(86 days)
The LactoSorb® Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.
The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a 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 to be biocompatible in both soft tissue and bone tissue. Both preclinical and clinical studies have proven the safety and effectiveness of these devices, in trauma and reconstructive procedures in the midface and craniofacial skeleton .
The provided information does not describe acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary for the LactoSorb® Panels and Fasteners, which is a regulatory submission to the FDA. It declares the device's substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria: The document describes the device, its material (bio-resorbable and biocompatible polymers), and its intended use. It states that "Both preclinical and clinical studies have proven the safety and effectiveness of these devices, in trauma and reconstructive procedures in the midface and craniofacial skeleton." However, it does not specify any quantitative acceptance criteria for performance (e.g., specific thresholds for tensile strength, degradation rates, or clinical success rates).
- No Detailed Study Description: While it mentions "preclinical and clinical studies," it does not provide details about these studies. It does not describe their methodology, sample sizes, data provenance, ground truth establishment, or any specific performance metrics measured against acceptance criteria.
- Focus on Substantial Equivalence: The core of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to an already legally marketed predicate device. This process typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. It does not generally require presenting detailed performance data against specific, pre-defined acceptance criteria in the same way a de novo or PMA submission might.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document serves as an FDA notification of intent to market, asserting safety and effectiveness based on previous studies and equivalence, but does not contain the detailed study results or acceptance criteria themselves.
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510 (k) Summary of Safety and Effectiveness
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Submitter : Biomet, Inc. P.O. Box 587 Airport Industrial Park 46581-0587 Warsaw, IN
Mary L. Verstynen Contact Person:
Product Code: JEY
LactoSorb® Panels and Fasteners Device Name:
The LactoSorb® Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.
The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a 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 to be biocompatible in both soft tissue and bone tissue. Both preclinical and clinical studies have proven the safety and effectiveness of these devices, in trauma and reconstructive procedures in the midface and craniofacial skeleton .
Use of the LactoSorb® devices in this non-load bearing mandibular bone graft indication does not raise any new safety and effectiveness questions.
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Image /page/0/Picture/11 description: The image shows the number 00004 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1898 JUN
Ms. Mary Verstynen Clinical Research Manager Biomet, Incorporated Airport Industrial Park P.O. Box 587 46581-0587 Warsaw, Indiana
Re : K980927 Lactosorb Panels and Fasteners Trade Name: Regulatory Class: II Product Code: JEY Dated: March 9, 1998 Received: March 11, 1998
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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. ರ್ಕ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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
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Page 2 - Ms. Verstynen
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 of 1
510(k) NUMBER (IF KNOWN):
DEVICE NAME: LactoSorb Panels and Fasteners
INDICATIONS FOR USE:
The LactoSorb Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter-Use(Optional Format 1-2-96) |
|---|---|---|---|
| ------------------------------------------ | --------------------------------------- | ---- | -------------------------------------------------- |
Susan Roaser
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | 10980927 |
|---|---|
| --------------- | ---------- |
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§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.