LIFE IMAGING SYSTEMS, MODEL L3DI

K990560 · Life Imaging Systems, Inc. · IYO · May 20, 1999 · Radiology

Device Facts

• Record ID: K990560
• Device Name: LIFE IMAGING SYSTEMS, MODEL L3DI
• Applicant: Life Imaging Systems, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

Device Story

L3Di is an add-on accessory for existing diagnostic ultrasound systems; functions as a computer-based image processing workstation. Inputs: 2D ultrasound image slices and spatial transducer position data (via positioner assemblies or 6-degree-of-freedom tracking). Processing: proprietary software reconstructs 3D volumes from 2D slices; performs measurements (distance, area, volume, angle). Output: 3D reconstructed images and quantitative data. Used in clinical settings (radiology, surgery, etc.) by healthcare professionals. Benefits: enables 3D visualization and quantification of ultrasound data to assist in clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through internal company protocols and third-party standards testing to confirm design intent and system specifications.

Technological Characteristics

Computer system based on Apple Computer and Windows NT architecture. Includes image digitizer circuit board. Employs transducer positioner assemblies or 6-degree-of-freedom coordinate tracking. Software-based 3D reconstruction and measurement. Standalone workstation configuration.

Indications for Use

Indicated for acquisition of 2D ultrasound image sets and 3D reconstruction for diagnostic purposes. Intended for use in radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics, and gynecology. No specific patient population or contraindications defined.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Life Imaging Systems LIS 6000A (K961403)

Submission Summary (Full Text)

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K990560 p 1 q 2

# 510(k) Summary Life Imaging Systems L3Di

# Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454

# Submitter (Consultant) Contact Person

Kevin Morningstar. Senior Consultant phone [phone] fax: [phone]

#### Manufacturer Name and Address

Life Imaging Systems, Inc. Suite 300, 195 Dufferin Avenue London, Ontario, Canada N6A 1K7

#### Manufacturer Contact Person

Tom Holbrook, Quality and Regulatory Affairs Manager phone [phone] ext. 217 fax [phone]

# Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name:

Digital Ultrasound Image Analysis System System, Image Processing Life Imaging Systems L3Di

#### Predicate Device

Life Imaging Systems LIS 6000A K961403

#### Device Description

The Life Imaging Systems L3Di is a high performance computer system based on Apple Computer and Windows NT standards. It incorporates a commercially

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available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

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K990560

The device records ultrasound transducer spatial position during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.

# Intended Use

The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

# Technological Characteristics Comparison

The LIS L3Di is nearly identical in performance and intended use to the LIS 6000A. Both systems are based on Apple Computer architecture, with proprietary software added for ultrasound image acquisition, 3D reconstruction, analysis, archival and retrieval. Both systems are used in the same clinical setting. Both systems work with any existing diagnostic ultrasound imaging system.

# Test Discussion

Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Additional system testing was done by a third party standards test house.

# Test Conclusions

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the system performance specifications.

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MAY 20 1999

Life Imaging Systems. Inc. c/o Kevin Morningstar Morningstar Consulting Group P.O. Box 218 Indian Hills, Colorado 80454

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990560 Life Imaging Systems L3 Di Digital Ultrasound Image Analysis System Dated: February 15, 1999 Received: February 22, 1999 Regulatory Class: II 21 CFR 892 1560/Procode: 90 IYO 21 CFR 892.1550/Procode: 90 IYN

Dear Mr. Morningstar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act indude 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990560

510(k) Number (if known):

Device Name: Life Imaging Systems L3Di

Indications for Use:

The Life Imaging Systems L3Di is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing such as distance, area, volume and angle measurements. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use