(105 days)
No
The summary describes a computer-assisted surgical navigation system that uses optical tracking and pre-operative imaging for guidance. There is no mention of AI or ML in the intended use, device description, or performance studies. The software functions described are related to planning, registration, and navigation based on established algorithms, not learning or adaptive processes.
No
Explanation: The device is a surgical navigation system and its accessories, intended to assist surgeons with planning and guidance during spinal and pelvic procedures, rather than directly providing therapy.
No
The device is described as a planning and intraoperative guidance system for computer-assisted surgery, assisting in the positioning of instruments during spinal procedures. It does not provide a diagnosis of a patient's medical condition.
No
The device description explicitly states that the system is comprised of a platform (computer, camera, monitor, IO Tablet), navigated instruments (trackers, pointers), and accessories, in addition to the software. This indicates significant hardware components are part of the medical device.
Based on the provided information, the Stryker Navigation System and its accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Intended Use: The intended use of the Stryker Navigation System and its accessories is for planning and intraoperative guidance during surgery. It assists surgeons in positioning instruments relative to anatomical structures using medical images.
- Device Description: The device description details a system comprised of hardware (computer, camera, monitor, tablet), software, and navigated instruments (trackers, pointers, clamps, drill guides, awl taps, serrato taps). These components are used for surgical navigation and instrument guidance, not for testing biological samples.
- Lack of Mention of Biological Samples: There is no mention of the device being used to analyze or test any biological samples from the patient.
The Stryker Navigation System is clearly described as a surgical navigation and guidance system used during surgical procedures, which falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system 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 rigid anatomical structure such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including: - Screw Placement in the spine, ilium, or pelvis
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, 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.
The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set may be used as part of the Stryker 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.
The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps 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.
The Navigated Xia 3 Awl Taps are intended for use with the Rotation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps may be used as part of the Stryker 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.
The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Stryker Navigation System with the SpineMap® 3D 3.1 software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using wireless optical tracking technology and displaying the position of navigated surgical instruments relative to medical images such as CT images.
The Stryker Navigation System with SpineMap 3D 3.1 software is comprised of a platform, SpineMap 3D software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to medical images, such as a CT image. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap 3D 3.1 software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery also required when a battery powered navigated instrument or calibration device is used.
The SpineMap 3D 3.1 software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap 3D 3.1 software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i, NAV3, and NavSuite3.
SpineMap 3D 3.1 is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for planning, patient registration, and instrument navigation. It also guides the user through the preoperative and intraoperative workflow process.
The SpineMap 3D 3.1 Software Application provides new features including improved patient registration with non-Hounsfield calibrated imaging devices, updated screw database that includes new Stryker Spine spinal implant screws, an updated Coordinate Engine to improve the visibility of the nGenius Universal Tracker when used on the Rotational Navigation Adapter, implements an Automatic Intraoperative Mask (AIM) Registration fallback workflow to allow the surgeon to identify LEDs when the automatic LED detection for AIM registration fails due to poor image quality or when using non-Hounsfield calibrated systems, implements a new indirect vector calibration workflow to calibrate the new Navigated Drill Guides, and implements new cybersecurity measures.
The nGenius Spine Clamps are manual surgical instruments that are intended to be used in spine surgery to attach a patient tracker to the lumbar or thoracic spinous processes to enable surgical navigation. They are intended to be accessories to the Stryker Spine Navigation System. The nGenius Spine Clamps are available in two different sizes (i.e., short and long). They can be used in open or percutaneous procedures. The nGenius Spine Clamps are compatible with the nGenius Universal Tracker and the Spine Tracker.
The OrthoLock is a manual surgical instrument intended to be used to anchor a patient tracker. It is an anchoring system that is used to anchor a patient tracker during computer assisted orthopedic, trauma, and spinal surgeries. It can be used with the Stryker Orthopedic, Trauma, and Spine Navigation Systems.
The OrthoLock anchoring system is intended to be used with the Stryker Navigation Pins and OrthoLock Ex-Pins. It can be tightened or loosened with the screwdriver or Universal Joint Screwdriver.
The OrthoLock Indications for Use are being updated as part of this Traditional 510(k) to allow them to be used during spinal surgical procedures.
