(282 days)
Not Found
No
The document describes a mechanical bone distractor and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "mandibular bone lengthener" for conditions like "mandibular micrognathia or hemifacial microsomia," indicating it is used to treat or alleviate a medical condition.
No
This device is a therapeutic device (mandibular bone lengthener/subcutaneous bone distractor) used for treatment, not diagnosis. It is indicated for patients diagnosed with specific conditions, meaning the diagnostic step has already occurred.
No
The device description clearly states it is a "subcutaneous bone distractor" with physical components like bars, a threaded wire, and bone screws, indicating it is a hardware device.
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.
- Device Description: The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It is a physical device implanted to lengthen bone.
- Intended Use: The intended use is for mandibular distraction osteogenesis, a surgical procedure to lengthen the jawbone. This is a direct intervention on the body, not a test performed on a sample.
The description clearly indicates a surgical implant used for a therapeutic purpose, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.
Product codes
MQN
Device Description
The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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
Not Found
Key Metrics
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 1 4 2002
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters are "KO13618". The characters are written in black ink on a white background.
Image /page/0/Picture/2 description: The image shows the logo for Osteomed Corporation. The text "OSTEOMED" is in large, bold, sans-serif font. Below that, in a smaller font, is the word "CORPORATION".
510(k) Summary
| Device Proprietary Name: | OsteoMed Intraoral Mandibular
Distraction System |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External Mandibular
Fixator and/or Distractor |
| Name of Submitter: | OsteoMed Corporation
3750 Realty Road
Addison, Texas 75001
Phone: (972) 241-3401
Fax: (972) 241-3507 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | October 31, 2001 |
Summary:
This submission describes the OsteoMed Intraoral Mandibular Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.
The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Intraoral Distraction System (K990944), Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Mandibular Distraction 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 logo is a stylized "M" with four vertical bars. The text is in a smaller font and is located to the right of the logo. The image is simple and clean, with a focus on the Marmon brand.
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 human face in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, emphasizing the organization's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
Ms. Dawn T. Holdeman Regulatory Affairs & Document Control OsteoMed Corporation 3750 Realty Road Addison, Texas 75001-4311
Re: K013618
Trade/Device Name: Intraoral Mandibular Distraction System Regulation Number: Bone Plate Regulation Name: 872.4760 Regulatory Class: II Product Code: MQN Dated: June 4, 2002 Received: June 5, 2002
Dear Mr. 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.
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.
2
Page 2 – Ms. Holdeman
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); v 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.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Patricia Caccavellor
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
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OsteoMed "Indications for Use" Submission
510(k) Number: 4013618 _______________________________________________________________________________________________________________________________________________________
| Device Name: | Osteomed Intraoral Mandibular
Distraction System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | Indicated for use as a mandibular bone
lengthener for patients diagnosed with
conditions where treatment includes
mandibular distraction osteogenesis.
These conditions may include
diagnoses such as mandibular
micrognathia or hemifacial microsomia.
The OsteoMed Intraoral Mandibular
Distraction System is intended for
single patient use only. |
Susan Roares
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K(1)3(1)8