(93 days)
Not Found
No
The summary describes image processing and navigation capabilities 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 a surgical guidance and navigation system, not one that directly treats a disease or condition for therapeutic purposes.
No
The device is described as assisting with "precise positioning of spinal implants" and tracking "the position of instruments, during spinal surgery." While it uses "diagnostic or intraoperative images," its primary function is surgical navigation and guidance, not the diagnosis of a disease or condition. Its imaging capabilities are for surgical assistance, not diagnostic interpretation by a clinician.
No
The device description and performance studies clearly indicate the Mazor X System includes hardware components (mechanical positioning, surgical arm, accessories) in addition to software for navigation and imaging.
Based on the provided information, the Mazor X device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "precise positioning of spinal implants during general spinal and brain surgery." This describes a surgical guidance and navigation system used during a surgical procedure on a patient's body.
- Device Description: The description focuses on mechanical positioning, tracking of surgical instruments, and displaying their position on images. This is consistent with a surgical navigation system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Mazor X does not perform any such tests on biological samples.
The device utilizes imaging and image processing, but this is for the purpose of guiding surgical instruments in vivo (within the living body), not for analyzing biological samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The Mazor X is indicated for precise positioning of spinal implants during general spinal and brain surgery. It may be used in 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.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
Product codes
OLO, HAW, LLZ
Device Description
The Mazor X System integrates a new Navigation feature, which enables tracking compatible spine instruments. The previously cleared Mazor X System enables mechanical positioning of a tool or instrument and determining its orientation and trajectory. The new Navigation feature tracks the position of compatible surgical instruments in or on the patient anatomy during surgery and continuously updates the instrument position on the image of the patient's anatomy. The modified Mazor X System can operate with or without the Navigation feature.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic projections from standard C-Arms
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
- Mazor X System Accuracy Workflow Validation Test (VV-07444)
The key performance testing to validate the modified Mazor X System navigation feature consisted of navigation accuracy testing. The navigation accuracy validation included testing the overall navigation accuracy under worst-case scenario navigation tool positioning. The overall accuracy under worst-case scenario navigation tool positioning calculated the position and trajectory errors.
Minor modifications were made to the released Mazor X System and accessories and therefore, the following validation tests were conducted:
- Mazor X System Surgical System Test (MCP0721-01)
- · Mazor X System Surgical Arm Test (MCP0695-01)
- · Mazor X System Accuracy (CT-Fluro, Scan & Plan) Tests) (CT-Fluro -MCP0881-01 & Scan & Plan - MCP0882-01)
- · Mazor X System Accessories Tests Summary (MCP0885-01)
- · Cadaver validation activities (GC17021, TP-GC17021)
The tests performed to validate the modifications to the previously cleared Mazor X System included testing the modified Surgical System and the modified Surgical Arm. The modified Mazor X System was also tested to ensure that the software changes did not affect the previously cleared robotic guidance trajectory accuracy (i.e..
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mazor Robotics Ltd. % Ahava Stein Regulatory Affairs Consultant A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as St. Kfar Saba, 44425 Il
November 2, 2018
Re: K182077
Trade/Device Name: Mazor X System (Mazor X Stealth Edition) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: July 23, 2018 Received: August 1, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The name "Jesse Muir -S" is displayed twice, once as the name and once as the signer. The date of the signature is November 2nd, 2018, and the time is 11:25:49 -04'00'.
by Jesse Muir -S
Date: 2018.11.02
11:25:49 -04'00'
For: 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) K182077
Device Name Mazor X System (Mazor X Stealth Edition)
Indications for Use (Describe)
Indications for Use The Mazor X is indicated for precise positioning of spinal implants during general spinal and brain surgery. It may be used in 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.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
K182077
(Premarket Notification [510(k)] Number)
Submitter Information 1.
| 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 |
Date Prepared: July 24, 2018 2.
3. Device Name Mazor X
| Proprietary Name: | Mazor X System (Mazor X Stealth Edition) |
|---|---|
| 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 device:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics Ltd. | Mazor X System | K180307 | April 30, 2018 |
| Medtronic | StealthStation System with | K170011 | May 1, 2017 |
| Navigation Inc. | the S8 Spine Software | and | |
| K162309 | March 31, 2017 |
4
5. Device Description
The Mazor X System integrates a new Navigation feature, which enables tracking compatible spine instruments. The previously cleared Mazor X System enables mechanical positioning of a tool or instrument and determining its orientation and trajectory. The new Navigation feature tracks the position of compatible surgical instruments in or on the patient anatomy during surgery and continuously updates the instrument position on the image of the patient's anatomy. The modified Mazor X System can operate with or without the Navigation feature.
Indications for Use 6.
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.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Mazor X.
Performance Testing 8.
The following performance tests were conducted on the modified Mazor X System with the Navigation feature.
5
- Mazor X System Accuracy Workflow Validation Test (VV-07444)
The key performance testing to validate the modified Mazor X System navigation feature consisted of navigation accuracy testing. The navigation accuracy validation included testing the overall navigation accuracy under worst-case scenario navigation tool positioning. The overall accuracy under worst-case scenario navigation tool positioning calculated the position and trajectory errors.
Minor modifications were made to the released Mazor X System and accessories and therefore, the following validation tests were conducted:
- Mazor X System Surgical System Test (MCP0721-01)
- · Mazor X System Surgical Arm Test (MCP0695-01)
- · Mazor X System Accuracy (CT-Fluro, Scan & Plan) Tests) (CT-Fluro -MCP0881-01 & Scan & Plan - MCP0882-01)
- · Mazor X System Accessories Tests Summary (MCP0885-01)
- · Cadaver validation activities (GC17021, TP-GC17021)
The tests performed to validate the modifications to the previously cleared Mazor X System included testing the modified Surgical System and the modified Surgical Arm. The modified Mazor X System was also tested to ensure that the software changes did not affect the previously cleared robotic guidance trajectory accuracy (i.e..