(198 days)
Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
The OsteoMed Orthodontic Screw System is comprised of screws in diameters of 1.2mm to 2.0mm in thread lengths of 4.0mm to 8.0mm. The screws are made from titanium alloy. Pilot Drills and screwdrivers will also be a part of the system.
This document is a 510(k) premarket notification for the OsteoMed Orthodontic Screw System. It is a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study evaluating the performance of AI. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods for an AI device.
The document discusses:
- Device Proprietary Name: OsteoMed Orthodontic Screw System
- Device Common Name: Bone Screw
- Intended Use: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
- Materials: Titanium alloy
- Predicate Devices: Straumann Ortho Implant (K982509) and Nobel Biocare Inplant Orthodontic Anchor System (K000643).
- Basis for Equivalence: Similarities in intended use, material, design, and operational principle to the predicate devices.
- Conclusion: OsteoMed believes the device does not raise new safety or effectiveness issues due to these similarities.
In summary, there is no information in the provided text to answer your questions about acceptance criteria and an AI study. This document is a regulatory submission for a physical medical device, not an AI software.
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JAN - 7 2004
510(k) Summary
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Orthodontic Screw System
Bone Screw
DZE, Implant, Endosseous
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Dawn T. Holdeman
May 23, 2003
Date Prepared:
Summary:
This submission describes the OsteoMed Orthodontic Screw System intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
The OsteoMed Ofthodontic Screw System is comprised of screws in diameters of 1.2mm to 2.0mm in thread lengths of 4.0mm to 8.0mm. The screws are made from titanium allov. Pilot Drills and screwdrivers will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Straumann Ortho Implant (K982509) and the Nobel Biocare Inplant Orthodontic Anchor System (K000643).
Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Orthodontic Screw System does not raise any new safety or effectiveness issues.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMcd L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K031936
Trade/Device Name: Osteomed Orthodontic Screw System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 9, 2003 Received: October 10, 2003
Dear Ms. Holdeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 mensiale commerce prior to tray been reclassified in accordance with the provisions of Amendinena, I. 1. 10 ab road Cosmetic Act (Act) that do not require approval of a premarket the I cacial I ood, 171ag, dAD Obbu may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls process 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 (1 vir y, it may be bacyco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Ecdgral 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 mount that 1 Drimal statutes and regulations administered by other Federal agencies. or the Act of ally I outhal the Act's requirements, including, but not limited to: registration r our must comply with a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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 white wification. 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), n you deathe specifical at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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 yours,
Chiu-Ling Lu, 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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OsteoMed "Indications for Use" Submission
510(k) Number:
KO31936
| Device Name: | OsteoMed Orthodontic Screw System |
|---|---|
| Indications for Use: | Indicated to provide a fixed anchorage point for attachment oforthodontic appliances to facilitate the orthodontic movement ofteeth. It is used temporarily and is removed after orthodontictreatment has been completed. Screws are intended for singleuse only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031931
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.