(56 days)
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).
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.
Let's break down the information provided about the K981755 device, "LM Anchor," in relation to your request.
Acceptance Criteria and Device Performance for LM Anchor (K981755)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Mitek Surgical Products GII Anchor, K915889) in terms of pullout strength. | The mean pullout strength of the LM Anchor was substantially equivalent to or exceeded the mean pullout strength of the Mitek anchor. |
Explanation: The K981755 submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. In this context, the "acceptance criteria" are implicitly tied to demonstrating that the new device performs at least as well as, or equivalently to, the predicate device in relevant performance characteristics. For a bone anchor, pullout strength is a critical mechanical property.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Pre-clinical testing in cadaver specimen," implying a certain number of cadaver specimens were used, but the exact count of anchors tested or specimens involved is not provided.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified, but "Pre-clinical testing" generally implies a prospective study design conducted for the purpose of the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device is a bone anchor, and the performance assessment (pullout strength) is a physical, objective measurement, not typically subject to interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device would be.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the "ground truth" is a direct physical measurement (pullout strength), there's no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images. The LM Anchor is a medical implant, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? This question is generally relevant for AI/ML algorithms. The LM Anchor is a mechanical device, so the concept of an "algorithm only" performance study does not apply. The performance data presented (pullout strength) is the standalone performance of the device.
7. Type of Ground Truth Used
- Type of Ground Truth: Objective physical measurement: Pullout Strength. This is a direct, quantifiable mechanical property of the device when implanted in bone.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The LM Anchor is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The engineering design and manufacturing processes are based on established biomechanical principles and material science, not machine learning.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no "training set." The performance characteristics of the device are validated through pre-clinical testing, comparing its physical properties to those of an established predicate device.
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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 PresidentMay 15, 1998 |
| Classification Name:Common Name:Proprietary Name: | Staple, Fixation, BoneBone anchorLM Anchor or other proprietary name |
| Predicate Device: | Mitek Surgical Products GII Anchor (K915889) |
| Device Description: | Made from surgical grade stainless steel (316L), theLM Anchor is designed with a crown and a center pinthrough which suture is passed to provide a means forsoft tissue to bone attachment. |
| Intended Use: | Shoulder (bankart repair, rotator cuff repair, SLAPlesion, acromio-clavicular separation, biceps tenodesis,deltoid repair, capsular shift reconstruction,capsulolabral reconstruction), Hand/Wrist (ulnar orlateral collateral ligament reconstruction, radialcollateral ligament, scapholunate ligament reconstruction),Foot/Ankle (hallux valgus reconstruction, midfootreconstructions, lateral stabilization, medial stabilization,achilles tendon), Elbow (biceps tendon, ulnar collateralligament, radial collateral ligament), Knee (medial collateralligament, lateral collateral ligament, patellar tendon,patellar ligament avulsions, posterior oblique ligament, jointcapsule to tibia, iliotibial band tenodesis). |
| Technical Comparison: | The LM Anchor is similar to the Mitek anchors in itscylindrical shape, however, the bony purchase isaccomplished by the LM Anchor through cantileveredbeams versus nitinol arcs with the Mitek anchors. |
| Performance Data: | Pre-clinical testing in cadaver specimen showed thatthe mean pullout strength of the LM Anchor wassubstantially equivalent to or exceeded the mean pulloutstrength of the Mitek anchor. |
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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.
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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
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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)
§ 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.