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 ultrasound systems.

Device Description

The IMT LAB software is a Windows 2000/XP software application package that runs on a stand-alone personal computer. Video images from the carotid artery made with a standard ultrasound system can be used as input for the IMT.LAB software package. These images can be transferred digitally by means of a DICOM, BMP, or JPEG files from the ultrasound system to the IMT.LAB software. IMT.LAB uses proprietary techniques and algorithms to measure the Intima Media Thickness (IMT) from the far wall of the carotid artery. This information is used in addition to other medical data by a physician to help assess the cardiovascular health of a patient.

IMT.LAB can store the images and the measurement results on the hard disk for future reference.

AI/ML Overview

Here's a summary of the provided 510(k) document regarding the IMT.LAB software, focusing on acceptance criteria and study details.

Please note: The provided 510(k) summary (K062598) primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria. The document asserts equivalence based on intended use and technological characteristics. Therefore, many of the requested fields will be marked as "Not Provided in Document."

IMT.LAB Software: Acceptance Criteria and Study Details (K062598)

This 510(k) summary for the IMT.LAB software primarily establishes substantial equivalence to previously cleared devices. It describes the device's intended use as an automatic measurement tool for carotid artery Intima Media Thickness (IMT) from ultrasound images. The document does not detail specific performance acceptance criteria or present a formal study proving the device meets such criteria in the way a clinical trial or performance study report might. Instead, equivalence is drawn to predicate devices that presumably already met applicable performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Accuracy, Precision)	Reported Device Performance
Not Provided in Document	Not Provided in Document

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not Provided in Document
Data Provenance: Not Provided in Document (No specific test set or study is detailed)

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not Provided in Document
Qualifications of Experts: Not Provided in Document

4. Adjudication Method for the Test Set

Adjudication Method: Not Provided in Document

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No
Effect Size of Human Readers with AI vs. Without AI: Not Applicable (No MRMC study was described)

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done?: No (The document describes the software and its intended use, but not a standalone performance study with metrics.)

7. Type of Ground Truth Used (for Test Set)

Type of Ground Truth: Not Provided in Document

8. Sample Size for the Training Set

Sample Size for Training Set: Not Provided in Document

9. How the Ground Truth for the Training Set Was Established

Method for Establishing Ground Truth: Not Provided in Document

Summary of Device Claimed Equivalence:

The IMT.LAB software is deemed substantially equivalent based on similarity in:

Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound images.
Image Source: Ultrasound images.
Operating Environment: Standalone application on a personal computer with Microsoft Windows.
Image Format: DICOM, JPEG, and Windows BMP (IMT.LAB v2.0 as submitted, vs. only JPEG and BMP for predicate SonoCalc, and AVI/BMP for QLAB).
Features: Image storage, report generation, automatic distance measurement.
Classification: 90LLZ (Radiological Image Processing System).

The 510(k) process for this device relies on demonstrating that the new version (IMT.LAB C:2.0) has technological characteristics and intended use that are equivalent to already legally marketed predicate devices, rather than presenting a de novo performance study against pre-defined acceptance criteria.

Summary

{0}------------------------------------------------

Ko62598

510(k) Summary IMT.LAB Esaote Europe

OCT 3 1 2006

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).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent The Anson Group 11460 N. Meridian St., Ste. 150 Carmel, IN 46032 (317) 569-9500, extension 103 Phone: Facsimile: (317) 569-9520

Carri Graham Contact Person:

Date: August 7, 2006

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)

Esaote Europe	IMT.LAB	K043360
SonoMetric Health	SonoCalc	K030223
Phillips	QLAB	K021966

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

{1}------------------------------------------------

510(k) Summary IMT.LAB Esaote Europe

807.92(a)(4)

Device Description

IMT.LAB can store the images and the measurement results on the hard disk for future reference.

Intended Use(s) 807.92(a)(5)

Esaote's IMT.LAB software is a Windows 2000/XP software application package. It is designed 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 ultrasound systems.

