(263 days)
Not Found
No
The description focuses on the device being a computer-controlled, image-guided electromechanical arm for spatial positioning based on external imaging software and surgeon input. There is no mention of AI, ML, training data, or algorithms that learn or adapt.
No.
The device is a Stereotactic System that assists the surgeon in spatial positioning and orientation of surgical instruments, but does not directly deliver therapy itself or make contact with the patient's head for therapeutic purposes.
No
The device is described as a system for spatial positioning and orientation of surgical instruments in neurosurgery, assisting the surgeon in guiding instruments. It does not perform any diagnostic function.
No
The device description explicitly states it is an "electromechanical multijointed arm" with "24V DC motors" and other hardware components, clearly indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- NeuroMate's Function: The NeuroMate Stereotactic System is a surgical guidance system. It assists the surgeon in positioning and orienting surgical instruments during neurosurgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is for "spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments." This is a surgical assistance function, not an in vitro diagnostic function.
- Device Description: The description details a robotic arm that positions surgical instruments based on imaging data. It does not mention any components or processes related to analyzing biological samples.
Therefore, the NeuroMate Stereotactic System falls under the category of a surgical device or a medical device for surgical guidance, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).
The NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic System are intended for the sterectactic spatial positioning and onlentation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).
NeuroMate assists the surgeon in its operating tasks by providing a stable, accurate, and reproducible mechanical guidance for surgical instruments, while not directly entering in contact with the patient's head. The instrument holder's sterectactic soatial positioning and orientation are determined by the neurosurgeon using an "external" (i.e., not provided by IMMI Inc.) imaging software for stereotactic planning and specific to the intended clinical application.
The NeuroMate Stereotactic System acts like a motorized stereotactic frame driven by the external imaging software supported by a PC or a computer workstation providing visualization of anatomical structures and brain targets specific for the intended application (e.g., 3-D image databases from CT, MR, DSA, PET, SPECT),
Following a carefully prepared stereotactic treatment plan, at the neurosumeon request. the NeuroMate Stereotactic System slowly moves and subsequently nointains an instrument holder proximal to the patient's head: NeuroMate automatically and accurately insure the correct stereotactic angular and spatial positioning of surgical instruments, thereby reducing potential human errors. During most of the duration of a neurosurgical procedure, NeuroMate is motionless and the instrument holder rigidly holds the surgical instrument chosen by the neurosurgeon prior to initiating stereotactic surgery. Only when changing spatial position and/or orientation does NeuroMate actually move. Finally, NeuroMate must be used in conjunction with a stereotactic head ring.
The treatment strategy, including the choice of the entry point on the patient's head and the associated rectilinear route to reach a pre-selected brain target, are entirely left under the neurosurgeon's control. NeuroMate enables the surgeon to spatially position a surpleal instrument along a virtually infinite number of angular onentations centered onto a pre-selected brain target point.
The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:
- electronic and PC circuit boards powered by switching power supplies:
- an electromechanical 5-axis multiliointed arm displaced by 24V DC motors:
- a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.
The NeuroMate Stereotactic System's controller has been specifically developed for surgical applications. It includes several functions at the mechanical and software levels, which, in case of dysfunction, quarantee the patient safety and the medical staff safety.
NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:
- an axis controller for each joint:
- a main controller module coordinating NeuroMate's motion; it performs the necessary transformations between the Cartesian space and joint space;
- a field bus linking the main controller to the axis controllers;
- a supervisor module performing all functions related to user interface, and generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, DSA, PET, SPECT
Anatomical Site
patient's head, brain
Indicated Patient Age Range
8-75 years (mean 42 years)
Intended User / Care Setting
neurosurgeon, neurosurgical operating room
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
A cohort of 45 patients (16 females; 29 males) with a mean age of 42 years (range 8-75) underwent various stereotactic procedures with the assistance of NeuroMate. The procedures were as follows: biopsy (11 cases), cystemostomy (4 cases), turnoral cyst (1 case), Parkinson (17 cases), electro-encephalogram stimulation for the treatment of acute epilepsy (12 cases).
