(230 days)
Not Found
No
The summary describes image processing and guidance capabilities but does not mention AI, ML, or related terms, nor does it describe the characteristics of an AI/ML model (training/test sets, performance metrics like AUC).
No
The Renaissance X System is a guidance system used for precise positioning of surgical instruments or implants and for intraoperative 3D image processing during spinal surgery. It does not directly treat or cure a disease or condition, which is the primary function of a therapeutic device.
No
The device is indicated for positioning surgical instruments and implants and provides intraoperative imaging for guidance, which are functions related to surgical assistance and navigation rather than diagnosis.
No
The device description and performance studies clearly indicate the Renaissance X System includes hardware components (e.g., mechanical integrity testing, collision avoidance testing, integrated system testing) in addition to software.
Based on the provided information, the Renaissance X System is not an IVD (In Vitro Diagnostic) device.
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.
- Renaissance X System's Function: The Renaissance X System is used for surgical guidance and positioning of instruments or implants during spinal surgery. It processes medical images (fluoroscopy, CT) to aid the surgeon in the operating room. It does not analyze biological specimens.
The device's function is clearly focused on intraoperative surgical assistance based on medical imaging, not on analyzing samples taken from the patient's body.
N/A
Intended Use / Indications for Use
The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Renaissance X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
Product codes
OLO, HAW, LLZ
Device Description
The Renaissance X System hosts guidance for spine procedures and intraoperative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Renaissance X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. With the imaging capabilities of the system the user can also visualize the implants on the patients CT.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic projections from standard C-Arms, CT scan, 3D image uploaded from an external 3D image acquiring system
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrate that the modified software version meets its design requirements.
- Accuracy and Repeatability Testing - these tests demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required.
- Rigidity Testing - these tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins.
- Collision Avoidance Testing - these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract design featuring three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2014
Mazor Robotics Ltd. % Ahava Stein Regulatory Consultant A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as St. (Beit Hapaamon, Suite 102) Kfar Saba 44425 Israel
Re: K140167
Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: August 3, 2014 Received: August 11, 2014
Dear Ahava Stein:
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
1
(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 (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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INDICATIONS FOR USE
K140167 510(k) Number (if known):
Device Name:
Renaissance System
Indications for Use:
The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Renaissance X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
Prescription Use V (Per 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
K140167
(Premarket Notification [510(k)] Number)
1. Submitter Information Manufacturer Name and Address Official Correspondent Mazor Robotics Ltd. Ahava Stein PO Box 3104, A. Stein - Regulatory Affairs Consulting Ltd. 7 HaEshel St., 20 Hata'as St. (Beit Hapaamon, Suite 102) Caesarea Park South 38900, Kfar Saba 44425, Israel Israel 2. Date Prepared: July 28, 2014 3. Device Name Renaissance X System Proprietary Name: Renaissance X System Common Name: Combination of: Spinal/Orthopedic Stereotaxic instrument; and 1. 2. System, Image Processing, Radiological FDA Classification 21 CFR 882.4560; Stereotaxic instrument Name:
FDA Classification: Class II, Product Code OLO, HAW and LLZ
4. Predicate Devices
The Renaissance System is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Renaissance System | K113228 | December 1, 2011 |
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ട്. Device Description
The Renaissance X System hosts guidance for spine procedures and intraoperative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Renaissance X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. With the imaging capabilities of the system the user can also visualize the implants on the patients CT.
Indications for Use 6.
The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Renaissance X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Renaissance X System.
8. Performance Testing
The following Performance tests were performed on the Renaissance X System:
- Software validation testing in accordance with the FDA Guidance for the ● Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrate that the modified software version meets its design requirements.
- . Accuracy and Repeatability Testing - these tests demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required.
- Rigidity Testing - these tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins.
- . Collision Avoidance Testing - these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation.
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Technological Characteristics Compared to Predicate Device 9.
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the modified Renaissance X System are substantially equivalent to the predicate device cited above.