(118 days)
Not Found
No
The summary describes image processing and proprietary algorithms for image-guided surgery but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development (training/test sets, specific performance metrics like AUC).
No.
This device is an image-guided surgery system intended for precise positioning of surgical instruments or spinal implants, not for directly treating a disease or condition. Its purpose is to assist surgeons, not to provide therapy itself.
No
The device is intended for precise positioning of surgical instruments and spinal implants during surgery, and for processing and converting 2D fluoroscopic images into volumetric 3D images for surgical planning and guidance. It assists surgeons in performing procedures and analyzing existing medical images, rather than diagnosing conditions.
No
The device description explicitly lists hardware components such as the RBT Device, Workstation Console, Planning PC Workstation, and various accessories like the RBT Base and Skull Screws. The performance studies also include tests related to the stability and accuracy of the anchoring system to the skull, which are hardware-related validations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "precise positioning of surgical instruments or spinal implants during general spinal and brain surgery." This describes a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a "computer controlled miniature medical image-guided surgery (IGS) system" that assists surgeons in guiding tools and implants. This aligns with a surgical navigation or robotic system, not an IVD.
- Input Imaging Modality: The inputs are MRI, CT, and fluoroscopic images. These are used for surgical planning and guidance, not for analyzing biological specimens.
- Anatomical Site: The anatomical sites are related to the surgical procedure (spine, brain, skull).
- Performance Studies: The performance studies focus on accuracy, stability, and registration in the context of surgical guidance, not on the analytical or clinical performance of an IVD test.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to provide information about a patient's health status. This device's function is to assist in performing a surgical procedure based on medical imaging.
N/A
Intended Use / Indications for Use
The Renaissance System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures.
Renaissance 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
Product codes
HAW, LLZ
Device Description
The Renaissance System is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide accuracy, precision and accessibility in performing general spinal and brain procedures. The Renaissance System is designed to assist surgeons in precisely guiding handheld surgical tools and/or implants (in spinal surgery) according to a computerized, image-based, pre-operative plan along a given traiectory. The Renaissance System Brain Application was developed based on the same principles of operation for image guided brain surgeries. The Renaissance System Brain Application processes MRI and CT images via proprietary algorithms and based on the preoperative plan the RBT Device is programmed to position its articulating arm and thus the surgical instrument at the desired coordinates. Using a special skull attachment component (i.e., the RBT Base), the RBT Device attaches to the skull in the area where the procedure is being performed, and assists surgeons in precisely positioning the handheld surgical tools according to the computerized, image-based, pre-operative plan.
The main components of the Renaissance System Brain Application include:
- A. The RBT Device
- B. Workstation Console in the OR and Planning PC Workstation in the physician's office
- C. Renaissance Brain Application Accessories including RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.
The RBT Device and Workstation Console were previously cleared under K113228 and K110911. This 510(k) submission describes the addition of the new accessories (RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.) which enable increased accessibility for the RBT Device over the skull and the changes in the SW application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, 2D fluoroscopic projections from standard C-Arms
Anatomical Site
general spinal and brain, rigid anatomical structure, such as the spine, skull, hip, etc.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician. Hospital setting.
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)
Non-Clinical Performance Data
- Software validation testing (IEC 60601-1-4 & FDA Guidelines): Validation of the device software was performed according to the IEC 60601-1-4 standard and the FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices. Each software validation document was written according to the relevant IEEE standard. The software validation documentation has been prepared for the Renaissance System with Brain Application and software version 3.4.
- Stability Test: The objective of the Stability Test was to validate the stability of the anchoring system to the skull. The anchoring system consists of the RBT Base mounted on the skull using three Skull Screws. The stability was validated by applying forces in three different planes and measuring the resulting shift in the position of the RBT Base, as well as the pull-out force. The results demonstrated that the anchoring of the Renaissance System Brain Application is stable and pull-resistance.
- Registration Accuracy Test: The goal of the study was to measure the accuracy of the registration method of the multimodality medical images for the Renaissance System Brain Application. The modalities in question are various types of Magnetic Resonance Imaging (MRI) scans (e.g. proton-density, T1-weighted, T2-weighted) and X-ray Computed Tomography (CT). The accuracy assessment was performed on a human head phantom. The accuracy of the registration process met the predefined device specifications.
- Bench Accuracy Study: The objective of the study was to quantify the accumulative error of the system. This was measured based on the deviation of the tool tip from the center of the target, as well as, the measurement of the tip depth. The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth.
- Cadaver Accuracy Study: The aim of this study was to evaluate the system accuracy and repeatability in simulated clinical conditions, i.e., on a cadaver brain. The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth, as well as repeatable performance.