The Navigated Drill Guide Set consists of short and long Navigated Drill Guides, short and long Navigated Drill Guide Calibrators, short and long Navigated Drill Bits, a Navigated Drill Bit Stop, and a Navigated Drill Guide Set Container (class 1 exempt). The instruments of the Navigated Drill Guide Set are intended to be used with the Stryker Navigation System with the SpineMap 3D 3.1 software application.
The Navigated Drill Guides are manual instruments that are intended to provide guidance during drilling. They can be used in open or percutaneous procedures. The Navigated Drill Guides can be used as accessories to the Stryker Spine Navigation System. The Navigated Drill Guides can be navigated using the nGenius Universal Tracker as an instrument tracker.
The Navigated Drill Guides are available in two sizes (i.e., short and long). The Navigated Short Drill Guide is intended for use with the Navigated Short Drill Bits and in spine surgical procedures on the cervical, thoracic, and lumbar spine. The Long Navigated Drill Guide is intended for use with the Long Navigated Drill Bits and in spine surgical procedures on the cervical, thoracic and lumbar spine.
The Navigated Drill Guides can be calibrated using the Navigated Drill Guide Calibrators. Calibration of the Navigated Drill Guides has been incorporated into the SpineMap 3D 3.1 software application workflow. The Navigated Drill Guides can also be calibrated using the Vector Calibration Device (VCD) or the Point Calibration Device (PCD).
The Navigated Drill Guide Calibrators are manual instruments that are intended to be used to calibrate the Navigated Drill Guides when used with the SpineMap 3D 3.1 software in combination with the Point Calibration Device or Vector Calibration Device. The Navigated Drill Guide Calibrators come in short and long lengths and are intended to be used with the corresponding Navigated Drill Guide. They are not intended to be used for calibrating the Navigated Drill Guides when they are not being used with Navigation.
The Navigated Drill Guide Calibrator cannot be navigated.
The Navigated Drill Bits are manual instruments that are intended to drill holes of a specified diameter. They drill non-threaded holes. They are designed for use with the Navigated Drill Bit Stop. While the design is based on the Xia CT Drill Bits, they are not designed to be used exclusively with any Stryker Spine Implant System.
The short and long Navigated Drill bits come in a variety of sizes. They must be used with a handle and are designed to be used with Stryker Spine's Short Quick Release Handle (class 1, exempt) and Quick Release Handles (class 1, exempt) which have previously been released to market as Class 1, exempt devices.
The Navigated Drill Bits are single-use only. They will be provided non-sterile, but will need to be sterilized prior to use.
The Navigated Drill Bits cannot be navigated and can be used during non-navigated spine surgical procedures.
The Navigated Drill Bit Stop is a manual instrument that is intended for use with the short and long Navigated Drill Bits. The Navigated Drill Bit Stop allows the drilling depth of the Navigated Drill Bits to be controlled by pre-setting the drill depth. The Navigated Drill Bit Stop cannot be navigated.
The Navigated Xia 3 Awl Taps are manual surgical instruments intended to facilitate placement of Stryker Spine implants. They are a combination of an awl and a tap. The Awl Taps have an awl tip that includes a range of tap diameter sizes with thread designs that are only compatible with bone screws from Stryker Spine's Xia 3, Xia 4.5 (not including Xia Bone CT), ES2, MANTIS, and MANTIS Redux implant systems.
The Navigated Xia 3 Awl Taps are intended as accessories to the Stryker Spine Navigation System. The Awl Taps are designed for use with the Rotational Navigation Adaptor when used for navigated spinal procedures. The Navigated Xia 3 Awl Taps can be used with the Navigated Xia 3 Round Ratchet Handle, Navigated Xia 3 Ratchet T-Handle, and the Navigated Mantis Short Ratchet T-Handle, which have previously received market clearance via letter to file for both navigated and non-navigated spine surgical procedures.
The Serrato Navigated Taps are manual surgical instruments intended to facilitate placement of Stryker Spine's Xia 3 - Serrato screw implants. They have a dual-lead thread geometry and come in a variety of diameter sizes. The thread profile is designed to match that of the Serrato screw implants which is critical in achieving a rigid bone fixation. The Xia 3 Serrato Navigated Taps have a color-anodized titanium ring that corresponds to a specific diameter size for each tap.
