(78 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a stainless steel anchor, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is described as an anchor for soft tissue to bone attachment, used in reconstructive surgeries. This function is structural and aids in healing rather than directly treating a disease or condition, which is the primary function of a therapeutic device.
No
The device description indicates it is a surgical implant (anchor for soft tissue to bone attachment) used for reconstruction, not for diagnosis.
No
The device description explicitly states it is made from surgical grade stainless steel and is a physical anchor, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the LM Anchor is a surgical implant made of stainless steel designed for soft tissue to bone attachment during surgical procedures. It is a physical device used in vivo (within the body) during surgery.
- Intended Use: The intended use describes surgical repairs and reconstructions of ligaments and bones in various anatomical locations. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under the category of medical devices used for treatment or repair, not for diagnosing conditions based on in vitro testing.
N/A
Intended Use / Indications for Use
Shoulder (bankart repair), Hand (ulnar or lateral
collateral ligament reconstruction), Wrist
(scapholunate ligament reconstruction), Foot (hallux
valgus reconstruction), and Ankle (midfoot
reconstructions)
Product codes
Not Found
Device Description
Made from surgical grade stainless steel (316L), the
LM Anchor is designed with a crown and a center pin
through which suture is passed to provide a means for
soft tissue to bone attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Hand, Wrist, Foot, Ankle
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)
Pre-clinical testing in cadaver specimen showed that
the mean pullout strength of the LM Anchor was
substantially equivalent to the mean pullout strength of
the Mitek Mini Anchor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Li Medical Technologies Inc.
4 Armstrong Road
Shelton, Connecticut 06484
203-944-2800
K96 0448
דו APR 1
Image /page/0/Picture/3 description: The image shows a black abstract shape. The shape is composed of several geometric figures, including triangles and trapezoids. The overall shape is irregular and asymmetrical. There is a smaller shape that mirrors the larger shape.
Li Medical
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510(K) SUMMARY
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Date: | Rhodemann Li, Vice President
December 31, 1995 |
| Classification Name:
Common Name:
Proprietary Name: | Staple, Fixation, Bone
Bone anchor
LM Anchor or other proprietary name |
| Predicate Devices: | Mitek Surgical Products Mini Anchor (K921873 and
K930892)
Li Medical Bone Anchor (K951233) |
| Device Description: | Made from surgical grade stainless steel (316L), the
LM Anchor is designed with a crown and a center pin
through which suture is passed to provide a means for
soft tissue to bone attachment. |
| Intended Use: | Shoulder (bankart repair), Hand (ulnar or lateral
collateral ligament reconstruction), Wrist
(scapholunate ligament reconstruction), Foot (hallux
valgus reconstruction), and Ankle (midfoot
reconstructions) |
| Technical Comparison: | The LM Anchor is similar to the Mitek Mini Anchor in
its cylindrical shape, however, the bony purchase is
accomplished by the LM Anchor through cantilevered
beams versus nitinol arcs with the Mitek Mini Anchor. |
| Performance Data: | Pre-clinical testing in cadaver specimen showed that
the mean pullout strength of the LM Anchor was
substantially equivalent to the mean pullout strength of
the Mitek Mini Anchor. |