(57 days)
Not Found
No
The description focuses on "RF based signal processing" and "automatic measurement" without mentioning AI, ML, or related concepts. The technology described appears to be traditional signal processing and algorithmic measurement.
No
The device is a software package for measurement and calculation of arterial characteristics, not for treatment or therapy.
Yes
The "Intended Use" section explicitly states that ART.LAB is used for "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." These measurements are used to calculate the "Arterial Stiffness Indicator," which are all diagnostic indicators for assessing vascular health.
No
The device description explicitly states that the ART.LAB software operates in conjunction with an ultrasound system, a linear probe, a data acquisition card, and a connection cable. These are hardware components that are integral to the device's function as described. While the ART.LAB itself is software, the overall medical device system includes significant hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ART.LAB software processes ultrasound signals obtained from an ultrasound system, which is a non-invasive imaging modality. It does not analyze blood, urine, tissue, or any other biological sample taken from the patient.
- The intended use is for measurement of anatomical structures and physiological indicators. The software measures Intima Media Thickness, diameter, distension, and calculates the Arterial Stiffness Indicator based on these measurements and blood pressure. These are measurements of the physical characteristics and function of the carotid artery, not the analysis of a biological sample for diagnostic purposes.
Therefore, ART.LAB falls under the category of a medical device that processes imaging data, not an IVD.
N/A
Intended Use / Indications for Use
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).
Product codes
90IYO, 90IYN, 90ITX, 90LLZ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
RF signal processing obtained from Esaote or Pie Medical ultrasound systems.
Anatomical Site
carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: | 90IYO | |
| 90IYN | ||
| 90ITX | ||
| 90LLZ |
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.
1
510(k) Summary ART.LAB Pie Medical
Device Description 807.92(a)(4)
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
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).
2
3
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
4
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
5
Indications for Use
510(k) Number (if known): __