(112 days)
The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.
Not Found
The provided text is a 510(k) summary for the SonicWeld Rx Endobrow Fixation device, which is a bone plate. 510(k) summaries primarily focus on demonstrating substantial equivalence to predicate devices and detailing the intended use and classification of the device.
Therefore, the document does not contain information related to acceptance criteria, specific device performance studies, or clinical trial details such as sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.
A 510(k) submission generally relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device features, materials, and mechanical properties, but typically does not involve the kind of detailed clinical study data and performance metrics that would be found in a PMA (Pre-Market Approval) application or a clinical trial report.
Based on the provided text, I cannot complete the requested tables and information.
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KUS SERVER L.P.
SEP 2 1 2006
SonicWeld Rx Endobrow Fixation
510(k) Summary
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector RA/QA |
| Date of Summary: | 19 May 2006 |
| Device Name: | SonicWeld Rx Endobrow Fixation |
| Trade Name: | SonicWeld Rx Endobrow Fixation |
| Common Name: | Bone Plate |
| ClassificationName and Number: | Bone plate (CFR 872.4760) |
| Regulatory Class: | II |
| Predicate Devices: | Resorb-X SF (K051236) |
| Predicate Devices: | The Bioplate Resorbable Endobrow FixationSystem (K051845) |
| Predicate Devices: | LactoSorb Craniofacial Anchor-Push Screw(K013557) |
| Intended Use: | The SonicWeld Rx Endobrow Fixation will beused to support non-load bearing tissues of thecraniofacial skeleton, including but not limitedto endobrow fixation |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2006
Ms. Jennifer Damato Director RA/QA KLS-Martin, L.P. 11239 St. Johns Industrial, Parkway South Jacksonville, Florida 32246
Re: K061507
Trade/Device Name: SonicWeld Rx Endobrow Fixation Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 1, 2006 Received: September 6, 2006
Dear Ms. Damato:
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.
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Page 2 - Ms. Damato
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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Indications for Use
KOGISOT 510(k) Number (if known):
Device Name: SonicWeld Rx Endobrow Fixation
Indications For Use:
The SonicWeld Rx Endobrow Fixation will be used to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of
§ 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.