(84 days)
No
The summary describes a system of plates, screws, and instruments for rigid internal fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device, comprising plates and screws, is intended for rigid internal fixation to stabilize fractures and surgical procedures, not to treat or cure a disease or condition.
No
This device is a surgical fixation system consisting of plates and screws used for internal fixation in various facial and cranial surgeries. It is used for treatment and reconstruction, not for diagnosing conditions.
No
The device description explicitly states that the system is comprised of various plates, screws, depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments, which are all 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, tissue) to provide information about a person's health.
- Device Description: The OsteoMed OSA Rigid Internal Fixation System is described as a system of plates and screws used for surgical fixation of bones in the face and skull.
- Intended Use: The intended use is for surgical procedures to fix bones in the midface, craniofacial skeleton, maxilla, and mandible. This is a surgical implant, not a diagnostic test performed on a sample.
The description clearly indicates a device used within the body for structural support and fixation, not a device used to analyze samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.
Product codes
JEY
Device Description
The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton; maxilla and mandible
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
§ 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
AUG 0 8 2002
510(k) Summary
| Device Proprietary Name: | OsteoMed OSA Rigid Internal
Fixation System |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Bone Plate |
| Classification Name: | Plate, Bone |
| Name of Submitter: | OsteoMed Corporation
3750 Realty Road
Addison, Texas 75001
Phone: (972) 241-3401
Fax: (972) 241-3449 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 15, 2002 |
Summary:
This submission describes the OsteoMed OSA Rigid Internal Fixation System intended for use in a variety of pan facial indications. Specifically, this system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible.
The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes 1.5mm/2.0mm Orthognathic Plates and Screws system (K980199), the KLS Martin Lindorf System (K944565), and the Leibinger Profil-O-Plastic, Titanium Implant System.
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed OSA Rigid Internal Fixation System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/11 description: The image shows the Marmon logo and the text "A member of The Marmon Group of companies". The Marmon logo is a stylized "M" made up of three vertical bars. The text is located to the right of the logo. The text indicates that the entity represented by the logo is part of the Marmon Group of companies.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
AUG 0 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311
K021618 Re:
Trade/Device Name: OSA Rigid Internal Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: May 15, 2002 Received: May 16, 2002
.
Dear Ms. Holdeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -- Ms. Holdeman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
OsteoMed "Intended Use" Submission
| Device Name: | OsteoMed OSA Rigid Internal Fixation System |
|---|---|
| Intended Use: | OsteoMed OSA Rigid Internal Fixation System is |
| intended for a variety of pan facial indications. | |
| Specifically, the system is intended for selective | |
| trauma of the midface and craniofacial skeleton; | |
| craniofacial surgery; reconstructive procedures; and | |
| selective orthognathic surgery of the maxilla and | |
| mandible. Implants are single use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 810.109)
510(k) Number:
Over-The Counter-Use (Optical Format 1-)
Susan Ruarrer
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number._**_