The Navigated Xia 3 Serrato Taps are intended as accessories to the Stryker Spine Navigation System. They are designed for use with the Rotational Navigation Adaptor when being used for navigated spinal procedures. The Navigated Xia 3 Serrato Taps are designed to be used with a Modular Handle (Class 1, exempt) if used for non-navigated surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CTA, MR, MRA, PET
Anatomical Site
pelvis, spine, ilium, lumbar spinous processes, thoracic spinous processes, cervical spine, thoracic spine, lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room (OR)
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)
The subject devices were validated with intended users in cadaver labs or simulated use tests to ensure the user needs and intended use requirements were met. All requirements were met and no new issues of safety or effectiveness were raised.
Accuracy testing: The System is designed to work in the working space with a mean accuracy of 2 mm point and 2 degrees angular axis displacement within the registration zone. The 95th percentile of the point displacement is
§ 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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
October 18, 2017
Stryker Corporation Andrea Wallen-Gerding Principal Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, DE D-79111
Re: K172034
Trade/Device Name: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock. nGenius Spine Clamp. Navigated Drill Guide Set. Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 22, 2017 Received: September 26, 2017
Dear Andrea Wallen-Gerding:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE) 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 (DICE) 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.
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172034
Device Name
Stryker Navigation System with SpineMap® 3D software application
Indications for Use (Describe)
The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system 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 rigid anatomical structure such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including: - Screw Placement in the spine, ilium, or pelvis
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known) K172034
Device Name OrthoLock
Indications for Use (Describe)
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172034
Device Name nGenius Spine Clamp
Indications for Use (Describe)
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172034
Device Name Navigated Drill Guide Set
Indications for Use (Describe)
The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set may be used as part of the Stryker 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172034
Device Name Navigated Xia 3 Awl Tap
Indications for Use (Describe)
The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps 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.
The Navigated Xia 3 Awl Taps are intended for use with the Rotation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172034
Device Name Navigated Xia 3 Serrato Taps
Indications for Use (Describe)
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps may be used as part of the Stryker 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.
The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
6.0 Submitter Information
This Premarket Notification is submitted by: 6.1
Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany
Contact Information 6.2
| Contact Name: | Andrea N. Wallen-Gerding |
|---|---|
| Office Telephone: | (269) 389-2884 |
| Fax: | (269) 389-5412 |
| Email: | andrea.wallengerding@stryker.com |
| Date Prepared: | June 26, 2017 |
6.3 Device Name
Table 6-1: Device Name
| Subject (Modified) Device Information | |
|---|---|
| Trade/ Proprietary Name | Stryker Navigation System with SpineMap 3D software |
| application, OrthoLock, nGenius Spine Clamp, Navigated Drill | |
| guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato | |
| Tap | |
| Common Name | Spine Navigation System, Anchoring Device, Navigated Drill |
| Guide, Navigated Drill Guide Calibrator, Navigated Drill | |
| Bits, Navigated Drill Bit Stop, Navigated Awl Tap, | |
| Navigated Tap | |
| Classification | Class II |
| Classification Product Code | OLO |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Classification Regulation | 21 CFR 882.4560 |
| Review Panel | Orthopedic |
Predicate Devices 6.4
The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k):
9
| Subject Device | Predicate Device
Trade Name | 510(k) | Product
Code | Manufacturer |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------|----------------------------------------|
| Stryker Navigation
System with the
SpineMap 3D
Software
Application | Stryker SpineMap
3D Navigation
System | K141941 | OLO | Stryker Leibinger
GmbH & Co. KG |
| nGenius Spine
Clamp | Percutaneous Spine
Clamp | K012380 | HAW | Stryker Leibinger
GmbH & Co. KG |
