(90 days)
No
The description focuses on electromechanical positioning based on a pre-operative plan and validated accuracy against a predicate device. There is no mention of AI, ML, or any learning-based algorithms.
No.
The device is for guiding instruments during neurosurgical procedures, not for providing therapy directly.
No
The device is described as a "stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide." Its purpose is to guide standard neurosurgical instruments, not to diagnose medical conditions.
No
The device description explicitly states it is a "stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide," indicating it includes significant hardware components beyond just software.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states the device is a stereotactic system used for spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments. This is a device used during a surgical procedure, directly interacting with the patient's body (albeit indirectly through instrument guidance).
- Intended Use: The intended use is for stereotactic spatial positioning and orientation for surgical guidance, not for analyzing biological samples.
- Input: The input is patient imaging data, not biological samples.
The device is a surgical guidance system, which falls under the category of medical devices used in surgical procedures, not IVDs.
N/A
Intended Use / Indications for Use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
Product codes
HAW
Device Description
A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Patient imaging data is visualized on the supplied workstation running neuro inspire software.
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon, Operating rooms
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: Performance Validation
Sample size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: The neuromate Gen III system was validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer). The result of this validation confirmed that the accuracy of the system complies with its claimed performances and is equivalent to those of the predicate system.
Key Metrics
Overall positioning accuracy (including imaging) In Frame-based mode:
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 24, 2018
Renishaw Mayfield Sarl Stéphane Vinot Quality Assurance & Regulatory Affairs Manager 31. Rue Ampère Chassieu, 69680 Fr
Re: K180206
Trade/Device Name: neuromate Gen III Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 4, 2018 Received: January 24, 2018
Dear Stéphane Vinot:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS 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) K180206
Device Name neuromate Gen III
Indications for Use (Describe)
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CEB 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) SUMMARY
-
- SUBMITTER:
RENISHAW mayfield S.A.R.L. 31, rue Ampère 69680 Chassieu FRANCE 011-33 4 37 23 89 00 Phone: 011-33 4 78 90 75 22 Fax:
- SUBMITTER:
Contact person:
Stéphane Vinot Quality Assurance & Regulatory affairs Manager quality@renishawmayfield.com
Preparation date:
January 4th, 2018
2. DEVICE NAME:
| Trade name: | neuromate® Gen III |
|---|---|
| Common name: | neuromate Gen III stereotactic system |
| Classification : | Regulation: 882.4560 Stereotaxic Instrument |
| Product Code: | HAW - Neurological Stereotaxic Instrument |
3. PREDICATE DEVICE(s):
K132755 - neuromate Frameless Gen II - RENISHAW Mayfield S.A.R.L.
4. REFERENCE DEVICE:
K163666 - neuro | inspire™ - Renishaw plc.
Renishaw Mayfield sarl
31 rue ampère F-69680 Chassieu - France Téléphone +33 (0) 4 37 23 89 00 +33 (0) 4 78 90 75 22 Fax
RCS Lyon 480 820 307 SIRET 48082030700027 APE 3250A Nº identification TVA FR26 480 820 307 Capital : 250 000 €
Société Générale Lyon République Code Banque 30003 Code guichet 01200 Nº compte 00020839167 Clé 57 IBAN FR76 30003 01200 00020839167 57 BIC SOGEFRPP
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5. DEVICE DESCRIPTION:
A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
6. INDICATION FOR USE:
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
7. COMPARISON WITH PREDICATE DEVICE:
The neuromate Gen III system (this submission) has the same intended use and the same fundamental scientific technology as the predicate device cleared under K132755.
The differences between the two devices are about the use of a new planning software named neuro|inspire (reference device K163666).
- . Substitution of neuro|inspire planning software in the system:
The predicate device used a software package called VoXim as the planning software application. The neuromate Gen III (this submission) uses a planning software package called neuro|inspire (replacing Voxim). neuro|inspire contains a subset of functionalities of Voxim.
Moreover, the PC provided with the workstation has been changed to support the neuro|inspire software.
The proposed neuromate Gen III (this submission) is identical in design, intended use, construction and operation to the predicate K132755.
The itemised comparison between the device and its predicate is provided in the following paragraph 7 (Substantial Equivalence Summary) of this document.
