(87 days)
Not Found
No
The description focuses on a computer-controlled electromechanical arm for spatial positioning based on pre-operative plans and registration methods (fiducial markers, optical registration). There is no mention of AI or ML algorithms being used for planning, guidance, or any other function. The performance studies focus on accuracy and repeatability of the robotic arm and registration methods, not on the performance of an AI/ML model.
No.
The "ROSA Surgical Device" is intended to be used for "spatial positioning and orientation of an instrument holder or tool guide" and to "guide standard neurosurgical instruments." It assists in performing surgical procedures but does not directly provide therapy or treatment itself.
No.
The ROSA Surgical Device is described as a computer-controlled electromechanical arm intended for spatial positioning and orientation of surgical instruments and guidance during neurosurgical procedures. Its function is to facilitate surgery, not to diagnose a condition.
No
The device description explicitly states it is a "computer-controlled electromechanical arm," indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ROSA Surgical Device Function: The description clearly states that the ROSA Surgical Device is a computer-controlled electromechanical arm used for spatial positioning and orientation of surgical instruments during neurosurgery. It guides instruments based on pre-operative imaging and registration, directly within the operating room on a patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical guidance based on anatomical landmarks and imaging data.
Therefore, based on the provided information, the ROSA Surgical Device is a surgical guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, & MRI modalities
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgeons / 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
Description: The test bench permits to simulate a neurosurgical procedure. Test consists in thoroughly following the ROSA stereotactic procedure and measuring the distance between the targeted point and the attained instrument tip position. Equipment for this test includes a phantom skull featuring small metallic balls that materialize target points and a portable CMM for the measures (FARO Titanium arm, 50 um single point accuracy). Application accuracy is computed as the mean distance error for the N targets.
For fiducial markers: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching nine targets distributed within a volume comparable to a human head.
For optical registration: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching various targets distributed within a volume comparable to a human head.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Device Performance Tests (in vitro)
Sample Size: 45 measurements for fiducial markers, 45 measurements for optical registration.
Key results:
Expected results for ROSA surgical device for an in vitro application should yield a mean accuracy equivalent to other commonly used surgical localization systems: below 2 mm.
For fiducial markers: Average in vitro application accuracy is below than 2 mm.
For optical registration: Average in vitro application accuracy is below than 2 mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Application Accuracy
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K092239, K001801, K023651, K991081
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image shows a logo with a rectangular shape on the left and a circular shape on the right. The rectangular shape contains some text or patterns that are difficult to discern due to the image quality. The circular shape is incomplete, with the top part missing, and it appears to be connected to the rectangular shape by a line or a series of dots.
:
:
.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Page 6 of 45
ROSA SURGICAL DEVICE
5 - 510(K) SUMMARY
[As Required by 21 CFR 807.92] Summary of Safety and Effectiveness
| 1 | Submitter | MedTech S.A Parc Euromédecine Bâtiment 8 1006 rue de la Croix Verte 34090 Montpellier France | K101791 SEP 23 2010 |
|---|---|---|---|
| Contact Person | Bertin NAHUM, President Phone number : (+33) 467 107 740 Fax number : (+33) 467 597 418 | ||
| Preparation date | June 10, 2010 | ||
| Revision date | July 20, 2010 | ||
| Revision date | August 18, 2010 | ||
| Revision date | September 02, 2010 | ||
| 2 | Device name | ||
| Trade Name | ROSA Surgical Device | ||
| Common Name | Computer-assisted surgical device | ||
| Code product and classification name | Stereotaxic Instrument (HAW), 21 CFR Section 882.4560 | ||
| 3 | Predicate devices | ROSA Surgical Device, manufactured by MedTech SAS, K092239, cleared November 17, 2009 | |
| StealthStation Treatment Guidance Platform, manufactured by Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 | |||
| VectorVision Cranial / ENT, manufactured by BrainLAB AG, K023651, cleared February 17, 2004 | |||
| Frameless Neuromate Stereotactic System, manufactured by Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999 | |||
| 4 | Description | ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. | |
| Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. | |||
| The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. |
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PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE
Explanation of how the device operates
ROSA Surgical Device assists the neurosurgeon in planning the position of instruments relative to preoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial positions of patient head with fiducial markers or a laser telemeter.
When using the fiducial markers registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm anywhere in the operating field by simply grabbing the tip. Pinpoint collection of fiducial markers is carried out with ROSA and its navigation probe with the cooperative mode.
When using the optical registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm with the laser telemeter at its end and digitize selected anatomical landmarks on the patient's head. Then, the robot arm automatically scans an appropriate surface of the patient's head.
