(53 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, Extended is intended for single patient use only.
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.
The provided text is a 510(k) summary for the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended. It describes a medical device for bone stabilization and lengthening in the mandible for pediatric patients under 4 years of age.
Based on the information provided in the document, here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria or report device performance in a quantitative manner. This 510(k) relies on "substantial equivalence" to predicate devices. The primary assertion is that due to similarities in materials and design, the device "does not raise any new safety or effectiveness issues."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set, sample size, or data provenance for evaluating the performance of the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended. The submission is based on a determination of substantial equivalence to previously cleared devices rather than a new performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The submission does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. No ground truth adjudication method is mentioned as there is no described test set or study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. The device is a physical surgical implant, not an AI or digital diagnostic tool, thus an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. No ground truth is mentioned as there is no described performance study for this device.
8. The sample size for the training set
This information is not applicable and not provided. The device is a physical medical implant, and the submission is based on substantial equivalence, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, there is no ground truth establishment method described.
Summary of the study and acceptance process based on the provided document:
The document describes a medical device, the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended, which is an intraoral distractor intended for bone stabilization and lengthening in the mandible of pediatric patients under 4 years of age.
Acceptance Criteria and Study:
The acceptance of this device by the FDA is based on a 510(k) premarket notification which asserts "substantial equivalence" to legally marketed predicate devices. This means that the device is considered safe and effective because it shares similar intended use, materials, design, and operational principles with devices already cleared by the FDA.
- Predicate Devices:
The submission explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended does not raise any new safety or effectiveness issues."
Therefore, there was no new, independent clinical or performance study described in this 510(k) summary with specific acceptance criteria beyond demonstrating substantial equivalence to the identified predicate devices. The FDA's letter confirms their finding of "substantial equivalence" as the basis for allowing the device to be marketed.
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510(k) Summary
NOV 17 2006
| Device Proprietary Name: | OsteoMed Pediatric IntraoralMandibular Distraction System,Extended |
|---|---|
| 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: | 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
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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.
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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
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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
Page __ of __
(Posted November 13, 2003) •••••••• Number
§ 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.