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).

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.

AI/ML Overview

This document describes the performance data for the Stryker Universal Neuro III System AXS Screw, specifically regarding the transition to sterile packaging configurations. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, not on validating the performance of an AI algorithm. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Category / Test Type	Acceptance Criteria	Reported Device Performance
Sterilization Methods (Gamma Radiation)	Established Method	Gamma Radiation (Terminally sterilized in final packaging)
Sterility Assurance Level (SAL)	SAL 1 x 10-6 for all products	Met SAL 1 x 10-6 for all products
Pyrogenicity	Acceptance Criteria met	Acceptance Criteria met
Process Cleaning Validation	(Implicit) Bioburden level, process residuals, endotoxin level within acceptable limits.	Performed and referenced in support of substantial equivalence.
Sealing Validation	(Implicit) Integrity and effectiveness of seals for sterile barrier systems.	Performed and referenced in support of substantial equivalence.
Process Sterilization Validation (Gamma Radiation)	(Implicit) VDmax25 Cycle effective for sterilization.	Performed and referenced in support of substantial equivalence.
Biocompatibility Assessment	(Implicit) No adverse biological effects due to additional manufacturing steps for sterile packaging.	Substantial equivalence proven.
Transport safety	(Implicit) Product and sterile barrier system integrity maintained during transport (weight/compression).	Met all pre-defined acceptance criteria.
Shelf-life and integrity of sterile barrier system	(Implicit) Barrier system maintains sterility for defined shelf-life duration.	Met all pre-defined acceptance criteria.
Handling test of overall packaging functionality	(Implicit) Packaging can be safely and effectively handled for its intended purpose.	Met all pre-defined acceptance criteria.

Note: The "acceptance criteria" are often implied as "met" or "proven" in this summary rather than explicitly stated with numerical values, which is common for regulatory submissions demonstrating equivalence to an existing product, especially for changes in manufacturing or packaging.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., sterilization validation, packaging tests). Instead, it states that "validations were performed and referenced."

Data Provenance: The tests were conducted to support the market clearance of a device by Stryker Leibinger GmbH& Co. KG (Germany) for the US market. The nature of these tests (e.g., sterilization, packaging integrity) suggests they are laboratory-based, prospective studies conducted by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not an AI algorithm requiring expert ground truth for its performance. The tests described are engineering and manufacturing validations.

4. Adjudication method for the test set

Not applicable. This is not an AI device requiring diagnostic adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used

Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to established engineering standards, regulatory requirements for sterility, pyrogenicity, biocompatibility, and packaging integrity. For example:

Sterility: Achieved based on a demonstrated SAL of 1 x 10-6.
Biocompatibility: Determined through assessment against ISO standards for medical device biocompatibility.
Packaging Integrity: Evaluated against industry standards for sterile barrier systems (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. This is not an AI device that utilizes a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

Summary

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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

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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)

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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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. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Jonathan SchellStaff Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-5596Fax: 877-648-7114
Date prepared:	May 12, 2017
II.DEVICE
Trade Name:	Stryker Universal Neuro III System AXS screw
Common or Usualname:	Cranioplasty plate fastener
Classificationname:	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

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IV. DEVICE DESCRIPTION

1. UN III AXS Screws packed in sterile procedure packs, and
1. 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.

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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.

Regulation Number and Section

§ 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).