| OrthoLock | OrthoLock | K162341 | OLO | Stryker Leibinger
GmbH & Co. KG |
| Navigated Drill
Guide | OASYS Adjustable
Drill Guide | N/A - Class 1,
510(k) exempt | LXH | Stryker Corporation
(Stryker Spine) |
| Navigated Drill
Guide Calibrator | N/A - The Navigated Drill Guide Calibrators are designed specifically for use
with the Navigated Drill Guides when they are being calibrated as part of the
SpineMap 3D 3.1 software workflow | | | |
| Navigated Drill
Bits | Predicate for Handle
Connection:
OASYS Drill Bits | N/A - Class 1,
510(k) exempt | LXH | Stryker Corporation
(Stryker Spine) |
| | Predicate for Cutting
Flute Design:
Xia CT Drill Bit | N/A - Class 1,
510(k) exempt | LXH | Stryker Corporation
(Stryker Spine) |
| Navigated Drill Bit
Stop | Xia 4.5 Refresh
Locking Knob | N/A - Class 1,
510(k) exempt | LXH | Stryker Corporation
(Stryker Spine) |
| Navigated Xia 3
Awl Tap | Predicate for Awl
Design:
Navigated Xia 3 Awl
Predicate for Tap
Design:
Navigated Xia 3
Taps | Letter to File,
K012380 | OLO | Stryker Corporation
(Stryker Spine) |
| Navigated Xia 3
Serrato Taps | Navigated Xia 3
Tap | Letter to File,
K012380 | OLO | Stryker Corporation
(Stryker Spine) |
| Table 6-2: Predicate Device List | ||
|---|---|---|
Device Descriptions 6.5
6.5.1 Stryker Navigation System with the SpineMap 3D 3.1 Software Application Overview
The Stryker Navigation System with the SpineMap® 3D 3.1 software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon
10
in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using wireless optical tracking technology and displaying the position of navigated surgical instruments relative to medical images such as CT images.
The Stryker Navigation System with SpineMap 3D 3.1 software is comprised of a platform, SpineMap 3D software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to medical images, such as a CT image. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap 3D 3.1 software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery also required when a battery powered navigated instrument or calibration device is used.
6.5.2 SpineMap 3D 3.1 Software Application
The SpineMap 3D 3.1 software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap 3D 3.1 software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i, NAV3, and NavSuite3.
SpineMap 3D 3.1 is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for planning, patient registration, and instrument navigation. It also guides the user through the preoperative and intraoperative workflow process.
The SpineMap 3D 3.1 Software Application provides new features including improved patient registration with non-Hounsfield calibrated imaging devices, updated screw database that includes new Stryker Spine spinal implant screws, an updated Coordinate Engine to improve the visibility of the nGenius Universal Tracker when used on the Rotational Navigation Adapter, implements an Automatic Intraoperative Mask (AIM) Registration fallback workflow to allow the surgeon to identify LEDs when the automatic LED detection for AIM registration fails due to poor image quality or when using non-Hounsfield calibrated systems, implements a new indirect vector calibration workflow to calibrate the new Navigated Drill Guides, and implements new cybersecurity measures.
6.5.3 nGenius Spine Clamps
The nGenius Spine Clamps are manual surgical instruments that are intended to be used in spine surgery to attach a patient tracker to the lumbar or thoracic spinous processes to enable surgical navigation. They are intended to be accessories to the Stryker Spine Navigation System. The nGenius Spine Clamps are available in two different sizes (i.e., short and
11
long). They can be used in open or percutaneous procedures. The nGenius Spine Clamps are compatible with the nGenius Universal Tracker and the Spine Tracker.
OrthoLock 6.5.4
The OrthoLock is a manual surgical instrument intended to be used to anchor a patient tracker. It is an anchoring system that is used to anchor a patient tracker during computer assisted orthopedic, trauma, and spinal surgeries. It can be used with the Stryker Orthopedic, Trauma, and Spine Navigation Systems.
The OrthoLock anchoring system is intended to be used with the Stryker Navigation Pins and OrthoLock Ex-Pins. It can be tightened or loosened with the screwdriver or Universal Joint Screwdriver.
The OrthoLock Indications for Use are being updated as part of this Traditional 510(k) to allow them to be used during spinal surgical procedures.
6.5.5 Navigated Drill Guide Set
The Navigated Drill Guide Set consists of short and long Navigated Drill Guides, short and long Navigated Drill Guide Calibrators, short and long Navigated Drill Bits, a Navigated Drill Bit Stop, and a Navigated Drill Guide Set Container (class 1 exempt). The instruments of the Navigated Drill Guide Set are intended to be used with the Stryker Navigation System with the SpineMap 3D 3.1 software application.
