(35 days)
Not Found
Not Found
No
The summary describes a mechanical clamp for reattaching bone and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No
Explanation: This device is for reattaching a cranial bone flap, which is a structural repair, not a therapeutic treatment for a disease or condition.
No
Explanation: The device description states its purpose is to "reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure," which is a therapeutic or surgical function, not a diagnostic one. It does not mention identifying diseases or conditions.
No
The device description clearly describes a physical clamp made of discs and a shaft, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Synthes Cranial Flap Tube Clamp is a surgical implant used to physically reattach a bone flap to the skull during a surgical procedure. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for reattaching a cranial bone flap after a craniotomy. This is a surgical function, not a diagnostic one.
The information provided about the device's function, intended use, and anatomical site all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Synthes Cranial Flap Tube Clamp 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)
GXN
Device Description
Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The disc diameters range between 8.0 mm to 20 mm. The Cranial Flap Tube Clamp is MRI safe and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Aesculap's Craniofix Titanium Clamp System
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot 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 stylized image inside. A small circle with a line through it is located to the right of the word.
99200
JUL 20 1999
Attachment VII:
SUBMITTER
DEVICE NAME:
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
Fastener, Plate, Cranioplasty
Plate, Cranioplasty, Preformed, Alterable;
Class II, 21 CFR 882.5320 and 882.5360
Synthes Cranial Flap Tube Clamp
COMMON OR USUAL NAME
DEVICE CLASSIFICATION:
Aesculap's Craniofix Titanium Clamp System PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The disc diameters range between 8.0 mm to 20 mm. The Cranial Flap Tube Clamp is MRI safe and is for single use only.
Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
CONFIDENTIAL
1
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 eagle with three lines representing its wings and a wavy line representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
K992000 Re:
Trade Name: Synthes Cranial Flap Tube Clamp Regulatory Class: II Product Code: GXN Dated: June 9, 1999 Received: June 15, 1999
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 Regulations, 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 Regulation (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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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) 594-4595. 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
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Indications for Use Statement 2.0
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| Labels | Values |
|---|---|
| 510(k) Number (if known): | 5992000 |
| Device Name: | Synthes Cranial Flap Tube Clamp |
Indications For Use:
Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
(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 _________________________________________________________________________________________________________________________________________________________
tasley
(Division Sign-Off)
Division of General Restorative Devices K992000
510(k) Number
Synthes (USA) Cranial Flap Tube Clamp CONFIDENTIAL