(84 days)
The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
BONAMATES® Series
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the BONAMATES® Series, which are bone plates. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
The document includes:
- The device name: BONAMATES® Series.
- The regulation number and name: 872.4760, Bone Plate.
- The product code: JEY.
- Indications for Use: Trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance).
- Information on how ground truth was established for training or testing sets.
Therefore, I cannot provide the requested information based on the input given.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
BioTech One, Incorporated C/O Ms. Karen Uyesugi U.S. Consultant Uyesugi & Associates 92 Costa Brava Laguna Niguel, California 92677
Re: K040650
Trade/Device Name: BONAMATES® Series Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 29, 2004 Received: March 11, 2004
Dear Ms. Uyesugi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the relefenced above and nave acternialsoure) 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 that have been reclassified in accordance with the provisions of Amendinents, or to activelic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (boo acc iditional controls. Existing major regulations affecting (1 MA), it hay of subject to tax 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. Uyesugi
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 1 D a determination that your device complies with other requirements modi that I Dri mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bane Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rate 007), abstitus (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadisation 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) This letter will anow your even finding of substantial equivalence of your device to a premarket notification. - Indevice 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), If you desire specific at 100 % pliance 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 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,
Carl Liu, 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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BioTech One, Inc. 510(k) Notification
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BONAMATES® Series
:
: : : : :
510(k) number (if known):
BONAMATES® Series Device Name:
: : :
Indications for Use:
BONAMATES® Series:
The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
Susan Ryan
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoulors.
510(k) Number:
(PLEASE DO NOT WRITE BFILOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ________
TABLE OF CONTENTS
§ 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.