(23 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and pullout strength of a surgical anchor, with no mention of AI or ML.
Yes
The device is designed to facilitate the reattachment of soft tissue to bone, which is a therapeutic function aimed at repairing an injury (rotator cuff repair).
No
The device description indicates it is an anchor for soft tissue to bone attachment in rotator cuff repair, which is a surgical tool, not a diagnostic one.
No
The device description explicitly states it is made from surgical grade PLL and is a physical anchor device, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Shoulder - rotator cuff repair," which is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a surgical anchor made from PLL, designed for soft tissue to bone attachment during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / Indications for Use
Shoulder - rotator cuff repair
Shoulder: rotator cuff repair
Product codes (comma separated list FDA assigned to the subject device)
MAI, GAS
Device Description
Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device 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
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 showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullour strength of the predicate device.
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.
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
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SEP 2 3 1999
1499293B
510(K) SUMMARY
Device Sponsor:
Contact: Date:
Classification Name: Common Name: Proprietary Name:
Predicate Device:
Device Description:
Intended Use:
Technical Comparison:
Performance Data:
Li Medical, 4 Armstrong Road, Shelton, CT 06484.
Rhodemann Li, Vice President August 30, 1999
Unclassified Bone anchor Li Medical RotorBlade™
Li Medical RotorBlade™ (K983435)
Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
Shoulder - rotator cuff repair
7
The LM Anchor is identical to the predicate devicein its intended use, and similar in safety and effectiveness. The only difference between the new anchor and the predicate device is that the dimensions have been increased slightly in areas of stress and the suture eyelets have been widened to accommodate up to two (2) USP #2 sutures.
Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullour strength of the predicate device.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with a single snake entwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Mr. Rhodemann Li Vice President Li Medical Technologies Inc. 4 Armstrong Road Shelton, Connecticut 06484
Re: K992938
Trade Name: RotorBlade™ Suture Anchor Regulatory Class: II Product Code: MAI and GAS Dated: August 19, 1999 Received: August 31, 1999
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 of the Act. The general controls provisions 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 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 (OS) 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 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 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
J cotella
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
Page 1 of 1
=
510(k) Number (if known); K992938
Device Name:
LM Anchor
Indications For Use: rotator cuff repair Shoulder:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEWS (CONTINE SECTION) (VEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jocelle Jo
(Division Sign-Off)
Division of General Restorative Devices K992938
510(k) Number
11/2 Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)