ROSA BRAIN (v3.0.0.5)

• 2 recalls, same reason

  • Terminated Z-1151-2020 FDA Class II ·initiated 6 Jan 2020
  • Terminated Z-1150-2020 FDA Class II ·initiated 6 Jan 2020

  Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

• • Terminated Z-0172-2020 FDA Class I ·initiated 10 Sep 2019

  The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.

• • Terminated Z-0638-2018 FDA Class II ·initiated 1 May 2017

  Robot arm being sent to the wrong position

510(k) Number

K172444 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• ROSA ONE Spine application

  Class II

  FDA 510(k) K192173 Active Cleared 29 Oct 2019

• Rosa Surgical Device, Model Rosa 1.1

  Class II

  FDA 510(k) K092239 Active Cleared 17 Nov 2009

• ROSA Brain

  Class II

  FDA 510(k) K151359 Active Cleared 18 Dec 2015

• ROSA Spine

  Class II

  FDA 510(k) K151511 Active Cleared 4 Jan 2016

• ROSA ONE Brain Application Open recall

  Class II

  FDA 510(k) K182417 Active Cleared 7 Feb 2019

• ROSA ONE Spine application

  Class II

  FDA 510(k) K182848 Active Cleared 22 Mar 2019

See all devices from Medtech S.A →

• What is the ROSA BRAIN (v3.0.0.5) used for in neurosurgery?

  The ROSA BRAIN (v3.0.0.5) is a robotic surgical system designed specifically for spatial positioning and orientation of instrument holders or tool guides during neurosurgical procedures. It integrates robotic arm technology to improve accuracy, reduce exposure to critical anatomical structures, and enable targeted interventions with greater control. This aligns with advanced neurosurgical navigation, making it ideal for minimally invasive techniques where precision is critical.

• How is the ROSA BRAIN (v3.0.0.5) supplied and intended for use?

  The ROSA BRAIN (v3.0.0.5) is supplied by Medtech S.A. and is intended exclusively for use in operating room environments. It is not classified as single-use or reusable in the provided regulatory records, though standard surgical protocols for robotic systems typically apply. The system is cleared for use in neurosurgical procedures where robotic assistance enhances precision.

• Is sterility or MRI safety information provided for the ROSA BRAIN (v3.0.0.5)?

  The regulatory records for the ROSA BRAIN (v3.0.0.5) do not explicitly state details regarding sterility or MRI safety. However, as a robotic surgical system, it is likely designed to be compatible with standard surgical imaging protocols, including MRI, though users should always verify compatibility with their specific imaging equipment and protocols. Sterility considerations would follow standard surgical device practices for reusable systems.

• What regulatory clearance does the ROSA BRAIN (v3.0.0.5) hold?

  The ROSA BRAIN (v3.0.0.5) has received FDA 510(k) clearance under the reference number K172444. This clearance was determined through a review by the Neurology (NE) advisory committee, confirming that the device is substantially equivalent to a predicate device. The clearance process involved a traditional review pathway, ensuring compliance with regulatory standards for robotic surgical systems in neurosurgery.

• Are there specific storage or handling instructions for the ROSA BRAIN (v3.0.0.5)?

  The regulatory records for the ROSA BRAIN (v3.0.0.5) do not provide detailed storage or handling instructions. As a reusable robotic system, it would typically require adherence to standard surgical device maintenance protocols, including cleaning, disinfection, and calibration procedures. Users should consult Medtech S.A.’s operational manuals for specific guidance tailored to the device’s maintenance and storage requirements.