(61 days)
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No
The description focuses on the mechanical properties and intended surgical uses of a physical anchor device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, an LM Anchor, is a surgical implant designed for soft tissue to bone attachment, used in various repairs and reconstructions. It is a tool used during a therapeutic procedure, but it is not itself a therapeutic device that directly treats or heals a condition.
No
The device description indicates it is an implantable anchor for soft tissue to bone attachment, used for surgical repairs, not for diagnosing conditions.
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, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes surgical procedures for repairing soft tissue to bone in various anatomical locations. This is a therapeutic/surgical device, not a diagnostic one.
- Device Description: The description details a surgical implant made of stainless steel designed for tissue attachment. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance study focuses on the mechanical strength (pullout strength) of the anchor, which is relevant to its function as a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon), Elbow (biceps tendon, tennis elbow, ulnar collateral ligament, radial collateral ligament), Knee (medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis), Bladder Neck Suspension.
Product codes
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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
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Anatomical Site
Shoulder, Hand/Wrist, Foot/Ankle, Elbow, Knee, Bladder Neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 anchors.
Key Metrics
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
4 Armstrong Road
Shelton, Connecticut 06484 203-944-2800
510(K) SUMMARY
| Image: Medical logo | Device Sponsor:
Contact:
Date: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800
Rhodemann Li, Vice President
February 28, 1996 APR 30 1996 |
|---------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Medical | Classification Name:
Common Name:
Proprietary Name: | Staple, Fixation, Bone
Bone anchor
LM Anchor or other proprietary name |
| | Predicate Devices: | Mitek Surgical Products GII Anchor (K915889)
Mitek Surgical Products SuperAnchor (K920213?)
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, rotator cuff repair, SLAP
lesion, acromio-clavicular separation, biceps tenodesis,
deltoid repair, capsular shift reconstruction,
capsulolabral reconstruction), Hand/Wrist (ulnar or
lateral collateral ligament reconstruction, radial
collateral ligament, scapholunate ligament
reconstruction), Foot/Ankle (hallux valgus
reconstruction, midfoot reconstructions, lateral
stabilization, medial stabilization, achilles tendon),
Elbow (biceps tendon, tennis elbow, ulnar collateral
ligament, radial collateral ligament), Knee (medial
collateral ligament, lateral collateral ligament, patellar
tendon, patellar ligament avulsions, posterior oblique
ligament, joint capsule to tibia, iliotibial band
tenodesis), Bladder Neck Suspension. |
| | Technical Comparison: | The LM Anchor is similar to the Mitek anchors in its
cylindrical shape, however, the bony purchase is
accomplished by the LM Anchor through cantilevered
beams versus nitinol arcs with the Mitek anchors. |
| | 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 anchors. |
Fax 203-944-2806