(17 days)
Not Found
No
The document describes a standard PACS system with image viewing, storage, and basic quantitative analysis capabilities, but makes no mention of AI or ML technologies.
No
The device is described as a picture archiving and communications system for storing and displaying cardiovascular information and images. It does not mention any therapeutic function or direct treatment of a disease or condition.
No
The device is a Picture Archiving and Communications System (PACS) that stores and displays medical images and information. While it allows for viewing, analysis, and report generation, it does not directly diagnose conditions. It is a tool that facilitates the work of a diagnostician but is not itself a diagnostic device.
Yes
The device is described as "comprised of modular software programs that run on standard 'off-the-shelf' personal computers and servers," indicating it is a software-only solution that utilizes existing hardware platforms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Ascentia is a "picture archiving and communications system intended to be used as a networked cardiovascular information and image data storage and display system." It focuses on managing and displaying medical images and related data.
- IVD Definition: 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. Ascentia does not perform any such tests on biological samples.
- Functionality: The described functionalities (image storage, display, viewing, analysis, reporting, archiving) are typical of a PACS (Picture Archiving and Communication System) and are not related to in vitro testing.
Therefore, Ascentia falls under the category of a medical imaging system or a medical image management system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ascentia ™ (formally Encompass™) is a picture archiving and communications system intended to be used as a networked cardiovascular information and image management system. Ascentia™ is comprised of modular software programs and run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia™ accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical images, perform quantitative analysis and quantitative measurements on both cine and cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive. Ascentia™ is a scalable network.
Product codes
LLZ
Device Description
Ascentia is comprised of modular software programs and run on standard "off-the-shelf" personal computers and servers running the Windows 2000/2007/XP operating system. Ascentia accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging equipment from multiple OEM vendors, consolidate images, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical images, perform quantitative analysis and quantitative measurements on both cine and cath images, generate and review patient reports with additional measurement capabilities and provides accessible digital image archive.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM
Anatomical Site
cardiovascular
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 (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
FEB 1 8 2005
Special 510(K) Summary
This is a summary of 510(k) safety and effectiveness information is being submitted in accordance with the SMDA 1990 and 21 CFR 807.92.
DATE:
31 January 2005
SUBMITTER:
Heartlab Inc. One Crosswind Road Westerly, RI 02891 Phone: (401) 596-0592 Fax: (401) 596-8562
CONTACT PERSON:
Richard Petrocelli Tel No: (401) 596-0592
IDENTIFICATION OF THE PRODUCT
| TRADE NAME: | Ascentia™ | |
|---|---|---|
| COMMON NAME: | Encompass Cardiac Network | |
| CLASSIFICATION NAME: | Image Processing System, LLZ | CFR 892.2050 |
SUBSTANTIAL EQUIVALENCE INFORMATION
Ascentia is considered comparable and substantially equivalent to the following predicate devices currently in commercial distribution:
Model Impax (K022292) Inturis Suite (K994210) Manufacturer Agfa Corp. Philips Medical Systems
1
| Feature | Heartlab, Inc.
Ascentia
(formally
Encompass) | Agfa Corp.
Impax | Philips
Inturis Suite |
|---------------------|-------------------------------------------------------|---------------------|--------------------------|
| Operating
System | Windows NT /
2000 / 2003 /
XP | Windows NT | Windows NT |
| Image
Source | DICOM | DICOM | DICOM |
| Display Rate | Over 30 fps | Up to 30 fps | Up to 30 fps |
| Multiple
Windows | Yes | Yes | Yes |
| Image
Export | bmp, jpg, mpg | bmp, jpg, mpg | bmp, jpg, avi |
| Network
Access | Yes | Yes | Yes |
| Analysis | Yes | Yes | Yes |
| Reporting | Yes | Yes | Yes |
Predicate Technical Characteristics
Very little difference can be found between Heartlab, Inc. Ascentia™ and the predicate devices noted above. Both systems take DICOM images from DICOM compliant imaging systems. Both systems archive this data in the DICOM format and provide a retrieval function for review, analysis and reporting.
For the acquisition of images from DICOM compliant imaging systems and the conversion of these images for distribution over a network; the Heartlab, Inc. system, and both the Agfa and Philips systems use similar techniques and offer the same functionality. Thus, for DICOM compliant image distribution over a network, the Heartlab, Inc. Ascentia™ device is substantially equivalent to the predicate devices noted above.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2005
Mr. Richard Petrocelli President Heartlab Cardiac Solutions One Crosswind Road WESTERLY RI 02891
Re: K050228 Trade/Device Name: Ascentia® (formally Encompass®) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 31, 2005 Received: February 1, 2005
Dear Mr. Petrocelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your roother evere is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to e enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chaetinent use or sisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accercal of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act de nee, subject to the general 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 n your de roo be subject to such additional controls. Existing major regulations affecting your Apployally, it the you be of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA do roce our of fourt announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Toase of advised that i in that your device complies with other requirements of the Act or any I DA has made a actemination administered by other Federal agencies. You must comply with all the I caraf statues und regarding, 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) (21 CFR Part 801); 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) 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.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 Division of Small Manufacturers, 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/cdrh/industry/support/index.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
Image /page/4/Picture/1 description: The image shows the logo for Heartlab Cardiac Solutions. The word "Heartlab" is in large, bold, white letters against a black background. Below "Heartlab" are the words "CARDIAC SOLUTIONS" in smaller, white, block letters, also against a black background. The logo is simple and professional.
Attachment A
K050228 510(k) Number: Ascentia™ (formally Encompass™) Device Name:
Indications For Use:
Ascentia ™ (formally Encompass™) is a picture archiving and communications system intended Ascentia ™ (formally Encompass - ) is a precers and management system. Ascentia™ is
to be used as a networked cardiovascular information and toff the shelf" ne to be used as a networked caldrovascum mornans that run on standard " toff-the-shel" personal software comprised of modular software programs and one of the system. Ascentia™ is
computers and servers running the Windows 2000/2007/XP operating and computers and servers rumming the wines as accepts DICOM (Digital Imaging and image data storage and display sollware that accepted by on DICOM standad imaging
Communications in Medicine) data from laboratories, which support DIC equipment from Communications in Medicine) dad non iaovo, consolidate images generated by equipment from
transfer. The system provides the capability to, consolidate imming the essecunted multiple OEM vendors, view images, enter clinical findings while viewing the associated multiple OEM velidors, view mages, onter enterestation of coronary arteries, perform images, perform digital subtraction, create graphisond images, perform quantitative analysis on quantialive measurements on both and and and and and measurement and report writer
cath images, generate and review patient reports with additional measurement cath images, generate and review patient reporter. Ascentia™ is a scalable network.
capabilities and provides accessible digital image archive. Ascential with 2 an 2 year capabilities and provides accession digital image areas and departments (with 2 or 3 users) to large hospital networks (with tens of users).
Prescription Use
David R. Shippee
Division Sign-Off