Descriptions of the instruments that comprise the Navigated Drill Guide Set are included below.
6.5.5.1 Navigated Drill Guides
The Navigated Drill Guides are manual instruments that are intended to provide guidance during drilling. They can be used in open or percutaneous procedures. The Navigated Drill Guides can be used as accessories to the Stryker Spine Navigation System. The Navigated Drill Guides can be navigated using the nGenius Universal Tracker as an instrument tracker.
The Navigated Drill Guides are available in two sizes (i.e., short and long). The Navigated Short Drill Guide is intended for use with the Navigated Short Drill Bits and in spine surgical procedures on the cervical, thoracic, and lumbar spine. The Long Navigated Drill Guide is intended for use with the Long Navigated Drill Bits and in spine surgical procedures on the cervical, thoracic and lumbar spine.
The Navigated Drill Guides can be calibrated using the Navigated Drill Guide Calibrators. Calibration of the Navigated Drill Guides has been incorporated into the SpineMap 3D 3.1 software application workflow. The Navigated Drill Guides can also be
12
calibrated using the Vector Calibration Device (VCD) or the Point Calibration Device (PCD).
- 6.5.5.2 Navigated Drill Guide Calibrators
The Navigated Drill Guide Calibrators are manual instruments that are intended to be used to calibrate the Navigated Drill Guides when used with the SpineMap 3D 3.1 software in combination with the Point Calibration Device or Vector Calibration Device. The Navigated Drill Guide Calibrators come in short and long lengths and are intended to be used with the corresponding Navigated Drill Guide. They are not intended to be used for calibrating the Navigated Drill Guides when they are not being used with Navigation.
The Navigated Drill Guide Calibrator cannot be navigated.
- 6.5.5.3 Navigated Drill Bits
The Navigated Drill Bits are manual instruments that are intended to drill holes of a specified diameter. They drill non-threaded holes. They are designed for use with the Navigated Drill Bit Stop. While the design is based on the Xia CT Drill Bits, they are not designed to be used exclusively with any Stryker Spine Implant System.
The short and long Navigated Drill bits come in a variety of sizes. They must be used with a handle and are designed to be used with Stryker Spine's Short Quick Release Handle (class 1, exempt) and Quick Release Handles (class 1, exempt) which have previously been released to market as Class 1, exempt devices.
The Navigated Drill Bits are single-use only. They will be provided non-sterile, but will need to be sterilized prior to use.
The Navigated Drill Bits cannot be navigated and can be used during non-navigated spine surgical procedures.
6.5.5.4 Navigated Drill Bit Stop
The Navigated Drill Bit Stop is a manual instrument that is intended for use with the short and long Navigated Drill Bits. The Navigated Drill Bit Stop allows the drilling depth of the Navigated Drill Bits to be controlled by pre-setting the drill depth. The Navigated Drill Bit Stop cannot be navigated.
6.5.6 Navigated Xia 3 Awl Taps
The Navigated Xia 3 Awl Taps are manual surgical instruments intended to facilitate placement of Stryker Spine implants. They are a combination of an awl and a tap. The Awl Taps have an awl tip that includes a range of tap diameter sizes with thread designs that are only compatible with bone screws from Stryker Spine's Xia 3, Xia 4.5 (not including Xia Bone CT), ES2, MANTIS, and MANTIS Redux implant systems.
13
The Navigated Xia 3 Awl Taps are intended as accessories to the Stryker Spine Navigation System. The Awl Taps are designed for use with the Rotational Navigation Adaptor when used for navigated spinal procedures. The Navigated Xia 3 Awl Taps can be used with the Navigated Xia 3 Round Ratchet Handle, Navigated Xia 3 Ratchet T-Handle, and the Navigated Mantis Short Ratchet T-Handle, which have previously received market clearance via letter to file for both navigated and non-navigated spine surgical procedures.
Navigated Xia 3 Serrato Taps 6.5.7
The Serrato Navigated Taps are manual surgical instruments intended to facilitate placement of Stryker Spine's Xia 3 - Serrato screw implants. They have a dual-lead thread geometry and come in a variety of diameter sizes. The thread profile is designed to match that of the Serrato screw implants which is critical in achieving a rigid bone fixation. The Xia 3 Serrato Navigated Taps have a color-anodized titanium ring that corresponds to a specific diameter size for each tap.
