(53 days)
Not Found
No
The summary describes a bioresorbable screw for meniscal repair and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is employed in the repair of meniscal tears, which is a therapeutic intervention aimed at restoring the function of the meniscus.
No
The document describes a medical device (meniscal screw) used for surgical repair, not for diagnosis. Its intended use is to treat existing tears, not to identify or characterize them.
No
The device description explicitly states it is a "Meniscal Screw" made of "bioresorbable and biocompatible polymers," indicating it is a physical implantable 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 states the device is for the repair of meniscal tears. This is a surgical procedure performed on the patient's body.
- Device Description: The description details the material and how it functions within the body (bioresorbable, degrades in vivo). This is consistent with an implantable surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body to repair tissue.
N/A
Intended Use / Indications for Use
The LactoSorb® Meniscal Screw is indicated for the repair of vertical longitudinal fullthickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
Product codes
MAI
Device Description
The LactoSorb® Meniscal Screw is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 2 5 2000
Koo2020
510 (K) Summary of Safety and Effectiveness
Biomet, Inc. Submitter: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Mary L. Verstynen
Product Code: MAI
Device Name: LactoSorb® Meniscal Screw
The LactoSorb® Meniscal Screw is indicated for the repair of vertical longitudinal fullthickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The LactoSorb® Meniscal Screw is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.
Predicate Device:
The LactoSorb® Meniscal Screw is substantially equivalent to the following:
- LactoSorb® Meniscal Staple
The LactoSorb® Meniscal Screw described in this notification has the same intended use and characteristics as the LactoSorb® Meniscal Staple.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The image is in black and white.
AUG 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet Inc. P.O. Box 587 Warsaw. Indiana 46581
Re: K002020
Trade Name: LactoSorb® Meniscal Screw Regulatory Class: II Product Code: MAI Dated: June 30, 2000 Received: July 3. 2000
Dear Ms. Verstynen:
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 (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 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.
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.
2
Page 2 - Ms. Mary L. Verstynen
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Norell Suize
Lelia 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 _ of _
510(k) NUMBER (IF KNOWN):
K002020
DEVICE NAME: LactoSorb® Meniscal Screw
INDICATIONS FOR USE:
The LactoSorb Meniscal Screw is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
12 Prescription Use 5 (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Nussly Lyon
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _ 00 2020
000004