(25 days)
Not Found
No
The 510(k) summary describes a mechanical clip and its packaging, with no mention of AI or ML technology.
Yes
The device is an implantable clip used to occlude the left atrial appendage, which is a therapeutic intervention aimed at treating or preventing a medical condition.
No
The device is described as an implantable clip used for occluding the left atrial appendage during open cardiac surgical procedures. Its purpose is treatment (occlusion), not diagnosis.
No
The device description clearly states it is an "implantable Clip" and a "Reusable Clip Applier," which are physical hardware components. The 510(k) focuses on packaging modifications for the hardware.
Based on the provided text, the AtriClip Gillinov-Cosgrove LAA Clip is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures." This describes a surgical implant used directly on a patient's organ during a procedure.
- Device Description: The description clearly states it is a "single use, sterile, self-closing, implantable Clip." This is a physical device implanted in the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The AtriClip does not perform any such diagnostic testing on specimens.
Therefore, the AtriClip Gillinov-Cosgrove LAA Clip is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
The AtriClip Gillinov-Cosgrove Clip is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The AtriClip Gillinov Cosgrove LAA Clip is a single use, sterile, self-closing, implantable Clip to be deployed with a Reusable Clip Applier. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. This Special 510(k) does not include any changes to the Clip.
This Special 510(k) includes modifications to package the Clip individually to be loaded on a Reusable Clip Applier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrial appendage (LAA), heart's left atrial appendage
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 Clip was tested to confirm new packaging of the Clip adequately protects the device during shipment. Complete Design Control testing for the Clip was previously included in the original 510(k) K093679.
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.
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