(15 days)
Not Found
No
The description mentions "proprietary techniques and algorithms" for image processing and measurement, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on comparison to manual measurements and a phantom, not on training or validation of an AI/ML model.
No
The device measures anatomical structures from medical images and generates a report, which is used adjunctively by a physician for assessment. It does not provide any treatment or therapy.
Yes
The device measures intima-media thickness (IMT) of the carotid artery from ultrasound images, which is used by a physician to assess the cardiovascular health of a patient. This functionality directly contributes to the diagnosis or assessment of a medical condition.
Yes
The device is described as a "software package" that runs on a "stand-alone computer" and processes images digitally transferred from an ultrasound machine. It explicitly states "There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images". This indicates the device itself is solely the software component.
Based on the provided information, the SonoCalc software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The SonoCalc software analyzes images of the carotid artery obtained from an ultrasound system. It does not directly interact with or analyze biological samples like blood, urine, or tissue.
- The intended use is image analysis and measurement. The software's purpose is to automatically measure the intima media thickness from ultrasound images. While this information is used adjunctively with other medical data to assess cardiovascular health, the software itself is not performing a diagnostic test on a biological specimen.
The SonoCalc software falls under the category of medical image analysis software or medical device software. It is a tool that assists physicians in interpreting medical images and obtaining quantitative measurements, but it is not an IVD.
N/A
Intended Use / Indications for Use
The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
SonoCalc is a software package that runs on a stand-alone computer running a Microsoft Windows™ operating system. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. SonoCalc then uses proprietary techniques and algorithms to measure the Intima-Media Thickness (IMT) of either or both of the near or far wall(s) of the carotid artery. SonoCalc can generate a report indicating what the patient's IMT value is. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient.
SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound images
Anatomical Site
Carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used adjunctively with other medical data by a physician.
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
An ultrasound phantom and image calibration markings verification study for the SonoCalc software was performed. This test consisted of SonoCalc measuring the distance of targets in an ultrasound phantom from images obtained from a commercially available ultrasound system.
A clinical validation comparison was performed using the SonoCalc software and manual measurements of subjects' IMT values. The study consisted of 120 ultrasound images obtained from 20 different subjects who were scanned with a commercially available ultrasound system. Manual caliper measurements of IMT values from the ultrasound system performed by 3 trained sonographers were compared to measurements of the same images performed by SonoCalc.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study type: Verification study using an ultrasound phantom. Sample size: Not explicitly stated beyond "targets in an ultrasound phantom". Key results: The results of this test showed that the SonoCalc software performed equivalently to the commercial ultrasound system's caliper measurements of the same phantom.
- Study type: Clinical validation comparison. Sample size: 120 ultrasound images obtained from 20 different subjects. Key results: The results of this study showed that the SonoCalc software performed equal to or better than the manual measurements with respect to accuracy and reproducibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy and reproducibility (relative to manual measurements).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided in accordance with 21 CFR 807.92.
Date of preparation: 12/31/02
-
- Submitter SonoMetric Health, LLC 1373 E. Skyline Dr. Bountiful, UT 84010
FEB 0 6 2003
- Submitter SonoMetric Health, LLC 1373 E. Skyline Dr. Bountiful, UT 84010
2. Contact
Helmuth Fritz, MD, RVT SonoMetric Health, LLC 1373 E. Skyline Dr. Bountiful, UT 84010 Phone: (909) 553-2650 Fax: (909) 790-5284 hsfritz@hotmail.com
3. Device Identification
Tradename: SonoCalc Common name: Medical image measurement software Classification: 892.2050 - Radiology - System, Image Processing
4. Indications for use
The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.
5. Device Description
SonoCalc is a software package that runs on a stand-alone computer running a Microsoft Windows™ operating system. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. SonoCalc then uses proprietary techniques and algorithms to measure the Intima-Media Thickness (IMT) of either or both of the near or far wall(s) of the carotid artery. SonoCalc can generate a report indicating what the patient's IMT value is. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient.
SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.
1
6. Substantial Equivalence
SonoMetric Health believes that SonoCalc is substantially equivalent to other legally marketed products, specifically the Q LAB software package (K021966) developed by ATL Ultrasound (d/b/a Philips Ultrasound) a Philips Medical System Company, when O LAB is used for the automatic measurement of the IMT of the carotid artery.
| Characteristic | SonoMetric Health
SonoCalc | QLAB (K021966) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended use | Automatic measurement
of intima media thickness
of carotid arteries. | Automatic measurement
of intima media thickness
of carotid and other
arteries. |
| Image source | Ultrasound images | Ultrasound images |
| Operating
environment, system
and hardware | Stand-alone application
program for use on a
personal computer
operating with Microsoft
Windows | Stand-alone application
program for use on a
personal computer
operating with Microsoft
Windows |
| Image format | JPEG and Windows BMP | AVI and BMP |
| Image storage and
report generation | Yes | Yes |
7. Performance standards
There are no Section 514 performance standards for this class of device. The SonoCalc software has been designed to comply with the following voluntary standards:
- 트 ISO Joint Photographic Experts Group (JPEG) Image
- . Microsoft Windows Bitmap (BMP) Image Encoding
- 트 A ultrasound phantom and image calibration markings verification study for the SonoCalc software was performed. This test consisted of SonoCalc measuring the distance of targets in an ultrasound phantom from images obtained from a commercially available ultrasound system. The results of this test showed that the SonoCalc software performed equivalently to the commercial ultrasound system's caliper measurements of the same phantom
- 트 A clinical validation comparison was performed using the SonoCalc software and manual measurements of subjects' IMT values. The study consisted of 120 ultrasound images obtained from 20 different subjects who were scanned with a commercially available ultrasound system. Manual caliper measurements of IMT values from the ultrasound system performed by 3 trained sonographers were compared to measurements of the same images performed by SonoCalc. The results of this study showed that the SonoCalc software performed equal to or better than the manual measurements with respect to accuracy and reproducibility
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
FEB 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SonoMetric Health, LLC % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. Madison Ave. SE GRAND RAPIDS MI 49548 Re: K030223 Trade/Device Name: SonoCalc Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving 3033 and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 10, 2003 Received: January 22, 2003
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of February 6, 2003 regarding the date.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed on 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as describe 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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained form the Division of Small Manufactures, International and Consumer 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,
David A. Ingram
Nancy C. Brogdon
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SonoMetric Health, LLC
Indications for Use Statement
510(k) Number (if known): _ Ko 30 223
SonoCalc Device Name: _________________________________________________________________________________________________________________________________________________________________
Indication for Use:
The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
David h. Seznmm
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number _