Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image-guided robotic assistance for surgical planning and execution based on pre-operative images and surgeon-defined parameters. There is no mention of AI or ML for image analysis, planning optimization, or real-time adaptation.

Therapeutic

No.
The ROSA BRAIN device assists neurosurgeons by providing guidance for instruments, but it does not directly treat or diagnose a disease or condition; it is a surgical aid.

Diagnostic

No.
The device is a robotized platform that provides guidance for neurosurgical instruments based on pre-operative planning, rather than diagnosing a condition itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "robotized platform providing guidance" and is "composed of a compact robotic arm and a touch screen mounted on a robot stand." This indicates significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the ROSA BRAIN device clearly states its purpose is for the spatial positioning and orientation of surgical instruments during neurosurgical procedures. It guides instruments within the patient's body, not for analyzing samples outside the body.
The device uses pre-operative images (MRI/CT) for planning and provides mechanical guidance. This is a surgical guidance system, not a diagnostic test performed on a biological sample.

The device is a surgical robot intended to assist neurosurgeons in performing procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

Product codes (comma separated list FDA assigned to the subject device)

HAW

Device Description

The ROSA BRAIN device is a robotized platform providing guidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle).

The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed.

The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands.

ROSA BRAIN is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.

An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device.

In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument lenath).

During surgery, the device provides accurate and rigid guidance of the required instrument according to the previously completed planning.

The optical distance sensor used with the ROSA BRAIN is susceptible to Electrostatic Discharge (ESD).

The ROSA BRAIN device is intended to be used with anti-static sterile drapes which are designed for the device and listed in the list of compatible devices. The anti-static sterile drapes are mitigations to ROSA Brain device ESD immunity.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

3D MRI / CT

Anatomical Site

Brain / Head (implied by neurosurgical procedures and patient's head image acquisition)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Neurosurgeon (User), Neurosurgical operating room (Where used)

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)

Biocompatibility testing:

Study Type: Biocompatibility evaluation.
Test Method Summary: 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."
Results: The evaluation reveals that biocompatibility requirements are met by the ROSA BRAIN device. 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.

Electrical safety and electromagnetic compatibility (EMC):

Study Type: Electrical safety and EMC testing.
Test Method Summary: Complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility. EMC testing 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.
Results: Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device.

Software Verification and Validation Testing:

Study Type: Software verification and validation testing.
Test Method Summary: 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). Software verification activities performed during "Design, coding & testing" and "Verification" phases. Code inspections and software tests at the unit, integration and system levels performed according to Software Test Plan. Verification tests performed for each software requirement according to Software Verification Plan. Conformity of software with user needs and intended use performed through "Validation" phase.
Results: Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device.

Cleaning- and Sterilization Validation:

Study Type: Automated cleaning validation and sterilization validation.
Test Method Summary: Automated cleaning validation according to FDA Guidance Document Reprocessing of Reusable Medical Devices: Information for Manufacturers and AAMI TIR 30 Technical report. Sterilization validation performed according to ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12 Technical report using two cycles.
Results: Evaluation was performed of the subject device and demonstrated to be substantially equivalent to the identified predicate devices.

System applicative accuracy In vitro testing:

Study Type: Performance bench Testing.
Test Method Summary: In compliance with internal Biomet medtech /Zimmer robotics procedures.
Results: Testing on the subject device was performed and demonstrated to be substantially equivalent to the predicate device: Robot arm positioning accuracy

Regulation Number and Section

§ 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).

Summary

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March 28, 2018

Medtech S.A. Elise Lagacherie RA/QA Manager ZAC Eureka 900 rue du Mas de Verchant 34000 Montpellier, France

Re: K172444

Trade/Device Name: ROSA BRAIN (v3.0.0.5) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 22, 2018 Received: February 26, 2018

Dear Elise Lagacherie:

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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172444

Device Name ROSA BRAIN (v3.0.0.5)

Indications for Use (Describe)

The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	×
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

l 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: August 7, 2017

ll DEVICE

Name of Device: ROSA BRAIN (v3.0.0.5) Common Name: Computer-assisted surgical device Classification Name: Stereotaxic Instrument (21CFR 882.4560) Classification Panel: Neurology Regulatory Class: II Product Code: HAW 510k #: K172444

�� PREDICATE DEVICE

ROSA BRAIN (v3.0.0.0), manufactured by Medtech S.A., K151359, cleared December 19, 2015

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DEVICE DESCRIPTION IV