ROSA Surgical Device provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with a preoperative planning.
a computer-controlled ROSA Surgical Device is electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Intended use
5
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Performance data 6
Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.
Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process).
Device performance tests were performed to validate the absolute accuracy and repeatability of the device (robot arm).
Device performance tests were performed to validate the application accuracy of the device for fiducial markers and optical registration.
The test bench permits to simulate a neurosurgical procedure. Test consists in thoroughly following the ROSA stereotactic procedure and measuring the distance between the targeted point and the attained instrument tip position. Equipment for this test includes a phantom skull featuring small metallic balls that materialize target points and a portable CMM for the measures (FARO Titanium arm, 50 um single point accuracy). Application accuracy is computed as the mean distance error for the N targets.
Expected results for ROSA surgical device for an in vitro application should yield a mean accuracy equivalent to other commonly used surgical localization systems: below 2 mm.
For fiducial markers: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching nine targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.
For optical registration: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching various targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.
ROSA application accuracy with optical registration ાંક equivalent to the application accuracy of the previous cleared ROSA (below than 2 mm).
Testing protocol
Tests results .
3
200000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE
Page 9 of 45
7 summary
Substantial equivalence The technological characteristics, features, specifications, materials, mode of operation, and intended use of the ROSA Surgical Device are substantially equivalent to the predicate devices cited above.
The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the ROSA Surgical Device.
| COMPARISON TABLE | |||||
|---|---|---|---|---|---|
| Reference | Frameless | ||||
| Neuromate | |||||
| Stereotactic | |||||
| System | |||||
| K991081 | VectorVision | ||||
| Cranial / ENT | |||||
| K023651 | ROSA Surgical | ||||
| Device | |||||
| K092239 | StealthStation | ||||
| Treatment | |||||
| Guidance | |||||
| Platform | |||||
| K001801 | ROSA Surgical | ||||
| Device (for new | |||||
| submission) | |||||
| Design | |||||
| General device | |||||
| description | Computer controlled | ||||
| electromechanical | |||||
| multi-jointed arm | |||||
| indicated for use as a | |||||
| stereotactic | |||||
| instrument | Neuronavigation | ||||
| system providing | |||||
| localization means for | |||||
| neurosurgical | |||||
| instruments | Computer | ||||
| controlled | |||||
| electromechanical | |||||
| multi-jointed arm | |||||
| indicated for use as | |||||
| a stereotactic | |||||
| instrument | Neuronavigation | ||||
| system providing | |||||
| localization means for | |||||
| neurosurgical | |||||
| instruments | Computer | ||||
| controlled | |||||
| electromechanical | |||||
| multi-jointed arm | |||||
| indicated for use as | |||||
| a stereotactic | |||||
| instrument | |||||
| Localization means | Robot arm absolute | ||||
| encoders | Infrared cameras | Robot arm absolute | |||
| encoders | Infrared cameras | ||||
| (NDI Polaris system) | Robot arm absolute | ||||
| encoders | |||||
| Image-guided | Yes | Yes | Yes | Yes | Yes |
| Integrated planning | |||||
| software | No | ||||
| (third-party software) | Yes | Yes | Yes | Yes | |
| Registration | |||||
| method | Bone-mounted | ||||
| ultrasound device | Fiducial markers | ||||
| "Softouch" | |||||
| mechanical probe | |||||
| system | |||||
| Laser scanning | |||||
| device (Z-touch | |||||
| system) | Fiducial markers | Fiducial markers | |||
| "Tracer" mechanical | |||||
| probe system | |||||
| Laser registration | |||||
| device (Fazer) | Fiducial markers | ||||
| Optical registration | |||||
| device | |||||
| Instrumentation | Laser pointer | ||||
| Tool holder | Probes | ||||
| Frameless biopsy | |||||
| system | Navigation probe | ||||
| Tool holder | Probes | ||||
| Frameless biopsy | |||||
| system | Navigation probe | ||||
| Tool holder | |||||
| Laser pointer | |||||
| Instrument fixation | Instruments are | ||||
| mounted onto robot | |||||
| arm's flange. | Freehand | ||||
| instruments. | |||||
| A localizer is attached | |||||
| to each navigated | |||||
| instrument. | Instruments are | ||||
| mounted onto robot | |||||
| arm's flange. | Freehand | ||||
| instruments. | |||||
| A localizer is attached | |||||
| to each navigated | |||||
| instrument. | Instruments are | ||||
| mounted onto robot | |||||
