ROSA Spine

K151511 · Medtech S.A · OLO · Jan 4, 2016 · Neurology

Device Facts

• Record ID: K151511
• Device Name: ROSA Spine
• Applicant: Medtech S.A
• Product Code: OLO · Neurology
• Decision Date: Jan 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach

Device Story

ROSA Spine is a computer-controlled electromechanical arm providing robotic guidance for neurosurgical instruments during spine surgery. Input consists of 3D CT scan data; surgeon defines surgical plan (entry point, target, trajectory) using integrated ROSANNA SPINE software. System uses absolute encoders on robot joints and an optical infrared camera for patient registration and real-time tracking. Device is used in the operating room by neurosurgeons or orthopedic surgeons. The robot arm positions an instrument guide according to the pre-operative plan; surgeon performs the final surgical gesture through the guide. Provides stable, accurate, and reproducible mechanical guidance; assists in precise placement of pedicle screws. Benefits include improved accuracy and reproducibility of instrument positioning compared to manual techniques.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (accuracy/repeatability per ASTM F2554-10). Simulated clinical environment testing on cadaveric specimens was performed to evaluate safety and effectiveness.

Technological Characteristics

Electromechanical robotic arm with absolute encoders and optical infrared tracking system. Class 2 laser (635 nm, 1 mW). DICOM compliant. Software-controlled kinematic transformation between Cartesian and joint space. Mobile stand with stabilization feet. Sterilization via disposable sterile drapes. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for surgeons performing pedicle screw placement in lumbar vertebrae via posterior approach using 3D CT-based intra-operative planning.

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

• ROSA Surgical Device (K101797)
• StealthStation System (K133444)

Submission Summary (Full Text)

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

January 4, 2016

Medtech S.A. Ms. Colette Maurin Regulatory Affairs Director ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, Lamguedoc-Rousillon FRANCE

Re: K151511

Trade/Device Name: ROSA Spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2015 Received: December 16, 2015

Dear Ms. Maurin:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.

### TRADITIONAL 510(K) PREMARKET NOTIFICATION ROSA SPINE

Page 7/63

### 4 - INDICATIONS FOR USE

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) K151511

Device Name ROSA Spine

#### Indications for Use (Describe)

The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach

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.

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FORM FDA 3881 (8/14)

PSC Publishing Jhevines (1005/903-163-676) (16)

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Image /page/3/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

# 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

#### I SUBMITTER

Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel [phone] Fax [phone]

Contact Person: Colette Maurin Regulatory Affairs Director [e-mail]

Date prepared: December 31, 2015

#### II DEVICE

Name of device: ROSA Spine Common Name: Computer-assisted surgical device Classification name: Stereotaxic Instrument (21CFR 882.4560) Regulatory class: II Code product: OLO

# III PREDICATE DEVICE

ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010

StealthStation System, manufactured by Medtronic Navigation Inc., K133444, cleared July 25, 2014

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#### IV DEVICE DESCRIPTION

ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.

ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.

Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.

ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.

#### V INDICATIONS FOR USE

ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool quides to be used by surgeons to quide standard neurosurgical instruments during spine surgery.

Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans.

The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach

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Image /page/5/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.

#### VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| | Predicate Devices | | Subject Device | | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Device | ROSA Surgical Device | StealthStation System | ROSA Spine | | |
| | (K101791) | (K133444) | (Submission subject) | | |
| Device description and indications for use | | | | | |
| Indications for use | Intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. The system is intended to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). Indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate. | Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone or a vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. | ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach | | |
| Where used | Operating room | Operating room | Operating room | | |
| User | Neurosurgeon | Neurosurgeon<br>Orthopedic surgeon | Neurosurgeon<br>Orthopedic surgeon | | |
| General device description | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Navigation system helping the surgeon in manual guidance of navigated neurosurgical instruments | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | | |
| Anatomical site | Head | Head, spine | Spine | | |
| Surgical approach | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | | |
| | | Technology | | | |
| Principle of operation | - Preoperative images;<br>- Surgical planning;<br>- Patient registration;<br>- Guidance of instruments | For Spine application:<br>- Intraoperative images;<br>- Patient registration;<br>- Surgical planning;<br>- Real-time tracking of navigated instruments | - Intraoperative images;<br>- Patient registration;<br>- Surgical planning;<br>- Guidance of instruments;<br>- Real-time tracking of navigated instruments | | |
| Input images | 3D pre-operative exam | 3D pre-operative exam<br>3D intra-operative exam<br>2D intra-operative exam | 3D intra-operative exam | | |
| DICOM compliance | Yes | Yes | Yes | | |
| Integrated planning Software | ROSANNA (Medtech) | Synergy Spine software<br>(Medtronic) | ROSANNA SPINE (Medtech) | | |
| Save/load planning | Yes | Yes | Yes | | |
| Merge images functionality | Yes | Yes | Yes | | |

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Image /page/6/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.

