(29 days)
No
The 510(k) summary describes a system of bone plates and screws and focuses on sterile packaging configurations. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is described as a system of bone plates and screws for reconstruction and rigid fixation, not for delivering therapy.
No.
The device is described as a system of bone plates and screws intended for "reconstruction and/or rigid fixation of non loadbearing bony areas." This describes a therapeutic, rather than a diagnostic, purpose. The "Intended Use" section clearly states its role in reconstruction and fixation, not in identifying diseases or conditions.
No
The device description explicitly states it consists of "an assortment of different bone plates and screws," which are physical hardware components. The 510(k) is for changes to the sterile packaging of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Stryker Universal Neuro III System clearly state that it is a system of bone plates and screws intended for the reconstruction and rigid fixation of bony areas in the skull. This is a surgical implant used directly on the patient's body, not a test performed on a sample taken from the body.
The information provided focuses on the physical characteristics of the device, its intended surgical application, and performance testing related to packaging and handling, all of which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).
Product codes (comma separated list FDA assigned to the subject device)
HBW
Device Description
The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:
-
- UN III AXS Screws packed in sterile procedure packs, and
-
- UN III AXS Screws packed in a sterile screw cartridge.
The specific devices included are:
| Description | Packaging Configuration Type |
|---|---|
| 2-Hole Plate Set, SD Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, ST Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, Low Profile with Tab | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 20mm Set | UN III AXS Sterile Procedure Pack |
| Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| UN III AXS Screw, ST, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x6mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x3mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, Emergency, 1.7x4mm | UN III AXS Sterile Screw Cartridge |
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
Prescription Use
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)
Process Validations:
- . Process Cleaning Validation (Bioburden level, Process residuals, Endotoxin Level)
- . Sealing Validation of seals closing the sterile barrier systems
- . Process Sterilization Validation Gamma Radiation with VDmax25 Cycle .
- A Biocompatibility Assessment was performed.
Performance Bench Testing:
- . Transport safety of product and sterile barrier system including weight and compression test
- . Shelf life and integrity of sterile barrier system .
- . Handling test of overall packaging functionality
- Key Results: The subject device met all pre-defined acceptance criteria. Overall, the results of the performance bench tests support the substantial equivalence of the subject device to the predicate 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.
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
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).
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Public Health Service
Image /page/0/Picture/2 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 of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Stryker Craniomaxillofacial Jonathan Schell Staff Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage. Michigan 49002
Re: K171152
Trade/Device Name: Stryker Universal Neuro III System AXS Screw Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: HBW Dated: April 19, 2017 Received: April 20, 2017
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 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
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171152
Device Name
Stryker Universal Neuro III System AXS Screw
Indications for Use (Describe)
The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is capitalized. A registered trademark symbol is located to the upper right of the word. The word is in black and the background is white.
Section 5. 510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- SUBMITTER I.
| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact
Person: | Jonathan Schell
Staff Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-5596
Fax: 877-648-7114 |
| Date prepared: | May 12, 2017 |
| II.
DEVICE | |
| Trade Name: | Stryker Universal Neuro III System AXS screw |
| Common or Usual
name: | Cranioplasty plate fastener |
| Classification
name: | Cranioplasty Plate Fastener 21 CFR §882.5360 |
| Regulatory Class: | Class II |
| Product Code: | HBW |
PREDICATE DEVICE III.
Predicate: Stryker Universal Neuro III System AXS Screw – K151387 Reference Devices: K120352 Stryker QuikFlap Sterile Procedure Pack, and K131775 Universal Neuro 3 System
4
IV. DEVICE DESCRIPTION
The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:
-
- UN III AXS Screws packed in sterile procedure packs, and
-
- UN III AXS Screws packed in a sterile screw cartridge.
The specific devices included are:
| Description | Packaging Configuration Type |
|---|---|
| 2-Hole Plate Set, SD Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, ST Screw | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate Set, Low Profile with Tab | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| 2-Hole Plate / Burr Hole Cover 20mm Set | UN III AXS Sterile Procedure Pack |
| Burr Hole Cover 14mm Set | UN III AXS Sterile Procedure Pack |
| UN III AXS Screw, ST, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, ST, 1.5x6mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x3mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x4mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, SD, 1.5x5mm | UN III AXS Sterile Screw Cartridge |
| UN III AXS Screw, Emergency, 1.7x4mm | UN III AXS Sterile Screw Cartridge |
V. INDICATIONS FOR USE
The Stryker Universal Neuro III 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).
Offering the AXS screw sterile does not alter the Indications for Use statement for the proposed device. The Indications for Use is identical to the predicate device from the Stryker Universal Neuro III System (K151387).
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The basic operational principle of the UN III AXS screw is unchanged from the predicate and remains the same.
B. Technological Characteristics
The technological characteristics remain the same as the predicate and are unchanged.
VII. PERFORMANCE DATA
In Table 5.1 below, the relevant topics, as given in "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff (2016)," are referenced.
Table 5-1: Reference of testing
| Category A Sterilization Methods –
| Established Method | Gamma Radiation |
|---|---|
| Sterilization Chamber: | Terminally sterilized in final packaging. |
| SAL | SAL 1 x 10-6 for all products |
| Pyrogenicity | Acceptance Criteria met |
| Packaging Description | Sterile Barrier Systems: |
| Procedure Packs: Flexible bag (sealed) | |
| Screws: Blister (sealed) |
Process Validations
Overall the subject device is unchanged and has the same implant material and manufacturing process, and the same duration or location of contact to the patient as the predicate device. The only difference between subject device and predicate device lies in the sterile packaging process required with the two sterile barrier systems referenced above.
6
To evaluate the influence of the changes compared to the predicate device, and based on the Risk Analysis performed on the modification of providing the UN III AXS screw sterile, the following validations were performed and referenced in support of substantial equivalence:
- . Process Cleaning Validation (Bioburden level, Process residuals, Endotoxin Level)
- . Sealing Validation of seals closing the sterile barrier systems
- Process Sterilization Validation Gamma Radiation with VDmax25 Cycle .
A Biocompatibility Assessment was performed to support substantial equivalence respecting the additional manufacturing process steps due to the sterile packaging compared to the predicate device. Substantial equivalence was proven.
Performance Bench Testing
The following performance bench tests were completed and referenced.
- . Transport safety of product and sterile barrier system including weight and compression test
- Shelf life and integrity of sterile barrier system .
- . Handling test of overall packaging functionality
The subject device met all pre-defined acceptance criteria. Overall, the results of the performance bench tests support the substantial equivalence of the subject device to the predicate 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.
VII. CONCLUSIONS
The results of the non-clinical data demonstrate that the modified UN III AXS sterile screws perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.