(160 days)
Not Found
No
The description focuses on the physical properties and instrumentation of a mesh implant, with no mention of AI or ML capabilities.
No
The device is described as an implant used for reconstruction and stabilization of cranial structures, not for treating a disease or condition.
No
The device is a non-diagnostic medical implant (mesh) used for reconstruction and stabilization of cranial bones, not for identifying the presence or nature of a disease or condition.
No
The device description clearly states it consists of mesh implants and associated physical instruments for modification and fixation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstruction and stabilization of the cranial skeleton. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a mesh implant designed to be physically placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).
Product codes (comma separated list FDA assigned to the subject device)
GWO
Device Description
The Stryker Universal Mesh consists of mesh implants in different shapes, thicknesses and perforation patterns which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh implants and Hybrid Mesh implants. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for three-dimensional adaptations. The necessary instrumentation for mesh modification, Mesh Cutter (coarse), Mesh Step Bender, and the Mesh Clipper are included with the system. The Stryker Universal Mesh implants are provided nonsterile and are for single use only. The instrumentation and storage system is reusable.
Also, the mesh can be fixated to the bone with screws available in previously marketed Stryker CMF implant systems. The previously marketed screws are not specifically packaged with the subject device, but the implant tray of the Universal Mesh Storage system contains space to store the screw disc if that option is chosen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial skeleton
Indicated Patient Age Range
adults and adolescents (age 12 and higher)
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)
Biocompatibility Testing
The biocompatibility evaluation for the Stryker Universal Mesh system was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests supported the biocompatibility of the device.
The implant is made from titanium which conforms to ASTM F67 for chemical composition, the same as the predicate. Cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Chemical residual analysis was conducted according to validated methods with results that met the established acceptance criteria. These tests support the biocompatibility of the device.
Performance Testing
- Life time reprocessing: Verify the reprocessing life of the Subject device, instruments, and storage container are according to internal standard. Results: Internal Acceptance Criteria.
- Cleaning Validation: Verify the cleaning process for Subject device, instruments and storage container are according to recommendations in ISO 17664, AAMI TIR 30, and AAMI TIR 12. Results: Method validated.
- Sterilization Validation: Validate the sterilization instructions for the Subject device, instruments, and storage container are according to internal standard. Referenced standards: ISO 14937, ISO 17664, ISO 17665 - 1&2, AAMI TIR 12, AAMI ST 81, AAMI ST79. Results: Method validated.
- Mechanical performance Testing: Static Load Test and Dynamic Load Test. Results: Acceptance criterion were met, tests were passed.
- Corrosion Testing: Verify corrosion behavior of Subject device, instruments, and storage device. Results: Acceptance criterion was met, test was passed.
- MR Compatibility: Magnetic Resonance (MR) testing was performed on the subject device mesh implants in accordance with FDA draft guidance for industry "Assessment of Radiofrequency - Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices," June 29, 2015. MR heat testing has been performed on the Subject device according to FDA final guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014. Results: Based on the results of these evaluations, the Stryker Universal mesh will be labeled as MR conditional.
The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.
Animal Testing: Animal testing was not required as a basis for substantial equivalence.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, with three human profiles forming the staff and a cloth draped around the base.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2016
Stryker Craniomaxillofacial Mr. Jonathan Schell Sr. Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, MI 49002
Re: K161821
Trade/Device Name: Stryker Universal Mesh Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: November 4, 2016 Received: November 7, 2016
Dear Mr. Schell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161821
Device Name Stryker Universal Mesh
Indications for Use (Describe)
The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).
| Type of Use (Select one or both, as applicable) |
|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- SUBMITTER [§807.92(a)(1)] I.
| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG |
|---|---|
| Boetzinger Strasse 41 | |
| 79111 Freiburg, Germany |
- Submitter/ Contact Jonathan Schell Person: Sr. Regulatory Affairs Specialist Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-5596 Fax: 877-648-7114
- Date prepared: November 4, 2016
II. DEVICE [§807.92(a)(2)]
| Trade Name: | Stryker Universal Mesh |
|---|---|
| Common or Usual | |
| name: | Bone Plate |
| Classification | |
| name: | Preformed Alterable Cranioplasty Plate; 21 CFR 882.5320 |
| Regulatory Class: | Class II |
| Product Code: | GWO |
| Classification | |
| Panel: | Neurology |
PREDICATE DEVICE [§807.92(a)(3)] III.
Universal CMF System – K022185
4
IV. DEVICE DESCRIPTION [§807.92(a)(4)]
The Stryker Universal Mesh consists of mesh implants in different shapes, thicknesses and perforation patterns which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh implants and Hybrid Mesh implants. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for three-dimensional adaptations. The necessary instrumentation for mesh modification, Mesh Cutter (coarse), Mesh Step Bender, and the Mesh Clipper are included with the system. The Stryker Universal Mesh implants are provided nonsterile and are for single use only. The instrumentation and storage system is reusable.
Also, the mesh can be fixated to the bone with screws available in previously marketed Stryker CMF implant systems. The previously marketed screws are not specifically packaged with the subject device, but the implant tray of the Universal Mesh Storage system contains space to store the screw disc if that option is chosen.
