(25 days)
Not Found
Not Found
No
The summary describes standard cranial plates and screws, with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as being used for reconstructive procedures and selective trauma, which implies therapeutic intervention for injuries or conditions.
No
The device is described as Synthes Cranial Plates and burr hole covers, used for surgical procedures like trauma repair, reconstructive procedures, and orthognathic surgery. Its function is to provide structural support and is implanted, which is therapeutic in nature, not diagnostic.
No
The device description clearly indicates physical components (plates, screws, burr hole covers) and their intended use in surgical procedures, which are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in surgical procedures (trauma, reconstructive, orthognathic surgery) on the midface and craniofacial skeleton. This is a direct surgical intervention on the patient's body.
- Device Description: The device description talks about plates and screws used for bone fixation. This is a physical implant used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted or used directly in surgical procedures on the body itself.
N/A
Intended Use / Indications for Use
The Synthes Cranial 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
JEY, GXR
Device Description
The Synthes burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.3 mm (1.7 mm emergency) or 1.5 mm (2.0 mm emergency) self-tapping bone 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes Cranial Plates
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word "SYNTHES". The logo and text are the main elements of the image.
510(k) Summary
3.0
NOV 2 3 3 2004
Page ________ of ____ of __1
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Cranial Plates |
| Classification: | 21 CFR 882.5250: Cover, Burr Hole |
| Predicate Devices: | Synthes Cranial Plates |
| Device Description: | The Synthes burr hole covers come in various sizes to
accommodate various fracture and osteotomy sites, have a low
plate/screw head profile and use existing (previously cleared) 1.3
mm (1.7 mm emergency) or 1.5 mm (2.0 mm emergency) self-
tapping bone screws. |
| Intended Use: | The Synthes Cranial 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: | Comparative information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042987
Trade/Device Name: Synthes (USA) Cranial Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, GXR Dated: October 28, 2004 Received: October 29, 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 (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) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Ling, 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
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word "SYNTHES" and the logo. The logo and word are likely part of a company or brand identity.
Page 1 of l
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Cranial Plates
Indications for Use:
The Synthes Cranial Plates are intended for use in selective trauma of the midface and I no bynnitos Craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Prescription Use X (Per 21 CFR 801.109) 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)
Suna Rmn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042987