(52 days)
Not Found
No
The description mentions "proprietary, patent-pending algorithms" for image measurement, but there is no mention of AI, ML, deep learning, or any related terms. The focus is on measurement repeatability using a coefficient of variation, which is a standard statistical metric and not indicative of AI/ML.
No.
The device is for viewing, measuring, and reporting carotid artery intima-media thickness, which aids in cardiovascular risk assessment but does not directly treat or prevent a disease.
Yes
The device is intended for "viewing carotid ultrasound images and measuring arterial wall thickness," specifically "intima-media thickness (IMT)." This information is used by a physician "in the assessment of a patient's cardiovascular risk," which clearly indicates a diagnostic purpose.
Yes
The device is described as a "software program" that operates on a "stand-alone personal computer" and processes images transferred to it. There is no mention of any proprietary hardware component included with the device.
Based on the provided information, the Prowin™ software program 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. They are used to provide information for diagnosis, monitoring, or screening.
- Prowin™'s Function: Prowin™ operates on ultrasound images of the carotid artery. It processes these images to measure the thickness of the arterial wall. This is an in vivo measurement (performed on the living body) using an imaging modality, not an in vitro test on a biological sample.
- Intended Use: The intended use clearly states it's for "viewing carotid ultrasound images and measuring arterial wall thickness." This aligns with image analysis and measurement, not laboratory testing of biological samples.
Therefore, Prowin™ falls under the category of medical image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Prowin™ software program is a Windows-based application used on a personal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may use this information in conjunction with other medical data in the assessment of a patient's cardiovascular risk.
Product codes
LLZ
Device Description
Prowin™ is a software program designed to measure carotid artery intima-media thickness from ultrasound images. Prowin™ operates on a stand-alone personal computer running a Microsoft Windows™ operating system.
Carotid artery images from any ultrasound machine are transferred to the computer running Prowin™ by way of any media.
Following the transfer of images, Prowin™ uses proprietary, patent-pending algorithms to measure intima-media thickness (IMT) of the near and far walls of the carotid artery. The Prowin™ software also has the capability to generate a report indicating the IMT value.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound images
Anatomical Site
Carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As an indicator of measurement repeatability, data collected using Prowin™ indicated the coefficient of variation to be
§ 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
2005 APR 7 -
510(k) SUMMARY
This summary of safety and effectiveness is provided in accordance with 21 CFR 807.92.
Date of preparation: 14 February 2005
1. Submitter
Medical Technologies International, Inc. ("MTI") 74-980 Highway 111 Indian Wells, California 92210 FDA Owner/Operator Number: 9062380
Contact
Gary F. Thompson, Chairman & CEO Medical Technologies International, Inc. 74-980 Highway 111 Indian Wells, California 92210 Phone: (760) 200-1179 Fax: (760) 200-1168 Email: gthompson@i-mti.com
2. Device Identification
Tradename: Prowin™ Common name: Medical image measurement software Classification: 892.2050 - System, Image Processing, Radiological FDA has classified these devices as Class II devices under FDA Product Code LLZ.
3. Substantial Equivalence
MTI believes that Prowin™'s measurement of IMT is substantially equivalent to other legally marketed products, specifically Intelligence in Medical Technologies' M'Ath® Std (K040686), SonoMetric Health's SonoCalc™ (K030223) and ATL Ultrasound's (d.b.a. Philips Ultrasound) QLAB™ software package (K021966) when the latter is used for the automated measurement of carotid intima-media thickness.
4. Device Description
Prowin™ is a software program designed to measure carotid artery intimamedia thickness from ultrasound images. Prowin™ operates on a stand-alone personal computer running a Microsoft Windows™ operating system.
Carotid artery images from any ultrasound machine are transferred to the
1
computer running Prowin™ by way of any media.
Following the transfer of images, Prowin™ uses proprietary, patent-pending r vilowing one trailerer of attammedia thickness (IMT) of the near and argoritimins of the carotid artery. The Prowin™ software enc has the capability to generate a report indicating the IMT value.
5. Intended Use
The Prowin ™ software program is a Windows-based application used on a Firsonal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may (111) from in fromation in conjunction with other medical data in the assessment of a patient's cardiovascular risk.
2
Image /page/2/Picture/4 description: The image contains two small, dark, indistinct shapes against a white background. The shapes are simple and lack detail, making it difficult to determine what they represent. The composition is minimalist, with the focus solely on these two isolated elements.
| CHARACTERISTIC | PRINCIPLE
DEVICE | PREDICATE
DEVICE | PREDICATE
DEVICE | PREDICATE
DEVICE |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | MEDICAL
TECHNOLOGIES
INTERNATIONAL,
INC. (MTI)
PROWIN™ | INTELLIGENCE
IN MEDICAL
TECHNOLOGIES
(IMT)
M'ATH® STD
(K040686) | SONOMETRIC
HEALTH, LLC
SONOCALC™
(K030223) | ADVANCED
TECHNOLOGY
LABORATORIES
(ATL)
QLAB™
(K021966) |
| Intended Use | Automatic
measurement of
intima-media
thickness of
carotid arteries. | Automatic
measurement
of intima-
media
thickness of
carotid
arteries. | 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 | 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. | 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, Windows
BMP, TIFF, &
DICOM single
file formats
(DIC, DCM and
ACR) | AVI, JPEG,
GIF, TIFF,
BMP, PCX,
PCD, TGA,
EPS, IMG | JPEG &
Windows BMP | AVI, BMP,
TIFF, &
DICOM |
| Image Storage | Yes | Yes | Yes | Yes |
| Report Generation | Yes | Yes | Yes | Yes |
| Vascular Indices
Related to Patient
Database | Yes | Unknown | Yes (in
labeling) | No |
.
6. Comparison with substantially equivalent devices
:
3
7. Performance Standards
There are no Section 514 performance standards for this class of device. The There are no becaller of i perfact to comply with the following voluntary standards:
- ISO Joint Photographic Experts Group (JPEG) Image .
- Microsoft Windows Bitmap (BMP) Image Encoding .
- TIFF standard lossless format encoding .
- DICOM single file images (DIC, DCM and ACR) as defined in the . ACR-NEMA DICOM working group in 1993.
- Data Translation images converted to BMP .
8. Performance Testing
As an indicator of measurement repeatability, data collected using Prowin™ As an marcator of model the coefficient of variation to be