THE ROBOGUIDE

K961849 · Shai Syg Motion and Innovations, Ltd. · IZH · Aug 21, 1996 · Radiology

Device Facts

• Record ID: K961849
• Device Name: THE ROBOGUIDE
• Applicant: Shai Syg Motion and Innovations, Ltd.
• Product Code: IZH · Radiology
• Decision Date: Aug 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1710
• Device Class: Class 2

Intended Use

The ROBOGUIDE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or for core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.

Device Story

Automatic needle guidance system; attachment for mammography systems. Inputs: stereotactic X-ray images (plain film or digital camera). Operation: robotic unit calculates lesion coordinates; drives needle holder along three orthogonal axes to target site. Used in clinical settings by physicians/technicians. Output: precise needle positioning for biopsy. Benefits: accurate penetration of breast lesions; supports FNA or core biopsy via interchangeable carriers. Safety: includes immobilization and needle carrier locking mechanisms.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Robotic biopsy unit; film read out and motor control evaluation unit. Three-axis orthogonal drive system. Compatible with plain film X-ray or digital camera. Mechanical breast compression and immobilization. Safety interlocks for needle carrier movement.

Indications for Use

Indicated for patients with detectable breast lesions requiring fine needle aspiration (FNA) or core biopsy procedures.

Regulatory Classification

Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Cytoguide (Phillips Medical)
• Mammoguide (Elscint Ltd.)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## Submitter:

Shai - Syg Motion & Innovations Ltd., P.O. Box 2412, Ra'anana 43654, Israel
Contact person: Jacob Gross
Tel: [phone] Fax: [phone]

## Name of the Device:

ROBOGUIDE

AUG 21 1996

K 961849

## Predicate Devices:

The ROBOGUIDE is substantially equivalent to a combination of the Cytoguide manufactured by Phillips Medical and the Mammoguide manufactured by Elscint Ltd.

## Description of the Device:

The ROBOGUIDE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or for core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.

## Comparison of Technological Characteristics:

The systems share many hardware and functional characteristics:

- The biopsy units of the ROBOGUIDE and the Mammoguide are identical.
- All three units employ stereotaxis to identify the location of a breast lesion and then drives a needle carrier along three coordinate axes to a point that allows accurate placement of the biopsy needle point into the lesion.
- All three units have means for compressing and immobilizing the breast during the procedure.
- All three units employ safety mechanisms to assure no movement of the needle carrier during biopsy needle injection.

The differences between the systems raise no new issues of safety or effectiveness.

MAY, 1, 1996
Date

Mr. Jacob Gross, President