(167 days)
Not Found
No
The summary describes standard image viewing, measurement, and analysis software for IVUS images, with no mention of AI or ML capabilities.
No.
The device is described as a software product intended to review, analyze, and measure medical images, aiding in post-procedure analysis. It does not directly treat or diagnose a disease or condition.
Yes
The device is described as a software product that allows medical professionals to review, analyze, and measure intravascular ultrasound (IVUS) images to quantify vessel and stent dimensions, which aids in post-procedure analysis. This functionality directly supports making a determination about the physiological state of a patient (i.e., vessel and stent dimensions), thereby making it a diagnostic device.
Yes
The device is explicitly described as a "software product" throughout the summary, and its functionalities are solely related to the processing, analysis, and visualization of existing IVUS images. There is no mention of any hardware components being part of the device itself.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- echoPlaque's Function: echoPlaque is a software product designed to review, analyze, and measure intravascular ultrasound (IVUS) images. IVUS is an imaging technique performed inside the body using a catheter with an ultrasound transducer. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states it's for examining and measuring IVUS images to aid in post-procedure analysis regarding the placement of interventional devices. This is an imaging analysis tool, not a diagnostic test performed on biological samples.
Therefore, echoPlaque falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
echoPlaque is a software product intended to be used to review, analyze, and measure intravascular ultrasound (IVUS) images. echoPlaque is intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements to quantify vessel and stent dimensions. These features aid in post-procedure analysis regarding the placement of interventional devices.
Product codes
LLZ
Device Description
echoPlaque is a software product that provides capabilities for loading, acquiring, viewing, analyzing and saving vendor-neutral, multi-frame DICOM data from Intravascular Ultrasound (IVUS) studies, INDEC echoPlaque IMG/BMG IVUS files, and medical datasets saved as Microsoft Video 1 codec compressed AVI files. echoPlaque's main functionality includes viewing and playback of medical images and ancillary files, acquiring new images from analog and digital signals, image analysis including 2D and volumetric measurements, and the ability to resave multi-frame images in either a compressed or uncompressed format for future visualization and analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound (IVUS)
Anatomical Site
vessel and stent
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
1092842
Submitted by:
MAR - 1 2010
Tel: 408-986-1600 Fax: 408-986-1605
Contact Person: Carol Hubler Date: September 14, 2009
INDEC Systems, Inc.
Santa Clara, CA 95050
2210 Martin Ave.
Device Trade Name: echoPlaque
Common Name: Classification:
echoPlaque Intra Vascular Analysis Software Picture Archiving and Communication System, Class II Sec. 21 CFR 807.92
Predicate Devices:
QIVA Intra Vascular Ultrasound Analysis software (K021495) QCU-CMS Analytical Software Package (K011582)
Description of the Device:
echoPlaque is a software product that provides capabilities for loading, acquiring, viewing, analyzing and saving vendor-neutral, multi-frame DICOM data from Intravascular Ultrasound (IVUS) studies, INDEC echoPlaque IMG/BMG IVUS files, and medical datasets saved as Microsoft Video 1 codec compressed AVI files. echoPlaque's main functionality includes viewing and playback of medical images and ancillary files, acquiring new images from analog and digital signals, image analysis including 2D and volumetric measurements, and the ability to resave multi-frame images in either a compressed or uncompressed format for future visualization and analysis.
Intended Use of the Device:
.
echoPlaque is a software product intended to be used to review, analyze, and measure intravascular ultrasound (IVUS) images. echoPlaque is intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements to quantify vessel and stent dimensions. These features aid in post-procedure analysis regarding the placement of interventional devices.
Substantial Equivalence to Predicate Device:
echoPlaque 3.0 is substantially equivalent in intended use, design, and operation characteristics to the following currently marketed devices:
- QIVA Intra Vascular Ultrasound Analysis software (K021495)
- Medis Medical Imaging Systems B.V. QCU-CMS Analytical Software Package (K011582)
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The symbol on the right is a stylized representation of three overlapping figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2010
Ms. Carol Hubler Vice President Indec Systems, Inc. 2210 Martin Ave. SANTA CLARA CA 95050
Re: K092842
Trade/Device Name: echoPlaque Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 22, 2010 Received: January 26, 2010
Dear Ms. Hubler:
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 adultcration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: _ _ _ _ _ echoPlaque
Indications for Use:
echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPlaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.
Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K092842
(Posted November 13, 2003)
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