(84 days)
Not Found
No
The summary describes a mechanical bone anchor and surgical procedure, with no mention of AI or ML terms, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for bladder neck suspension to treat female urinary incontinence, which is a therapeutic purpose.
No.
The device is a surgical implant (anchor) used for bladder neck suspension, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it is made from surgical grade stainless steel or titanium and is designed with a crown and center pin, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (bladder neck suspension) to treat urinary incontinence by fixing tissue to bone. This is a therapeutic intervention performed on the patient's body.
- Device Description: The device is a physical implant (anchor) made of surgical materials, designed for mechanical fixation.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly falls outside that category.
N/A
Intended Use / Indications for Use
Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.
Product codes
Not Found
Device Description
Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are 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
pubic bone
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
Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor Products were substantially equivalent to the mean pullout strength of the Mitek anchors
Key Metrics
Not Found
Predicate Device(s)
K904436, K951233, K951472, K953764, K960448, K960439, K960825
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
NOV 1 3 1995
510(K) SUMMARY
长963288
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Rhodemann Li, Vice President |
| Date: | October 30, 1996 |
| Classification Name: | Staple, Fixation, Bone |
| Common Name: | Bone anchor |
| Proprietary Name: | LM Anchor Products or other proprietary names |
| Predicate Devices: | Mitek Surgical Products GII QuickAnchor (K904436)
Li Medical Bone Anchor (K951233), (K951472),
(K953764), (K960448), (K960439), (K960825) |
| Device Description: | Made from surgical grade stainless steel (316L) or titanium
(6A1-4V ELI), the LM Anchor Products are 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:
(UltraFix RC,
UltraFix Mini,
UltraFix) | Bladder neck suspension for female urinary incontinence
due to urethral hypermobility. Fixation in pubic bone for
the purpose of bladder neck suspension using USP #2 Class
I, non-absorbable, synthetic suture (e.g., polypropylene). A
minimum of two LM Anchors should be used in this
(modified MMK, Raz, or Stamey, i.e., Benderev)
procedure. |
| Technical Comparison: | The LM Anchor Products are similar to the Mitek anchors
in its cylindrical shape however, the bony purchase is
accomplished by the LM Anchor Products 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 Products were
substantially equivalent to the mean pullout strength of
the Mitek anchors |