The Navigated Xia 3 Serrato Taps are intended as accessories to the Stryker Spine Navigation System. They are designed for use with the Rotational Navigation Adaptor when being used for navigated spinal procedures. The Navigated Xia 3 Serrato Taps are designed to be used with a Modular Handle (Class 1, exempt) if used for non-navigated surgical procedures.
6.6 Indications for Use
6.6.1 Stryker Navigation System with the SpineMap 3D 3.1 Software Application
The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system 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 such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
- Screw Placement in the spine, ilium, or pelvis ●
6.6.2 nGenius Spine Clamps
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can
14
be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
6.6.3 OrthoLock
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
6.6.4 Navigated Drill Guide Set
The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set 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.
6.6.5 Navigated Xia 3 Awl Taps
The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps 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.
The Navigated Xia 3 Awl Taps are intended for use with Rotational Navigation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
6.6.6 Navigated Xia 3 Serrato Taps
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps 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
15
system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
Comparison of Technological Characteristics 6.7
A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in the tables below.
6.7.1 Technological Comparison between the Stryker Navigation System with SpineMap 3D 3.1 Software and the Stryker SpineMap 3D Navigation System
The technological comparison between the subject device. Stryker Navigation System with SpineMap 3D 3.1 software application, and the predicate device (Stryker SpineMap 3D Navigation System) is included in Table 6-3 below. The Stryker SpineMap 3D Navigation System received 510(k) clearance per 510(k) number K141941.
| Table 6-3: Technological Comparison between Stryker Navigation System with SpineMap 3D 3.1 | ||||
|---|---|---|---|---|
| software application (Subject Device) and the Predicate Device |
| Item | Subject Device:
Stryker Navigation System with
SpineMap 3D 3.1 Software Application | Predicate Device:
Stryker SpineMap 3D 3.0 Navigation
System (141941) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Stryker Navigation System, when
used with the SpineMap® 3D software
application, is intended as a planning and
intraoperative guidance system to enable
open or percutaneous computer assisted
surgery. | The Stryker SpineMap® 3D Navigation
System, when used with a Stryker
computer workstation, is intended as a
planning and intraoperative guidance
system to enable open or percutaneous
computer assisted surgery. |
| Indications for
Use | The system 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 such as the
pelvis or spine can be identified. | The system 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. |
| | The system assists in the positioning of
instruments for procedures on the pelvis
and spine, including:
•
Screw Placement in the spine,
ilium, or pelvis | The Stryker SpineMap® 3D Navigation
system assists in precise positioning of
instruments for procedures on the spine,
including:
•
Pedicle screw placement |
| Main System
Components | • Platform
• SpineMap 3D 3.1 Software
Application
• Navigated Instruments
• Accessories | • Platform
• SpineMap 3D 3.0 Software
Application
• Navigated Instruments
• Accessories |
| Item | Subject Device:
Stryker Navigation System with
SpineMap 3D 3.1 Software Application | Predicate Device:
Stryker SpineMap 3D 3.0 Navigation
System (141941) |
| Modes of
Operation | Patient Preparation System Set-up Image Import Planning Patient Registration Navigation | Patient Preparation System Set-up Image Import Planning Patient Registration Navigation |
| Localizing and
Tracking
Technology | Infrared optical active sensing
technology: Infrared light emitted by
diodes placed in specific locations on
navigated surgical instruments is sensed
by a camera array (navigation camera) on
the platform, which allows for
computation of the spatial information | Infrared optical active sensing
technology: Infrared light emitted by
diodes placed in specific locations on
navigated surgical instruments is sensed
by a camera array (navigation camera)
on the platform, which allows for
computation of the spatial information |
