(214 days)
Not Found
No
The description focuses on computer-controlled electromechanical guidance based on pre-operative planning and registration, without mentioning adaptive learning, pattern recognition beyond basic spatial calculations, or any terms associated with AI/ML. The performance studies also focus on mechanical accuracy and navigation, not AI/ML performance metrics.
No.
The device is strictly for guiding surgical instruments and positioning, it does not directly treat or diagnose.
No
The device is an electromechanical arm designed for guiding surgical instruments during spine surgery, not for diagnosing medical conditions.
No
The device description explicitly states it is a "computer controlled electromechanical arm," 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is a computer-controlled electromechanical arm used for the spatial positioning and orientation of surgical instruments during spine surgery. It guides the surgeon based on intra-operative imaging and planning.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely related to surgical guidance and instrument positioning within the body.
Therefore, the ROSA Spine device falls under the category of a surgical guidance system or robotic surgical assistant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
Product codes
OLO
Device Description
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D intra-operative exam
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon
Orthopedic surgeon
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
Not Found
Summary of Performance Studies
Device performance tests were performed to validate the absolute accuracy and repeatability of the robot arm, the application accuracy of the device, and the navigation accuracy according to ASTM F2554-10. Testing were conducted on cadaveric specimens in a simulated clinical environment to evaluate the device safety and effectiveness (clinical performance).
Software Verification and Validation Testing:
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern, since a failure of the software could result in serious injury or death to the patient.
Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:
- . Code walkthroughs
- Unit test reports ●
- . Integration test reports
- . System test reports
- Overall software test report .
- Verification test reports
- Overall software verification report ●
Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirements according to the Software Verification Plan. Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA Spine device.
Key Metrics
- Robot absolute accuracy:
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2016
Medtech S.A. Ms. Colette Maurin Regulatory Affairs Director ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, Lamguedoc-Rousillon FRANCE
Re: K151511
Trade/Device Name: ROSA Spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2015 Received: December 16, 2015
Dear Ms. Maurin:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
TRADITIONAL 510(K) PREMARKET NOTIFICATION ROSA SPINE
Page 7/63
4 - INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151511
Device Name ROSA Spine
Indications for Use (Describe)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle serews in lumbar vertebrae with a posterior approach
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Jhevines (1005/903-163-676) (16)
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Image /page/3/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
I SUBMITTER
Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel +33 (0)4 67 10 77 40 Fax +33 (0)4 67 59 74 18
Contact Person: Colette Maurin Regulatory Affairs Director c.maurin@medtechsurgical.com
Date prepared: December 31, 2015
II DEVICE
Name of device: ROSA Spine Common Name: Computer-assisted surgical device Classification name: Stereotaxic Instrument (21CFR 882.4560) Regulatory class: II Code product: OLO
III PREDICATE DEVICE
ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010
StealthStation System, manufactured by Medtronic Navigation Inc., K133444, cleared July 25, 2014
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IV DEVICE DESCRIPTION
ROSA Spine is a computer controlled electromechanical arm providing guidance of neurosurgical instruments during spinal surgery.
ROSA Spine assists the surgeon in planning the position of instruments relative to intraoperative images.
Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
ROSA Spine provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with an intraoperative planning.
V INDICATIONS FOR USE
ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool quides to be used by surgeons to quide standard neurosurgical instruments during spine surgery.
Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans.
The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach
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Image /page/5/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Predicate Devices | Subject Device | ||||
|---|---|---|---|---|---|
| Device | ROSA Surgical Device | StealthStation System | ROSA Spine | ||
| (K101791) | (K133444) | (Submission subject) | |||
| Device description and indications for use | |||||
| Indications for use | 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. | Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone or a vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. | ROSA Spine is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach | ||
| Where used | Operating room | Operating room | Operating room | ||
| User | Neurosurgeon | Neurosurgeon | |||
| Orthopedic surgeon | Neurosurgeon | ||||
| Orthopedic surgeon | |||||
| General device description | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | Navigation system helping the surgeon in manual guidance of navigated neurosurgical instruments | Computer controlled electromechanical arm providing guidance of neurosurgical instruments | ||
| Anatomical site | Head | Head, spine | Spine | ||
| Surgical approach | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | Open, minimally invasive or percutaneous | ||
| Technology | |||||
| Principle of operation | - Preoperative images; |
- Surgical planning;
- Patient registration;
- Guidance of instruments | For Spine application:
- Intraoperative images;
- Patient registration;
- Surgical planning;
- Real-time tracking of navigated instruments | - Intraoperative images;
- Patient registration;
- Surgical planning;
- Guidance of instruments;
- Real-time tracking of navigated instruments | | |
| Input images | 3D pre-operative exam | 3D pre-operative exam
3D intra-operative exam
2D intra-operative exam | 3D intra-operative exam | | |
| DICOM compliance | Yes | Yes | Yes | | |
| Integrated planning Software | ROSANNA (Medtech) | Synergy Spine software
(Medtronic) | ROSANNA SPINE (Medtech) | | |
| Save/load planning | Yes | Yes | Yes | | |
| Merge images functionality | Yes | Yes | Yes | | |
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Image /page/6/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys the company's focus on technology and innovation.
