(29 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on "automatic measurement" which can be achieved through traditional image processing techniques without necessarily employing AI/ML.
No
The device is a software application for measuring the intima media thickness of the carotid artery from ultrasound images, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as "automatic measurement of the intima media thickness of the carotid artery," which provides information used for diagnosis, making it a diagnostic device. Also, it shares predicates with other diagnostic ultrasound analysis software.
Yes
The device is explicitly described as a "software application package" and a "software package" that runs on a personal computer. While it processes images from an ultrasound system, the device itself is the software component performing the measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device function: The IMT.LAB software processes ultrasound images of the carotid artery to measure intima media thickness. This is an analysis of images obtained from a medical imaging device, not a test performed on a biological sample.
Therefore, the IMT.LAB software falls under the category of medical image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IMT.LAB software is a Windows 2000/XP software 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.
Product codes
90 LLZ
Device Description
The IMT.LAB software is a Windows 2000/XP software 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.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound images
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
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).
807.92(a){1)
.
Submitter Information
Carri Graham, Official Correspondent
7992 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916, extension 103 |
|---|---|
| Facsimile: | (317) 577-9070 |
| 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.
1
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
IMT.LAB
Via this Submission | SonoMetric Health
SonoCalc
(K030223) | Philips Medical
Systems
QLAB (K021966) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The IMT.LAB
software is a
Windows 2000/XP
software 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. | The SonoCalc
software is a
Windows-based
application program
used on a personal
computer for the
automatic
measurement of the
intima media
thickness of the
carotid artery from
images obtained
from ultrasound
systems | The Q LAB
Quantification
software is a
Windows
2000/Windows XP
software application
package. It is
designed to view
and quantify image
data acquired on
Philips Medical
Systems ultrasound
products. |
| Image source | Ultrasound images | Ultrasound images | Ultrasound images |
| Operating
environment,
system and
hardware | Stand alone
application program
for use on a
personal computer
with Microsoft
Windows | Stand alone
application program
for use on a
personal computer
with Microsoft
Windows | Stand alone
application program
for use on a personal
computer with
Microsoft Windows |
| Image format | DICOM, JPEG and
Windows BMP | JPEG and Windows
BMP | AVI and Windows
BMP |
| Image storage and
report generation | Yes | Yes | Yes |
| Automatic distance
measurement of the
intima media
thickness of an
artery | Yes | Yes | Yes |
| Classification | 90LLZ
892.2050 | 90LLZ
892.2050 | 90LLZ
892.2050 |
| Image Compression | JPEG
Loss-less | JPEG
Lossy | None |
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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 __