: | Class II |
| SUBMITTED BY: | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, CA 92618 | CONTACT: | Tom Daughters | |
| Regulatory Affairs | |||
| (949) 837-3700 | |||
| PREDICATE | |||
| DEVICE | Micro Therapeutics, Inc. Easy Rider Micro Catheter, K974473 | ||
| DEVICE | |||
| DESCRIPTION | The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a | ||
| steerable guidewire into the distal vasculature. The proximal end of the catheter | |||
| incorporates a standard luer adapter to facilitate the attachment of accessories. The | |||
| catheter has a semi-rigid proximal shaft which tapers into the flexible distal shaft to | |||
| facilitate the advancement of the catheter in the anatomy. The outer surface of the | |||
| catheter has a lubricious hydrophilic coating. The catheter has a radiopaque marker at | |||
| the distal end to facilitate fluoroscopic visualization. Select catheter models (.0165" | |||
| lumen) have a secondary marker 3 cm proximal of the distal tip marker. | |||
| INDICATIONS | |||
| FOR USE | The Rebar Micro Catheter is intended for the controlled selective infusion of physician- | ||
| specified therapeutic agents or contrast media into the vasculature of the peripheral and | |||
| neuro anatomy. | |||
| SAFETY AND | |||
| PERFORMANCE | |||
| TESTS | Biocompatibility of the Rebar catheter was verified in accordance with ISO 10993-1, | ||
| Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of | |||
| the Rebar catheter when tested as an external communicating, blood contact, short | |||
| duration device ( |