(52 days)
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.
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 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.
Here's a breakdown of the acceptance criteria and study information for K050376, Prowin™ Medical Image Measurement Software, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in terms of performance metrics (e.g., minimum accuracy, maximum deviation). Instead, it focuses on demonstrating measurement repeatability as an indicator of performance.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Measurement | Coefficient of variation < 1% | Coefficient of variation < 1% |
| Repeatability |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify the sample size used for performance testing. It only mentions "data collected using Prowin™."
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from what country.
3. Number of Experts for Ground Truth and Qualifications
This information is not provided in the document. The text does not mention the use of experts to establish a ground truth for performance testing.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, a MRMC comparative effectiveness study is not mentioned in the document.
- Effect size: Not applicable, as no such study was reported.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The performance testing section states: "As an indicator of measurement repeatability, data collected using Prowin™ as an automated measurement model the coefficient of variation to be <1%." This directly refers to the device's algorithmic performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. Given the focus on "measurement repeatability" and the lack of mention of human experts or other objective standards like pathology, it's highly likely that the "ground truth" for repeatability was established by the device's own repeated measurements on the same image data, or perhaps by comparing its measurements to a manually (but not necessarily expert-adjudicated) derived set of measurements. However, this is an inference; the document does not clarify.
8. Sample Size for the Training Set
This information is not provided in the document. The submission is for software that measures IMT using "proprietary, patent-pending algorithms," but it does not detail the development process of these algorithms, including whether they involved machine learning with a separate training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as details about a training set or its ground truth are absent.
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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
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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.
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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 | PRINCIPLEDEVICE | PREDICATEDEVICE | PREDICATEDEVICE | PREDICATEDEVICE |
|---|---|---|---|---|
| MEDICALTECHNOLOGIESINTERNATIONAL,INC. (MTI)PROWIN™ | INTELLIGENCEIN MEDICALTECHNOLOGIES(IMT)M'ATH® STD(K040686) | SONOMETRICHEALTH, LLCSONOCALC™(K030223) | ADVANCEDTECHNOLOGYLABORATORIES(ATL)QLAB™(K021966) | |
| Intended Use | Automaticmeasurement ofintima-mediathickness ofcarotid arteries. | Automaticmeasurementof intima-mediathickness ofcarotidarteries. | Automaticmeasurementof intima-mediathickness ofcarotidarteries. | Automaticmeasurementof intima-mediathickness ofcarotid andother arteries. |
| Image Source | Ultrasoundimages | Ultrasoundimages | Ultrasoundimages | Ultrasoundimages |
| Operatingenvironment,system andhardware | Stand-aloneapplicationprogram for useon a personalcomputeroperating withMicrosoftWindows. | Stand-aloneapplicationprogram foruse on apersonalcomputeroperating withMicrosoftWindows. | Stand-aloneapplicationprogram foruse on apersonalcomputeroperating withMicrosoftWindows. | Stand-aloneapplicationprogram foruse on apersonalcomputeroperating withMicrosoftWindows. |
| Image Format | JPEG, WindowsBMP, TIFF, &DICOM singlefile formats(DIC, DCM andACR) | 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 IndicesRelated to PatientDatabase | Yes | Unknown | Yes (inlabeling) | No |
.
6. Comparison with substantially equivalent devices
:
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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 <1%.
9. Conclusions
Based on available information, Prowin™ is substantially equivalent to predicate devices for viewing carotid ultrasound images and measuring prodicate are and thickness. The Prowin™ software application has the same intended use and incorporates the same basic features and benefits of the described predicate devices cleared through premarket notification without raising any new issues of safety or effectiveness.
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APR 7
2005
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the seal. The text is in all capital letters.
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Medical Technologies International, Inc. % Mr. Marc Bozeman, Esq. Partner Hogan & Hartson, LLP Biltmore Tower, 500 South Grand Avenue Suite 1900 LOS ANGELES CA 90071
Re: K050376 Trade/Device Name: Prowin™ Medical Image Measurement Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2005 Received: February 14, 2005
Dear Mr. Bozeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Scellon 510(x) prehement in the indications for use stated in
above and have determined the device is substantially equivalent (for the stated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed producted as a sendments, or to devices that have been May 28, 1976, the enactment and of the Federal Food, Drug, and Cosmetic Act (Act) that feclassified in accordance with the provisions al application (PMA). You may, therefore, market the A do not require approval of a prematic approval of the Act. The general controls provisions of the Act. device, subject to the general controls provisions 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 If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), it they be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA device can be tound in the code of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that TDA 's Issualled of a subscannon vith other requirements of the Act or any
FDA has made a determination that your device complies with other requiremen FDA has made a delemination mar your do rise Federal agencies. You must comply with all the Federal statues and regulations administer of existerion and listing (2 CFR Part 807); labeling Act's requirements, including, but not thinked to regurements as set forth in the quality systems (QS) (21 CFR Part 801), good manufacturing product the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 5 (0(k) This letter will allow you to begin marketing your antine equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA midnig of substantial organistics of 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 If you desire specific advice for your device on our labering roganized the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "thisoriation on your responsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections at its toll-free number (800) DIVIsion of Cinal of (301) 443-6597 or at its Internet address 056-2041 Of (2017 v/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Not assigned at this time:
Device Name: Prowin™ Medical Image Measurement Software
Indications for Use: The Prowin™ software program is a Windows-based Indications for Use: "The frompter intended for viewing carotid ultrasound
application used on a personal cisi in the seconding indicated for the application used on a personal computer mess. It is specifically indicated for the images and measuring arterial wall theshios. "I has a media thickness (IMT) from
measurement of carotid artery far and near may as this information measurement of carold artery ial and noter neephysician may use this information
images obtained from an ultrasound system. A physician to for notient's images obtained from an ultrasound by on the assessment of a patient's cardiovascular risk.
Prescription Use _X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ___ of _
Nancy C. Proydon
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
§ 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).