(117 days)
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.
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.
The ROSA Surgical Device is a computer-controlled electromechanical arm intended for the spatial positioning and orientation of an instrument holder or tool guide in neurosurgery. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial marker registration.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Repeatability | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Electrical Safety | Compliance with IEC 60601-1 standard for electrical safety. | "Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety..." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard for electromagnetic compatibility. | "...and IEC 60601-1-2 standard for electromagnetic compatibility." |
| Software Regulations | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process). | "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)." |
2. Sample Size and Data Provenance
The provided text does not explicitly state a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Device performance tests were performed," but no details on the specifics of these tests are given.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not specify the number or qualifications of experts used to establish ground truth for any testing.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The submission focuses on the performance of the device itself, not on human-in-the-loop performance or the effect size of AI assistance on human readers.
6. Standalone Performance Study
Yes, the information implies a standalone (algorithm only without human-in-the-loop performance) study was done. The "Device performance tests" focused on validating the "accuracy and repeatability of the device" itself, suggesting an evaluation of the system's inherent performance.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given the nature of a computer-controlled electromechanical arm for spatial positioning and orientation, it is highly likely that the ground truth for "accuracy and repeatability" would be established through precision measurements and validated spatial references within a controlled environment, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.
8. Sample Size for the Training Set
The provided text does not state the sample size for the training set. It refers to "pre-operative planning developed with three-dimensional imaging software," which would require data for algorithm training, but no details are given.
9. How Ground Truth for the Training Set Was Established
The provided text does not describe how ground truth for the training set was established. The device uses "fiducial markers registration" and "three-dimensional imaging software" for planning, which implies that the training data would be related to accurate spatial mapping and image processing, but the method of establishing their ground truth is not detailed.
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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[As Required by 21 CFR 807.92]Summary of Safety and Effectiveness | ||
|---|---|---|
| 1 | Submitter | MedTech S.AParc Euromédecine Bâtiment 81006 rue de la Croix Verte34090 MontpellierFranceNOV 17 2009 |
| Contact Person | Bertin NAHUM, PresidentPhone number : (+33) 467 107 740Fax number : (+33) 467 597 418 | |
| Preparation dateRevision date | July 21, 2009October 12, 2009November 02, 2009 | |
| 2 | Device name | |
| Trade Name | ROSA Surgical Device | |
| Common Name | Computer-assisted surgical device | |
| Code product andclassification name | Stereotaxic Instrument (HAW), 21 CFR Section 882.4560 | |
| 3 | Predicate devices | Frameless Neuromate Stereotactic System, manufactured byIntegrated Surgical Systems, Inc., K991081, cleared June 25, 1999 |
| StealthStation Treatment Guidance Platform, manufactured byMedtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000 | ||
| BRIGIT Surgical Device, manufactured by Zimmer, Inc.,K060556, cleared July 31, 2006 | ||
| 4 | Description | ROSA Surgical Device is a computer controlledelectromechanical arm. It is intended to be used in theoperating room for the spatial positioning and orientation of aninstrument 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 (800) 638-2041 or (301) 796-7100 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
§ 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).