(118 days)
No
The summary describes image processing and surgical guidance but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is indicated for precise positioning of surgical instruments or spinal implants and for generating 3D imaging, which are functions related to surgical guidance and imaging, not direct treatment of a disease or condition.
No
The device is primarily indicated for precise positioning of surgical instruments or spinal implants and for generating 3D images from 2D fluoroscopic projections, which are functions related to surgical guidance and imaging for procedure planning, rather than diagnosing a disease or condition.
No
The device description and performance studies mention "mechanical integrity" and "system's design," implying hardware components beyond just software. The predicate devices are also described as "systems," further suggesting hardware is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "precise positioning of surgical instruments or spinal implants during general spinal and brain surgery." This is a surgical guidance and navigation system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on surgical planning, instrument positioning, and imaging capabilities for visualization during surgery. It does not mention analyzing biological samples.
- Input: The inputs are imaging modalities (fluoroscopy, CT, 3D images), not biological specimens like blood, urine, or tissue.
- Anatomical Site: The device is used on the patient's body (spinal and brain), not on samples taken from the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic or other health information. This device's function is to assist in surgical procedures using imaging and navigation.
N/A
Intended Use / Indications for Use
The Renaissance X System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain 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 prom 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 modified Renaissance X System hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). 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. The modified Renaissance X System enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The modified Renaissance X System is a device modification of the original Renaissance X System cleared in 510(k) K140167 and the original Renaissance System with Brain Application cleared in 510(k) K120812.
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, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician; general spinal and brain surgery settings (open, minimally invasive, or percutaneous procedures).
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)
The following Performance tests were performed on the modified 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.
- Stability Testing - these tests demonstrate the mechanical integrity of the modified Renaissance X System. The results show that the system's design meets the functional requirements of the system with the same safety margins as the predicate devices.
- Usability Testing - these tests demonstrate that the Renaissance X System has maintained the required usability, as specified in the device design requirements. These tests have established that the system is easy to use, that the surgical procedure can be completed successfully without any interruptions, problems, safety or other issues.
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).
0
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Mazor Robotics Ltd. % Moshe Rosenberg Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. (POB 124) Kfar Saba, 4442520 ISRAEL
Re: K152041
Trade/Device Name: Renaissance X System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: September 24, 2015 Received: October 5, 2015
Dear Moshe Rosenberg:
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 (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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152041
Device Name Renaissance X System
Indications for Use (Describe)
The Renaissance X System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain 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 prom 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.
| 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."
3
SUMMARY OF SAFETY AND EFFECTIVENESS
(Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name and Address | Mazor Robotics Ltd. |
|---|---|
| PO Box 3104, | |
| 7 HaEshel St., | |
| Caesarea Park South 3088900, | |
| Israel | |
| Official Correspondent | Ahava Stein |
| A. Stein - Regulatory Affairs Consulting Ltd. | |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) | |
| Kfar Saba 4442520 | |
| Israel |
-
- Date Prepared: September 24, 2015
3. Device Name Renaissance X System
| Proprietary Name: | Renaissance X System |
|---|---|
| Common Name: | Combination of: |
- Stereotaxic instrument; and
- System, Image Processing, Radiological |
| FDA Classification Name: | 21 CFR 882.4560; Stereotaxic instrument |
FDA Classification: Class II, Product Code OLO, HAW and LLZ
4. Predicate Devices
The modified Renaissance X System is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Renaissance X System | K140167 | September 10, 2014 |
| Mazor Robotics Ltd. | Renaissance System with | ||
| Brain Application | K120812 | July 12, 2012 |
4
5. Device Description
The modified Renaissance X System hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). 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. The modified Renaissance X System enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The modified Renaissance X System is a device modification of the original Renaissance X System cleared in 510(k) K140167 and the original Renaissance System with Brain Application cleared in 510(k) K120812.
Indications for Use 6.
The modified Renaissance X System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain 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.
Performance Standards 7.
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the modified Renaissance X System.
Performance Testing 8.
The following Performance tests were performed on the modified Renaissance X System:
21
21
5
- 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.
- . Stability Testing - these tests demonstrate the mechanical integrity of the modified Renaissance X System. The results show that the system's design meets the functional requirements of the system with the same safety margins as the predicate devices.
- Usability Testing these tests demonstrate that the Renaissance X System has . maintained the required usability, as specified in the device design requirements. These tests have established that the system is easy to use, that the surgical procedure can be completed successfully without any interruptions, problems, safety or other issues.
9. Technological Characteristics Compared to Predicate Device
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 devices cited above.