(57 days)
Not Found
Not Found
No
The summary describes a resorbable plate for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for treating (adapting plates for) comminuted fractures, which is a therapeutic intervention.
No
The device is an adaptation plate used to stabilize fractures, not to diagnose medical conditions.
No
The device description clearly states it is a physical plate made of a resorbable copolymer, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The 20-Hole Adaptation Plate is a physical implant made of a resorbable copolymer. It is intended to be surgically implanted to stabilize bone fractures.
- Intended Use: The intended uses are for treating bone fractures in specific anatomical areas. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for structural support and fixation, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 20-Hole Adaptation Plate is intended for use in the following indications:
-
- comminuted fractures of the naso-ethmoidal infraorbital areas
-
- comminuted fractures of the frontal sinus wall
-
- orbital floor fractures
Product codes
87 HRS
Device Description
The 20-Hole Adaptation Plate is made of LactoSorb®. LactoSorb®, resorbable copolymer, is a synthetic polyester" derived from lactic and glycolic acids. Polylactic/ polycolic acid copolymer degrades and re-sorbs 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
naso-ethmoidal infraorbital areas, frontal sinus wall, orbital floor
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 20-Hole Adaptation Plate was found to have similar biomechanical strength as predicate devices used in similar indications.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 20 1998
510(k) Summary of Safety and Effectiveness
Submitter: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Mary L. Verstynen
Product Code: 87 HRS
Device Name: 20-Hole Adaptation Plate
SUMMARY :
The 20-Hole Adaptation Plate is intended for use in the following indications:
-
- comminuted fractures of the naso-ethmoidal infraorbital areas
-
- comminuted fractures of the frontal sinus wall
-
- orbital floor fractures
The 20-Hole Adaptation Plate is made of LactoSorb®. LactoSorb®, resorbable copolymer, is a synthetic polyester" derived from lactic and glycolic acids. Polylactic/ polycolic 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.
The 20-Hole Adaptation Plate was found to have similar biomechanical strength as predicate devices used in similar indications.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Ms. Mary Verstynen Clinical Research Manager Biomet, Incorporated Airport Industrial Park Warsaw, Indiana 46581-0587
K981070 Re : 20-Hole Adaptation Trade Name: Requlatory Class: II Product Code: JEY Dated: March 23, 1998 March 24, 1998 Received:
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 reqistration, 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 requlations 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 requirements, as set forth in the Quality System Regulation (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 regulatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Ms. Verstynen
through 542 of the Act for devices under the Electronic emrough 542 or the notrol 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 described in your sie\n privalence of your device to a legally marketed predicate device results in a classification for your marketed production wour 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
3
K981070 510 (k) NUMBER (IF KNOWN) :
20-Hole Adaptation Plate DEVICE NAME:
INDICATIONS FOR USE:
The 20-Hole Adaptation Plate is used in the following ・ indications:
-
- comminuted fractures of the naso-ethmoidal infraorbital areas
-
- comminuted fractures of the frontal sinus wall
-
- orbital floor fractures
(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) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
Suser Runve
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | RAK 1070 |
|---|---|
| --------------- | ----------------- |