(53 days)
No
The description focuses on the mechanical function of the device (threaded wire, hex driver, plates, screws) for bone distraction and stabilization. There is no mention of software, algorithms, or data processing that would suggest AI/ML is involved.
Yes
The device is described as a bone stabilizer and lengthening device used to correct congenital deficiencies or post-traumatic defects, which directly addresses a medical condition to improve health.
No
The device is described as a "bone stabilizer and lengthening (and/or transport) device" used for "gradual distraction" to correct "congenital deficiencies or post traumatic defects of the mandible." Its function is therapeutic (stabilizing, lengthening, distracting bone) rather than diagnostic (identifying or characterizing a condition).
No
The device description explicitly states it is a "subcutaneous bone distractor" with "various curved and straight bars, activated with a threaded wire, that have plates that are fixed to bone via 1.2mm bone screws." This clearly describes a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "bone stabilizer and lengthening (and/or transport) device" that is "fixed to bone via 1.2mm bone screws." It is a surgical implant used directly on the patient's bone.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens. Its function is mechanical and structural.
Therefore, based on the provided information, the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, Extended is intended for single patient use only.
Product codes
MQN
Device Description
The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended 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 45mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible (including ramus, body, symphisis)
Indicated Patient Age Range
pediatric population for children under 4 years of age including infants and neonates.
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 logo for OsteoMed. The logo is in black and white and features the word "OsteoMed" in a bold, sans-serif font. The word is enclosed in an oval shape. The oval shape is also in black and white and has a thick border.
510(k) Summary
NOV 17 2006
| Device Proprietary Name: | OsteoMed Pediatric Intraoral
Mandibular Distraction System,
Extended |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | MQN, External Mandibular
Fixator and/or Distractor |
| Name of Submitter: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Piedad Peña |
| Date Prepared: | September 21, 2006 |
Summary:
This submission describes the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended 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, Extended is intended for single patient use only.
The OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended 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 45mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434) and the KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154).
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, Extended does not raise any new safety or effectiveness issues.
OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Image /page/0/Picture/11 description: The image shows the logo for "A Colson Associate". The logo consists of a black circle with a white vertical line through the center and the word "Colson" written in white letters inside the circle. To the right of the circle, the text "A Colson Associate" is written in black letters.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the nation.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2006
Ms. Piedad Peña Regulatory Affairs Associate OsteoMed. L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K062851
Trade/Device Name: OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: September 22, 2006 Received: September 25, 2006
Dcar Ms. Pena:
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 adultcration.
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.
2
Page 2 - Ms. Pena
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 (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,
Snette Y. Michien Om.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
3
Indications for Use
510(k) Number (if known):
Device Name: OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended
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, Extended 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)
Susan Rump
gn-)
[sion of Anesthesiology, General Hospital,
f-bction Control, Dental Devices
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