(139 days)
No
The summary describes image processing and surgical planning capabilities but does not mention AI, ML, or related terms. The performance studies focus on software validation and measurement comparison, not AI/ML model performance.
No.
The device is used for precise positioning of surgical implants and instruments, and for 3D imaging, but it does not directly treat a disease or condition. It is a tool for surgical guidance rather than a therapeutic intervention itself.
No
The device is described as a system for precise positioning of surgical instruments and implants, planning surgical procedures, and visualizing implants, rather than for diagnosing medical conditions. While it uses imaging, its purpose is for surgical guidance and not diagnosis.
No
The device description explicitly states that the Mazor X enables the surgeon to precisely position surgical instruments and/or implants, indicating it is a robotic or guided surgical system that includes hardware components beyond just software. It also mentions "accurate deployment of surgical accessories," further supporting the presence of hardware.
Based on the provided information, the Mazor X is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Mazor X is for "precise positioning of surgical implants during general spinal and brain surgery." This is a surgical guidance and planning system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on enabling surgeons to "precisely position surgical instruments and/or implants," "guidance for spine and brain procedures," and "planning of the surgical procedure." These are all related to surgical intervention and planning, not laboratory testing or analysis of biological samples.
- Input Imaging Modality: While it uses imaging data (fluoroscopic projections, CT scans, 3D images), this data is used for surgical planning and guidance, not for diagnostic purposes in the IVD sense.
- Anatomical Site: The focus is on the spinal and brain anatomy for surgical procedures.
- Intended User: The intended users are surgeons and clinicians, who are performing surgical procedures.
- Performance Studies: The performance studies mentioned are software validation and measurement comparison, which are relevant to the functionality and accuracy of a surgical guidance system, not the performance metrics typically associated with IVD devices (like sensitivity, specificity, etc.).
In summary, the Mazor X is a surgical guidance and planning system, not a device used for in vitro examination of biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Mazor 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 Mazor X enables the surgeon to precisely position surgical instruments and/or implants (in spinal and brain surgery). The Mazor X enables guidance for spine and brain procedures and intra-operative 3D image processing capabilities. 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 Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X 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 Mazor X is a device modification of the original Renaissance X System cleared in 510(k) K152041.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic projections from standard C-Arms, patient's CT scan, Mazor X 3D Scan image, 3D image uploaded from an external 3D image acquiring system.
Anatomical Site
Spinal and brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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) and the IEC 62304 standard for Medical Device Software - Software Life Cycle Processes. The software validation tests demonstrate that the modified software version meets its design requirements.
- Measurement Comparison testing comparison testing of the X Align module and the . Surgimap measurement calculations.
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 symbol that resembles a caduceus, featuring three abstract human profiles connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Mazor Robotics Ltd. % Ahava Stein Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hatas St., (Beit Hapaamon, Suite 102) Kfar Saba. IL 4442520
Re: K163221
Trade/Device Name: Mazor X Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: March 8, 2017 Received: March 13, 2017
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Mazor X
vice Name
zor X
Indications for Use (Describe)
The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Mazor 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.
| 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) |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K163221
(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 and Moshe Rosenberg |
| A. Stein - Regulatory Affairs Consulting Ltd. | |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) | |
| Kfar Saba 4442520, | |
| Israel |
-
- Date Prepared: November 13, 2016
-
- Device Name Mazor X
| Proprietary Name: | Mazor X |
|---|---|
| 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 Mazor X is substantially equivalent to the following devices:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Renaissance X System | K152041 | November 17, 2015 |
| Nemaris Inc. | Surgimap | K111019 | September 30, 2011 |
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5. Device Description
The Mazor X enables the surgeon to precisely position surgical instruments and/or implants (in spinal and brain surgery). The Mazor X enables guidance for spine and brain procedures and intra-operative 3D image processing capabilities. 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 Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X 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 Mazor X is a device modification of the original Renaissance X System cleared in 510(k) K152041.
6. Indications for Use
The Mazor X 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.
Mazor 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 Mazor X.
8. Performance Testing
The following Performance tests were performed on the Mazor X:
- Software validation testing in accordance with the FDA Guidance for the Premarket . Submissions for Software Contained in Medical Devices (May 11, 2005) and the IEC
5
62304 standard for Medical Device Software - Software Life Cycle Processes. The software validation tests demonstrate that the modified software version meets its design requirements.
- Measurement Comparison testing comparison testing of the X Align module and the . Surgimap measurement calculations.
Technological Characteristics Compared to Predicate Device 9.
The differences in the software do not adversely affect the safety, effectiveness or performance of the Mazor X. The Mazor X was tested according to the aforementioned validation and performance tests (detailed in section 8) and found compliant.
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the Mazor X are substantially equivalent to the predicate devices cited above.
10. Conclusion
The performance testing and comparison to the predicate devices demonstrate that the Mazor X is as safe, as effective and performs as well as the legally marketed Renaissance X System and Surgimap predicate devices. Therefore, the Mazor X is substantially equivalent to the predicate devices and may be cleared for marketing.