(246 days)
Not Found
No
The 510(k) summary describes a passive implant (plate and screws) and associated manual surgical instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical equivalence to predicate devices.
No.
The device is a permanent implant intended for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision, which fixes bone rather than providing therapy.
No
The device is a permanent implant used for reconstructive treatment of orbital trauma, not for diagnosing a condition.
No
The device description clearly states it is a permanent implant made of titanium and includes associated hardware like screws and instrumentation. It is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The OsteoMed Low Profile Plate System is a permanent implant made of titanium, intended for the reconstruction of bone in the orbit. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant used for structural support and reconstruction within the body, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The OsteoMED Low Profile Orbital Floor Plate System is a permanent implant that is provided non sterile and is manufactured from commercially pure Titanium (ASTM F 67). The OSTEOMED Low Profile Orbital Floor Plates are offered with hole sizes which are able to accept 1.2mm and 1.6mm standard and auto drive bone screws and 1.9mm and 1.9mm safety screws and are offered in thicknesses ranging from .2mm to .5mm.
The implant is also provided in a variety of shapes including both nonpreformed shapes and pre formed left and right profiles. The implant is fixed to the infra orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself to reconstruct the orbital floor and/or medial wall in adult patients.
The OsteoMed CFX system which is already available in the marketplace includes the screws (ASTM F136) and instrumentation to facilitate implantation of the Low Profile Orbital Floor Plate System. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade plastic. All instruments included in the CFX system are Class I, standard, manual, surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
floor and/or medial wall of the orbit
Indicated Patient Age Range
adult patients
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)
Mechanical testing was performed demonstrating the new OsteoMed Low Profile Plate System meets that of the predicate device, the Synthes MatrixMIDFACE System.
Performance equivalence was shown through the verification comparison to the predicate Synthes MatrixMIDFACE System (K031761).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18,2014
OsteoMed c/o Mrs. Piedad Pena, M.S. Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K140978
Trade/Device Name: OsteoMed Low Profile Orbital Plate System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 17, 2014 Received: November 18, 2014
Dear Mrs. Piedad Pena:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K140978 510(k) Number (if known):
OsteoMed Low Profile Orbital Floor Plate System Device Name:
Indications for Use:
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Prescription Use: _X (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
OsteoMed Low Profile Orbital Floor Plate System
Summary Date: November 17, 2014
Submitter Data: OsteoMed 3885 Arapaho Road Addison, TX 75001 972 677 4600 972 677 4601 (fax)
Primary Contact: Mrs. Piedad Pena, M.S.
Device Trade Name: OsteoMed Low Profile Orbital Plate System
Common Name: Orbital Floor Plate System
Classification Name: Plate, bone
Product Code: JEY- Bone Plate
Device Classification: 21 CFR Part §872.4760 - Bone plate
Legally Marketed Predicate Devices:
Synthes MatrixMIDFACE System (K031761) Stryker Universal Orbital Floor Plate System (K123786)
Device Description:
The OsteoMED Low Profile Orbital Floor Plate System is a permanent implant that is provided non sterile and is manufactured from commercially pure Titanium (ASTM F 67). The OSTEOMED Low Profile Orbital Floor Plates are offered with hole sizes which are able to accept 1.2mm and 1.6mm standard and auto drive bone screws and 1.9mm and 1.9mm safety screws and are offered in thicknesses ranging from .2mm to .5mm.
The implant is also provided in a variety of shapes including both nonpreformed shapes and pre formed left and right profiles. The implant is fixed to the infra orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself to reconstruct the orbital floor and/or medial wall in adult patients.
The OsteoMed CFX system which is already available in the marketplace includes the screws (ASTM F136) and instrumentation to facilitate implantation of the Low Profile Orbital Floor Plate System. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade
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plastic. All instruments included in the CFX system are Class I, standard, manual, surgical instruments.
Intended Use/ Indications for Use:
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Performance Testing:
Mechanical testing was performed demonstrating the new OsteoMed Low Profile Plate System meets that of the predicate device, the Synthes MatrixMIDFACE System.
Performance equivalence was shown through the verification comparison to the predicate Synthes MatrixMIDFACE System (K031761).
Technological Characteristics:
The OsteoMed Orbital Floor Plate System is considered to be substantially equivalent in design, intended use and material to the predicate devices. There are not any design differences between the systems that would affect safety or effectiveness or raise new questions regarding safety and effectiveness.
Sterilization:
The OsteoMed Low Profile Orbital Floor Plate System components are single use, supplied non sterile and require sterilization prior to use.
Substantial Equivalence:
The basis of substantial equivalence for this device is based on similarities in intended use, indications for use, material, function, technology, performance, and operational principles to the predicate device; Synthes MatrixMIDFACE System which was cleared under K031761 on September 3, 2003 and the Stryker Universal Orbital Floor Plate System which was cleared under K123786 on April 9, 2013.
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Device Comparison Chart:
| Features | OsteoMed Low Profile
Orbital Floor Plate
System (NEW) | Synthes MatrixMIDFACE
System (K031761) | Stryker Universal
Orbital Floor System
(K123786) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | Intended Use:
The OsteoMed Low Profile
Orbital Floor Plate System is
intended to be used in the
reconstruction of the floor
and/or medial wall of the
orbit.
Indications for Use:
The OsteoMed Low Profile
Orbital Floor Plate System is
indicated for the
reconstructive treatment of
the orbital floor and/or
medial wall trauma or bone
excision in adult patients. | Intended
Use/Indications for Use:
The Synthes Craniofacial
Plate and Screw System is
intended for use in selective
trauma of the midface and
craniofacial skeleton,
craniofacial surgery,
reconstructive surgery of
the maxilla and chin.
Indications: Synthes
MatrixMIDFACE Preformed
Orbital Plates are intended
for trauma repair and
reconstruction of the
craniofacial skeleton.
-Orbital floor fractures
-Medial orbital wall
fractures
-Combined orbital floor and
medial wall fractures. | Intended Use:
The Stryker Universal
Orbital Floor System is
intended to be used in
the reconstruction of the
floor and/or medial wall
of the orbit.
Indications for Use:
The Stryker Universal
Orbital Floor System is
indicated for the
reconstructive treatment
of the orbital floor
and/or medial wall
trauma or bone excision
in adult patients. |
| Material &
Biocompatibility | Plates are manufactured
from CP (Pure) Titanium (as
per ASTM F67). | Plates are manufactured
from CP (Pure) Titanium. | Plates are manufactured
from CP (Pure) Titanium,
Grade 2. |
| Method of
Fixation | Plate fixation with screws
inserted through dedicated
screw holes. | Plate fixation with screws
inserted through dedicated
screw holes. | Plate fixation with screws
inserted through
dedicated screw holes. |
| Sterility | Provided as single use, non
sterile | Non sterile/sterile | Provided non sterile |
| Profile
(Thickness)
Range | .2mm-.5mm | .2mm-.5mm | .3mm-.6mm |
| Screw Diameters
Accepted | 1.2mm and 1.6mm screws
1.5mm and 1.9mm safety
screws | 1.5mm screws 1.85 mm
safety screws | 1.2mm and 1.4mm
screws 1.7mm safety
screws |
| Application Area | CMF/Orbital | CMF/Orbital | CMF/Orbital |
| Target
Population | Adults | Unknown | Adults |
| Technology | Plates & Screw Fixation | Plates & Screw Fixation | Plates & Screw Fixation |
| Operational
Principle | Reconstruct the orbital floor
and/or medial wall. | Reconstruct the orbital floor
and/or medial wall. | Reconstruct the orbital
floor and/or medial wall. |
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