(105 days)
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system.
This document is a 510(k) summary for the Stryker® Leibinger Universal Neuro System, a medical device for craniofacial fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, many of the requested items related to a study design and performance metrics cannot be found in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or a table reporting device performance against such criteria are provided in the document. The submission is a 510(k) premarket notification, which primarily seeks to establish substantial equivalence to existing legally marketed devices, rather than performing a de novo effectiveness study with pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical or performance test set with a sample size. The substantial equivalence argument relies on comparison to predicate devices, not data from a new test set.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. Ground truth establishment by experts is relevant for studies where a new device's output is compared to a diagnostic or measurement standard. This 510(k) focuses on mechanical properties and intended use comparison.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned or implied because this is a mechanical fixation system, not a diagnostic imaging or AI-assisted system.
6. Standalone Performance Study (Algorithm Only)
No. This is a system of physical plates and screws, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" as typically applied to diagnostic or AI studies is not relevant here. The evidence for substantial equivalence would likely involve bench testing of mechanical properties (e.g., strength, fatigue) and material biocompatibility, comparing them to the predicate devices. These specific tests and their results are not detailed in this summary.
8. Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Summary of Device Comparison and Substantial Equivalence:
The core of this 510(k) submission is to demonstrate substantial equivalence to existing devices, specifically:
- K022185 Universal CMF System
- K924138 Osteomed M 3 System
- K023260 Osteomed 1.2 mm Autodrive Screw System
- K022012 Synthes Low Profile Neuro System
The argument for substantial equivalence is based on the device's intended use (osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas), which is consistent with the predicate devices. The "low-profile plate and screw system" description also implies similar design and mechanism of action to the predicates. The FDA's letter (K031659) confirms that they reviewed the submission and determined the device to be substantially equivalent for the stated indications for use. This means the FDA concluded that the new device is as safe and effective as the legally marketed predicate devices, and does not raise different questions of safety and effectiveness.
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K03/659
SEP. 1 0 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Leibinger Universal Neuro System
General Information
| Proprietary Name: | Stryker® Leibinger Universal Neuro System |
|---|---|
| Common Name: | Bone PlatesBone Fixation Fasteners |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 76 JEY87 HWC |
| Submitter: | Stryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. RutkoskieAssociate Manager RA QAPhone: 269-323-4226Fax: 269-323-4215 |
| Summary Preparation Date: | May 20, 2003 |
Intended Use
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction.
Substantial Equivalency Information
The Stryker® Leibinger Universal Neuro System is substantially equivalent to legally marketed K022185 Universal CMF System, K924138 Osteomed M 3 System, K023260 Osteomed 1.2 mm Autodrive Screw System, and K022012 Synthes Low Profile Neuro System.
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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" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K031659
Trade/Device Name: Sryker® Leibinger Universal Neuro System Bone Plates and Bone Fixation Fasteners Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 20, 2003 Received: June 17, 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, 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.
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Page 2 - Mr. Rutkoskie
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 (301) 594-4613. 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,
Susan Runs
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): K031659
Device Name: Stryker® Leibinger Universal Neuro System
Indication for Use:
The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.
Kein Mulvey for MSA
y, General Hospital, n of Anesthesiolo ion Control, Den
510(k) Number: K031659
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (per 21 CFR 801.109) |
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.