| | Predicate Devices | | Subject Device |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Device | ROSA Surgical Device<br>(K101791) | StealthStation System<br>(K133444) | ROSA Spine<br>(Submission subject) |
| Trajectory<br>planning<br>parameters | Entry point, target point,<br>length of the instrument,<br>diameter | Entry point, target point, length<br>of the instrument, diameter | Entry point, target point, length<br>of the instrument, diameter |
| Localization<br>means | Robot arm absolute<br>encoders | Optical system (infrared<br>camera)<br>or electromagnetic system | Robot arm absolute encoders<br>+ optical system (infrared<br>camera) |
| Image-guided | Yes | Yes | Yes |
| Controller | Axis controller for each joint<br>Kinematic transformation<br>between the Cartesian<br>space and joint space<br>Supervisor module | No controller -<br>The instrument is manually<br>positioned by the surgeon | Axis controller for each joint<br>Kinematic transformation<br>between the Cartesian space<br>and joint space<br>Supervisor module |
| Patient<br>registration<br>method | Fiducial markers (skin)<br>Optical registration device | Point-to-point registration with<br>anatomical markers | 3D registration with X-Ray<br>pattern containing radio-opaque<br>markers |
| Accuracy<br>verification on<br>anatomical<br>landmarks | Yes (probe, laser beam) | Yes (probe) | Yes (probe) |
| Laser class for<br>optical system | Class 2 laser<br>Wavelength - 650 nm,<br>Maximum output - 1 mW<br>(complies with 21 CFR<br>1040.10) | Class 2 laser<br>Wavelength - 635 nm,<br>Maximum output - 1 mW<br>(complies with 21 CFR<br>1040.10) | Class 2 laser<br>Wavelength - 635 nm,<br>Maximum output - 1 mW<br>(complies with 21 CFR<br>1040.10) |
| Real time<br>display of the<br>instrument<br>position | Yes | Yes | Yes |
| Provide<br>guidance for<br>instruments | Yes - Instruments are<br>mounted onto the robot<br>arm. The guidance is<br>robotized. | No - The instrument is manually<br>positioned by the surgeon. | Yes - Instruments are mounted<br>onto the robot arm. The<br>guidance is robotized. |
| Surgeon<br>carries out the<br>final gesture | Yes - through the<br>instrument guide | Yes - the surgeon holds the<br>instrument | Yes - through the instrument<br>guide |
| Instrument | Instrument holder,<br>endoscope holder and<br>adaptors, optical sensor | Navigated instruments | Instrument holder, cannula,<br>adaptors, navigated<br>instruments |
| Instrument<br>calibration<br>method | Factory calibration | Factory calibration | Factory calibration |
| Associated<br>equipment | 3D imaging system<br>● Fiducial markers<br>● Head holder<br>● Endoscope<br>● Stereovision system<br>● 3D visualization<br>● headset<br>● Light source | 3D/2D imaging system<br>● Retro-reflective sterile<br>● spheres<br>● Implants and<br>instrumentation | 3D imaging system<br>● Retro-reflective sterile<br>● spheres<br>● Implants and<br>instrumentation |
| Patient<br>immobilization | Yes - The device is<br>attached to the head holder<br>via an adaptor. | No - a reference is fixed in the<br>patient's iliac crest or clamped<br>on the patient's spinous for<br>tracking system | No - a reference is fixed in the<br>patient's iliac crest for tracking<br>system |
| Device<br>mobility | Yes - mobile stand with<br>wheels, immobilized with<br>stabilization feet | Yes - mobile stands with<br>wheels; Stands immobilized<br>with wheels brakes | Yes - mobile stands with<br>wheels; Robot stand<br>immobilized with stabilization |

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Image /page/7/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

| | Predicate Devices | | Subject Device |
|-------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Device | ROSA Surgical Device<br>(K101791) | StealthStation System<br>(K133444) | ROSA Spine<br>(Submission subject)<br>feet and camera stand<br>immobilized with wheels brakes |
| Sterility | Non-sterile and sterile<br>instruments<br>Disposable sterile drapes<br>on device | Non-sterile and sterile<br>instruments<br>Disposable sterile drapes on<br>device | Non-sterile and sterile<br>instruments<br>Disposable sterile drapes on<br>device |
| Power supply | 110 V | 115 V | 115 V |
| Footprint | Robot stand ≈ 91cm × 66cm | Surgeon cart ≈ 60cm x 63cm<br>Staff cart ≈ 58cm x 61cm | Robot stand ≈ 121cm × 65cm<br>Camera stand ≈ 81cm x 76cm |
| Performance | | | |
| - Robot<br>absolute<br>accuracy<br>- Robot<br>repeatability | < 0.75 mm<br>< 0.10 mm | Not applicable | < 0.75 mm<br>< 0.10 mm |
| Guidance<br>application<br>accuracy | < 2.00 mm | Not applicable | < 2.00 mm |
| Navigation<br>accuracy | Not applicable | < 2.00 mm | < 1.50 mm |

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Image /page/8/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and expertise.

#### PERFORMANCE DATA VII

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing

The biocompatibility evaluation for ROSA Spine device has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met by the ROSA Spine device.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on ROSA Spine. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

# Device performance Testing

Device performance tests were performed to validate the absolute accuracy and repeatability of the robot arm, the application accuracy of the device, and the navigation accuracy according to ASTM F2554-10

Testing were conducted on cadaveric specimens in a simulated clinical environment to evaluate the device safety and effectiveness (clinical performance).

# Software Verification and Validation Testing

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern, since a failure of the software could result in serious injury or death to the patient.

Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:

- . Code walkthroughs
- Unit test reports ●
- . Integration test reports
- . System test reports
- Overall software test report .
- Verification test reports
- Overall software verification report ●

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Image /page/9/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirements according to the Software Verification Plan. Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA Spine device.

# Animal study

The 510(k) does not contain animal study test results for the ROSA Spine.

# Clinical Studies

The 510(k) does not contain clinical information for the ROSA Spine.

# VIII CONCLUSIONS

The non-clinical data support the safety of the device and the verification and validation demonstrate that the ROSA Spine device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the ROSA Spine device performs comparably to the predicate devices that are currently marketed for the same intended use.