(25 days)
Not Found
No
The summary describes image processing and surgical guidance capabilities but does not mention AI, ML, or related terms. The focus is on precise positioning and 3D image conversion, which are not inherently AI/ML functions.
No
The device is indicated for precise positioning of surgical instruments or spinal implants and 3D imaging capabilities, not for directly treating a disease or condition.
No
The device is indicated for precise positioning of surgical instruments or spinal implants and for generating 3D imaging from 2D fluoroscopic projections for surgical guidance, not for diagnosing a disease or condition. While it processes images, its primary purpose is for surgical planning and navigation, not diagnosis.
No
The device description explicitly mentions "The Mazor X 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...". This indicates the device includes hardware components for guidance and positioning, not just software.
Based on the provided information, the Mazor X device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Mazor X Function: The Mazor X is a surgical guidance system. Its primary function is to assist surgeons in precisely positioning instruments and implants during spinal and brain surgery. It uses imaging data (CT, fluoroscopy, 3D scans) to plan and guide the surgical procedure.
- No Specimen Analysis: The description of the Mazor X does not mention any analysis of specimens taken from the patient's body. It works directly with imaging data and the patient's anatomy during surgery.
Therefore, the Mazor X falls under the category of a surgical guidance or robotic system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mazor X is indicated for precise posical instruments or spinal implants during general spinal and brain surgerv. 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 (comma separated list FDA assigned to the subject device)
OLO, HAW, LLZ
Device Description
The Mazor X 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 intraoperative 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic projections from standard C-Arms, 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; general spinal and brain surgery 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)
No additional performance tests were required for the modified Mazor X system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mazor Robotics Ltd. % Ahava Stein Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St., Beit Hapaamon Suite 102 Kfar Saba, 4442520 Israel
Re: K172522
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: August 16, 2017 Received: August 21, 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
Image /page/0/Picture/10 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 to the right, with flowing lines connecting them.
September 15, 2017
1
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 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 (DICE) 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 (DICE) 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
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)
Device Name Mazor X
Indications for Use (Describe)
The Mazor X is indicated for precise posical instruments or spinal implants during general spinal and brain surgerv. It mav 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)
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
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FORM FDA 3881 (8/14)
3
SUMMARY OF SAFETY AND EFFECTIVENESS
(Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name and Address | Mazor Robotics Ltd. |
|---|---|
| PO Box 3104, | |
| 5 Shacham St., | |
| Caesarea Park North 3088900, | |
| Israel |
| Official Correspondent | Ahava Stein |
|---|---|
| A. Stein – Regulatory Affairs Consulting Ltd. | |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) | |
| Kfar Saba 4442520, | |
| Israel |
| 2. Date Prepared: | August 16, 2017 |
|---|---|
| ------------------- | ----------------- |
| 3. 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 |
Class II, Product Code OLO, HAW and LLZ FDA Classification:
Predicate Devices 4.
The Mazor X is substantially equivalent to the following device:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Mazor X System | K163221 | April 04, 2017 |
| MedTech Inc. | Rosa Surgical System | K101791 | September 23, 2010 |
| MedTech Inc. | Rosa Spine System | K151511 | January 4, 2016 |
4
Device Description 5.
The Mazor X 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 intraoperative 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.
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.
7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Mazor X.
5
8. Performance Testing
No additional performance tests were required for the modified Mazor X system:
Technological Characteristics Compared to Predicate Device 9.
The modifications do not adversely affect the safety, effectiveness and performance of the Mazor X system. The intended use and technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc. of the Mazor X system are substantially equivalent to the predicate devices cited above.
Conclusion 10.
The comparison to the predicate devices demonstrate that the Mazor X system is substantially equivalent to the predicate devices.