SPINEASSIST SYSTEM

K063607 · Mazor Surgical Technologies , Ltd. · HAW · Aug 23, 2007 · Neurology

Device Facts

• Record ID: K063607
• Device Name: SPINEASSIST SYSTEM
• Applicant: Mazor Surgical Technologies , Ltd.
• Product Code: HAW · Neurology
• Decision Date: Aug 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

Device Story

SpineAssist is a computer-controlled miniature image-guided surgery (IGS) system. It processes pre-operative CT images and intra-operative fluoroscopic images to guide surgical tools or implants along planned trajectories. The system consists of a workstation and a miniature device that attaches directly to the patient's bone via a clamp and bridge assembly (e.g., Hover-T bridge). The device positions an articulating arm and tool guide based on coordinates derived from the image-based plan. Used in thoracic and lumbar spinal surgery, the system assists surgeons in achieving precise instrument placement. The surgeon operates the system in the OR, using the output to guide manual tool insertion. Benefits include increased accuracy and precision in spinal procedures. The system includes accessories like wedges and prisms to facilitate access to extreme angles.

Clinical Evidence

No clinical data. Performance supported by non-clinical bench testing, including software validation (IEC 60601-1-4), biocompatibility (ISO 10993), and various accuracy/stability tests (General Spinal Accuracy, Hover-T Accuracy/Stability, Vertebroplasty, and case studies for Osteoid Osteoma, Thoracic Hover-T, and Translaminar Facet cases).

Technological Characteristics

Stereotactic instrument (21 CFR 882.4560). Components: workstation, miniature device, bone-attachment bridges/clamps. Connectivity: image-guided workstation. Software: proprietary registration and trajectory planning algorithms. Biocompatibility: ISO 10993. Software standards: IEC 60601-1-4.

Indications for Use

Indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery in open or percutaneous procedures.

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

• SpineAssist™ system (K033413)
• SpineAssist™ system (K051676)
• StealthStation System (K954276 to K050438)

Submission Summary (Full Text)

{0}------------------------------------------------

#### SECTION 5 -510(K) SUMMARY OF SAFETY & EFFECTIVENESS

#### SPINEASSIST™ SYSTEM

## 510(k) Number K063607

AUG 2 3 2007

#### Applicant's Name:

| Company name: | Mazor Surgical Technologies Ltd. |
|---------------|-----------------------------------------|
| Address: | 7 HaEshel Str. |
| | P.O.B. 3104 |
| | Southern Caesarea Industrial Park 38900 |
| | ISRAEL |
| Tel.: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |

#### Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|------------------------------------------|
| Company name: | A. Stein - Regulatory Affairs Consulting |
| Address: | Beit Hapaamon (Suite 213) |
| Address: | 20 Hata'as Str. (Box 124) |
| Address: | Kfar Saba 44425 |
| Address: | ISRAEL |
| Tel: | + 972-9-7670002 |
| Fax: | [phone] |
| e-mail: | [e-mail] |

#### Name of the device:

SpineAssist™ System

# Trade or proprietary name, if applicable:

SpineAssist™ System

## Common or usual name:

Surgical Navigation System / Image Guided Surgery

## Establishment Registration No.:

3005075696

## Classification Name:

Stereotactic Instrument

{1}------------------------------------------------

#### Classification:

FDA has classified Stereotactic devices as a Class II medical device, with product code HAW and 21 CFR classification code 882.4560. Review by the General & Plastic Surgery Devices Panel.

#### Predicate Device:

The SpineAssist™ system is substantially equivalent to the original SpineAssist™ system (manufactured by Mazor Surgical Technologies Ltd., and the subject of 510(k) document no. K033413 and K051676) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438). A comparison table and detailed discussion are presented in Section 12 of this application.

#### Device Description:

The SpineAssist™ system 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 or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan.

The main components of the SpineAssist™ system include:

- A. SpineAssist™ device
- B. Workstation
- A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.

#### Intended Use / Indication for Use:

The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

#### Comparison of Technological Characteristics with the predicate device:

The modified SpineAssist system is identical to the original SpineAssist system regarding all components, design, materials, basic scientific technology, etc. The only differences are that the "modified" device is intended for general spinal surgery and a software change enabling a quicker and easier registration process using two fluoroscopy images instead of four and one target instead of two. The SpineAssist also includes some new accessories, including the wedge and prism for accessing extreme angles or trajectories, additional sterile sheaths to

{2}------------------------------------------------

cover the C-arm and X-ray shield and a few other minor accessories that are described later in this submission.

#### Non-Clinical Performance Data

The following performance tests were conducted on the SpineAssist™ system:

- 1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
- 2. Biocompatibility Testing (ISO 10993)
- 3. Osteoid Osteoma Case Study
- 4. Thoracic Hover-T Case Study
- 5. General Spinal Accuracy Test
- 6. New Imaging and Lateral to 30 degree Accuracy Test
- 7. Use of Prisms in Translaminar Facet Cases Study
- 8. Hover-T Accuracy Test Results Report
- 9. Hover-T Stability Test Results Report
- 9. Vertebroplasty Summary Report

#### Clinical Performance Data

Not Applicable

## Conclusions Drawn from Non-Clinical and Clinical Tests:

The performance tests demonstrate that SpineAssist system may be safely and effectively used in general spinal surgical procedures requiring precise positioning of surgical instruments or implants during open or percutaneous thoracic and lumbar spinal surgery. The software validation and accuracy performance tests demonstrate that the SpineAssist system meets its design and performance specifications and is substantially equivalent to the previously cleared SpineAssist system.

## Substantial Equivalence:

In summary, the intended use of the modified SpineAssist™ system is substantially equivalent to a combination of the original SpineAssist™ system and the StealthStation device, Furthermore, the basic technological characteristics of the modified SpineAssist™ system are identical to the original SpineAssist™ system, except for the minor software changes enabling an easier registration process using only one target. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the SpineAssist™ system is substantially equivalent to the original SpineAssist™ system and the StealthStation device.

## Performance Standards:

The SpineAssist™ system complies with the voluntary recognized standards:

- 1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
- 2. Biocompatibility Testing (ISO 10993)

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mazor Surgical Technologies Ltd. % A. Stein Regulatory Affairs Consulting Ahava Stein 20 Hata'as Str. Kfar Saba Israel 44425

AUG 2 3 2007

Re: K063607

Trade/Device Name: SpineAssist™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 2, 2007 Received: August 8, 2007

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.

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 CFR 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - 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 predicate 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/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K063607

Device Name:

SpineAssist™ System

Indications for use:

The SpineAssist™ system is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use (Optional Format Subpart C)

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

Concur(Division Sign Off) of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K063607