(260 days)
No
The document describes a manual surgical instrument used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is not described in enough detail to determine if it uses AI/ML.
No
The device is described as a "manual surgical instrument" and a "tool for bone screw placement, insertion, and removal," intended to facilitate the placement of spinal implants. It does not directly treat or cure a medical condition but rather aids in a surgical procedure, making it an accessory rather than a therapeutic device itself.
No
The device is a manual surgical instrument intended for bone screw placement during spine surgery, used in conjunction with a navigation system for guidance, not for diagnosing medical conditions.
No
The device is described as a "manual surgical instrument" and a "manual tool for bone screw placement, insertion, and removal," indicating it is a physical hardware device. While it is used with navigation software, the device itself is not software-only.
Based on the provided information, the Stryker Xia 4.5 Polyaxial Screwdriver is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that it is a "manual surgical instrument" used in spine surgery to facilitate the placement of implants. This is an in vivo application (within a living organism), not an in vitro application (testing outside the body, typically on biological samples).
- Device Description: The description reinforces its function as a "manual tool for bone screw placement, insertion, and removal," which is a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing conditions based on test results, or any of the typical functions associated with IVD devices.
Therefore, the Stryker Xia 4.5 Polyaxial Screwdriver is a surgical instrument used during a medical procedure, not a device for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.
Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.
Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.
The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.
Product codes (comma separated list FDA assigned to the subject device)
OLO, LXH
Device Description
The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Clinical setting
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)
Simulated Use: Tested the Navigated XIA 4.5 Polyaxial Screwdriver together with the Stryker Spine Navigation System and its components and accessories in a cadaveric setting according to its requirements.
Navigation Accuracy: Verified the navigation accuracy of ± 2 mm and ± 2° of the Navigated XIA 4.5 Polyaxial Screwdriver by verifying its tracking accuracy of (80th percentile
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(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 and 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 a stylized symbol of three human profiles facing right, with flowing lines representing connection and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Leibinger GmbH & Company KG Ms. Becky Ditty Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
September 4, 2015
Re: K143597
Trade/Device Name: Navigated XIA® 4.5 Polyaxial Screwdriver Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 5, 2015 Received: August 7, 2015
Dear Ms. Ditty:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Becky Ditty
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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143597
Device Name Navigated XIA® 4.5 Polyaxial Screwdriver
Indications for Use (Describe)
The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.
Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.
Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.
The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.
| 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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510(k) Summary
This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
Section 5.1 Submitter
| Applicant Name: | Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany
Phone number: +49-761-4512117
Fax number: +49-761-451249117 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 8010177 |
| Name of Contact Person: | Becky Ditty
Sr. Staff Regulatory Affairs Specialist
4100 E. Milham Ave
Kalamazoo, MI 49001
becky.ditty@stryker.com
(269) 389-3434 |
| Date Prepared: | September 4, 2015 |
Section 5.2 Device
| Trade Name: | Navigated XIA® 4.5 Polyaxial Screwdriver | ||||
|---|---|---|---|---|---|
| Common Name: | Navigated Screwdriver | ||||
| Classification | |||||
| Name: | Product | ||||
| Code | Device | Regulation | |||
| Number | Class | Review | |||
| Panel | |||||
| Primary | |||||
| Code | |||||
| OLO | Orthopedic | ||||
| Stereotaxic | |||||
| Instrument | 21 CFR | ||||
| §882.4560 | II | Orthopedic | |||
| Secondary | |||||
| Code: LXH | Orthopedic | ||||
| Manual | |||||
| Surgical | |||||
| Instrument | 21 CFR | ||||
| §882.4540 | I | Orthopedic |
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Section 5.3 Predicate Devices
| Trade Name | Stryker Navigation System –
Spine & Fluoroscopy Module:
Stryker Adapted Smart Manual
Instruments (Primary Predicate) | XIA ® 4.5 Polyaxial Screwdriver |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | K012380 | N/A — Class I/ 510(k) exempt
device |
| Product Code | HAW | LXH |
| Manufacturer | Stryker Leibinger GmbH & Co. KG | Stryker Spine SAS |
These predicate devices have not been subject to a design-related recall.
Section 5.4 Device Description
The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.
Image /page/4/Figure/6 description: The image shows two different views of a navigated XIA 4.5 polyaxial screwdriver. The top view shows the screwdriver with the text "XIA 4.5 SCREWDRIVER" printed on the side. The bottom view shows the screwdriver with labels pointing to the handle, rotational navigation adapter, instrument tracker, shaft, and bone screw. The figure is labeled as "FIGURE 5-1: NAVIGATED XIA 4.5 POLYAXIAL SCREWDRIVER".
FIGURE 5-2: NAVIGATED XIA 4.5 POLYAXIAL SCREWDRIVER ATTACHED TO ROTATION NAVIGATION ADAPTER, INSTRUMENT TRACKER AND HANDLE
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Section 5.5 Indications for Use
The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.
Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.
Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.
Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Navigational Adaptor and associated Trackers to facilitate the placement of the pedicle screws of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.
The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.
Section 5.6 Comparison of Technological Characteristics with the Predicate Device
The Navigated XIA 4.5 Polyaxial Screwdriver (subject device) and the predicate devices are intended to be used during the preparation and placement of Stryker Spine screws during spinal surgery, including insertion and removal of bone screws.
The subject and predicate devices have similar technologies, such that the devices interface with a handle and have a tip that the user inserts into the screw head to turn it.
Additionally, the subject device and the Stryker Adapted Smart Manual Instruments predicate device are both designed to interface with Stryker Navigation Systems via the previously cleared Stryker Spine Navigation System accessories: the Rotational Navigation Adapter (K012380) and an Instrument Tracker (K141941). The
6
attachment of the Rotational Navigation Adapter and Instrument Tracker to the instrument allows for the localization and navigation of the manual surgical instruments and thus the technology is not included in the subject device itself.
The subject device includes minor design changes as compared to the predicate devices. The main change is a longer shaft to enable the attachment of the Rotational Navigation Adapter; however the subject device also has a modified locking mechanism, and can interface with a wider range of handles.
The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the Stryker Spine Navigation Systems. None of the changes identified affect how the spinal screw is placed or removed. The navigation of the manual instrument is not performed by the instrument itself, but by previously cleared Stryker Spine Navigation System accessories. The accuracy testing provided demonstrates that the Stryker Spine Navigation System accessories (Rotational Navigation Adapter and Instrument Tracker) can be sufficiently connected to the Navigated XIA 4.5 Polyaxial Screwdriver such that the accuracy requirements of the Stryker Spine Navigation System can be achieved.
Section 5.7 Performance Data
The following performance data were provided in support of the substantial equivalence decision:
| Test | Description |
|---|---|
| Simulated Use | Tested the Navigated XIA 4.5 Polyaxial Screwdriver together with the |
| Stryker Spine Navigation System and its components and accessories in a | |
| cadaveric setting according to its requirements. | |
| Navigation Accuracy | Verified the navigation accuracy of $\pm$ 2 mm and $\pm$ 2° of the Navigated XIA |
| 4.5 Polyaxial Screwdriver by verifying its tracking accuracy of (80th | |
| percentile |