ROSA SURGICAL DEVICE, MODEL ROSA 1.1

K092239 · Medtech S.A · HAW · Nov 17, 2009 · Neurology

Device Facts

• Record ID: K092239
• Device Name: ROSA SURGICAL DEVICE, MODEL ROSA 1.1
• Applicant: Medtech S.A
• Product Code: HAW · Neurology
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

ROSA Surgical Device is a computer-controlled electromechanical arm for OR use; assists neurosurgeons in spatial positioning/orientation of instrument holders or tool guides. Input: preoperative 3D imaging data and fiducial marker registration. Operation: system calculates instrument holder position based on surgical planning parameters; provides mechanical guidance for standard neurosurgical instruments. Features a 'cooperative mode' allowing surgeons to manually move the arm by grabbing the tip for navigation probe collection. Output: stable, accurate, reproducible mechanical guidance. Benefit: assists in precise instrument placement relative to preoperative plans, enhancing surgical accuracy.

Clinical Evidence

No clinical data. Bench testing performed to validate accuracy, repeatability, and compliance with electrical safety and electromagnetic compatibility standards.

Technological Characteristics

Computer-controlled electromechanical arm; stereotaxic instrument (HAW). Operates via 3D imaging software planning and fiducial marker registration. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Software developed per IEC 62304.

Indications for Use

Indicated for any neurosurgical condition where stereotactic surgery is appropriate; intended for use by neurosurgeons.

Regulatory Classification

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.

Predicate Devices

• Frameless Neuromate Stereotactic System (K991081)
• StealthStation Treatment Guidance Platform (K001801)
• BRIGIT Surgical Device (K060556)

Submission Summary (Full Text)

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K092239

Image /page/0/Picture/1 description: The image shows a logo for a company called "Coherent". The logo is black and white and features the company name in a stylized font. Below the company name is the tagline "Innovative Surgical Technology". To the right of the company name is a circular graphic that appears to be a representation of a surgical tool.

## PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

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| 5-510(K) SUMMARY<br>[As Required by 21 CFR 807.92]<br>Summary of Safety and Effectiveness | | |
|-------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Submitter | MedTech S.A<br>Parc Euromédecine Bâtiment 8<br>1006 rue de la Croix Verte<br>34090 Montpellier<br>France<br>NOV 17 2009 |
| | Contact Person | Bertin NAHUM, President<br>Phone number : ([phone]<br>Fax number : ([phone] |
| | Preparation date<br>Revision date | July 21, 2009<br>October 12, 2009<br>November 02, 2009 |
| 2 | Device name | |
| | Trade Name | ROSA Surgical Device |
| | Common Name | Computer-assisted surgical device |
| | Code product and<br>classification name | Stereotaxic Instrument (HAW), 21 CFR Section 882.4560 |
| 3 | Predicate devices | Frameless Neuromate Stereotactic System, manufactured by<br>Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999 |
| | | StealthStation Treatment Guidance Platform, manufactured by<br>Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 |
| | | BRIGIT Surgical Device, manufactured by Zimmer, Inc.,<br>K060556, cleared July 31, 2006 |
| 4 | Description | ROSA Surgical Device is a computer controlled<br>electromechanical arm. It is intended to be used in the<br>operating room for the spatial positioning and orientation of an<br>instrument holder or tool guide. |

Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration.

The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

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Image /page/1/Picture/0 description: The image shows a logo for a company called "Extrac-Tech" with the tagline "Innovative Surgical Technology." The logo features a stylized text design for the company name, with the tagline appearing in smaller font beneath it. To the right of the company name is a circular graphic with a dotted pattern, possibly representing a technological or medical concept.

ROSA Surgical Device assists the neurosurgeon in planning Explanation of how the device operates 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 spatial positions of fiducial markers. 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. ROSA Surgical Device provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with a preoperative planning. Intended use ROSA Surgical Device is a computer-controlled 5 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 registration. The system is intended for use by neurosurgeons to quide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate. Testing was carried out to assure compliance with recognized Performance data 6 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 accuracy and repeatability of the device. Substantial equivalence The technological characteristics, features, specifications, 7 materials, mode of operation, and intended use of the ROSA summary

devices cited above.

The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the ROSA Surgical Device.

Surqical Device are substantially equivalent to the predicate

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MedTech S.A. c/o Mr. Bertin Nahum 10006 Rue de la Croix Verte Parc Euromedecine batiment 8 34090 Montpellier France

NOV 1 7 2009

Re: K092239

Trade/Device Name: ROSA Surgical Device, Model ROSA 1.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: October 12, 2009 Received: October 19, 2009

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.

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

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

RuhRhen, M.D.

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows a logo with the text "BIOTECH" in a stylized font. Below the main text, there is a smaller line of text that reads "INNOVATIVE SURGICAL TECHNOLOGY". The logo also includes a circular graphic element to the right of the text, which appears to be a stylized representation of a cell or a similar biological structure.

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510(k) Number (if known): K092239

Device Name: ROSA Surgical Device

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 threedimensional imaging software, and uses fiducial markers 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)

Rickey Adkins
(Division Director)

Division of Other Official of Otherological and Ear, In
Nose and Throat Devices Nose and Throat Devices

510(k) Number K092239