(101 days)
Not Found
No
The description details a purely mechanical device (a ligating clip) and makes no mention of any software, algorithms, or data processing that would involve AI or ML.
No.
The device is used to occlude blood flow, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The Miltex Ligating Clip is an implanted device designed to occlude blood flow in vessels, functioning as a surgical tool rather than for diagnosing any condition. Its purpose is therapeutic (occluding vessels), not diagnostic (identifying or characterizing disease).
No
The device description explicitly states it is constructed of titanium wire and is a physical, implanted device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "occlude by compression blood flow within small, non-intracranial vessels." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical clip designed to be implanted to physically compress a blood vessel.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for direct surgical intervention on a living patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.
Product codes (comma separated list FDA assigned to the subject device)
DSS, FZP
Device Description
The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small, non-intracranial vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Practitioner / Not 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)
When used with the appropriate clip applier, the Miltex Ligating Clip functions in the same manner as the predicate device to occlude blood vessels. The clip is biocompatible, is not endo-toxic, and is supplied sterile.
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
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FDA 510(k) Pre-Market Notification Miltex Ligating Clip
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and Neurological Devices
| 510(k) Number | R05 2018 |
|---|---|
| --------------- | ---------- |
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