Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

K162929 · Stryker Corporation · HAW · Feb 22, 2017 · Neurology

Device Facts

• Record ID: K162929
• Device Name: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
• Applicant: Stryker Corporation
• Product Code: HAW · Neurology
• Decision Date: Feb 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Stryker Navigation System, with the CranialMap 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 can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The system assists in the positioning of instruments for cranial procedures, including: Cranial bionsies Puncture of abscesses Craniotomies Craniectomies Resection of tumors and other lesions Removal of foreign objects Skull base procedures Transnasal neurosurgical procedures Transphenoidal pituitary surgery Shunt placement, including pediatric shunt placement Placement of electrodes for recording, stimulation and lesion generation Endoscopic Sinus Surgery (ESS) Intranasal procedures Ear implant procedures Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs.

Device Story

Stryker Navigation System provides image-guided planning and intraoperative guidance for cranial surgery. Inputs include preoperative/intraoperative medical images (CT, CTA, MR, MRA, fMRI, PET, SPECT). System uses wireless optical tracking (IR LED) to determine position of navigated instruments relative to patient anatomy. Output is 3D/orthogonal images, target guidance, and microscope injection displayed on a monitor. Used in OR by surgeons/staff. CranialMap Planning software allows preoperative planning on compliant computers. CranialMask Tracker (non-invasive, skin-applied) enables automatic patient registration. System assists in precise instrument positioning, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data required. Verification and validation testing included system-level software verification, accuracy testing, planning software verification, and component-level code verification. CranialMask Tracker evaluated for communication, visibility, flexibility, adhesion, battery life, electrical safety, EMC, biocompatibility, shelf-life, and sterilization. Mean navigation accuracy is 1.11 mm (positional) and 1.02° (trajectory).

Technological Characteristics

Stereotaxic image-guided system. Components: platform (computer, camera, IO-Tablet), software, navigated instruments, accessories. Tracking: active wireless optical (IR LED). Materials: flexible PCB mask, adhesive backing. Power: AC 100/240V, battery for instruments. Connectivity: wireless tracking, USB. Sterilization: EO (mask). Software: Windows 8.1, rule-based navigation/planning algorithms.

Indications for Use

Indicated for patients undergoing open or percutaneous cranial procedures, including biopsies, abscess puncture, craniotomies, craniectomies, tumor/lesion resection, foreign object removal, skull base/transnasal/transphenoidal/craniofacial/skull reconstruction/orbital cavity procedures, shunt placement, electrode placement, ESS, intranasal, and ear implant procedures. Operated by trained surgeons and clinic staff.

Regulatory Classification

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.

Predicate Devices

• CranialMap Neuro (K131214)

Reference Devices

• Stryker SpineMask Tracker (K141941)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2017

Stryker Corporation Brittney Larsen Staff Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttemberg, D-79111 DE

Re: K162929

Trade/Device Name: Stryker Navigation System With Cranialmap Software Application, Stryker Cranialmap Planning Software Application, Stryker Cranialmask Tracker Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 20, 2017 Received: January 23, 2017

Dear Ms. Larsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

### K162929

Device Name

Stryker Navigation System with CranialMap software application

Indications for Use (Describe)

The Stryker Navigation System, with the CranialMap 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 can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff.

The system assists in the positioning of instruments for cranial procedures, including:

- Cranial bionsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures

The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs.

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.

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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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration

## Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

# 510(k) Number (if known)

K162929

Device Name

Stryker CranialMap Planning software application

Indications for Use (Describe)

The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computer-assisted surgery.

The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate.

The software application should be operated only by trained personnel such as surgeons and clinic staff.

This can include the following cranial procedures:

- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures

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.

{5}------------------------------------------------

### 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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |

| Number (if known) | |
|-------------------|--|
|-------------------|--|

# 510(k) N

## K162929

Device Name Stryker CranialMask Tracker

#### Indications for Use (Describe)

The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient's face on top of the skin.

- In combination with preoperative and intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.

- The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial procedures.

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)

### 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 5 of 5

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# 510(K) SUMMARY

| | | | Contact Information |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------|
| 510(k) Submitter | Stryker Leibinger GmbH & Co. KG<br>Bötzinger Straße 41<br>79111 Freiburg, Germany<br>Ph: [phone]<br>Fax: [phone] | | |
| FDA Establishment<br>Registration No. | 8010177 | | |
| Contact Person | Brittney Larsen MS, RAC<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] | | |
| Date Prepared | October 18, 2016 | | |
| | | | Subject Information |
| Trade Name | Stryker Navigation System with CranialMap software application;<br>Stryker CranialMap Planning software application; and<br>Stryker CranialMask Tracker. | | |
| Common Name | Stereotaxic instrument | | |
| Classification | II, non-exempt | | |
| Classification<br>Name and Product<br>Code | Neurological Stereotaxic Instrument<br>(21 CFR 882.4560, Product code HAW) | | |
| | Predicate Information | | |
| 510(k) Number | Product<br>Code | Trade Name | Manufacturer |
| K131214 | HAW | CranialMap Neuro | Stryker Leibinger GmbH<br>& Co. KG |
| | | | Reference Information |
| K141941 | OLO | Stryker SpineMask<br>Tracker | Stryker Leibinger GmbH<br>& Co. KG |

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### Device Description

The devices subject to this Traditional 510(k) are within the Stryker Navigation System with CranialMap software application. Subject devices include the CranialMap software application, CranialMap Planning software application, and CranialMask Tracker.

