(21 days)
Not Found
No
The summary describes image post-processing and analysis techniques based on established methods like Tissue Doppler Imaging and 3D reconstruction, without mentioning AI or ML.
No
The device is described as software that post-processes images to obtain clinically relevant information for detection, diagnosis, and risk management of cardiovascular disease and radiology, indicating a diagnostic rather than therapeutic purpose.
Yes
The intended use states that the software can be used for "detection of cardiovascular disease and radiology diagnosis and risk management" and provides examples of analysis of "ultrasound diagnostic images".
Yes
The device is described as "software packages" applied to an existing imaging processing system (Encompass). It focuses solely on post-processing and analysis of existing ultrasound images, without mentioning any associated hardware components being part of the submission.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes images: The description clearly states that this software post-processes and analyzes images obtained from ultrasound diagnostic equipment. It does not interact with or analyze biological samples directly.
- The intended use is image analysis for diagnosis: The purpose is to extract clinically relevant information from images for the detection and diagnosis of cardiovascular disease and radiology diagnosis. This is a function of medical imaging analysis, not in vitro diagnostics.
Therefore, while this device is a medical device used for diagnosis, it falls under the category of medical imaging software rather than an IVD.
N/A
Intended Use / Indications for Use
The software that can be used with the imaging processing system Encompass enables to provide images for the stress echo, to reconstruct three dimensional images for radiology examination and to provide images of TDI (Tissue Doppler Imaging) for cardiac diagnosis.
Using the software listed to post-process images, various analysis and reconstruction Osing the soltware librod to poor prostain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:
- URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
- URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
- URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
- Gray scale (display of only black-and-white images)
- Velocity display (display of the velocity after angle correction and smoothing)
- Display of the velocity gradient based on the velocity image
- Display of the degree of myocardial strain based on the velocity image
- Display of the displacement based on the velocity image
- Display of the dyssynchrony imaging based on the above imaging methods
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
These software packages are to be applied to the imaging processing system Encompass from Agfa Corp. Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:
- URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
- URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
- URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
- Gray scale (display of only black-and-white images)
- Velocity display (display of the velocity after angle correction and smoothing)
- Display of the velocity gradient based on the velocity image
- Display of the degree of myocardial strain based on the velocity image
- Display of the displacement based on the velocity image
- Display of the dyssynchrony imaging based on the above imaging methods
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
cardiac, abdominal, small organs, peripheral vascular.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Agfa Corp. Encompass [K040896], Toshiba SSA-770A [K041499], General Electric Vivid 7 with TSI [K031663]
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Kos 3043
| 510(k) Summary | NOV 1 8 2005 |
|---|---|
| Date: | October 7, 2005 |
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Manager (714) 730- |
| 5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | Software for Encompass |
| URSE-001A, URFR-001A, URTQ-001A | |
| Common Name: | Software |
| Regulatory Class: | Class II |
| Performance Standard: | none |
| Predicate Device(s): | Agfa Corp. Encompass [K040896], Toshiba SSA- |
| 770A [K041499], General Electric Vivid 7 with TSI | |
| [K031663] | |
| Reason For Submission | new device (software) |
Description of this Device:
These software packages are to be applied to the imaging processing system Encompass from Agfa Corp. Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:
-
URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
-
URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
-
URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
-
Gray scale (display of only black-and-white images)
-
Velocity display (display of the velocity after angle correction and smoothing)
1
- Display of the velocity gradient based on the velocity image
- Display of the degree of myocardial strain based on the velocity image
- Display of the displacement based on the velocity image
- Display of the dyssynchrony imaging based on the above imaging methods
Summary of Intended Uses:
The software that can be used with the imaging processing system Encompass enables to provide images for the stress echo, to reconstruct three dimensional images for radiology examination and to provide images of TDI (Tissue Doppler Imaging) for cardiac diagnosis.
Technological Characteristics:
These software are similar in uses and applications as those of the predicate devices.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and the imaging processing system Encompass comply with Underwriters Laboratories (U.L.) Standard No.544 for Medical and Dental Equipment.
Substantial Equivalence:
The software URSE-001A, URFR-001A and URTQ-001A is substantially equivalent to the predicate devices, Agfa Corp. Encompass [K040896], Toshiba SSA-770A [K041499], General Electric Vivid 7 with TSI [K031663].
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
NOV 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re.: K053043
Trade/Device Name: Encompass Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: October 26, 2005 Received: October 28, 2005
Dear Mr. Job:
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 (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 (PMA), it may be subject to 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 (OS) 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) 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. Hogdon
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): __ K053043
Device Name: Software for Encompass (Model Numbers: URSE-001A, URFR-001A, URTQ-001A)
Indications for Use:
Using the software listed to post-process images, various analysis and reconstruction Osing the soltware librod to poor prostain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:
- URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .
- URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.
- URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.
- Gray scale (display of only black-and-white images)
- Velocity display (display of the velocity after angle correction and smoothing)
- Display of the velocity gradient based on the velocity image
- Display of the degree of myocardial strain based on the velocity image
- Display of the displacement based on the velocity image
- Display of the dyssynchrony imaging based on the above imaging methods
Prescription Use × (Part 21 CFR 801 Subpart D) OR
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)
David A. Simpson
(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices K053042
510(k)
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