(55 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 or related concepts.
No.
The device description and intended use indicate it is an implantable anchor for soft tissue reattachment to bone following surgical repairs, rather than a device for treatment or therapy.
No
Explanation: The device description states it is an anchor designed for "soft tissue to bone attachment," which indicates a surgical tool used for repair or reconstruction, not for diagnosing medical 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.
Based on the provided information, 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 description clearly states the device is a surgical anchor made of stainless steel designed for soft tissue to bone attachment during surgical procedures.
- Intended Use: The intended uses are all surgical procedures performed directly on the patient's body (shoulder, hand/wrist, skull, foot/ankle).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
This device is a surgical implant used during a procedure, not a diagnostic tool used on a sample outside the body.
N/A
Intended Use / Indications for Use
Shoulder (bankart repair), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment), Skull (lateral canthoplasty), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions.
Product codes
MBI, HWC, GAT
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, Skull, 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 or exceeded the mean pullout strength of the Mitek anchor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mitek Surgical Products Mini Anchor (K930892)
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
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JUL 1 3 1998
510(K) SUMMARY
:
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Rhodemann Li, Vice President |
| Date: | May 18, 1998 |
| Classification Name: | Staple, Fixation, Bone |
| Common Name: | Bone anchor |
| Proprietary Name: | LM Anchor or other proprietary name |
| Predicate Device: | Mitek Surgical Products Mini Anchor (K930892) |
| 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/Wrist (ulnar or lateral
collateral ligament reconstruction, scapholunate ligament
reconstruction, PIP collateral ligament, profundus tendon
reattachment), Skull (lateral canthoplasty), Foot/Ankle
(hallux valgus reconstruction, midfoot reconstructions. |
| 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 or exceeded the mean pullout
strength of the Mitek anchor. |
:
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Mr. Rhodemann Li ·Vice President Li Medical Technologies, Inc. 4 Armstrong Road 06484 Shelton, Connecticut
Re: K981764 Trade Name: LM Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 18, 1998 Received: May 19, 1998
Dear Mr. Li:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Rhodemann Li
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K981764
LM Bone Anchor Device Name:
Indications For Use:
Shoulder - bankart repair
Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment
Skull - lateral canthoplasty
Foot/ankle - hallux valgus reconstruction, midfoot reconstructions
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcoolo
(Divest Sign Off)
D general
510(k) number K9821764
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
: |
(Optional Format 1-2-96)
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