(205 days)
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No
The summary describes a mechanical jaw tracking apparatus that measures distances using a 3D coordinate system and physical contact points. There is no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No
The device is described as a jaw tracking apparatus used by surgeons to measure distances and confirm the location/relocation of teeth and jaws; it does not directly treat or remedy a condition.
No
The device is designed to measure distances and confirm locations during surgery, assisting in the surgical procedure itself rather than diagnosing a condition. Its purpose is to guide treatment, not to identify or characterize a disease or condition.
No
The device description explicitly states it is a "jaw tracking apparatus" and mentions contact with the patient's skull via "tightening screws and a halo device," indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Gnathometer's function: The Gnathometer is a physical apparatus that measures distances and tracks the position of the jaw and teeth relative to the skull. It is used during surgery on the patient's head.
- Lack of biological sample analysis: The description does not mention the analysis of any biological samples from the patient.
The Gnathometer is a surgical instrument used for measurement and guidance during a surgical procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.
Product codes
JEY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's head, teeth and jaws, skull
Indicated Patient Age Range
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Intended User / Care Setting
maxillofacial surgeons
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three horizontal lines forming its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2004
Ortho Gnathics LLC C/O Mr. Kenneth J. Polk Kenneth J. Polk P.C. 5001 Baum Boulevard Suite 799 Pittsburgh, Pennsylvania 15213-1856
Re: K033092
Trade/Device Name: The Gnathometer Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 20, 2004 Received: February 23, 2004
Dear Mr. Polk:
We have reviewed your Scction 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, thereforc, 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.
1
Page 2 - Mr. Polk
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Kevin Mcley
$\sqrt{2}$
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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K0330092
STATEMENT OF INDICATIONS FOR USE SECTION F.
Page __ of _
510(k) Number (if known): _ Ko 33092
The Gnathometer Device Name:
Indications for Use:
The Gnathometer is a jaw tracking apparatus designed to provide maxillofacial surgeons with an accurate means to measure distances relative to a defined three-dimensional reference system of x-y-z coordinates on the patient's head. The Gnathometer is intended for use only by maxillofacial surgeons performing corrective surgical procedures on patients with dentofacial deformittes. The Gnathometer's use during surgery is intended to assist in confirming the location and relocation of the patient's teeth and jaws with prescribed, pre-surgically designed relocations that remedy the patients dentofacial deformities. The Gnathometer is intended only to make contact with a patient at four (4) predetermined points on the skull via tightening screws and a halo device, and not to be attached to the jaws.
(STEATE DO NOT WRITE BELOW THIS LINE-COMUNICE ON ANOTHER PACE OF MEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K033092 |
|---|---|
| ---------------- | --------- |
| Prescription Use | Over-The-Counter Use |
|---|---|
| (Per 21 FR 801.109) |
(Optional Format 3-10-98)
Section F, Statement of Indications for Use, Page 1 of 1