LIFE IMAGING SYSTEMS LIS 6000 A

K961403 · Life Imaging Systems, Inc. · LLZ · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K961403
• Device Name: LIFE IMAGING SYSTEMS LIS 6000 A
• Applicant: Life Imaging Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

B-Mode Acquisition, Ungated or Single Phase Gated The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). Color Flow Acquisition, Ungated or Single Phase Gated The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). B-Mode Acquisition, Multi-Phase Gated The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). Color Flow Acquisition, Multi-Phase Gated The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice). Image Display and Postprocessing Reformatting and Basic Display The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display Volumetric Rendering The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering. Measurements The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.

Device Story

LIS 6000A is an ultrasound image acquisition and post-processing system. It captures 2D planar ultrasound frames via video grabbing while an electromechanical positioner (linear or endocavity) moves the probe to span a predefined volume. Acquisition modes include ungated, single-phase gated, and multi-phase gated (using external cardiac/respiratory signals). The system re-aligns planar images using a phantom-based calibration procedure and reconstructs them into a 3D volumetric data set. Operators view data as faceted sub-volumes, 2D slices, or rendered images (maximum intensity, surface, volume). Measurements (distance, area, volume) are performed on user-defined cross-sections. The device is used in clinical settings as an adjunct to standard ultrasound systems. It benefits clinicians by providing 3D/4D visualization and quantitative analysis of ultrasound data, aiding in diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of LIS 6000A processing unit and electromechanical probe positioners (linear/endocavity). Uses DC motor/position encoder assembly for spatial tracking. Connectivity via analog/digital video input from ultrasound systems. Calibration via alignment phantom and jig. Software performs image re-alignment, volumetric reconstruction, and rendering. No geometric computation models used for measurements.

Indications for Use

Indicated for patients undergoing diagnostic ultrasound imaging requiring 3D/4D acquisition and post-processing of B-Mode or Color Flow data. Used as an adjunct to standard ultrasound systems for volumetric visualization and measurement.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• TomTec EchoScan (K941332)

Submission Summary (Full Text)

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510(k) Notification
LIS 6000A
K96/403
JUL - 3 1995

Submitter's Name: Life Imaging Systems
Submitter's Address: 306A Weathervane Office Commons
Richboro, PA 18954
Voice Phone: [phone]
Fax Phone: [phone]
Contact: Richard Derman

Device Name: Life Imaging Systems LIS 6000A – Image Processing System
Life Imaging Systems LIS 8000A – Endocavity Probe Positioner
Life Imaging Systems LIS 8030A – Linear Probe Positioner
Life Imaging Systems LIS 8100A – Alignment Phantom
Life Imaging Systems LIS 8150A – Endocavity Probe Alignment Jig

Common Name: 3D/4D Ultrasound Image Acquisition and Postprocessing System

Predicate Device: TomTec EchoScan, K941332.

Device Description:
LIS6000A
The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images.

Acquisition
Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.

Ungated Acquisitions
In this type of acquisition the probe positioner moves at a pre-determined, constant rate set by the system as appropriate for the imaging conditions.

Single Phase Gated Acquisitions
In this type of acquisition at each pre-determined 2D slice position the gating criteria must be satisfied for a video frame to be acquired. Once a frame has been acquired the positioner can move to the next acquisition position.

Multi Phase Gated Acquisitions
In multi-phase gating acquisitions the gating criteria must be satisfied, and video acquisition accomplished, for all required phases at each slice position, before the positioner moves the probe to the next position. The resulting “3D Loop” data set compises an independent 3D data set at each phase of the acquisition. As with any motion picture, cartoon or the like, when like

Summary of Safety and Effectiveness
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LIS 6000A

images from each phase are displayed in rapid succession a moving effect is created for the viewer.

## Calibration

Calibration of the pixel dimensions is provided either through operator input immediately after an acquisition sequence has been completed, or through direct communication between the LIS 6000 and the ultrasound imaging system.

## Alignment

Probe to probe variations of true image position are determined via a semi-automated alignment procedure utilizing the LIS Alignment Phantom and Alignment Jig, described below.

## Post-Processing

Post processing involves two distinct steps. In the first step the set of planar images obtained in acquisition are re-aligned, based on the parameters obtained in the alignment procedure. In the second step the aligned images are reconstructed into a volume of data. These two steps may be carried out simultaneously from the operator's perspective.