INDICATIONS FOR USE [§807.92(a)(5 )] V.
| Subject Device | Predicate - K022185 | |
|---|---|---|
| Indications for | ||
| Use | The Universal Mesh is indicated for | |
| reconstruction, stabilization and/or | ||
| rigid fixation subsequent to | ||
| craniotomy, craniectomy, | ||
| cranioplasty, and cranial fractures in | ||
| adults and adolescents (age 12 and | ||
| higher). | The Stryker Leibinger Universal | |
| CMF System is a Cranio- | ||
| maxillofacial (CMF) plate and screw | ||
| system intended for osteotomy, | ||
| stabilization and rigid fixation of | ||
| CMF fractures and reconstruction. |
TABLE 1: COMPARISON OF INDICATIONS FOR USE
The predicate device is indicated for use in a range of anatomic areas (cranial, craniofacial skeleton, mid-face, maxilla, mandible) for a variety of surgical applications (craniofacial surgery, reconstructive procedures). The Indications for Use statement of the Stryker Universal Mesh falls within the scope of the broader Indications statement of the predicate device. Additionally, the Subject device is intended to be used in adolescent patients 12 years of age and older. The differences in the Indications statement for the proposed device in comparison to the predicate does not constitute a new intended use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE [§807.92(a)(6)]
5
The Stryker Universal Mesh is compared to its predicate devices for substantial equivalence based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The Stryker Universal Mesh implants are designed for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. The necessary instrumentation and product storage are included with the system.
B. Technological and Operational Characteristics
-Substantial Equivalence of the Subject devices and Predicate devices are based on the following technological elements:
| Feature | Stryker Universal Mesh | Universal CMF System
K022185 | Explanation of Differences |
|--------------------------------------------------------|-----------------------------------|---------------------------------|----------------------------|
| | Subject Device | Predicate Device | |
| Sterility: End
User Sterilized | X | X | Same |
| Sizing | | | |
| Shape | Square, partly with rounded edges | Square | Similar |
| Sizes | 40x40mm
to
200x200mm | 40x40mm
to
200x200m | Similar |
| Implant
Thickness | 0.3mm -
0.8mm | 0.3mm -
0.6mm | Similar |
| Design | | | |
| 2-dimensional
(2D) | X | X | Same |
| Mode of
Fixation | | | |
| 1.2mm - 1.7mm
screws | X | X | Same |
| Material | | | |
| Titanium:
Commercially
pure titanium
ASTM F67 | X | X | Same |
Overall these changes do not alter the Subject device significantly and it does not represent a new worst case in design.
Strvk
6
VII. PERFORMANCE DATA [§807.92(b)(1)]
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Stryker Universal Mesh system was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests supported the biocompatibility of the device.
The implant is made from titanium which conforms to ASTM F67 for chemical composition, the same as the predicate. Cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Chemical residual analysis was conducted according to validated methods with results that met the established acceptance criteria. These tests support the biocompatibility of the device.
Performance Testing
| Test | Test Method Summary | Results |
|---|---|---|
| Life time | ||
| reprocessing | Verify the reprocessing life of the Subject device, instruments, and storage | |
| container are according to internal standard. | Internal Acceptance | |
| Criteria | ||
| Cleaning | ||
| Validation | Verify the cleaning process for Subject device, instruments and storage | |
| container are according to recommendations in ISO 17664, AAMI TIR 30, | ||
| and AAMI TIR 12. | Method validated. | |
| Sterilization | ||
| Validation | Validate the sterilization instructions for the Subject device, instruments, | |
| and storage container are according to internal standard. Referenced | ||
| standards: ISO 14937, ISO 17664, ISO 17665 - 1&2, AAMI TIR 12, | ||
| AAMI ST 81, AAMI ST79. | Method validated. | |
| Mechanical | ||
| performance | ||
| Testing | Static Load Test and Dynamic Load Test | Acceptance criterion |
| were met, tests were | ||
| passed. | ||
| Corrosion | ||
| Testing | Verify corrosion behavior of Subject device, instruments, and storage | |
| device. | Acceptance criterion | |
| was met, test was | ||
| passed. | ||
| MR | ||
| Compatibility | Magnetic Resonance (MR) testing was performed on the subject device | |
| mesh implants in accordance with FDA draft guidance for industry | ||
| "Assessment of Radiofrequency - Induced Heating in the Magnetic | ||
| Resonance (MR) Environment for Multi-Configuration Passive Medical | Based on the results of | |
| these evaluations, the | ||
| Stryker Universal mesh | ||
| will be labeled as MR |
The following performance tests were completed:
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Image /page/7/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is black and appears to be a logo. A small circled letter 'c' is present to the upper right of the word.
| Devices," June 29, 2015. MR heat testing has been performed on the
Subject device according to FDA final guidance "Establishing Safety and
Compatibility of Passive Implants in the Magnetic Resonance (MR)
| Environment," December 11, 2014. | conditional. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------- |
The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing [§807.92(b)(2)]
Clinical testing was not required as a basis for substantial equivalence.
VIII. CONCLUSIONS [§807.92(b)(3)]
The results of the non-clinical data demonstrate the Stryker Universal Mesh will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.92 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.