(90 days)
Not Found
No
The summary describes a mechanical implant and surgical instruments, with no mention of AI, ML, image processing, or data analysis.
No
The device is described as an implantable clamp system used to reattach a cranial bone flap after surgery, which is a structural or fixation device, not one that treats a disease or condition.
No
The device is described as an implant system used to reattach a cranial bone flap after surgery, not to diagnose a condition.
No
The device description explicitly states it consists of a "two-piece titanium implant and associated nonpowered neurosurgical instruments," indicating it is a hardware device, not software only.
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 "two-piece titanium implant and associated nonpowered neurosurgical instruments." This describes a physical implant and surgical tools used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not involve the analysis of biological specimens.
Therefore, the Leibinger Quik Disk Titanium Clamp System is a surgical implant and instrument system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Leibinqer Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Product codes
GXN
Device Description
The Leibinger Quik Disk Titanium Clamp System consists of a two-piece titanium implant and associated nonpowered neurosurgical instruments. The system allows for timely fixation of cranial flaps to the surrounding cranium after craniotomies in lieu of bone plate and screw methods. The Quik Disk has two parallel 15 mm diameter titanium disks that are connected by an internal, serrated breakaway stem and grasping clamp assembly that is fully contained between the two discs.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 2 2 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
General Information
| Proprietary Name: | Leibinger Quik Disk Titanium Clamp System |
|---|---|
| Common Name: | Plate, Cranioplasty, Preformed, Non-Alterable |
| Classification Name(s): | Plate, Cranioplasty, Preformed, Non-Alterable |
| Classification Code(s): | GXN, 882.5330 |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 800-253-7370 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 1811755 |
| Contact Person: | Kristyn R. Kelley |
| Project Engineer | |
| Quality Assurance and Regulatory Affairs | |
| 800-253-7370 x5045 | |
| Summary Preparation Date: | November 23, 1999 |
Device Description
The Leibinger Quik Disk Titanium Clamp System consists of a two-piece titanium implant and associated nonpowered neurosurgical instruments. The system allows for timely fixation of cranial flaps to the surrounding cranium after craniotomies in lieu of bone plate and screw methods. The Quik Disk has two parallel 15 mm diameter titanium disks that are connected by an internal, serrated breakaway stem and grasping clamp assembly that is fully contained between the two discs.
Intended Use
The Leibinqer Quik Disk Titanium Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Substantial Equivalence
The Leibinger Quik Disk Titanium Clamp System is substantially equivalent to the Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
FEB 2 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristyn R. Kelley Project Engineer Quality Assurance and Regulatory Affairs Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K993990
Trade Name: Leibinger Quik Disk Titanium Clamp System Regulatory Class: II Product Code: GXN Dated: November 23, 1999 Received: November 24, 1999
Dear Ms. Kelley:
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 requirements, 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.
2
Page 2 - Ms. Kristyn R. Kelley
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
James E. Rill and Wife
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1___ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Leibinger Quik Disk Titanium Clamp System Device Name:
Indications For Use:
: 上一篇:
The Leibinger Quik Disk Titanium Clamp System 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993990 |
| Prescription Use | X | OR | Over-The- Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)