PREMARKET NOTIFICATION 510(K) SUBMISSION

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.03.07

Silver Spring, MD 20993

www.fda.gov

Medtech S.A. March 22, 2019

Serge Tabet

RA Manager

ZAC Eureka - 900 Rue du Mas de Verchant

Montpellier, 34000 FR

Re: K182848

Trade/Device Name: ROSA ONE Spine application

Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic Instrument

Regulatory Class: Class II

Product Code: OLO

Dated: February 15, 2019

Received: February 21, 2019

Dear Serge Tabet:

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. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. 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 device-related adverse events) (21 CFR 803) for

K182848 - Serge Tabet Page

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)

for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

For;

Mark N. Melkerson

Director

Division of Orthopedic Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

Jesse Muir -S

Page 4 - 2

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 +33 (0)4 67 10 77 40

Fax +33 (0)4 67 59 74 18

Contact Person :

Serge Tabet

Quality & Regulatory Affairs Manager-Zimmer Biomet Robotics

serge.tabet@zimmerbiomet.com

Dated prepared: October 8, 2018

II DEVICE

Name of Device:

Common Name:

Classification Name:

Classification Panel:

Regulatory Class:

Product Code:

ROSA ONE Spine application

Computer-assisted surgical device

Stereotaxic Instrument (21CFR 882.4560)

Orthopaedic

OLO (Spine)

III PREDICATE DEVICES

ROSA SPINE, manufactured by Medtech S.A., K151511, cleared in January 4, 2016

K182848

Page 1 of 8.

IV DEVICE DESCRIPTION

The ROSA One device is a robotized image-guided device that assists the surgeon

during spine surgeries.

It provides guidance of surgical instruments compatible with the diameter of the

adaptors supplied by Medtech. It allows the user to plan the position of instruments or

screws on medical images and provides stable, accurate and reproducible guidance in

accordance with the planning.

The device is composed of two stands positioned around the operating table:

 a robot stand with a compact robot arm and a touchscreen

 a camera stand with an optical navigation system and a touchscreen

Different types of instruments may be attached to the end of the robot arm and

changed according to the intended surgical procedure.

The touchscreen ensures the communication between the device and its user by

indicating the actions to be performed with respect to the procedure.

Adequate guidance of instruments is obtained from three-dimensional calculations

performed from desired surgical planning parameters and registration of spatial position

of the patient.

V INDICATIONS FOR 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 surgical instruments during

spine surgeries.

Guidance is based on an intraoperative 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 intended for the placement of pedicle screws

in vertebrae with a posterior approach in the thoracolumbar region.

K182848, Page 2 of 8.

VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Device

ROSA SPINE

(K151511)

ROSA ONE 3.1

Spine application

(submission subject)

Comparison Analysis

Device description and indications for use

General device description

Computer controlled electromechanical arm

providing guidance of neurosurgical

instruments

Computer controlled electromechanical arm

providing guidance of neurosurgical

instruments

Identical

Indications for 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

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.

The device is intended for the spatial

positioning and orientation of instrument

holders or tool guides to be used by

surgeons to guide standard surgical

instruments during spine surgeries.

Guidance is based on an intraoperative 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

intended for the placement of pedicle

screws in vertebrae with a posterior

approach in the thoracolumbar region.

Identical, the only addition is the

expansion of the Spine

Application to the

thoracolumbar spine

Where used

Operating room

Identical

User

Neurosurgeon

Orthopaedic Surgeon

Neurosurgeon

Orthopaedic Surgeon

Identical

Anatomical site

Spine

Identical

Principle of operation

 Intraoperative images

 Patient registration

 Surgical planning

 Guidance of instruments

 Real-time tracking of navigated

instruments

 Intraoperative images

 Patient registration

 Surgical planning

 Guidance of instruments

 Real-time tracking of navigated

instruments

Identical

Preoperative images & surgical planning

K182848, Page 3 of 8.

Device

ROSA SPINE

(K151511)

ROSA ONE 3.1

Spine application

(submission subject)

Comparison Analysis

Images type

3D intra-operative CT exam

Identical

DICOM compliance

Yes

Identical

Merge images (multimodality

image fusion capability)

Yes

Identical

Integrated planning software

ROSANNA SPINE

(Medtech)

ROSANNA SPINE

(Medtech)

Identical

Trajectory planning

parameters

Entry point, target point, length of the

instrument, diameter

Entry point, target point, length of the

instrument, diameter, name, color

Identical, with addition of name and

color

Save/load planning

Yes

Identical

Patient Registration

Localization means

Robot arm absolute encoders

+ optical system (infrared camera)

Robot arm absolute encoders

+ optical system (infrared camera)

Identical

Controller

Axis controller for each joint

Kinematic transformation between the

Cartesian space and joint space

Supervisor module

Axis controller for each joint

Kinematic transformation between the

Cartesian space and joint space

Supervisor module

Identical

Patient registration methods

 3D registration with X-Ray pattern

containing radio-opaque markers

 3D registration with X-Ray pattern

containing radio-opaque markers

Identical

Laser class for optical

registration

Class 2 laser

Wavelength – 635 nm, Maximum output – 1

mW (complies with 21 CFR 1040.10)

Class 2 laser

Wavelength – 635 nm, Maximum output – 1

mW (complies with 21 CFR 1040.10)

Identical

Cooperative movement

Yes

Identical

Accuracy verification on

anatomical landmarks

Yes

Identical

Instruments guidance

Image-guided

Yes

Identical

K182848, Page 4 of 8.