| Operating
Principle | The software is installed on the
computer that is part of the platform Images are imported in DICOM
format The software displays the images and
planned items with navigational
information on a monitor | The software is installed on the
computer that is part of the platform Images are imported in DICOM
format The software displays the images
and planned items with navigational
information on a monitor |
| System
Accuracy | The system has a mean accuracy of 2 mm
for positional displacement and 2° for
trajectory angle displacement. Accuracy
values apply to tracking in the workspace. | Mean navigation accuracy of ± 2mm
point (tip) displacement and ± 2°
angular axis displacement |
| Supported
Imaging
Modalities | CT CTA MR MRA PET | CT CTA MR MRA PET |
| Planning
Features | Screws Measurements Planes Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions | Screws Measurements Planes Annotation Points Trajectories Segmentations Anatomical Systems Correlation 3D Models Compositions |
| Registration
Features | Anatomical Registration 3D C-Arm Registration | Anatomical Registration 3D C-Arm Registration |
| | Subject Device: | Predicate Device: |
| Item | Stryker Navigation System with
SpineMap 3D 3.1 Software Application | Stryker SpineMap 3D 3.0 Navigation
System (141941) |
| | Automatic Intraoperative Mask (AIM)
Registration which includes the AIM
Fallback Workflow | Automatic Intraoperative Mask
(AIM) Registration |
| Energy Source | Main Power: Alternating Current (AC)
power supply, 100/240 V and 50/60
Hz
Off-the-Shelf uninterruptable power
supply for power interruptions ≤ 6
minutes | Main Power: Alternating Current
(AC) power supply, 100/240 V and
50/60 Hz
Off-the-Shelf uninterruptable power
supply for power interruptions ≤ 6
minutes |
| Intended Use
Environment | Operating Room (OR) | Operating Room (OR) |
| Input | Analog Video Input (AVI) | Analog Video Input (AVI) |
| Output | 3D image,
Anatomic orthogonal images,
Analog video image (e.g., endoscopy,
target guidance image) | 3D image,
Anatomic orthogonal images,
Analog video image (e.g.,
endoscopy, target guidance image) |
| User Interface | Monitor with resolution display screen
Virtual keyboard
Mouse
IO Tablet with touch screen, USB
ports, and CD/DVD drive
Buttons on Navigated Instruments | Monitor with resolution display
screen
Virtual keyboard
Mouse
IO Tablet with touch screen, USB
ports, and CD/DVD drive
Buttons on Navigated Instruments |
| Camera
Working
Space | 1.25 m (meters) | 1.25 m (meters) |
16
17
6.7.2 Technological Comparison between the SpineMap 3D 3.1 Software and the Stryker SpineMap 3D 3.0 Software
The technological comparison between the subject device software (SpineMap 3D 3.1 software) and the predicate device (SpineMap 3D 3.0) is included in Table 6-4 below. The SpineMap 3D 3.0 software received 510(k) clearance per 510(k) number K141941.
Table 6-4: Technological Comparison between SpineMap 3D 3.1 software (Subject Device) and the Predicate Device Software
| Item | Subject Device:
SpineMap 3D 3.1 Software | Predicate Device:
SpineMap 3D 3.0 (141941) |
|------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Computer
Operating System | • Windows XP Embedded (SPC 3.0 -
Stryker Personal Computer)
• Windows 8.1 (SPC 3.1) | • Windows XP Embedded (SPC 3.0 -
Stryker Personal Computer)
• Windows 8.1 (SPC 3.1) |
18
| Item | Subject Device:
SpineMap 3D 3.1 Software | Predicate Device:
SpineMap 3D 3.0 (141941) |
|------------------|---------------------------------------------|-----------------------------------------------|
| | • Off-the-Shelf Service Pack 3 | • Off-the-Shelf Service Pack 3 |
| Software Version | 3.1-8/008 | 3.0-45/046 |
6.7.3 Technological Comparison of the Navigated Instruments with their Predicate Devices
The nGenius Spine Clamps are intended to be used to fixate a patient tracker during a navigated spine surgical procedure. The Navigated Drill Guide Set is intended to be used to provide guidance while drilling during a navigated surgical spine procedures. The Navigated Xia 3 Awl Taps are intended to be used to facilitate placement of Stryker Spine spinal implants. The Xia 3 Serrato Taps are intended to be used to facilitate the placement of screws of the Stryker Spine Xia 3 System - Serrato using a Stryker Spine Navigation System.
The nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, and the Navigated Xia 3 Serrato Taps have similar designs to their predicate devices and incorporate the same design features that allow them to be used for navigated spine surgical procedures.