Clinical Performance Data
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall mean accuracy of less than 1.5mm in both target plane and target depth.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SECTION 5
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
RENAISSANCE SYSTEM
(WITH BRAIN APPLICATION)
510(k) Number K__(2 08 |2 ﺳﮯ
Applicant's Name:
| Company name: | Mazor Robotics Ltd. |
|---|---|
| Address: | 7 HaEshel St. |
| PO Box 3104 | |
| Caesarea Park South 38900 | |
| Israel | |
| Tel: | +972-4-6187100 |
| Fax: | +972-4-6187111 |
| E-mail: | ayelet@mazorrobotics.com |
Contact Person:
Official Correspondent: Ahava Stein Company name: A. Stein - Regulatory Affairs Consulting Address: Beit Hapaamon (Suite 213) 20 Hata'as Str. (Box 124) Kfar Saba 44425 Israel Tel: + 972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com
Date Prepared: March 6, 2012
Name of the device: Renaissance System
Trade or proprietary name, if applicable: Renaissance System
Common or usual name: Image Guided Surgery
Establishment Registration No .: 3005075696
Classification Name:
Combination of:
- a. Stereotaxic Instrument; and
- b. System, Image Processing, Radiological
1
Classification: The subject of this 510(k) is the Renaissance System, with the CFR classification sections 882.4560; Stereotaxic Instrument with product code HAW and 892.2050; System, Image Processing, Radiological and product code LLZ.
Predicate Device: The Renaissance System with Brain Application is substantially equivalent to the original Renaissance system (manufactured by Mazor Robotics Ltd., and the subject of 510(k) document no. K113228 and K110911) and to the StealthStation System (manufactured by Medtronic and the subject of 510(k) document no K050438). A comparison table and detailed discussion are presented in Section 12 of this application.
Device Description: The Renaissance System is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide accuracy, precision and accessibility in performing general spinal and brain procedures. The Renaissance System is designed to assist surgeons in precisely guiding handheld surgical tools and/or implants (in spinal surgery) according to a computerized, image-based, pre-operative plan along a given traiectory. The Renaissance System Brain Application was developed based on the same principles of operation for image guided brain surgeries. The Renaissance System Brain Application processes MRI and CT images via proprietary algorithms and based on the preoperative plan the RBT Device is programmed to position its articulating arm and thus the surgical instrument at the desired coordinates. Using a special skull attachment component (i.e., the RBT Base), the RBT Device attaches to the skull in the area where the procedure is being performed, and assists surgeons in precisely positioning the handheld surgical tools according to the computerized, image-based, pre-operative plan.
The main components of the Renaissance System Brain Application include:
- A. The RBT Device
- B. Workstation Console in the OR and Planning PC Workstation in the physician's office
- C. Renaissance Brain Application Accessories including RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.
The RBT Device and Workstation Console were previously cleared under K113228 and K110911. This 510(k) submission describes the addition of the new accessories (RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.) which enable increased accessibility for the RBT Device over the skull and the changes in the SW application.
12
2
Indication for Use:
The Renaissance System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures.
Renaissance 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
Comparison of Technological Characteristics with the predicate device:
The modified Renaissance System with Brain Application is similar to the original Renaissance System (K113228 and K110911) and to the StealthStation System and Software (K050438) regarding indications for use. All of these devices are intended for precise positioning of surgical tools during surgery and all of these devices may be used in either open or percutaneous (i.e., minimally invasive) procedures. Furthermore, all of the above devices may be used in a surgical procedure where reference to a rigid anatomical structure, such as the spine, skull, hip, etc., can be identified relative to a CT, MR, fluoro or other image. The purpose of this 510(k) was to extend the indications for use of the original Renaissance System to include Brain Application, and thus include brain surgery procedures in which the skull (as the rigid anatomical structure) can be identified, similar to the StealthStation System. The target population (i.e., orthopedic and neurology patients), anatomical sites (i.e., any rigid anatomical structure, such as the spine or skull) and environment of use (i.e., hospital setting) are the same in the new Renaissance System with Brain Application and in the predicate devices.
The modified Renaissance System with Brain Application is identical to the original Renaissance System regarding components, design, materials, and basic scientific technology. The design of the Renaissance System with Brain Application is similar to the design of the original Renaissance System and the StealthStation System, as all systems consist of a planning and execution application and the ability to receive and merge multi-image scans. All of these devices use the same mechanism of action, i.e., computer assisted stereotaxy. The components of the modified Renaissance System with Brain Application are similar to the original Renaissance System, with the addition of new accessories to enable the brain approach, including the RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc. The combination of these accessories allows trajectories and range of operation for the device in general brain surgeries. The device features and operational procedure are the same as in the original Renaissance System. Additionally, software modifications were implemented to enable the new brain approach, including a software change enabling fusion/registration between MRU and CT scans for brain procedures. The accuracy of the Renaissance System with Brain Application is the same as previously cleared Renaissance System for spine procedures, i.e.,