Device

ROSA SPINE

(K151511)

ROSA ONE 3.1

Spine application

(submission subject)

Comparison Analysis

Real time display of the

instrument position

Yes

Identical

Provide guidance for surgical

instruments

Yes

Identical

Instrument guide position

adjustment

Automatic (robotized)

Identical

Surgeon carries out final

gesture through the

instrument guide with

traditional surgical instrument

Yes – through the instrument guide

Identical

Instrument fixation

Instruments are mounted onto robot arm’s

flange

Instruments are mounted onto robot arm’s

flange

Identical

Instruments

Instrument holder, cannula, adaptors,

navigated instruments

Instrument holder, cannula, adaptors,

navigated instruments

Identical

Instrument calibration method

Factory calibration

Identical

Associated equipment

 3D imaging system

 Retro-reflective sterile spheres

 Implants and instrumentation

 3D imaging system

 Retro-reflective sterile spheres

 Implants and instrumentation

Identical

Patient immobilization

No – A reference is fixed in the patient’s iliac

crest for tracking system.

No – A reference is fixed in the patient’s iliac

crest through percutaneous pin or onto

the patient’s spinous process through

spinous clamp for tracking system.

Identical with the addition of the

Spinous Clamp with Patient

Reference for the use during

thoracolumbar spine

interventions

Device mobility

Yes - Mobile stands with wheels; Robot

stand immobilized with stabilization

feet and camera stand immobilized

with wheels brakes

Yes - Mobile stands with wheels; Robot

stand immobilized with stabilization

feet and camera stand immobilized

with wheels brakes

Identical

Vigilance system

Yes – foot pedal

Identical

Sterility

Non-sterile and sterile instruments

Disposable sterile drapes for the robot arm

and touch screen

Non-sterile and sterile instruments

Disposable sterile drapes for the robot arm

and touch screen

Identical

K182848, Page 5 of 8.

VII PERFORMANCE DATA

The following performance data were provided in support of the substantial

equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the ROSA ONE Spine application has been

conducted in accordance with FDA Guidance Document: Use of International Standard

ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing

within a risk management process.” The evaluation reveals that biocompatibility

requirements are met by the ROSA ONE device.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on ROSA ONE Spine application.

The device complies with recognized electrical safety standards: IEC 60601-1 standard

for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility. The

EMC testing was performed according to the FDA EMC guidance document

“Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-

Powered Medical Devices” issued in July 11, 2016.

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

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 requirement according to the Software Verification Plan.

K182848, Page 6 of 8.

Conformity of software with the user needs and intended use of the device were

performed through the "Validation" phase of the ROSA ONE Spine application .

Cleaning- and Sterilization Validation

MEDTECH has performed an automated cleaning validation according to FDA

Guidance Document Reprocessing of Reusable Medical Devices: Information for

Manufacturers and AAMI TIR 30 Technical report. Additionally, the sterilization

validation was performed according to ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and

AAMI TIR 12 Technical report using two cycles.

In vitro studies

Tests on phantom and cadaver were performed to extend the indication for use to the

thoracic spine.

Animal studies

Data from animal studies were not required to support the safety and effectiveness of

ROSA ONE Spine application.

Clinical Studies

Clinical data were not required to support the safety and effectiveness of ROSA ONE

Spine application. All validation was performed based on non-clinical performance

tests.

VIII SUMMARY OF NON CLINICAL PERFORMANCE TESTING

Test

Test Method Summary

Results

System applicative accuracy

In vitro testing

Performance bench Testing in

compliance with internal

Medtech/Zimmer Biomet

robotics procedures

Testing on the subject device was

performed and demonstrated to be

substantially equivalent to the predicate

device:

 Robot arm positioning accuracy

<0.75 mm RMS

 Device applicative accuracy

<2mm

Electrical safety and

electromagnetic compatibility

(EMC)

Testing in compliance with the

IEC 60601-1:2005/A1:2012 and

IEC 60601-1-2:2014

Evaluation and testing were performed on

the subject device and demonstrated to

be substantially equivalent to the

predicate device.

Biocompatibility testing

Testing in compliance with FDA

Guidance “Use of International

Standard IS10993, Biological

evaluation of medical Devices

Part 1”.

The following non clinical tests were

performed on the predicate device:

Cytotoxicity, Sensitization, Irritation and

Acute systemic toxicity

The subject devices were evaluated

against the predicate testing and

determined to be substantially equivalent.

K182848, Page 7 of 8.

Software Verification and

Validation Testing

Software verification testing in

compliance with FDA guidance

“General Principles of Software

Validation” and IEC 62304:

2006

Evaluation and testing were performed on

the subject device and demonstrated

substantially equivalent performance to

identified predicate device

Cleaning and Sterilization

Validation

Testing in compliance with FDA

Guidance “Reprocessing

Medical Devices in Health Care

Settings: Validation Methods

and Labeling” and the following

standards: ISO 17665-1

Sterilization of health care

products -Moist heat - Part 1:

Requirements for

the Development, Validation

and Routine Control of a

Sterilization Process for Medical

Devices and ISO 17664-

Sterilization of medical devices -

-Information to be provided by

the manufacturer for the

processing of re-sterilizable

medical devices

Evaluation was performed of the subject

device and demonstrated to be

substantially equivalent to the identified

predicate devices.

In vitro studies

Testing in compliance with

internal Medtech/Zimmer

Biomet robotics procedures

The evaluation and tests were performed

on the subject device and demonstrated

the validation of the extension of the

indication for use to thoracic spine.

Animal studies

Not applicable

Clinical Studies

Not applicable

IX CONCLUSIONS

ROSA ONE Spine application is substantially equivalent in design and intended use to

the predicate device – ROSA SPINE (K151511).

Any differences between the subject and predicate devices have no significant

influence on safety or effectiveness as established through performance testing.

Therefore, ROSA ONE Spine application raises no new issues of safety or

effectiveness when compared to the predicate device.

K182848, Page 8 of 8.