(59 days)
Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.
The OsteoMed Pediatric Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars. activated with a threaded wire, that have plates that are fixed to bone via 1.2mm bone screws. The distractor is available in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.
The provided text describes the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434), a medical device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device submitted to the FDA. Such summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.
Therefore, I cannot fulfill your request for the detailed table and study information because the provided input lacks the necessary data.
To answer your request, the input document would need to include sections detailing:
- Specific performance metrics the device was designed to achieve (acceptance criteria).
- A study design that evaluated these metrics.
- Results from that study, comparing them to the acceptance criteria.
- Information on the data used (sample size, provenance), ground truth establishment (experts, adjudication), and training set details (if applicable for an AI device, which this is not).
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FEB 1 0 2005
510(k) Summarv
| Device Proprietary Name: | OsteoMed Pediatric IntraoralMandibular Distraction System |
|---|---|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External MandibularFixator and/or Distractor |
| Name of Submitter: | OsteoMed L. P.3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | December 7, 2004 |
Summary:
This submission describes the OsteoMed Pediatric Intraoral Mandibular Distraction System indicated for use as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis) require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.
The OsteoMed Pediatric Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars. activated with a threaded wire, that have plates that are fixed to bone via 1.2mm bone screws. The distractor is available 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 KLS-Martin Zurich Pediatric Distraction System (K010139), the KLS-Martin Micro Mandibular Distractor and the OsteoMed Intraoral Mandibular Distraction System (K013618).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Pediatric Intraoral Mandibular Distraction System does not raise any new safety or effectiveness issues.
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Public Health Service
FEB 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K043434
Trade/Device Name: OsteoMed Pediatric Intraoral Mandibular Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 10, 2004 Received: December 13, 2004
Dear Ms. 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.
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Page 2 - Ms. Holdeman
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 (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.
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
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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Indications for Use
510(k) Number (if known): K043434
Device Name:
Indications for Use:
Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction.
This system is intended for use in pediatric population for children under 4 years of age including infants and neonates.
The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swarn Kumar
insion Sion-Off) Vision of Anesthesiology, General Hospital, Intection Control, Dental Devices
10(k) Number: _
Page 1 of 1
§ 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.