(78 days)
This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.
The Chin Distractor is a distraction osteogenesis system consisting of two bone plates, a threaded activation rod and a distraction instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with a distraction instrument. The implanted components of the device are manufactured from titanium.
The provided text describes the 510(k) premarket notification for the Chin Distractor device. This document is a regulatory submission for a physical medical device (a distraction osteogenesis system), not a software or AI-based device.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of device and is not contained within the provided 510(k) summary. These criteria are typically associated with performance studies for diagnostic devices, particularly those involving algorithms or AI.
The 510(k) process for a device like the Chin Distractor focuses on demonstrating substantial equivalence to a predicate device already legally marketed. This typically involves comparing:
- Indications for Use: Are they the same or very similar?
- Technological Characteristics: Are the materials, design, and operating principles similar?
- Performance Data (if applicable): This might include biocompatibility testing, mechanical testing (e.g., strength, fatigue), and sterility testing, to ensure the new device performs as intended and is as safe and effective as the predicate. It does not typically involve the kinds of clinical performance studies with human readers or AI algorithms that your prompt suggests.
The 510(k) summary explicitly states: "The Chin Distractor is substantially equivalent to several other legally marketed devices." It lists four predicate devices to which it is compared.
In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, or AI performance can be extracted from the provided text because it pertains to a physical medical device cleared via the substantial equivalence pathway, not an AI or diagnostic algorithm.
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510(k) Summary
Device: Chin Distractor
The Chin Distractor is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge. This device is a distraction osteogenesis system consisting of two bone plates, a threaded activation rod and a distraction instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with a distraction instrument. The implanted components of the device are manufactured from titanium.
The Chin Distractor is substantially equivalent to several other legally marketed devices. Examples of these are:
| 1. Cohen Distractor | Howmedica Leibinger | K972154 |
|---|---|---|
| 2. Luhr® Micro Mesh | Howmedica | K901940 |
| 3. Titanium Osteosynthesis System | W. Lorenz Surgical | K953385 |
| 4. Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. | K874276 |
For information contact:
John Dichiara Group Regulatory Affairs Manager Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. John Dichiara Group Regulatory Affairs Manager Howmedica Incorporated 359 Veterans Boulevard Rutherford, New Jersey 07070
K973484 Re : Chin Distractor Trade Name: Requlatory Class: II Product Code: JEY Dated: September 12, 1997 Received: September 15, 1997
Dear Mr. Dichiara:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ರ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Dichiara
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timd Ulatowski ay A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Unknown
Device Name: Chin Distractor
Indications for Use:
This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.
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| Soncurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
(Optional Format 1-2-96)
§ 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.