(76 days)
The Synthes External Midface Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a Lefort II or III osteotomy, and/or the cranium utilizing a monoblloc osteotomy in adult and pediatric populations where gradual bone distraction is required.
The Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.
The provided text is a 510(k) summary for the Synthes External Midface Distractor. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's not a clinical trial report designed to establish de novo safety and effectiveness.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Performance: The document does not define specific performance metrics or acceptance criteria for the device's function (e.g., specific distraction rate, stability, force application limits) that would be evaluated in a study. It focuses on the device's description and intended use.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Information: A 510(k) summary relies on demonstrating similarity to existing devices and does not typically include information about clinical studies with human participants, ground truth establishment, expert adjudication, or AI algorithm performance (as this is a medical device, not an AI software).
The key takeaway from this document is that the FDA determined the device is substantially equivalent to predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This is a different regulatory pathway than demonstrating de novo safety and effectiveness through a clinical trial with pre-defined acceptance criteria.
{0}------------------------------------------------
MAR 3 1 2004
Summary of Safety and Effectiveness Information 3.
Synthes (USA) Sponsor 1690 Russell Road Paoli, PA 19301 Lisa M. Boyle Company Contact (610) 647-9700 Synthes External Midface Distractor Name of the Device Class II, §872.4760 - External Mandibular Fixator and /or Distractor Device Classification The Synthes External Midface Distractor is an external distraction Device Description osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla. The Synthes External Midface Distractor is intended for use in Indications craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy, and / or the cranium utilizing a monobloc osteotomy in adult and pediatric populations where gradual bone distraction is required. Substantial Equivalence Documentation is provided which demonstrates that the Synthes External Midface Distractor is substantially equivalent to other legally marketed devices. The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
MAR 3 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K040083
Trade/Device Name: Synthes External Midface Distractor Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: January 14, 2004 Received: January 15, 2004
Dear Ms. Boyle:
We have reviewed your Section 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, therefore, 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.
{2}------------------------------------------------
Page 2 - Ms. Boyle
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 (OS) 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,
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
{3}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K040083 |
|---|---|
| Device Name: | Synthes External Midface Distractor |
| Indications For Use: | The Synthes External Midface Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a Lefort II or III osteotomy, and/or the cranium utilizing a monoblloc osteotomy in adult and pediatric populations where gradual bone distraction is required. |
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Ruarez
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOYOO 83 510(k) Number:_
Page 1 of 1
§ 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.