(122 days)
Not Found
No
The document describes a system of physical implants and instruments for cranial fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for reconstruction, stabilization, and rigid fixation of bony areas, which are structural and mechanical functions, not therapeutic.
No
The device is intended for reconstruction, stabilization, and rigid fixation of bony areas after cranial procedures, not for diagnosing medical conditions.
No
The device description explicitly states it comprises an aluminum module housing plates, meshes, screws, and instrumentation, which are physical hardware components.
Based on the provided information, the Stryker Universal Neuro 3 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures". This describes a surgical procedure involving the implantation of medical devices into the body.
- Device Description: The device comprises "plates, meshes, screws and instrumentation needed to fixate cranial bone flaps". These are surgical implants and instruments.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Stryker Universal Neuro 3 System is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy. craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXR and HBW
Device Description
The Stryker Universal Neuro 3 System comprises of an aluminum module which houses a comprehensive selection of plates, meshes, screws and instrumentation needed to fixate cranial bone flaps. Currently, all devices are provided non-sterile and require cleaning and sterilization prior to implantation. All implants (plates and screws) are single use devices whereas all instruments except for drills (screwdriver handle, blade) can be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures
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)
Various verification and validation activities were performed based on results of the risk analysis to demonstrate that the design outputs of the modified device meets the design input requirements. Activities included - Sterilization to ensure a sterility assurance level of 10° Residual, Pyrogenicity and Cytotoxicity testing to assure reliable cleaning of the devices; Packaging and sealing validation to assure that sterility is maintained throughout shelf life taking into account shipping stresses and lastly, MRI compatibility to study displacement force, torque, artifacts and heating under magnetic resonance environment.
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
K131775 Stryker Universal Neuro 3 System
stryker
750 Trade Centre Way ் செய்வில் பல்கலைக்கு கொண்டுள்ளது.
Portage, MI 490002
1: 269 324 5346 (: 877 648 7114
1: 269 324 5346 (: 877 648 7114
100W 2018 5346 (: 1269 324 5346 1
510(k) Summary of Safety and Effectiveness:
| Stryker Universal Neuro 3 System | OCT 17 2013 | |
|---|---|---|
| -- | ---------------------------------- | ------------- |
| Proprietary Name: | Stryker Universal Neuro 3 System |
|---|---|
| Common Name: | Neuro Plating System |
| Classification Name and Reference: | Preformed alterable cranioplasty plate |
- 21 CFR §882.5320
Burr hole cover - 21 CFR §882.5250
Cranioplasty plate fastener - 21 CFR §882.5360 |
| Regulatory Class: | Class II |
| Device Product Code(s): | GWO, GXR and HBW |
| Predicate devices: | 1. Stryker Universal Neuro 3 System
(K112557)
- Stryker QuikFlap Sterile Procedure Pack
(K120352) |
| 510(k) Contact Person: | Manish Patel
Stryker Craniomaxillofacial
750 Trade Centre Way, Suite 200
Portage, MI 49002
Phone: 269-389-4271
Fax: 877-648-7114
manish.patel@stryker.com |
| Date Prepared: | June 14, 2013 |
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1
Traditional 510(k)
Introduction:
This Special 510(k) is being submitted to the U.S. FDA to grant clearance to market the Stryker Universal Neuro 3 System cleared via K 1 12557 with the proposed modifications.
Proposed Modifications:
The only modifications to the existing Stryker Universal Neuro 3 system are:
- し、 Change in sterility and packaging to offer the existing cleared implants in a sterile fashion in addition to the current non-sterile version.
-
- J Addition of MRI conditional statement to the IFU of the device.
Intended Use:
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy. craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Device Description:
The Stryker Universal Neuro 3 System comprises of an aluminum module which houses a comprehensive selection of plates, meshes, screws and instrumentation needed to fixate cranial bone flaps. Currently, all devices are provided non-sterile and require cleaning and sterilization prior to implantation. All implants (plates and screws) are single use devices whereas all instruments except for drills (screwdriver handle, blade) can be reused.
Technological Characteristics:
The subject Stryker Universal Neuro 3 System when provided sterile with MRI conditional statement, will have the exact same design as its predicate version. Both subject and predicate devices will offer the same set of plates and screws in same dimensional specifications. There will be no change in material compositions as well. All plates and screws will be fabricated from commercially pure grades of titanium.
2
Summary of Performance testing:
Various verification and validation activities were performed based on results of the risk analysis to demonstrate that the design outputs of the modified device meets the design input requirements. Activities included - Sterilization to ensure a sterility assurance level of 10° Residual, Pyrogenicity and Cytotoxicity testing to assure reliable cleaning of the devices; Packaging and sealing validation to assure that sterility is maintained throughout shelf life taking into account shipping stresses and lastly, MRI compatibility to study displacement force, torque, artifacts and heating under magnetic resonance environment.
3
Image /page/3/Picture/0 description: The image contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The image is a simple black and white image.
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
Stryker Craniomaxillofacial Mr. Manish Patel Senior Regulatory Compliance Analyst 750 Trade Centre Way, Suite 200 Portage, MI 49002
Re: K131775
Trade/Device Name: Stryker Universal Neuro 3 System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: July 18, 2013 Received: July 19, 2013
Dear Mr. Patel:
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
4
Page 2 - Mr. Manish Patel
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Joyce MWhang -S
Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131775
Device Name: Stryker Universal Neuro 3 System
Indications For Use:
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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