(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a surgical anchor, with no mention of AI or ML.
Yes
The device is described with indications for use in surgical repairs and reconstructions of various anatomical structures, which are therapeutic interventions.
No
The device description and intended use indicate it is an implantable surgical anchor for soft tissue to bone attachment, which is a therapeutic rather than a diagnostic function.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for attaching soft tissue to bone in various anatomical locations (shoulder, hand/wrist, foot/ankle, elbow, knee). This is a therapeutic and structural function within the body.
- Device Description: The device is described as a surgical grade stainless steel anchor with a crown and center pin for suture passage. This is a physical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any testing of biological samples or diagnostic purposes.
The device described is a surgical implant used for orthopedic repair, which falls under a different category of medical devices than IVDs.
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, 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
Product codes (comma separated list FDA assigned to the subject device)
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, Foot/Ankle, Elbow, Knee
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): 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.
Mitek Surgical Products GII Anchor (K915889)
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
§ 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
.
. . .
510(K) SUMMARY
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Date: | Rhodemann Li, Vice President
May 15, 1998 |
| Classification Name:
Common Name:
Proprietary Name: | Staple, Fixation, Bone
Bone anchor
LM Anchor or other proprietary name |
| Predicate Device: | Mitek Surgical Products GII Anchor (K915889) |
| 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, 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). |
| 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 U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three overlapping profiles facing to the right, with flowing lines suggesting movement or progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.
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: K981755 Trade Name: LM Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 15, 1998 May 18, 1998 Received:
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 against 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 requlations.
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.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K981755
Device Name:
LM Bone Anchor
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, 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aooooo
Prescription Use > (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)