(87 days)
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws.
The provided text describes a 510(k) submission for the "Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws." This is a medical device application that focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of diagnostic performance or clinical outcomes. The provided text is a regulatory filing for marketing clearance, not a clinical trial report.
Here's why the requested information is not available in the given text:
- Acceptance criteria and reported device performance: This type of information (e.g., sensitivity, specificity, accuracy, or other quantitative performance metrics) is typically found in clinical study reports. The 510(k) summary focuses on device description, intended use, and substantial equivalence to a predicate device, not on presenting novel performance data against pre-defined criteria.
- Sample size and data provenance: No clinical study is described, so no sample size for test sets or data provenance is mentioned.
- Number of experts and qualifications for ground truth: Since no clinical study with ground truth establishment is detailed, this information is absent.
- Adjudication method: Not applicable as no clinical study with ground truth adjudication is described.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance study: Not mentioned, as the focus is on substantial equivalence to an existing device.
- Type of ground truth used: Not applicable.
- Training set sample size: Not applicable, as this is a medical device for fixation, not an algorithm that requires a training set in the sense of machine learning.
- How ground truth for training set was established: Not applicable.
The 510(k) process for devices like these typically relies on:
- Bench testing: To demonstrate mechanical properties, biocompatibility, and sterilization effectiveness.
- Comparison to a predicate device: To show that the new device is as safe and effective as a legally marketed device.
The provided document verifies that the Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are substantially equivalent to the Synthes Midfacial System (K953806) for the stated indications. This "substantial equivalence" is the regulatory criterion met, rather than performance against a set of quantitative metrics for diagnostic accuracy or similar clinical outcomes.
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SYNTHES
APR 16 1998
Attachment VI:
Summary of Safety and Effectiveness Information
[510(k) Summary]
K
SUBMITTER
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Plate, Bone
1980199
Class II, 21 CFR 888.3030 and 872.4760
CLASSIFICATION:
PREDICATE DEVICE:
Synthes Midfacial System (K953806)
DESCRIPTION:
DEVICE
INTENDED USE:
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws.
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and craniofacial skeleton; surgery; reconstructive procedures; craniofacial and selective orthognathic surgery of the maxilla and chin.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 17 1998
Ms. Sheri L. Musqnung Regulatory Affairs Associates Synthes® (USA) 1690 Russell Road Post Office Box 1766 19301 Paoli, Pennsylvania
Re : K980199 Synthes® (USA) 1.5mm/2.0mm Orthognathic Trade Name: Maxillary Plates and Screws Requlatory Class: II Product Code: DZL January 19, 1998 Dated: Received: January 20, 1998
Dear Ms. Musgnung:
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 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 (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. ਜੋ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in 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
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Page 2 - Ms. Musgnung
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 findinq 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 requlation (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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041g or (301) 443-6597 or at its internet address "http://www.fda.gpv/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo 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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TES®
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
Page of
K980199 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Synthes (USA)1.5 mm / 2.0 mm Orthognathic Maxillary Plates Device Name: and Screws
Indications For Use:
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
(PLEASE DO NOT WRITE BELOW 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
Herold W. Shapiro
(Division Sign-Off)
ental, Infection Control. and General Hospital 510(k) Number
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.