(18 days)
Not Found
Not Found
No
The summary describes a physical implant (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical implant (plate) used for fixation in craniofacial and orthognathic surgery, which is a medical device but not specifically described as providing therapeutic action directly. Its purpose is structural support for recovery after trauma or surgery.
No
The device description indicates that the Synthes Craniofacial Plates are implants used for surgical procedures to stabilize bones, not to diagnose medical conditions.
No
The device description clearly describes physical plates and screws, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for fixing bones in the craniofacial region. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical plate and screws used for surgical fixation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
In summary, the Synthes Craniofacial Plates are a surgical implant, not a device used for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Synthes Craniofacial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes Double Adaption Plate can be cut or trimmed to the desired length to accommodate various fractures and meet the anatomical need of the patient. The plate has a low plate / screw head profile, uses 2.0 mm self-tapping or self-drilling bone screws and 2.4 mm emergency screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton, maxilla and chin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Sagittal Split Plate
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
FEB 2 3 2004
0272
Summary of Safety and Effectiveness Information [510 Summary] 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Craniofacial Plates |
| CLASSIFICATION: | Class II , 21 CFR 872.4760: Bone Plate |
| PREDICATE DEVICE: | Synthes Sagittal Split Plate |
| DEVICE DESCRIPTION: | The Synthes Double Adaption Plate can be cut or trimmed to the desired
length to accommodate various fractures and meet the anatomical need of
the patient. The plate has a low plate / screw head profile, uses 2.0 mm
self-tapping or self-drilling bone screws and 2.4 mm emergency screws. |
| INTENDED USE: | The Synthes Craniofacial Plates are intended for use in selective trauma of
the midface and craniofacial skeleton; craniofacial surgery; reconstructive
procedures; and selective orthognathic surgery of the maxilla and chin. |
| SUBSTANTIAL
EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes
CRANIOFACIAL Plates are substantially equivalent to other legally
marketed Synthes devices. |
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA), Incorporated 1690 Russell Road Paoli, Pennsylvania 19301
Re: K040272
Trade/Device Name: Synthes (USA) Craniofacial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bonc Plate Regulatory Class: II Product Code: JEY Dated: February 4, 2004 Received: February 5, 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. or the Flor of any I outh all the Act's requirements, including, but not limited to: registration 1 od intelse comp?) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } and ifsting (21 CF ret in the quality systems (QS) 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) Finis letter will anon you to begal finding of substantial equivalence of your device to a premarketed 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), n you deette opber of Compliance at (301) 594-. 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 Inter 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,
Carls
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 Statement 2.0
| 510(k) Number (if known): | K040272 |
|---|---|
| Device Name: | Synthes (USA) Craniofacial Plates |
Indications:
The Synthes Craniofacial Plates are intended for use in selective trauma of the midfacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Susan Runne
(Division Louis-U (Division of Anestin Looky) General Hospital, Infection Control. Deptai Lrevioes
510(k) Number K040272
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
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