(154 days)
Intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.
The OsteoMed Maxillary / LeFort III Distraction System is a distraction osteogenesis system consisting of distractor frame, bone plates, threaded rods, and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument.
This document is a 510(k) summary for the OsteoMed Maxillary / LeFort III Distraction System. This type of device is cleared through substantial equivalence to predicate devices, not through studies demonstrating a specific level of performance against acceptance criteria as might be expected for an AI/ML device.
Therefore, the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available and not applicable in the context of this 510(k) submission.
The 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices already on the market. This typically involves showing similarities in:
- Intended Use: The purpose and conditions for which the device is used.
- Materials: The components the device is made from.
- Design: The physical construction and mechanism of the device.
- Operational Principle: How the device functions.
The document explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Leibinger Cohen Distractor (K972154) and the Lorenz Maxilla Distraction System (K982604)." It further notes: "Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Maxillary / LeFort III Distraction System does not raise any new safety or effectiveness issues."
In summary, there are no acceptance criteria or a study demonstrating device performance in the way described for AI/ML devices in this 510(k) submission. The "study" here is a comparison to predicate devices to establish substantial equivalence.
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510(k) Summary
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Maxillary / LeFort III Distraction System
Intraoral Distractor
MQN, External Mandibular Fixator and/or Distractor
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-6401
Contact Person:
Date Prepared:
May 27, 2003
Dawn T. Holdeman
Summary:
This submission describes the OsteoMed Maxillary / LeFort III Distraction System intended for use in the treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / Lefort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. This device is intended to be removed after consolidation. The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.
The OsteoMed Maxillary / LeFort III Distraction System is a distraction osteogenesis system consisting of distractor frame, bone plates, threaded rods, and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Leibinger Cohen Distractor (K972154)and the Lorenz Maxilla Distraction System (K982604).
Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Maxillary / LeFort III Distraction System does not raise any new safety or effectiveness issues.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2003
OsteoMed L.P. Ms. Dawn T. Holderman Regulatory Affairs and Document Control 3885 Arapaho Road Addison, Texas 75001
Re: K031708
Trade/Device Name: Osteomed Maxillary/Lefot III Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: September 26, 2003 Received: September 29, 2003
Dear Ms. Holderman:
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.
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Page 2 - Mr. Holderman
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 (OS) 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucerella
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OsteoMed "Indications for Use" Submission
31 510(k) Number: Osteomed Maxillary / LeFort III Distraction System Device Name: Intended for use in the treatment of cranial or Indication for Use: midface conditions for for which reconstructive and segment advancement osteotomy are This includes conditions such as, indicated. syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OsteoMed Maxillary / LeFort III Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. The OsteoMed Maxillary / LeFort III Distraction System is intended for single patient use only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109)
Over-The Counter-Use (Optical Format 1-)
Susan Runn
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: k03170X
§ 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.