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Device | ROSA Surgical Device | ||
| (K101791) | StealthStation System | ||
| (K133444) | ROSA Spine | ||
| (Submission subject) | |||
| Trajectory | |||
| planning | |||
| parameters | Entry point, target point, | ||
| length of the instrument, | |||
| diameter | Entry point, target point, length | ||
| of the instrument, diameter | Entry point, target point, length | ||
| of the instrument, diameter | |||
| Localization | |||
| means | Robot arm absolute | ||
| encoders | Optical system (infrared | ||
| camera) | |||
| or electromagnetic system | Robot arm absolute encoders |
- optical system (infrared
camera) |
| Image-guided | Yes | Yes | Yes |
| Controller | Axis controller for each joint
Kinematic transformation
between the Cartesian
space and joint space
Supervisor module | No controller -
The instrument is manually
positioned by the surgeon | Axis controller for each joint
Kinematic transformation
between the Cartesian space
and joint space
Supervisor module |
| Patient
registration
method | Fiducial markers (skin)
Optical registration device | Point-to-point registration with
anatomical markers | 3D registration with X-Ray
pattern containing radio-opaque
markers |
| Accuracy
verification on
anatomical
landmarks | Yes (probe, laser beam) | Yes (probe) | Yes (probe) |
| Laser class for
optical system | Class 2 laser
Wavelength - 650 nm,
Maximum output - 1 mW
(complies with 21 CFR
1040.10) | Class 2 laser
Wavelength - 635 nm,
Maximum output - 1 mW
(complies with 21 CFR
1040.10) | Class 2 laser
Wavelength - 635 nm,
Maximum output - 1 mW
(complies with 21 CFR
1040.10) |
| Real time
display of the
instrument
position | Yes | Yes | Yes |
| Provide
guidance for
instruments | Yes - Instruments are
mounted onto the robot
arm. The guidance is
robotized. | No - The instrument is manually
positioned by the surgeon. | Yes - Instruments are mounted
onto the robot arm. The
guidance is robotized. |
| Surgeon
carries out the
final gesture | Yes - through the
instrument guide | Yes - the surgeon holds the
instrument | Yes - through the instrument
guide |
| Instrument | Instrument holder,
endoscope holder and
adaptors, optical sensor | Navigated instruments | Instrument holder, cannula,
adaptors, navigated
instruments |
| Instrument
calibration
method | Factory calibration | Factory calibration | Factory calibration |
| Associated
equipment | 3D imaging system
● Fiducial markers
● Head holder
● Endoscope
● Stereovision system
● 3D visualization
● headset
● Light source | 3D/2D imaging system
● Retro-reflective sterile
● spheres
● Implants and
instrumentation | 3D imaging system
● Retro-reflective sterile
● spheres
● Implants and
instrumentation |
| Patient
immobilization | Yes - The device is
attached to the head holder
via an adaptor. | No - a reference is fixed in the
patient's iliac crest or clamped
on the patient's spinous for
tracking system | No - a reference is fixed in the
patient's iliac crest for tracking
system |
| Device
mobility | Yes - mobile stand with
wheels, immobilized with
stabilization feet | Yes - mobile stands with
wheels; Stands immobilized
with wheels brakes | Yes - mobile stands with
wheels; Robot stand
immobilized with stabilization |
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Image /page/7/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Device | ROSA Surgical Device | ||
| (K101791) | StealthStation System | ||
| (K133444) | ROSA Spine | ||
| (Submission subject) | |||
| feet and camera stand | |||
| immobilized with wheels brakes | |||
| Sterility | Non-sterile and sterile | ||
| instruments | |||
| Disposable sterile drapes | |||
| on device | Non-sterile and sterile | ||
| instruments | |||
| Disposable sterile drapes on | |||
| device | Non-sterile and sterile | ||
| instruments | |||
| Disposable sterile drapes on | |||
| device | |||
| Power supply | 110 V | 115 V | 115 V |
| Footprint | Robot stand ≈ 91cm × 66cm | Surgeon cart ≈ 60cm x 63cm | |
| Staff cart ≈ 58cm x 61cm | Robot stand ≈ 121cm × 65cm | ||
| Camera stand ≈ 81cm x 76cm | |||
| Performance | |||
| - Robot | |||
| absolute | |||
| accuracy |
- Robot
repeatability |