## Visualization/Image Manipulation

In the visualization step the operator can interactively view the post processed data using the following display types: faceted sub-volumes (convex polyhedra), 2D planar slices, and rendered images.

## Planar Measurements

Planar measurements may be made based on the pixel calibration and acquisition parameters. Measurements offered include distance, area, curve length and volume. Volumes are calculated based on planar areas multiplied by slice thickness. No geometric assumptions are made or computation models used.

## LIS 8030A Linear Probe Positioner

The linear positioner is an electromechanical device intended to translate a standard ultrasound probe in as straight line across a patient's body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the linear positioner. The probe stage is attached to and driven by a lead screw which in turn is driven by a DC motor/position encoder assembly. The position encoder allows the LIS 6000A software to track the absolute position of the probe.

An optional stabilizer assembly mounts on the linear positioner to assist the operator in maintaining a steady contact with the patient.

The linear positioner does not attempt to follow a curved body surface. In order to acquire images from body parts which have significantly curved surfaces, multiple shorter acquisitions may need to be utilized. Some degree

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LIS 6000A

of flexibility is afforded by having the probe slide across a small pool of acoustic couplant.

## LIS 8000A Endocavity Probe Positioner

The axial positioner is an electromechanical device which is intended to rotate a standard ultrasound endocavity probe about its long axis while it is positioned in its normal imaging position within a patient’s body. In operation the probe is mounted in a probe cradle which has been designed to accept a specific probe or probe family. The probe cradle is in turn mounted to a probe stage which is on the axial positioner. A position encoder allows the LIS 6000A software to track the absolute position of the probe. When end-fired endocavitary probes are being rotated the Endocavity positioner an axial data set is obtained. When side fired probes are rotated with the Endocavity positioner a sector data set is obtained.

## LIS 8010A Alignment Phantom

The Alignment Phantom is an accessory device intended to be used with the Endocavity Positioner. Its function is to allow the critical alignment parameters, to be determined.

## LIS 8050 Endocavity Alignment Jig

The Endocavitary Probe Alignment Jig is a mechanical device which is an accessory to the Endocavitary Positioner. It is used to make certain that the center of the tip of an endocavitary probe is aligned with its axis of rotation.

Intended uses of the LIS 6000A

### B-Mode Acquisition, Ungated or Single Phase Gated

The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

### Color Flow Acquisition, Ungated or Single Phase Gated

The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

### B-Mode Acquisition, Multi-Phase Gated

The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

### Color Flow Acquisition, Multi-Phase Gated

The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing

Summary of Safety and Effectiveness
3

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510(k) Notification
LIS 6000A

externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).

**Image Display and Postprocessing**
Reformatting and Basic Display
The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display

**Volumetric Rendering**
The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering.

**Measurements**
The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.

Summary of Safety and Effectiveness
4

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510(k) Notification
LIS 6000A

Comparison of the LIS 6000A and the TomTec EchoScan

The following table compares the relevant features of the TomTec EchoScan and the LIS 6000A

| Property/Feature | LIS 6000A | TomTec EchoScan |
| --- | --- | --- |
| Device Use | Adjunct to ultrasound system | Adjunct to ultrasound system |
| Data Source | 2D images from standard ultrasound system | 2D images from standard ultrasound system |
| Scan Plane Positioning | Motor driven, ultrasound probe adapter | Motor driven, ultrasound probe adapter |
| Acquisition Gating types | None, Respiration, ECG, ECG and Respiration | None, Respiration, ECG, ECG and Respiration |
| Patient Contact Electrodes | No - Requires external ECG trigger and Respiration signals | Yes - On board ECG/Impedance plethysmograph |
| Effect on US acoustic output | None | None |
| Reconstructed 2D Slices | Yes | Yes |
| Rendering Modes | Surface, Volume, Maximum Intensity Projection | Surface, Maximum Intensity Projection, Minimum Intensity |
| Video Acquisition | Grayscale, Color | Grayscale |
| Measurements | Distance, Area, Volume | Distance, Area, Volume, 3D Distance |
| Artifact Reduction Processing | Probe mis-alignment and respiration | Respiration |
| Compression | None, Lossless | None |

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