(154 days)
Not Found
No
The summary describes a mechanical distraction system and makes no mention of AI or ML.
Yes
The device is intended for "treatment of cranial or midface conditions for which reconstructive osteotomy and segment advancement are indicated" and "provide temporary stabilization and gradual lengthening of the cranial or midfacial bones," indicating a therapeutic purpose.
No
The device is described as a "distraction osteogenesis system" used for the "treatment of cranial or midface conditions" and provides "gradual lengthening of the cranial or midfacial bones." This indicates a therapeutic, rather than diagnostic, function.
No
The device description explicitly lists hardware components such as "distractor frame, bone plates, threaded rods, and an activation instrument."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of cranial or midface conditions through reconstructive osteotomy and segment advancement. This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details a system of physical components (distractor frame, bone plates, rods, instrument) used to mechanically manipulate bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples from the body. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
Intended for use in the treatment of cranial or midface conditions for 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.
Product codes
MQN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial or midface bones
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
Image /page/0/Picture/1 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is surrounded by a black oval shape. The oval shape is not a perfect oval, but rather a more stylized shape that is wider in the middle and narrower at the ends.
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.
Image /page/0/Picture/21 description: The image shows a logo with the word "Colson" in a stylized font on the left. To the right of "Colson" are the letters "A C". The logo appears to be for a company or organization named Colson, possibly with the initials A and C associated with it.
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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 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.
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