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| Device | neuromate Gen III (this
submission) | neuromate Frameless Gen II
(510(k) K132755) | SE |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer | RENISHAW mayfield | RENISHAW mayfield | Same |
| | Intended Use | | |
| Intended Use | Stereotactic spatial
positioning and orientation of
an instrument holder or tool
guide to be used by a
surgeon to manually guide
standard neurosurgical
instruments. | Stereotactic spatial positioning
and orientation of an instrument
holder or tool guide to be used
by a surgeon to manually guide
standard neurosurgical
instruments. | Same |
| Indication for use | | | |
| Indication
for use | Stereotactic spatial
positioning and orientation of
an instrument holder or tool
guide to be used by a
surgeon to manually guide
standard neurosurgical
instruments.
neuromate Gen III has been
validated with the Leksell
Stereotactic System Type G
(comprising of head frame
and CT Localizer). | Stereotactic spatial positioning
and orientation of an instrument
holder or tool guide to be used
by a surgeon to manually guide
standard neurosurgical
instruments. | SE |
| Clinical
application | Neurological surgery | Neurological surgery | Same |
| Sites of use | Operating rooms | Operating rooms | Same |
| User | Neurosurgeon | Neurosurgeon | Same |
| Anatomical
site | Head | Head | Same |
| Principle of
operation | Patient imaging data is
visualized on the supplied
workstation running
neuro inspire software. It is
the surgeon who chooses the
tool, trajectory, point of
access and orientation.
The data is communicated to
the robot which located the
tool holder accordingly and
accurately.
The surgeon performs the
procedure by inserting tools
though the tool-holder, the
robot ensures the continued
stability of the position. | Patient imaging data is
visualized on the supplied
workstation running the VoXim
software. It is the surgeon who
chooses the tool, trajectory,
point of access and orientation.
The data is communicated to
the robot which located the tool
holder accordingly and
accurately.
The surgeon performs the
procedure by inserting tools
though the tool-holder, the robot
ensures the continued stability
of the position. | SE |
| Registration
methods | Framebased mode: the
patient wears a stereotactic
frame and the frame is
attached to the robot
| Framebased mode: the patient
wears a stereotactic frame and
the frame is attached to the
robot (mechanical registration)
Frameless mode: The patient
wears a light-weight microphone
frame and the registration is
made by ultrasound. | SE |
| Frame type
indicated | Leksell Stereotactic
System Type G (head ring
and CT localizer). | Leksell Stereotactic System
Type G (head ring, CT and
MRI localizers from Elekta)
- CRW (head ring with MRI
and CT localizers from
Integra) - Fischer (head ring with CT
localizer from Inomed) | SE |
| Technical Characteristics | | | |
| General
device
description | Computer-controlled
electromechanical multi-
jointed arm | Computer-controlled
electromechanical multi-jointed
arm | Same |
| System | • A robot, made of a
computer-controlled | • A robot, made of a computer-
controlled articulated | Same |
| Architecture | articulated motorized arm
and the base that supports
it and contains the control
electronics;
• A workstation on which
runs software for scanned
image processing,
procedure planning, robot
configuration, robot control
and system diagnostic;
• A series of attachments to
connect the robot to the
patient, to perform patient
registration and to support
the tools used by the
surgeon. | motorized arm and the base
that supports it and contains
the control electronics;
• A workstation on which runs
software for scanned image
processing, procedure
planning, robot configuration,
robot control and system
diagnostic;
• A series of attachments to
connect the robot to the
patient, to perform patient
registration and to support the
tools used by the surgeon. | |
| Axis control
technology | Incremental digital encoders
Absolute digital encoders | Incremental digital encoders
Absolute digital encoders | Same |
| Compliance
with
voluntary
standards | Yes
IEC 60601-1: 2005 + AC1 +
AC2 + A1: 2012
IEC 60601-1-2: 2007
ISO 14971: 2007
IEC 62304: 2006
IEC 62366: 2007
ISO 17665-1: 2006
DICOM 3 | Yes
IEC 60601-1: 2005 + AC1 +
AC2 + A1: 2012
IEC 60601-1-2: 2007
IEC 60601-1-4: 2000
ISO 14971: 2007
IEC 62304: 2006
IEC 62366: 2007
ISO 17665-1: 2006
DICOM 3 | SE |
| Maximum
instrument
payload | Maximum useful load: 5 kg
(11 lb)
1 kg (2.2 lb) for maximum
accuracy | Maximum useful load: 5 kg (11
lb)
1 kg (2.2 lb) for maximum
accuracy | Same |
| Working
volume
(subset of the
above in
which the
positioning
accuracy is
achived) | 20 cm (~8") long, 18 cm (7")
diameter horizontal cylinder
oriented
along the robot axis and with
its
centre 81 cm (~32") from the
base. | 20 cm (~8") long, 18 cm (7")
diameter horizontal cylinder
oriented
along the robot axis and with its
centre 81 cm (~32") from the
base. | Same |
| Overall
positioning
accuracy
(including
imaging) | In Frame-based mode: $