(43 days)
Not Found
No
The summary describes a mechanical fixation system and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a Cranial Fixation System, used for stabilizing a bone flap after surgery, which is a supportive rather than a therapeutic function.
No
The device is described as an implant system for fixation of a cranial bone flap, which implies a therapeutic or surgical purpose, not a diagnostic one.
No
The device description and intended use clearly indicate a physical cranial fixation system (implants and clamps), not a software-only device.
Based on the provided information, the Stryker® Leibinger Cranial Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of a cranial bone flap after a craniotomy. This is a surgical procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples or providing diagnostic information based on such analysis.
The device is a surgical implant used for structural support within the body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone flap
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.
K993990, K972332, K991860, K991029
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
030378
Page 1 of
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker Leibinger Cranial Fixation System
| General Information | ||||
|---|---|---|---|---|
| Proprietary Name: | Stryker Leibinger Cranial Fixation System | |||
| Common Name: | Plate, Cranioplasty, Pre-formed, Non-Alterable | |||
| Proposed Regulatory Class: | Class II | MAR 20 2003 | ||
| Device Classification: | GXN | |||
| 882.5330, Plate, Cranioplasty, Preformed, Non- Alterable | ||||
| Submitter: | Stryker Leibinger | |||
| 4100 East Milham Avenue | ||||
| Kalamazoo, MI 49001 | ||||
| 269-323-4226 | ||||
| Submitter's Registration #: | 1811755 | |||
| Manufacturer's Registration #: | 8010177 | |||
| Contact Person: | Wade T. Rutkoskie | |||
| Associate Manager RA QA | ||||
| Phone: 269-323-4226 | ||||
| Fax: 269-323-4215 |
Intended Use
The Stryker Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.
Substantial Equivalence
EQUIVALENT PRODUCTS:
The Stryker Leibinger Cranial Fixation System is substantially equivalent to the Leibinger Quik Disk Titanium Clamp System (K993990), Aesculap Craniofix Titanium Clamp System (K972332), the Synthes Cranial Flap Twist Clamp (K991860) and the Walter Lorenz RapidFlap Cranial Clamp (K991029).
Wude T. Rutterskiel
Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Mr. Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49087
Re: K030378
Trade/Device Name: Stryker® Leibinger Cranial Fixation System Regulation Number: 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: February 4, 2003 Received: February 5, 2003
Dear Mr. Rutkoskie:
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. Iisting 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.
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.
2
Page 2 - Mr. Wade T. Rutkoskie
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 (301) 594-4659. 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,
R. Mark N. Millham
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):___
Device Name: Stryker® Leibinger Cranial Fixation System
Indication For Use:
The Stryker® Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.
KO.303
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Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-The-Counter Use Or
(Optional Format 1-2-96)
for Mark N. Milkerson
(Di
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510(k) Nun