(212 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
No
The device, an LM Anchor, is used to facilitate soft tissue to bone attachment during rotator cuff repair. While this procedure aims to restore function and alleviate discomfort, the anchor itself is a mechanical device used for fixation rather than directly providing a therapeutic effect like drug delivery or active rehabilitation. Its purpose is to hold tissue in place, enabling the body's natural healing process.
No
The device description states it is "designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment." This indicates it is a surgical implant used for repair, not for diagnosing a condition.
No
The device description clearly states it is made from surgical grade PLL and is a physical anchor 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 is "Shoulder: rotator cuff repair." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a surgical anchor made from PLL, designed for soft tissue to bone attachment. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are used to perform tests in vitro (outside the body) on samples to diagnose, monitor, or screen for diseases or conditions. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Shoulder - rotator cuff repair
Product codes
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
Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek anchors.
Key Metrics
Not Found
Predicate Device(s)
Mitek Surgical Products PanaLok™ RC (K950272)
Reference Device(s)
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
4/29/99
Li Medical Technologies Inc. 4 Armstrong Road Shelton, Connecticut 06484 203-944-2800
:
K9834-35
: 上一
·
Li Medical
.
| Device Sponsor:
Contact:
Date: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,
203-944-2800
Rhodemann Li, Vice President
September 28, 1998 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name:
Common Name:
Proprietary Name: | Unclassified
Bone anchor
Li Medical RotorBlade™ |
| Predicate Device: | Mitek Surgical Products PanaLok™ RC (K950272) |
| 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. |
| Intended Use: | Shoulder - rotator cuff repair |
| Technical Comparison: | The LM Anchor is similar to the Mitek anchors in its
intended use, however, the bony purchase is accomplished by
the LM Anchor through a horizontal propeller blade design
versus a tapered rod design 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 the mean pullout strength of the Mitek anchors. |
:
ह
.
510(K) SUMMARY
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, resembling a bird in flight. The figures are connected and appear to be moving upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Mr. Rhodemann Li Vice President Li Medical Technologies, Inc. 4 Armstrong Road Shelton, Connecticut 06484
K983435 Re: RotorBlade™ Suture Anchor Trade Name: Regulatory Class: II Product Codes: MAI and GAS Dated: February 2, 1999 February 4, 1999 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 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 Requlation (QS) for Medical Devices: General requlation (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 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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
510(k) Number (if known):
K98, 3435
Device Name:
LM Anchor
Indications For Use: Shoulder: rotator cuff repair
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Devices
510(k) Number L983435
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use ___________
(Optional Format 1-2-96)