| arm's flange. | |||||
| Instrument | |||||
| calibration method | Factory calibration | Intra operative | Factory calibration | Intra operative | Factory calibration |
| System | |||||
| immobilization | |||||
| between the patient | |||||
| and the device | Yes | Not necessarily | |||
| A localizer is attached | |||||
| to the head holder as | |||||
| a reference | Yes | Not necessarily | |||
| A localizer is attached | |||||
| to the head holder as | |||||
| a reference | Yes | ||||
| Patient | |||||
| Immobilization | |||||
| (head holder) | Yes | Yes | Yes | Yes | Yes |
| Planning & Navigation Software | |||||
| Path planning and | |||||
| control Software | VoXimTM | ||||
| (IVS Solutions AG) | VectorVision Flex | ||||
| (BrainLAB) | ROSANNA | ||||
| (MedTech) | StealthStation | ||||
| (Medtronic) | ROSANNA | ||||
| (MedTech) | |||||
| CT, & MRI | |||||
| modalities | Yes | Yes | Yes | Yes | Yes |
| Merge images | Yes | Yes | No | Yes | Yes |
| Save/load path | Yes | Yes | Yes | Yes | Yes |
| Reference | Frameless | ||||
| Neuromate | |||||
| Stereotactic | |||||
| System | |||||
| K991081 | VectorVision | ||||
| Cranial / ENT | |||||
| K023651 | ROSA Surgical | ||||
| Device | |||||
| K092239 | StealthStation | ||||
| Treatment | |||||
| Guidance | |||||
| Platform | |||||
| K001801 | ROSA Surgical | ||||
| Device (for new | |||||
| submission) | |||||
| Fiducial markers | |||||
| registration with | |||||
| pointer probe | No | Yes | Yes | Yes | Yes |
| Optical registration | |||||
| with laser | |||||
| telemeter | No | Yes | No | Yes | Yes |
| Registration based | |||||
| on ultrasound | |||||
| measures | Yes | no | No | No | No |
| Cooperative | |||||
| movement | No | No | Yes | No | Yes |
| Accuracy | |||||
| verification on | |||||
| anatomical | |||||
| landmarks | Yes (laser pointer) | Yes (pointer probe) | Yes (navigation | ||
| probe) | Yes (pointer probe) | Yes (navigation | |||
| probe, laser beam) | |||||
| Display real-time | |||||
| instrument position | |||||
| on preoperative | |||||
| images | Yes | Yes | Yes | Yes | Yes |
| Provide mechanical | |||||
| guidance for | |||||
| surgical | |||||
| instruments | Yes | No | Yes | Only with the | |
| frameless biopsy | Yes | ||||
| Instrument guide | |||||
| position adjustment | Automatic (robotized) | Manual | Automatic | ||
| (robotized) | Manual | Automatic | |||
| (robotized) | |||||
| Surgeon carries out | |||||
| final gesture | |||||
| through the | |||||
| instrument guide | Yes | Yes | Yes | Yes | Yes |
| Indication(s) 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 (biopsy | |||||
| needle, stimulation or | |||||
| recording electrode, | |||||
| endoscope). | Intended as an aid for | ||||
| precisely locating | |||||
| anatomical structures | |||||
| in either open or | |||||
| percutaneous | |||||
| procedures. Indicated | |||||
| for any medical | |||||
| condition in which the | |||||
| use of stereotactic | |||||
| surgery may be | |||||
| appropriate, and | |||||
| where a reference to | |||||
| a rigid anatomical | |||||
| structure can be | |||||
| identified to a CT or | |||||
| MR based model. | Intended to be used | ||||
| in the operating | |||||
| room for the spatial | |||||
| positioning and | |||||
| orientation of an | |||||
| instrument holder | |||||
| or tool guide. The | |||||
| system is intended | |||||
| to be used by | |||||
| neurosurgeons to | |||||
| guide standard | |||||
| neurosurgical | |||||
| instruments (biopsy | |||||
| needle, stimulation | |||||
| or recording | |||||
| electrode). | |||||
| Indicated for any | |||||
| neurosurgical | |||||
| condition in which | |||||
| the use of | |||||
| stereotactic surgery | |||||
| may be | |||||
| appropriate. | Intended as an aid for | ||||
| precisely locating | |||||
| anatomical structures | |||||
| in either open or | |||||
| percutaneous | |||||
| procedures. Indicated | |||||
| for any medical | |||||
| condition in which the | |||||
| use of stereotactic | |||||
| surgery may be | |||||
| appropriate, and | |||||
| where a reference to | |||||
| a rigid anatomical | |||||
| structure can be | |||||
| identified to a CT or | |||||
| MR based model. | Intended to be used | ||||
| in the operating | |||||
| room for the spatial | |||||
| positioning and | |||||
| orientation of an | |||||
| instrument holder | |||||
| or tool guide. The | |||||
| system is intended | |||||
| to be used by | |||||
| neurosurgeons to | |||||
| guide standard | |||||
| neurosurgical | |||||
| instruments (biopsy | |||||
| needle, stimulation | |||||
| or recording | |||||
| electrode, | |||||
| endoscope). | |||||
| Indicated for any | |||||
| neurosurgical | |||||
| condition in which | |||||
| the use of | |||||
| stereotactic surgery | |||||
| may be | |||||
| appropriate. | |||||
| Anatomical site | Head | Head, ENT | Head | Head, Spine, ENT | Head |
| User | Neurosurgeon | Neurosurgeon | Neurosurgeon | Neurosurgeon | Neurosurgeon |