## System Overview

The Stryker Navigation System with CranialMap software is a computer-assisted, stereotaxic, image-guided, planning and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precise positioning of instrumentation during Cranial surgeries. The system provides intraoperative guidance to the surgeon by displaying the position of navigated surgical instruments relative to the medical images.

The Stryker Navigation System with CranialMap software is comprised of a platform, CranialMap software application, navigated instruments, and accessories. The predicate CranialMap Neuro navigation system includes the same parts. The platform consists of a computer, camera, and IO-Tablet (input/output). The CranialMap software is dedicated for the Cranial procedures as defined in the indications for use and identical to the predicate. Required navigated instruments include: a patient tracker; a pointer, suction tube, or seeker; shunt placement tool, and a frameless guide. A battery is the only required accessory of the system, and is used in the navigated instruments only.

## CranialMap software application

The CranialMap software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The CranialMap software is used with a Stryker platform and interfaces with Stryker navigated instruments and accessories. The software displays the intraoperative location of navigated surgical instruments relative to imported medical images via wireless optical tracking technology. The subject CranialMap software does not provide direct or indirect patient-contact.

CranialMap is an interactive software application, which provides the functions needed to conduct the indicated cranial procedures. The software application implements the methods for planning, patient registration, and instrument navigation. Furthermore, the software guides the user through preoperative and intraoperative workflow steps. The significant changes made to the subject CranialMap software when compared with the predicate include adding planes and mirroring functionalities and adding compatibility with the CranialMask Tracker.

## CranialMap Planning software application

The CranialMap Planning software is an optional accessory to the Stryker Navigation System with CranialMap software application. The CranialMap Planning software application is a standalone software device intended for use on compliant computers as defined in the Safety Information document. It is a new device introduced with this Traditional 510(k).

The subject CranialMap Planning software application is an identical subset of functionality copied from the subject CranialMap software. The planning version serves to preoperatively plan a navigated surgery, outside of the operating room, on a compliant computer. It does not provide registration functionality or surgical navigation guidance,

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and it does not interface with instruments or accessories. The preplanned patient record can only be exported to the Stryker Navigation System with CranialMap software. The subject CranialMap Planning software does not provide direct or indirect patient-contact.

## CranialMask Tracker

The CranialMask Tracker is a non-invasive patient tracker. It is indicated as an optional accessory to the Stryker Navigation System with CranialMap software application. The subject CranialMask Tracker directly contacts the patient skin, which is identical to the predicate Patient Registration Mask.

The CranialMask Tracker includes a flexible printed circuit board (PCB) mask and closed housing unit. It consists of tracking diodes, green status light emitting diode (LED), communication receiver, battery, an on/off switch, and adhesive backing. The electronic components in the communication unit of the CranialMask Tracker are identical to the components used in the reference device, SpineMask Tracker, cleared by K141941.

This Traditional 510(k) requests clearance for changes made to the CranialMap software used with the Stryker Navigation System. It also seeks clearance for the new CranialMap Planning software and CranialMask Tracker devices as optional accessories to the system. Indication for Use

## Stryker Navigation System with CranialMap software application

The Stryker Navigation System, with the CranialMap software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computerassisted 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 can be identified.

The system should be operated only by trained personnel such as surgeons and clinic staff.

The system assists in the positioning of instruments for cranial procedures, including:

- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures

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- Orbital cavity reconstruction procedures

The user should consult the Accuracy section of the Safety Instructions to assess if the accuracy of the system is suitable for their needs.

## CranialMap Planning software application

The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computerassisted surgery.

The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate.

The software application should be operated only by trained personnel such as surgeons and clinic staff.

This can include the following cranial procedures:

- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures

## CranialMask Tracker

The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient's face on top of the skin.

- In combination with preoperative and intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. - The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial procedures.

