(67 days)
Not Located
Not Found
No
The description focuses on the material properties and mechanical performance of a bioresorbable implant, with no mention of AI or ML.
Yes
The device is indicated for use in closed noncomminuted diaphyseal metacarpal fractures, which is a therapeutic purpose.
No
Explanation: The device is a surgical fixation system (plates and screws) used for treating metacarpal fractures, not for diagnosing conditions.
No
The device description explicitly states that the device is comprised of bioresorbable plates and screws made of a polymer, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- LactoSorb® Hand System Function: The provided description clearly states that the LactoSorb® Hand System is a surgical implant used to fix bone fractures (specifically metacarpal fractures). It is a physical device implanted in vivo (within the body) to provide structural support.
- Lack of Diagnostic Testing: The description does not mention any testing of samples from the body or any diagnostic function. Its purpose is purely therapeutic and structural.
Therefore, based on the provided information, the LactoSorb® Hand System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization. The LactoSorb® Hand System is indicated for surgical fixation of closed finatures in the presence of The LactoSorb® Hand System is marcared of the presence of appropriate immobilization.
Product codes
87 HRS, 87 HWC, MAI
Device Description
The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and re-sorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
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
The effectiveness of this resorbable system was determined by mechanical testing. This system is as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
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Summary of Safety and Effectiveness
| Submitter: | Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw, Indiana 46581-0587 |
|-----------------|---------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Product Code: | 87 HRS (Plate)
87 HWC (Screw) |
| Device Name: | LactoSorb® Hand System |
The LactoSorb® Hand System is indicated for use in closed noncomminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.
The LactoSorb® plates and screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The safety of PLLA/PGA material has been well documented since the early 1970s when the FDA first approved the use of resorbable PLLA/PGA sutures. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The effectiveness of this resorbable system was determined by mechanical testing. This system is as effective as similar metal fixation systems on the market as well as the LactoSorb® Bone Pin. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Michelle L. McKinley Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K991763 Trade Name: LactoSorb® Hand System Regulatory Class: II Product Code: HRS, HWC, MAI Dated: May 6, 1999 Received: May 24, 1999
Dear Ms. McKinley:
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 control provisions of the Act. The general control 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.
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Page 2 – Ms. Michelle L. McKinley
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 Radiological Health
Enclosure
3
:
510(k) NUMBER (IF KNOWN): K991763____________________________________________________________________________________________________________________________________________
DEVICE NAME: LactoSorb® Hand System
INDICATIONS FOR USE:
The LactoSorb® Hand System is indicated for surgical fixation of closed
of the success is indicated for any of finatures in the presence of The LactoSorb® Hand System is marcared of the presence of appropriate immobilization.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | X | OR | Over-The-Counter |
|---|---|---|---|
| Use (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
K(k) Number K991763