{2}------------------------------------------------

Technological Characteristics 807.92(a)(6)

ESAOTE believes that IMT.LAB is substantially equivalent to Esaote's IMT.LAB product (K043360), SonoMetric Health's SonoCalc product (K030223) and to Philips Medical Systems' QLAB product (K021966)

Characteristic	ESAOTEIMT.LAB (C:2.0)Via thisSubmission	ESAOTEIMT.LAB (C:1.0)(K043360)	SonoMetric HealthSonoCalc(K030223)	Philips MedicalSystemsQLAB (K021966)
Intended use	The IMT.LABsoftware is aWindows 2000/XPsoftware packageto be used on apersonal computerfor the automaticmeasurement of theintima mediathickness of thecarotid artery fromvideo imagesobtained fromEsaote ultrasoundsystems.	The IMT.LABsoftware is aWindows 2000/XPsoftware packageto be used on apersonal computerfor the automaticmeasurement of theintima mediathickness of thecarotid artery fromvideo imagesobtained fromEsaote ultrasoundsystems.	The SonoCalcsoftware is aWindows-basedapplicationprogram used on apersonal computerfor the automaticmeasurement of theintima mediathickness of thecarotid artery fromimages obtainedfrom ultrasoundsystems	The Q LABQuantificationsoftware is aWindows2000/Windows XPsoftwareapplicationpackage. It isdesigned to viewand quantify imagedata acquired onPhilips MedicalSystemsultrasoundproducts.
Image source	Ultrasound images	Ultrasound images	Ultrasound images	Ultrasound images
Operatingenvironment,system andhardware	Stand aloneapplicationprogram for use ona personalcomputer withMicrosoftWindows	Stand aloneapplicationprogram for use ona personalcomputer withMicrosoftWindows	Stand aloneapplicationprogram for use ona personalcomputer withMicrosoftWindows	Stand aloneapplicationprogram for use ona personalcomputer withMicrosoftWindows
Image format	DICOM, JPEG andWindows BMP	DICOM, JPEG andWindows BMP	JPEG andWindows BMP	AVI and WindowsBMP
Image storageand reportgeneration	Yes	Yes	Yes	Yes
Automaticdistancemeasurement ofthe intima mediathickness of anartery	Yes	Yes	Yes	Yes
	ESAOTEIMT.LAB (C:2.0)Via thisSubmission	ESAOTEIMT.LAB (C:1.0)(K043360)	SonoMetric HealthSonoCalc(K030223)	Philips MedicalSystemsQLAB (K021966)
Classification	90LLZ	90LLZ	90LLZ	90LLZ
	892.2050	892.2050	892.2050	892.2050
Image	JPEG	JPEG	JPEG	None
Compression	Loss-less	Loss-less	Lossy
				Lossy

{3}------------------------------------------------

510(k) Summary IMT.LAB

Esaote Europe

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the text "MINISTRY OF HEALTH & KL" arranged in a circular fashion on the left side. To the right of the text, there are three stylized, curved lines that appear to be stacked on top of each other. The lines are thick and black, and they create a sense of movement or flow. The overall design is simple and modern, with a focus on clean lines and a minimalist aesthetic.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT 3 1 2006

Esaote Europe, B.V. % Ms. Carri Graham The Anson Group 1460 N Meridian St., Ste 150 CARMEL IN 46032

Re: K062598

Trade/Device Name: IMT. LAB SOFTWARE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and IYO Dated: August 25, 2006 Received: September 1, 2006

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 Cost retic Act (Act) that do not require approval of a premarket approval application (PMA). You maxi. 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 affective 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.

Image /page/4/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in cursive. Three dots are arranged in a horizontal line at the bottom of the logo.

Protecting and Promoting Public Health

{5}------------------------------------------------

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.

This letter will allow you to begin marketing your device as described 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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): Ko 2598

Device Name: IMT.LAB Software

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/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 R. Lyman

Division Sign-Off) Orvision of Reproductive, Abdominal, · adiological Devices Erik) Number -

Page 1 of 1

Regulation Number and Section

§ 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).