(176 days)
Not Found, Not Found
Not Found
No
The summary describes a mechanical device for surgical procedures and does not mention any AI or ML components or functionalities.
No
The device is a surgical tool used for creating anastomoses and approximating tissue, which are procedures, not therapies designed to treat a disease or condition.
No
The device is described as an Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier™ intended for creating everting anastomoses and tissue approximation applications in blood vessels and other tubular structures. Its function is to apply clips, which is a therapeutic or surgical action, not a diagnostic one.
No
The device description clearly describes a physical device (Sutured-Clip and Clip Applier) made from standard medical and implantable grade materials, intended for physical application in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating anastomoses (connections) in blood vessels, grafts, and other tubular structures. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical instrument (a clip and applier) used for tissue approximation and vascular anastomosis. It is not designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical tool used for repair and connection within the body.
N/A
Intended Use / Indications for Use
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is intended for use in endoscopic and non-endoscopic creation and repair of arteriovenus fistulae and the creation of everting anastomoses in blood vessels, grafts and other tubular structures and in the approximation of other soft tissue structures.
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, other tubular structures, soft tissue structures
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)
Design analysis and in vitro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of mechanical integrity and the force required to open or dislodge clip. All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.
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.
Not Found
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0