IMT.LAB

K043360 · Pie Medical · LLZ · Jan 5, 2005 · Radiology

Device Facts

• Record ID: K043360
• Device Name: IMT.LAB
• Applicant: Pie Medical
• Product Code: LLZ · Radiology
• Decision Date: Jan 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote Pie ultrasound systems.

Device Story

IMT.LAB is a Windows-based software application for personal computers; it processes ultrasound video images acquired from Esaote Pie ultrasound systems. The device performs automatic distance measurements of the carotid artery intima-media thickness. It supports DICOM, JPEG, and Windows BMP image formats. The software is intended for use by clinicians to assist in the quantification of vascular image data. By automating the measurement process, the device provides objective data to support clinical decision-making regarding carotid artery health. It includes functionality for image storage and report generation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Windows 2000/XP software application; standalone PC-based; supports DICOM, JPEG, and Windows BMP formats; performs automatic distance measurement of intima-media thickness; includes image storage and report generation capabilities.

Indications for Use

Indicated for the automatic measurement of carotid artery intima-media thickness from ultrasound video images in patients undergoing carotid artery assessment.

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

• SonoMetric Health SonoCalc (K030223)
• Phillips QLAB (K021966)

Submission Summary (Full Text)

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510(k) Summary IMT.LAB Pie Medical

JAN - 5 2005

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

K043360

### 807.92(a){1)

.

#### Submitter Information

Carri Graham, Official Correspondent
7992 Castleway Drive
Indianapolis, IN 46250

| Phone: | [phone], extension 103 |
|------------|-------------------------------|
| Facsimile: | [phone] |

| Contact Person: | Carri Graham |
|-----------------|------------------|
| Date: | December 1, 2004 |

807.92(a)(2)

| Trade Name: | IMT.LAB software |
|-------------------------|---------------------------------------------|
| Common Name: | Picture archiving and communications system |
| Classification Name(s): | System, Image Processing, Radiological |
| Classification Number: | 90 LLZ |

807.92(a)(3)
Predicate Device(s)

| SonoMetric Health | SonoCalc | K030223 |
|-------------------|----------|---------|
| Phillips | QLAB | K021966 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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#### 510(k) Summary IMT.LAB Pie Medical 807.92(a)(6)

## Technological Characteristics

ESAOTE believes that IMT.LAB is substantially equivalent to the SonoMetric Health's SonoCalc product (K030223) and to the Philips Medical Systems' QLAB product (K021966)

| Characteristic | ESAOTE<br>IMT.LAB<br>Via this Submission | SonoMetric Health<br>SonoCalc<br>(K030223) | Philips Medical<br>Systems<br>QLAB (K021966) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The IMT.LAB<br>software is a<br>Windows 2000/XP<br>software package to<br>be used on a<br>personal computer<br>for the automatic<br>measurement of the<br>intima media<br>thickness of the<br>carotid artery from<br>video images<br>obtained from<br>Esaote Pie<br>ultrasound systems. | The SonoCalc<br>software is a<br>Windows-based<br>application program<br>used on a personal<br>computer for the<br>automatic<br>measurement of the<br>intima media<br>thickness of the<br>carotid artery from<br>images obtained<br>from ultrasound<br>systems | The Q LAB<br>Quantification<br>software is a<br>Windows<br>2000/Windows XP<br>software application<br>package. It is<br>designed to view<br>and quantify image<br>data acquired on<br>Philips Medical<br>Systems ultrasound<br>products. |
| Image source | Ultrasound images | Ultrasound images | Ultrasound images |
| Operating<br>environment,<br>system and<br>hardware | Stand alone<br>application program<br>for use on a<br>personal computer<br>with Microsoft<br>Windows | Stand alone<br>application program<br>for use on a<br>personal computer<br>with Microsoft<br>Windows | Stand alone<br>application program<br>for use on a personal<br>computer with<br>Microsoft Windows |
| Image format | DICOM, JPEG and<br>Windows BMP | JPEG and Windows<br>BMP | AVI and Windows<br>BMP |
| Image storage and<br>report generation | Yes | Yes | Yes |
| Automatic distance<br>measurement of the<br>intima media<br>thickness of an<br>artery | Yes | Yes | Yes |
| Classification | 90LLZ<br>892.2050 | 90LLZ<br>892.2050 | 90LLZ<br>892.2050 |
| Image Compression | JPEG<br>Loss-less | JPEG<br>Lossy | None |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2005

Pie Medical % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K043360

Trade/Device Name: IMT.LAB Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: December 1, 2004 Received: December 7, 2004

Dear Ms. Graham:

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 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 (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, 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This icler witi anow you to organ mating of substantial equivalence of your device to a legally premaired predicated. " The PDF mailing sification 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 If you desire specifice of Compliance at one of the following numbers, based on the regulation number at 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 807.97). You may obtain other general information on your responsibilities under the Act from the 807.77). Tou may obtain curers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/dsmadsmamain.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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IMT.LAB Software

Indications for Use:

The IMT.LAB software is a Windows 2000/XP software application I he IMT.LAD Software is a Wall omputer for the automatic measurement package to be used on a perse of the carotid artery from video images obtained from Esaote Pie ultrasound systems.

X Prescription Use (Part 21 CFR 801 Subpart D) AAD/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. degman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices V 04 93 510(k) Number __