The stereotactic approaches used included single oblique, double oblique, frontal, lateral, and parietal trajectories corresponding to standard accesses around the patient's head.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Overall performances
Overall performances of the NeuroMate Stereotactic System were assessed as a result of different testing sequences designed to:
- verify the device's technical and functional characteristics
- verify the operation of the device's safety systems, and
- measure the accuracy and repeatability performances in spatial positioning and orientation of the multi-jointed arm carrying a specific payload.
The results of these measurements are well within the performance specifications of the device and provide a clear indication of the relatively high spatial accuracy of the NeuroMate Stereotactic System.
- Accuracy: the measured positioning accuracy was 0.73 mm, and the measured angular accuracy was 0.14°.
- Repeatability: the measured repeatability was 0.136 mm.
Clinical Testing
Between Sept. 1995 and Apr. 1996, the NeuroMate Stereotactic System was tested at the Neurosurgery Department of Grenoble University Hospital in France.
Sample size: 45 patients
Key Results:
- In all cases, NeuroMate performed as intended and successfully positioned the instrument holder at the required stereotactic spatial and angular position.
- NeuroMate was successful in directly positioning its instrument holder at the appropriate stereotactic location in 75% of the cases; following readjustment judged clinically necessary by X-ray control in-situ, the requested positioning was achieved in every case (100%).
- Deviations between requested positioning and clinically optimal positioning were
§ 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
K963256
MAY 9, 1997
SMDA Summary of Safety and Effectiveness - 510(k) Summary
- A. Sponsor Information
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Innovative Medical Machines International, Inc. 70 Wainut Street Wellesley, MA 02181 Telephone: 617 239 8108 Contact Person: Dr. Jean-Luc Boulnois President
B. Device Identification
Common/Usual Name: Proprietary Name:
Stereotactic Instrument NeuroMate Stereotactic Svstem
C. Identification of Predicate Device(s)
The NeuroMate Stereotactic System is substantially equivalent to the following previously cleared and currently marketed devices:
- BRW Stereotactic System (Radionics: K811452) .
- COMPASS Stereotactic System (Stereotactic Medical Systems; K871046) .
D. Device Description
The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).
NeuroMate assists the surgeon in its operating tasks by providing a stable, accurate, and reproducible mechanical guidance for surgical instruments, while not directly entering in contact with the patient's head. The instrument holder's sterectactic soatial positioning and orientation are determined by the neurosurgeon using an "external" (i.e., not provided by IMMI Inc.) imaging software for stereotactic planning and specific to the intended clinical application.
The NeuroMate Stereotactic System acts like a motorized stereotactic frame driven by the external imaging software supported by a PC or a computer workstation providing visualization of anatomical structures and brain targets specific for the intended application (e.g., 3-D image databases from CT, MR, DSA, PET, SPECT),
Following a carefully prepared stereotactic treatment plan, at the neurosumeon request. the NeuroMate Stereotactic System slowly moves and subsequently nointains an instrument holder proximal to the patient's head: NeuroMate automatically and accurately insure the correct stereotactic angular and spatial positioning of surgical instruments, thereby reducing potential human errors. During most of the duration of a neurosurgical procedure, NeuroMate is motionless and the instrument holder rigidly holds the surgical instrument chosen by the neurosurgeon prior to initiating stereotactic surgery. Only when changing spatial position and/or orientation does NeuroMate actually move. Finally, NeuroMate must be used in conjunction with a stereotactic head ring.
1
Image /page/1/Picture/0 description: The image shows a robotic arm in a dark setting. The arm is white and has several joints, giving it flexibility. The arm is positioned in a way that suggests it is reaching out or manipulating something. There is a rectangular object to the right of the arm, which could be a sensor or another part of the robotic system.
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Joint Axis
11 11 11 11
Figure 1 : NeuroMate Stereotactic System Geometry
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:
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Image /page/1/Picture/3 description: The image shows a close-up of a document with some handwritten and printed elements. The printed part consists of the number "000047" in a stencil-like font. Above the numbers, there is a handwritten word that appears to be "Day" with a line crossing it out, and some other handwritten characters above it.
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The treatment strategy, including the choice of the entry point on the patient's head and the associated rectilinear route to reach a pre-selected brain target, are entirely left under the neurosurgeon's control. NeuroMate enables the surgeon to spatially position a surpleal instrument along a virtually infinite number of angular onentations centered onto a pre-selected brain target point.
The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:
- electronic and PC circuit boards powered by switching power supplies: .
- an electromechanical 5-axis multiliointed arm displaced by 24V DC motors: .
- a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.
The NeuroMate Stereotactic System's controller has been specifically developed for surgical applications. It includes several functions at the mechanical and software levels, which, in case of dysfunction, quarantee the patient safety and the medical staff safety.
NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:
- an axis controller for each joint: .
- a main controller module coordinating NeuroMate's motion; it performs the . necessary transformations between the Cartesian space and joint space;
- a field bus linking the main controller to the axis controllers; .
- a supervisor module performing all functions related to user interface, and . generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.
Performance Data ui
Overall performances of the NeuroMate Stereotactic System were assessed as a result of different testing sequences designed to:
- verify the device's technical and functional characteristics . .
- verify the operation of the device's safety systems, and .
- measure the accuracy and repeatability performances in spatial positioning and . orientation of the multi-jointed arm carrying a specific payload.
The results of these measurements are well within the performance specifications of the device and provide a clear indication of the relatively high spatial accuracy of the NeuroMate Stereotactic System.
- t Accuracy may be defined as the success of the device in reaching a known location in space: the measured positioning accuracy was 0.73 mm, and the measured angular accuracy was 0.14°
- Repeatability is the ability of the device to return to the same position in space . repeatedly: the measured repeatability was 0.136 mm.
- u Clinical Testing
Between Sept. 1995 and Apr. 1996, the NeuroMate Stereotactic System was tested at the Neurosurgery Department of Grenoble University Hospital in France. The objectives of the clinical testing were to establish that the NeuroMate Stereotactic System could
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position an instrument in any required stereotactic spatial position corresponding to predetermined entry and a target points, as determined by the neurosurgeon.
A cohort of 45 patients (16 females; 29 males) with a mean age of 42 years (range 8-75) underwent various stereotactic procedures with the assistance of NeuroMate. The procedures were as follows: biopsy (11 cases), cystemostomy (4 cases), turnoral cyst (1 case), Parkinson (17 cases), electro-encephalogram stimulation for the treatment of acute epilepsy (12 cases).
The stereotactic approaches used included single oblique, double oblique, frontal, lateral, and parietal trajectories corresponding to standard accesses around the patient's head. In all cases, NeuroMate performed as intended and successfully positioned the instrument holder at the required stereotactic spatial and angular position.
As a result of these clinical tests, the benefits of using the NeuroMate Stereotactic System for the positioning of an instrument holder can be summarized as follows:
- NeuroMate can access any part of the patient's head for single or multiple . traiectories without the mechanical limitations encountered in the use of frames;
- the choice of optimal trajectories adapted to anatomical, functional, and surgical ● considerations is facilitated by the accessibility provided by NeuroMate;
- NeuroMate was successful in directly positioning its instrument holder at the . appropriate stereotactic location in 75% of the cases; following readjustment judged clinically necessary by X-ray control in-situ, the requested positioning was achieved in every case (100%);
- NeuroMate's simulation capabilities, particularly when bi-planar X-rays are . available in the Operating Room, can significantly enhance the clinical effectiveness of the instrument holder positioning: deviations between requested positioning and clinically optimal positioning were