(243 days)
Not Found
No
The device description is purely mechanical and there is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is described as being used for the removal of arterial emboli and thrombi, which is a therapeutic intervention.
No
The device description indicates its use for removal of arterial emboli and thrombi (treatment), not for diagnosing conditions.
No
The device description clearly outlines physical components like a nylon tube, latex balloon, stopcocks, syringe, and stylet, 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 the "removal of arterial emboli and thrombi during embolectomy and thrombectomy." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for physical manipulation within the arterial system. This is a surgical/interventional device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Versa-Cath Arterial Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.
Product codes
74 DXE
Device Description
The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Ideas for Medicine, Inc.
Versa-Cath Arterial Catheter
510(k) Notification
K961883
SAFETY and EFFECTIVENESS SUMMARY
100 1 3 1997
PROPRIETARY NAME:
Versa-Cath Arterial Catheter
COMMON USUAL NAME:
Embolectomy Catheter
CLASSIFICATION:
Class II
CLASSIFICATION NUMBER:
74 DXE
DEVICE DESCRIPTION:
DESCRIPTION:
The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.
The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.
The catheter with the balloon deflated is advanced into the vessel and advanced beyond the obstruction. The balloon is inflated with sterile solution. The catheter is withdrawn pulling the embolism with it, thus removing it from the artery. The dual lumen design allows for a more versatile catheter. It can be used for injection of contrast media or heparinized saline, and/or irrigation and aspiration. The balloon when inflated can be used for vessel occlusion. Finally, it can be used for catheter placement over a guidewire.
1
The materials used on the Versa-Cath Arterial Catheters have been used for years on other models of Ideas for Medicine, Inc. catheters except the suture, which has been certified to USP grade. Other catheter materials have been certified to meet the requirements of USP Class VI tests. Every lot is supplied sterile and non-pyrogenic.
SUBSTANTIAL EQUIVALENCE:
The intended use of these devices is to remove arterial emboli and thrombi, vessel irrigation, aspiration and occlusion, perfusion and catheter placement using a guidewire. Both the Fogarty Thru-Lumen and Robicsek Angiography catheters have the same intended use.