(137 days)
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "T-Gear", which is a cervical headgear traction appliance.
While it indicates the device is substantially equivalent to legally marketed predicate devices and states its indications for use, it does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, or ground truth establishment for any test or training sets.
- Details about expert qualifications, adjudication methods, or MRMC studies.
- Results from standalone algorithm performance.
The letter is primarily a regulatory approval document confirming market clearance based on substantial equivalence, rather than a technical report detailing a performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2000
Mr. J.P. Jorens Orthoton bv Avelingenwest 27c 4202 MS Gorinchem, The Netherlands
K993224 Re : T-Gear, Model TG/400-70 Trade Name: Regulatory Class: II Product Code: DZB Dated: November 24, 1999 December 29, 1999 Received:
Dear Mr. Jorens:
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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.
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) 594-4692. 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 gener Other qeneral 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,
Patricio Cucurella
Timothy A. Ulatowski 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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510(k) Number : K993224
Device Name : T-Gear®, models 400/700 grams
Indications For Use :
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital J 1510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
OR
ver-The-Count
-The-Counter Use
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.