PROWIN

K050376 · Medical Technologies International, Inc. · LLZ · Apr 7, 2005 · Radiology

Device Facts

• Record ID: K050376
• Device Name: PROWIN
• Applicant: Medical Technologies International, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Prowin™ is a Windows-based software application for personal computers; processes carotid artery ultrasound images to measure intima-media thickness (IMT). Input: ultrasound images transferred via various media (JPEG, BMP, TIFF, DICOM). Operation: proprietary algorithms identify arterial walls; software calculates IMT for near and far walls; generates reports. Usage: clinical setting; operated by physicians or trained personnel. Output: IMT values and reports used by physicians to assess cardiovascular risk. Benefit: provides objective, repeatable measurements (coefficient of variation <1%) to support clinical decision-making regarding patient cardiovascular health.

Clinical Evidence

Bench testing only. No clinical trials or patient studies were conducted. Performance was validated through measurement repeatability testing, demonstrating a coefficient of variation of <1%.

Technological Characteristics

Software-only device; runs on standard Windows-based personal computers. Supports JPEG, BMP, TIFF, and DICOM (DIC, DCM, ACR) image formats. Proprietary algorithm for automated IMT measurement. Standalone deployment. No specific hardware requirements beyond standard PC specifications.

Indications for Use

Indicated for measurement of carotid artery far and near wall intima-media thickness (IMT) from ultrasound images to assist physicians in assessing cardiovascular risk in patients.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• M'Ath® Std (K040686)
• SonoCalc™ (K030223)
• QLAB™ software package (K021966)

Submission Summary (Full Text)

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K050376

#### 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: [phone] Fax: [phone] Email: [e-mail]

#### 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 | PRINCIPLE<br>DEVICE | PREDICATE<br>DEVICE | PREDICATE<br>DEVICE | PREDICATE<br>DEVICE |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | MEDICAL<br>TECHNOLOGIES<br>INTERNATIONAL,<br>INC. (MTI)<br>PROWIN™ | INTELLIGENCE<br>IN MEDICAL<br>TECHNOLOGIES<br>(IMT)<br>M'ATH® STD<br>(K040686) | SONOMETRIC<br>HEALTH, LLC<br>SONOCALC™<br>(K030223) | ADVANCED<br>TECHNOLOGY<br>LABORATORIES<br>(ATL)<br>QLAB™<br>(K021966) |
| Intended Use | Automatic<br>measurement of<br>intima-media<br>thickness of<br>carotid arteries. | Automatic<br>measurement<br>of intima-<br>media<br>thickness of<br>carotid<br>arteries. | Automatic<br>measurement<br>of intima-<br>media<br>thickness of<br>carotid<br>arteries. | Automatic<br>measurement<br>of intima-<br>media<br>thickness of<br>carotid and<br>other arteries. |
| Image Source | Ultrasound<br>images | Ultrasound<br>images | Ultrasound<br>images | Ultrasound<br>images |
| Operating<br>environment,<br>system and<br>hardware | Stand-alone<br>application<br>program for use<br>on a personal<br>computer<br>operating with<br>Microsoft<br>Windows. | Stand-alone<br>application<br>program for<br>use on a<br>personal<br>computer<br>operating with<br>Microsoft<br>Windows. | Stand-alone<br>application<br>program for<br>use on a<br>personal<br>computer<br>operating with<br>Microsoft<br>Windows. | Stand-alone<br>application<br>program for<br>use on a<br>personal<br>computer<br>operating with<br>Microsoft<br>Windows. |
| Image Format | JPEG, Windows<br>BMP, TIFF, &<br>DICOM single<br>file formats<br>(DIC, DCM and<br>ACR) | AVI, JPEG,<br>GIF, TIFF,<br>BMP, PCX,<br>PCD, TGA,<br>EPS, IMG | JPEG &<br>Windows BMP | AVI, BMP,<br>TIFF, &<br>DICOM |
| Image Storage | Yes | Yes | Yes | Yes |
| Report Generation | Yes | Yes | Yes | Yes |
| Vascular Indices<br>Related to Patient<br>Database | Yes | Unknown | Yes (in<br>labeling) | 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 [phone] 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:

K050376

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)

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Nancy C. Proydon

(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __