Mazor X

K172522 · Mazor Robotics , Ltd. · OLO · Sep 15, 2017 · Neurology

Device Facts

• Record ID: K172522
• Device Name: Mazor X
• Applicant: Mazor Robotics , Ltd.
• Product Code: OLO · Neurology
• Decision Date: Sep 15, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

Mazor X provides surgical guidance and intra-operative 3D imaging for spinal and brain procedures. System inputs include pre-operative CT scans, intra-operative 3D scans, or 2D fluoroscopic projections from standard C-Arms. The device processes these inputs to generate volumetric 3D images and enables virtual planning of instrument or implant placement. During surgery, the system guides the precise positioning of surgical accessories according to the pre-defined plan. Used in OR settings by surgeons; output visualized on system display to assist in accurate anatomical targeting. Benefits include enhanced surgical precision and visualization of implants relative to patient anatomy.

Clinical Evidence

No clinical data provided. Performance testing statement indicates no additional performance tests were required for the modified system.

Technological Characteristics

Stereotaxic instrument and image processing system. Features 3D imaging capability via conversion of 2D fluoroscopic projections. Supports pre-operative CT and intra-operative 3D image planning. Connectivity includes integration with external 3D image acquiring systems and standard C-Arms.

Indications for Use

Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery in open, minimally invasive, or percutaneous procedures; also indicated for processing 2D fluoroscopic projections into volumetric 3D images for high-contrast objects.

Regulatory Classification

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.

Predicate Devices

• Mazor X System (K163221)
• Rosa Surgical System (K101791)
• Rosa Spine System (K151511)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

K172522

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.

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FORM FDA 3881 (8/14)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

K172522

(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:<br>1. Stereotaxic instrument; and<br>2. 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 |

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#### 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.

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#### 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.