(282 days)
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.
I'm sorry, but the provided text does not contain the information required to describe acceptance criteria or a study proving device performance. The document is a 510(k) summary and FDA clearance letter for the OsteoMed Intraoral Mandibular Distraction System. It details the device's intended use, description, and claims of substantial equivalence to predicate devices, but it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study with sample sizes, data provenance, ground truth establishment, or expert involvement.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The document states that "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." This suggests that the clearance was based on equivalence rather than new performance studies demonstrating against specific acceptance criteria.
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AUG 1 4 2002
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510(k) Summary
| Device Proprietary Name: | OsteoMed Intraoral MandibularDistraction System |
|---|---|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External MandibularFixator and/or Distractor |
| Name of Submitter: | OsteoMed Corporation3750 Realty RoadAddison, Texas 75001Phone: (972) 241-3401Fax: (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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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 MandibularDistraction System |
|---|---|
| Indication for Use: | Indicated for use as a mandibular bonelengthener for patients diagnosed withconditions where treatment includesmandibular distraction osteogenesis.These conditions may includediagnoses such as mandibularmicrognathia or hemifacial microsomia.The OsteoMed Intraoral MandibularDistraction System is intended forsingle 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
§ 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.