(126 days)
Not Found
No
The device description and intended use focus on a mechanical spring clip for bone flap reattachment. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a Cranial Spring Clip intended to reattach a cranial bone flap, which is a structural fixation device, not a therapeutic device that administers therapy or treats a disease.
No
The device, Synthes CSC, is described as intended to reattach a cranial bone flap. Its function is to secure a bone flap after surgery, which is a therapeutic or reconstructive action rather than a diagnostic one. Diagnostic devices are used to identify a condition or disease.
No
The device description clearly details a physical implantable device made of Ti Alloy, including its dimensions and how it is secured with screws. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (Cranial Spring Clip) designed to mechanically secure bone.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for a surgical repair.
N/A
Intended Use / Indications for Use
Synthes CSC is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Product codes (comma separated list FDA assigned to the subject device)
GWO, HBW
Device Description
Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The CSC has a T-profile, which consists of two semi-circular tabs, and two projections that are bent into springs to lodge in the diploe of the cranial bone surrounding the osteotomy. The two tabs are 0.2 mm thick and rest on the superior surfaces of the cranial flap and the surrounding cranial bone. The CSC has a low profile, is 11.5 mm in length, 9.0 mm in width, and is 4.2 mm in height (0.2 mm above the cranial surface). 1.5 mm Ti Alloy Bone Screws will be inserted laterally through the CSC and into the diploe. The CSC is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone / cranium
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.
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
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. To the right of the word is a small circle with an R inside, indicating a registered trademark.
・
Summary of Safety and Effectiveness Information [510(k) Summary]
MAR | 6 1998
2974206
| SUBMITTER | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Sheri L. Musgnung |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON OR USUAL
NAME | Plate, Cranioplasty, Preformed, Alterable; Fastener, Plate, Cranioplasty |
| DEVICE
CLASSIFICATION | Class II, 21 CFR 882.5320 and 882.5360 |
| PREDICATE DEVICE | Synthes Midfacial System (K953806) |
| DESCRIPTION | Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The CSC has a T-profile, which consists of two semi-circular tabs, and two projections that are bent into springs to lodge in the diploe of the cranial bone surrounding the osteotomy. The two tabs are 0.2 mm thick and rest on the superior surfaces of the cranial flap and the surrounding cranial bone. The CSC has a low profile, is 11.5 mm in length, 9.0 mm in width, and is 4.2 mm in height (0.2 mm above the cranial surface). 1.5 mm Ti Alloy Bone Screws will be inserted laterally through the CSC and into the diploe. The CSC is for single use only. |
| INTENDED USE | Synthes CSC is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. |
The CSC is contraindicated in the following situations: in patients
with a skull thickness less than 4 mm; or when the gap surrounding
the bone flap is greater than 2 mm.
The CSC is MRI compatible.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes USA 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K974206 Synthes (USA) Cranial Spring Clip Regulatory Class: II Product Codes: GWO and HBW Dated: February 13, 1998 Received: February 17, 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 The general controls provisions of the Act 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 ... A ................................................................................ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/1/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
2
Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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. To the right of the word is a small circle with a capital R inside, indicating a registered trademark.
Indications for Use Statement:
K974206 510(k) Number (if known):
Synthes (USA) Cranial Spring Clip (CSC) Device Name: ...
Indications For Use:
Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm.
The CSC is MRI Compatible.
(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
signature
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974206