SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES

K051676 · Mazor Surgical Technologies , Ltd. · HAW · Sep 8, 2005 · Neurology

Device Facts

• Record ID: K051676
• Device Name: SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
• Applicant: Mazor Surgical Technologies , Ltd.
• Product Code: HAW · Neurology
• Decision Date: Sep 8, 2005
• 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 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. The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.

Device Story

SpineAssist is an image-guided surgical positioning system for spinal stabilization. Input: pre-operative fluoroscopic and CT images. Operation: software processes images via proprietary algorithms to create a pre-operative plan; system exports coordinates to an articulating arm and tool guide. The device attaches to the patient's bone via the Hover-T Bridge accessory. Usage: operating room; operated by surgeons. Output: physical guidance of handheld surgical tools along planned trajectories. Benefit: increased precision, miniaturization, and accessibility during spinal procedures; assists surgeons in maintaining planned orientation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design.

Technological Characteristics

Image-guided stereotaxic instrument. Components include an articulating arm, tool guide, and Hover-T Bridge bone attachment. Software-driven positioning based on pre-operative CT/fluoroscopic image planning. Class II device.

Indications for Use

Indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. Hover-T Bridge accessory indicated for lumbar spinal fusion stabilization surgery.

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 (K033413)

Submission Summary (Full Text)

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## SEP - 8 2005

#### Appendix B:

# SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

K051676 (Premarket Notification [510(k)] Number)

#### 1. Applicant

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

### Corresponding Official:

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

#### 2. Device Name

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

#### 3. Predicate Devices

The modified SpineAssist device is substantially equivalent to the following device:

| Device | Manufacturer | 510(k) No. |
|-------------|----------------------------------|------------|
| SpineAssist | Mazor Surgical Technologies Ltd. | K033413 |

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#### 4. Intended Use

The SpineAssist System 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.

The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.

#### 5. Description of the Device

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The SpineAssist device developed by Mazor Surgical Technologies is an accurate imageguided positioning system that extends surgical capability in terms of precision, miniaturization and accessibility. The SpineAssist surgical positioning system assists the surgeon in the operating room to accurately position hand held surgical tools according to a computerized image-based pre-operative plan and to accurately guide surgical tools 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 the Hover-T kit, a special bone attachment component, the SpineAssist device attaches to the bone on which the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.

#### 6. Technological Characteristics Compared to Predicate Devier

The technological characteristics of the modified device, 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 device cited above.

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. . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP - 8 2005

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 Israel

Re: K051676

Trade/Device Name: SpineAssist Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 18, 2005 Received: August 29, 2005

Dear Ms. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaon 310(t) per is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tise stated in the encrosule) to regars actment date of the Medical Device Amendments, or to Commerce provision of May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have occh recultion in avee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dierelove, mance as 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 FDA it may be subject to sach additions. Title 21, Parts 800 to 898. In addition, FDA can be found in the Oouverements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled or a badewice complies with other requirements of the Act that I DA has made a decidinations administered by other Federal agencies. You must or any Federal statutes and regulations annualites, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 807), ademig (21 OFF Part 820); and if applicable, the electronic forth in the quality systems (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 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,
Harbar Rouehud

Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix A:

#### Indications for Use Statement

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K 051676

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.

> The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.

Prescription Use V (Per 21 C.F.R. 801.109) QR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Number_