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| Technological Characteristic Comparison Summary | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Characteristic | Predicate Device (K131214) | Subject Device | |
| Type of Use | Prescription use only | No change | |
| Condition for Use | Single-use (battery only)<br>Reusable | No change | |
| Sterility | Sterile (battery only)<br>Non-sterile | No change | |
| Mode/Mechanism of Action | Image-guided planning and surgery Active wireless optical tracking via infrared (IR) LED signal detection by the camera Instrument tracking relative to patient anatomical images Spatial computation method | No change | |
| Imaging Modalities | Computed tomography (CT) Computed tomography angiography (CTA) Magnetic resonance (MR) Magnetic resonance angiography (MRA) Magnetic resonance imaging (MRI) Functional magnetic resonance imaging (fMRI), including Diffusion Tensor Imaging (DTI) Position emission tomography (PET) Single-photon emission computed tomography (SPECT) | No change | |
| External Power Source | Alternating current (AC) power supply, 100/240V (Volts) and 50/60Hz (Hertz) Off-the-shelf (OTS) uninterruptable power supply (UPS) for power interruptions less than or equal to six (6) minutes | No change | |
| Intended user group | Trained clinical staff | No change | |
| Intended use environment | Operating room (OR) | No change | |
| System Accuracy | Mean navigation accuracy of ±2mm and angular axis displacement of ±2° | No change | |
| Input | Analog video input (AVI) | No change | |
| Output | 3D image, anatomic orthogonal images, endoscopy analog video image, target guidance image, microscope injection | No change | |
| User Interface | Monitor with high resolution display screen Virtual keyboard | No change | |
| Technological Characteristic Comparison Summary | | | |
| Characteristic | Predicate Device (K131214) | Subject Device | |
| Camera Working Space | IO-Tablet with touch screen, USB ports, and CD/DVD drive Buttons on navigated instruments 1.25m (meters) | No change | |
| Computer Operating System | Windows XP Embedded (SPC 3.0) (Stryker Personal Computer) Windows 8.1 (SPC3.1) Off-The-Shelf (OTS) Service Pack 3 | <b>Software</b><br>No subject change. Windows 8.1 was implemented to maintain the latest technology. This change did not exceed the threshold requiring FDA premarket notification as per 21 CFR 807.81(a)(3). Windows XP and OTS service pack 3 remain identical to the predicate. | |
| Software Version | CranialMap software application Version 2.0 | The subject device software version 3.0 was modified, for marketing purposes, in the following manner: 1) addition planes and mirroring functionality, and 2) compatibility with the new CranialMask Tracker. Planes and mirroring offer additional software functionality to users during navigated surgery. The CranialMask Tracker is a new device introduced in this submission and intended as an optional accessory to the Stryker Navigation System with CranialMap software application. | |
| Standalone Software | None | The new CranialMap Planning software is indicated for use with a compliant computer as defined in user documentation. It is identical to the full version CranialMap software, except the registration and navigation features are disabled. It only allows for limited functionality that is within the predicate scope. | |
| Technological Characteristic Comparison Summary | | | |
| Characteristic | Predicate Device (K131214) | Subject Device | |
| Collision Zones | Segments and annotations can be defined Collision check option for segments, annotations, and functional overlays during navigation | No change | |
| Hardware | | | |
| Microscope Navigation Interfaces | Zeiss Pentero Zeiss Pentero 800 Zeiss Pentero 900 Leica M525, Leica M530 Leica M720 | No subject change. External, compatible microscope list updated to add more clarity and due to Zeiss portfolio obsolescence. The microscope and navigation system interface remains identical to the predicate. No software changes were made. This change was made since the predicate clearance, however did not require FDA notification as per 21 CFR 807.81(a)(3). | |
| Required System Components | Platform; Software application; Tracker; Pointer, suction tube, or seeker; Shunt placement tool; Frameless guide; and Battery | No change | |
| Mask Tracker | | | |
| Conditions of use | Flexible mask: single-use<br>Communication unit: Reusable | | |
| Anatomical Location | Patient's face | | |
| Battery | Lithium battery | | |
| Patient-contacting | Yes | No change | |
| Sterility | Sterile | No change | |
| Sterilization method | Ethylene oxide (EO) | No change | |
| Sterility assurance level | 10-6 | No change | |
| Sterilization cycle | Number 45 | No change | |
| | | Single-use.<br>Identical to reference device. | |
| Technological Characteristic Comparison Summary | | | |
| Characteristic | Predicate Device (K131214) | Subject Device<br>Performance Data | |
| | | Nonclinical | |
| The changes subject to this 510(k) include: software modifications to the CranialMap software, and the introduction of the CranialMap Planning software and CranialMask Tracker. Non-clinical verification and validation testing performed with the subject devices focused on the software changes implemented, and evaluated the visibility and communication, flexibility and adhesion, and working battery time performance of the CranialMask Tracker. | | | |
| The software changes have been tested in accordance with the Stryker software development life cycle procedure. Verification and validation testing activities were performed at the software system, integration, and component levels to show sufficient implementation of the changes as per the specifications.<br>Software testing conducted includes:<br>System level software verification; Accuracy testing; Planning software verification with compliant computers; and Component level code verification. | |…