SPINEASSIST DEVICE

K033413 · Mazor Surgical Technologies , Ltd. · HAW · Jan 7, 2004 · Neurology

Device Facts

• Record ID: K033413
• Device Name: SPINEASSIST DEVICE
• Applicant: Mazor Surgical Technologies , Ltd.
• Product Code: HAW · Neurology
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.

Device Story

SpineAssist is a miniature image-guided surgery (IGS) system for spinal stabilization. Inputs: preoperative fluoroscopic and CT images. Operation: software processes images via proprietary algorithms to generate a surgical plan; system exports coordinates to a Miniature Surgical Guidance (MSG) unit; MSG attaches directly to the patient's bone and positions an articulating arm and tool guide. Output: physical guidance for handheld surgical tools along pre-planned trajectories. Used in clinical settings by surgeons. Benefit: provides precise spatial positioning and orientation of surgical tools during spinal procedures, enhancing accuracy and accessibility.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing for electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2), software validation (IEC 60601-1-4), and device accuracy/repeatability performance testing.

Technological Characteristics

Miniature surgical guidance system comprising a planning system, workstation, and MSG unit. Attaches to bone. Software-controlled articulating arm for tool guidance. Complies with EN 60601-1 (electrical safety), EN 60601-1-2 (EMC), and IEC 60601-1-4 (software).

Indications for Use

Indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. No specific patient population age or gender restrictions provided.

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

• Neuromate (K963256, K991081)
• Vector Vision (K010968, K021306)
• Navitrack (K981315, K031156)

Submission Summary (Full Text)

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## SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

### Applicant:

Mazor Surgical Technologies Ltd. 7 HaEshel Str. P.O.B. 3104 Southern Caesarea Industrial Park 38900 ISRAEL Tel: [phone] Fax: [phone]

#### Corresponding Official:

Ahava Stein, Consultant Name: Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Ticl: [phone] Fax: [phone]

| Device Name: | SpineAssist Device |
|-----------------------------------|---------------------------------------------------|
| Device trade or proprietary name: | SpineAssist Device |
| Common Name: | Surgical Navigation System / Image Guided Surgery |
| Classification Name: | Stereotaxic Instrument, 21 CFR Section 882.4560 |

#### Description of the Device:

The SpineAssist device is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based preoperative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the MSG, which positions its articulating arm and tool guide. Through the bone-attaching procedure, the SpineAssist device attaches to the bone on which

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the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.

The main components of the SpineAssist device include:

- A. Planning System;
- B. Workstation; and
- C. Miniature Surgical Guidance System MSG

#### Intended Use:

The SpineAssist is indicated for precise positioning of surgical instruments during spinal stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.

#### Performance Data:

Testing was carried out to assure compliance with recognized electrical safety standards. Mazor Surgical Technologies has certified compliance with the EN 60601-1 standard for electrical safety and compliance with the EN 60601-1-2 standard for electromagnetic compatibility. Tests were also carried out to satisfy the requirements of the IEC 60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices. Additional device performance tests were performed to validate the accuracy and repeatability of the device.

#### Predicate Device:

The SpineAssist device is substantially equivalent to a combination of the following devices. Device names, manufacturers and 510(k) numbers are designated in the following table.

| Device | Manufacturer | Type of Device | 510(k) Number |
|---------------|-------------------------------------|------------------------|------------------|
| Neuromate | Brainlab AG | Stereotaxic Instrument | K963256, K991081 |
| Vector Vision | Integrated Surgical<br>Systems Inc. | Stereotaxic Instrument | K010968, K021306 |
| Navitrack | OrthoSoft Inc. | Stereotaxic Instrument | K981315, K031156 |

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C033413

### 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 intended use of the SpineAssist device are substantially equivalent to the predicate devices cited above. The differences that exist between the devices, relative to the technical specifications do not raise new issues of safety or effectiveness regarding the SpineAssist device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mazor Surgical Technologies Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. (Room 213) 44425 Kfar Saba

Re: K033413

Israel

Trade/Device Name: SpineAssist Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 22, 2003 Received: November 4, 2003

Dear Ms. 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.

JAN - 7 2004

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CHR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ahava Stein

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part.801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K033413

Device Name:

SpineAssist Device

Indications For Use:

The SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K033413