(87 days)
Not Found
No
The description focuses on standard image processing techniques for 3D reconstruction and measurements, with no mention of AI or ML algorithms.
No
This device is described as an image acquisition and processing tool for diagnostic ultrasound images, not for treating any medical condition.
Yes
The device is intended for the "acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images" and for "computerized 3-dimensional image processing such as distance, area, volume and angle measurements," which are processes that lead to a diagnosis. It is also described as an add-on accessory for "any existing diagnostic imaging ultrasound system."
No
The device description explicitly states it incorporates a commercially available image digitizer circuit board and mentions hardware components like transducer positioner assemblies or a 6-degree of freedom coordinate tracking system. This indicates it is not solely software.
Based on the provided information, the Life Imaging Systems L3Di is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The L3Di is described as an add-on accessory for existing ultrasound imaging systems. Its purpose is to acquire, process, store, and retrieve 3D ultrasound images. It works with ultrasound data, which is generated in vivo (within the living body) by the ultrasound system, not from in vitro samples.
- Intended Use: The intended use clearly states it's for processing diagnostic ultrasound images and is a general purpose digital 3D ultrasound image processing tool for various medical specialties. This aligns with medical imaging, not laboratory testing of biological samples.
Therefore, the L3Di falls under the category of a medical imaging device accessory, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
90 IYO, 90 IYN
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 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. The device records ultrasound transducer spatial position during use, either with transducer positioner assemblies or with a 6-degree of freedom coordinate tracking system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, cardiology, obstetrics and gynecology.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
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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 (303) 697-8198 fax: (303) 697-7907
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 (519) 679-4319 ext. 217 fax (519) 679-4320
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
1
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.
8242
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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
3
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