| Associated | |||||
| equipments | Sterile drapes | Sterile drapes | |||
| Fiducial markers | |||||
| Neurosurgical head | |||||
| holder | Sterile drapes | ||||
| Fiducial markers | |||||
| Neurosurgical head | |||||
| holder | |||||
| Light source (for | |||||
| visualization) | Sterile drapes | ||||
| Fiducial markers | |||||
| Neurosurgical head | |||||
| holder | |||||
| Surgical microscope | Sterile drapes | ||||
| Fiducial markers | |||||
| Neurosurgical head | |||||
| holder | |||||
| Light source (for | |||||
| visualization) |
4
100 2007 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000
PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE
Page 10 of 45
・
5
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SIMILARITIES AND DIFFERENCES
Similarities
All five devices are intraoperative stereotactic instruments used by neurosurgeons for assisting in the spatial positioning and orientation of a neurosurgical instrument.
ROSA Surgical device is substantially equivalent to:
- the Neuromate, StealthStation and VectorVision devices for assisting the spatial positioning and orientation of an endoscope (neurosurgical instrument).
the cleared ROSA, Neuromate, StealthStation and VectorVision devices concerning the preoperative planning process. All five take as input data CT or MRI DICOM 3.0 medical images. The neurosurgeon performs its preoperative plan by defining entry and target points on 3D and 2D views. Preoperative plan can be performed the day before surgery.
-
the cleared ROSA, StealthStation and VectorVision devices concerning the manual registration processes. It uses the same Image Guided Surgery multi-modality fiducial markers and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.
-
the StealthStation and VectorVision devices with regard to the optical registration processes. It uses the same Image Guided Surgery multi-modality and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.
-
the StealthStation which uses a laser telemeter for the optical registration.
-
the Neuromate device which provides a laser system for the navigation and accuracy verification.
-
the cleared ROSA and Neuromate devices as it provides mechanical guidance for neurosurgical instruments and allows optimal access according to patient anatomy. Both are computer controlled electromechanical multi-jointed arms with factory calibrated instruments.
-
the cleared ROSA Surgical Device as it provides cooperative movement where the surgeon can - the cleared ROOA Ourgour Dowlod in preating field simply by directing the surgical instrument attached to the robot arm.
ROSA Surgical Device combines the planning and registration functionalities of the Neuromate, NOOA Gurgiour Donio combines the pechanical guidance functionality of the cleared ROSA system and Neuromate.
DIFFERENCES
StealthStation and VectorVision devices use a Polaris system (infrared cameras) for locating it Steath Olation and vocuryical and registration instruments held by the surgeon, a localizer is position of the instrument. ROSA and Neuromate devices provide mechanical guidance for attached to the instruments, both are computer controlled electromechanical multijointed arms with embedded sensors to locate the position of instruments.
StealthStation device uses a Polaris system for locating the position of laser telemeter held by the Steath Diation device association. While the VectorVision device uses a Polaris system for locating the position of the laser spot on the patient face.
Neuromate device uses a registration method based on ultrasound measures. Rosa, StealthStation and VectorVision devices provide an optical registration method based on laser measures.
ROSA and Neuromate devices use a mechanical immobilization system between the head holder ROSA and Neuromate devices use a mechanion immobilization one vices provide a localizer attached to the patient head.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtech SAS c/o Ms. Cécile Genevieve Quality Regulation Affairs Manager Parc Euromedecine, Bâtiment 8 1006, rue de la croix verte 34090 Montpellier France
Re: K101791
Trade/Device Name: Rosa Surgical Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 19, 2010 Received: August 23, 2010
Dear Mr. Nahum:
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.
SEP 2 3 2010
7
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Rathm of
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
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Page 5 of 45
4 - INDICATIONS FOR USE
510(k) Number (if known): K101791
2 3 2010
Device Name:
ROSA Surgical Device
ROSA Surgical Device is a computer-controlled electromechanical Indications for Use: arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
Guidance is based on a pre-operative plan developed with threedimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Herman
(Division Sig Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101791