There are no changes to the design of the OrthoLock. The only change is to the Indications for Use for it to allow use with Stryker Spine Navigation Systems.
The modifications to the instruments described in this Traditional 510(k) do not adversely impact the technological characteristics of the predicate devices. A detailed comparison to the predicate devices can be found in Section 13 (Substantial Equivalence) of this Traditional 510(k).
Summary of Non-Clinical Testing 6.8
- 6.8.1 The function and performance of the subject devices (Stryker Navigation System with SpineMap 3D 3.1 software application, OrthoLock, nGenius Spine Clamps, Navigated Drill Guide Set, Navigated Xia 3 Awl Taps, and Navigated Xia 3 Serrato Taps) have been evaluated through non-clinical design verification and validation testing. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use.
- 6.8.2 Additional testing was performed on the subject devices to ensure the subject devices met their design requirements. A summary of the testing and the results are included in the table below.
| Item | Summary of Testing |
|---|---|
| Intended Use/ User Needs | The subject devices were validated with intended users in cadaver |
| labs or simulated use tests to ensure the user needs and intended use | |
| requirements were met. All requirements were met and no new issues | |
| of safety or effectiveness were raised. |
19
| Item | Summary of Testing | ||
|---|---|---|---|
| Accuracy | The System is designed to work in the working space with a mean | ||
| accuracy of 2 mm point and 2º angular axis displacement within the | |||
| registration zone. The 95th percentile of the point displacement is ≤ 3 | |||
| mm and ≤ 3° for angular axis displacement within the registration | |||
| zone. | |||
| Positional displacement (mm) | Trajectory angle displacement (degrees) | ||
| 99th Percentile | 2.70 | 1.07 | |
| Mean | 1.07 | 0.61 | |
| Standard Deviation | 0.50 | 0.12 | |
| 99 % Confidence Interval Upper Bound | 2.26 | 0.88 | |
| Safety | Verified the effectiveness of all risk controls determined in the device | ||
| risk analysis. No new issues of safety or effectiveness were raised. | |||
| General Requirements and | |||
| Performance | Verified all components against their design specifications. All | ||
| requirements were met and no new issues of safety or effectiveness | |||
| were raised. | |||
| Software | Software verification and validation testing was conducted as required | ||
| by IEC 62304 and FDA guidance on general principles of software | |||
| validation, January 11, 2002. All requirements were met and no new | |||
| issues of safety or effectiveness were raised. | |||
| Biocompatibility | The biocompatibility of all patient contact materials was verified | ||
| according to ISO 10993-1:2009 and FDA draft guidance on the use of | |||
| ISO 10993-1, June 16, 2016. No new issues of safety or effectiveness | |||
| were raised. | |||
| Electrical Safety | Verified conformance to ANSI/AAMI ES60601-1:2005/ (R)2012, | ||
| AND C1:2009 AND A2:2010(R)2012 | |||
| Electromagnetic Compatibility | Verified conformance to IEC 60601-1-2: 2007 +AC: 2010, CISPR 11 | ||
| Group 1, Class B requirements as well as additional testing to verify | |||
| compatibility with RFID devices operating in the 125 - 134 kHz | |||
| frequency band. | |||
| Shipping | The functionality of the devices after simulated shipping conditions | ||
| was verified. No new issues of safety or effectiveness were raised. | |||
| Sterilization | The reusable subject devices underwent a steam sterilization | ||
| validation to demonstrate that they can be expected to be sterile and | |||
| have a sterility assurance level (SAL) of 10-6 or greater after | |||
| processing. All requirements were met and no new issues of safety or | |||
| effectiveness were raised. |
Summary of Clinical Testing 6.9
No clinical testing was performed.
20
6.10 Conclusion
The subject devices, Stryker Navigation System with SpineMap 3D 3.1 software application, OrthoLock, nGenius Spine Clamps, Navigated Drill Guide Set, Navigated Xia 3 Awl Taps, and Navigated Xia 3 Serrato Taps, perform as intended and are substantially equivalent to their respective predicate device with respect to intended use, design, principles of operation, technology, materials, and performance. No new issues of safety or effectiveness have been raised.