ART.LAB is a software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery from RF based signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated from distension and blood pressure (systolic and diastolic).

Device Description

The ART.LAB software product is an optional software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery. The measurements are based upon RF signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated from the distension and blood pressure (systolic and diastolic). The ART.LAB software operates in conjunction with an ultrasound system, a linear probe and is installed on an external PC, used for signal processing.

Specifications: Ultrasound scanner with Fast-B-mode scanning capabilities and a linear probe PC P3 1 GHz with 256 MG memory Microsoft Windows 98 or XP Data acquisition card (for acquisition of RF-signals obtained from ultrasound system) Connection cable (from ultrasound system to PC, for RF, Z & trigger signals) ART.LAB software

AI/ML Overview

The provided 510(k) summary for ART.LAB does not contain details about acceptance criteria or a specific study proving the device meets said criteria with quantitative performance results.

The document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and general specifications. It lacks the quantitative performance data, sample sizes, ground truth establishment methods, and expert details typically found in acceptance criteria studies for medical devices.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The provided document is a 510(k) summary, which is a high-level overview for regulatory submission, and it generally refers to more detailed studies that would have been submitted as part of the full 510(k) application, but these details are not present in this particular summary.

Summary

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K06 196 1

510(k) Summary ART.LAB Pie Medical

SEP - 6 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
11460 N. Meridian Street, Suite 150
Carmel, IN 46032
Phone:	(317) 569-9500
Facsimile:	(317) 569-9520

Contact Person:	Carri Graham
Date:	July 7, 2006

807.92(a)(2)

Trade Name:	ART.LAB
Common Name:	Picture Archiving and Communication System
Classification Name(s):	Image Processing System	892.2050
Classification Number:	90IYO90IYN90ITX90LLZ

807.92(a)(3)

Predicate Device(s)

K043360	IMT.LAB	Pie Medical
K961144	Cardiovision MS. 2000	Touritu Engineering Co., Inc.
K032875	SSD-5500	Aloka

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

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510(k) Summary ART.LAB Pie Medical

Device Description 807.92(a)(4)

807.92(a)(5) ART.LAB is a software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery from RF based signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated from distension and

Intended Use(s)

blood pressure (systolic and diastolic).

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Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the top half of the circle. In the center of the seal is a stylized eagle-like symbol with three curved lines representing its wings or feathers. The seal appears to be a government or official emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Pie Medical % Ms. Carri Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032

SEP - 6 2006

Re: K061961

Trade/Device Name: ART.LAB Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2006 Received: July 11, 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 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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PDA" in the center, and "Centennial" below that. There are three stars below the word "Centennial". The logo has a dotted border.

Protecting and Promoting Public Health

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Page 2 -

ﺎ،

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of actives that i Driving that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I 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 CI K Pat 601); facemig (2) CFR Paulation (21 CFR Part 820); and if applicable, the electronic form in all quality bystelle (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) Phils letter with and To Jour finding of substantial equivalence of your device to a legally premaince noticated 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 If you desire specific as 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 (21 CF 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 yours,

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

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Indications for Use

510(k) Number (if known): __ < 0 6 / 9 / 1 6 0 / 1 / 6 / 1 / 6 /

Device Name: ART.LAB

Indications for Use:

ART.LAB is a software package to be used on an external personal computer for the real ANY LAD is a software paonage to otima Media Thickness, diameter and distension of thire automatic incasurement of the nal processing obtained from Esaote or Pie Medical the carond artery from Its base sigiffiess Indicator is calculated from distension and blood pressure (systolic and diastolic).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Nancy C. Bridger

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

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).