(168 days)
Not Found
No
The summary describes a standard image viewer with measurement tools and does not mention any AI/ML capabilities or algorithms.
No
The device is an image viewer that displays medical images and provides measurement tools. It does not directly treat or diagnose a medical condition.
No
The device is an image viewer and measurement tool for existing medical images (echocardiograms). While it aids in the review and analysis of diagnostic images, it does not itself acquire diagnostic data or provide a diagnosis. Its function is to display and measure images that are already acquired, which are then used by a clinician for diagnosis.
Yes
The device is explicitly described as a "software-only medical device" in the Intended Use section and the Device Description focuses solely on software functionalities for viewing and measuring medical images. There is no mention of accompanying hardware components.
Based on the provided information, the ASCEND Image Viewer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ASCEND Image Viewer's intended use is to display and measure medical images (echocardiograms) acquired directly from a patient using an ultrasound system. It does not process or analyze biological samples.
- The description focuses on image viewing and measurement. The core functionality is displaying and manipulating medical images, not performing tests on biological materials.
- The input is ultrasound images. Ultrasound is an imaging modality, not a method for obtaining biological specimens for in vitro analysis.
The ASCEND Image Viewer is clearly described as a software-only medical device for displaying and measuring medical images. This aligns with the definition of a medical image viewer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.
ASCEND Image Viewer is for prescription use only.
The Ascend device is intended for diagnostic review, quantification and reporting of cardiovascular structures and function of patients with suspected disease to support physicians in diagnosis.
Product codes
LLZ
Device Description
The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.
The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:
- . 2D
- Color Doppler
- M-mode
- . Spectral Doppler (Pulsed Wave and Continuous Wave)
The ASCEND Image Viewer provides Cine play review and control.
Standard Review supported study types include:
- TTE
- TEE
- Cath
- . Stress Echo
- Vascular
Supported Measurements include:
- Linear
- . Volume (method of discs)
- Velocity time integral
- Pressure half-time
- . Area
- Time
- Velocity
- Angle (measurement of two lines with a common vertex drawn on the image) .
The user can make measurements which persist for later use within the ASCEND Image Viewer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
cardiovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is generally used by medical professionals such as doctors and sonographers in need of displaying echocardiograms for diagnostic purposes.
The software is intended to be used in Health Care facilities including Office environments within hospitals and clinics.
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
Bench Testing: The test plan covers all aspects of the functionality, exercising every user interface, all menus and submenus, as well as the measurement tools. The software was tested according to the company's Design Control process. Risks were analyzed according to ISO 14971 to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. Hence, no measures are considered essential performance characteristics. The software is also verified for compliance with the DICOM standard.
Clinical Testing: ASCEND Image Viewer was tested in US city-hospital environments throughout the development cycle. Clinical testers consisted of resident cardiologists, cardiology fellows, and sonographers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: The software was tested according to the company's Design Control process. Risks were analyzed according to ISO 14971 to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. The software is also verified for compliance with the DICOM standard.
Clinical Testing: The clinical test results showed ASCEND Image Viewer performed effectively its intended use. Where the functionality of ASCEND Image Viewer intersected with the predicate device, it was found to be substantially equivalent. No late-arising risks or other safety concerns were recorded during clinical testing.
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
February 14, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ASCEND HIT % Robert A. Miller Director of Quality Assurance and Regulatory Affairs 801 Warrenville Road, Suite 200 LISLE IL 60532
Re: K192372
Trade/Device Name: ASCEND Image Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 13, 2020 Received: January 16, 2020
Dear Mr. Miller:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192372
Device Name ASCEND Image Viewer
Indications for Use (Describe)
ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.
ASCEND Image Viewer is for prescription use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 1
510(k) Summary
(as required by 21 CFR 807.92)
Date: 20-Jan-2020
| A. | Submitter's Information: | |||
|---|---|---|---|---|
| Name: | ASCEND HIT | |||
| Address: | 801 Warrenville Road | |||
| Suite 200 | ||||
| Lisle, Illinois 60532 USA | ||||
| Telephone Number: | (844) 413-2610 | |||
| Contact Name: | Andy Miller | |||
| Contact Email address: | amiller@ascendhit.com | |||
| B. | Device Information | |||
| Proprietary Name: | ASCEND Image Viewer | |||
| Common or Usual Name: | Image Processing System | |||
| Classification: | ||||
| Classification Panel: | Class II 21 CFR 892.2050 LLZ | |||
| Radiology | ||||
| Substantial Equivalence: | ASCEND Image Viewer is substantially equivalent to TomTec | |||
| Arena (K132544) |
Indications for Use:
ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.
ASCEND Image Viewer is for use by prescription only.
Intended Use:
4
The Ascend device is intended for diagnostic review, quantification and reporting of cardiovascular structures and function of patients with suspected disease to support physicians in diagnosis.
Device Description:
The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.
The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:
- . 2D
- Color Doppler
- M-mode
- . Spectral Doppler (Pulsed Wave and Continuous Wave)
The ASCEND Image Viewer provides Cine play review and control.
Standard Review supported study types include:
- TTE
- TEE
- Cath
- . Stress Echo
- Vascular
Supported Measurements include:
- Linear
- . Volume (method of discs)
- Velocity time integral
- Pressure half-time
- . Area
- Time
- Velocity
- Angle (measurement of two lines with a common vertex drawn on the image) .
The user can make measurements which persist for later use within the ASCEND Image Viewer.
Operator profile
The device is generally used by medical professionals such as doctors and sonographers in need of displaying echocardiograms for diagnostic purposes.
Intended use environment
5
The software is intended to be used in Health Care facilities including Office environments within hospitals and clinics.
Operating principle
- . On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard
Primary operating functions
Diagnostic viewing of echocardiograms in ultrasound DICOM format.
- C. Technological Characteristics of the Device as compared to Predicate Device:
| | Predicate Device
TomTec-Image Arena
TomTec Imaging
Systems GmbH
(K132544) | Subject Device
ASCEND Image Viewer
Ascend HIT | Substantially
Equivalent |
|-----------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------|
| Software only device | Yes | Yes | Yes |
| Web accessible | Yes | Yes | Yes |
| Display Images | still images and image
sequences | Yes | Yes |
| Select Images for closer
examination | Yes | Yes | Yes |
| Echocardiogram
analysis and review
capability | Manual only | Manual | Yes |
| Data Source | Multiple modalities | Ultrasound | Yes |
| DICOM compliant | Yes | Yes | Yes |
| Ultrasound mode
utilized for echo
analysis | B mode | 2D, Color Doppler, M-
mode, Spectral Doppler
images. | Yes |
| Viewing mode – 2D | Yes | Yes | Yes |
| Viewing mode - 3D | Yes | No | No |
6
| General Cardiac
Measurements | | Distance LV distance Angle Area Elipse Disks Time Velocity Heart rate Acceleration PHT VTI PIRI Slope | Linear (distance)
Angle
Area
Volume (method of disks)
Time
Velocity
VTI
PHT | Yes – Different features
from predicate have
been verified and
validation to assure
that there is no impact
on safety and
effectiveness. |
|---------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display format | | AVI, BMP, JPEG
or DCM export | Yes | Yes |
| Minimum Hardware Requirements | | | | |
| Operates on off the
shelf hardware | Yes | | Yes | Yes |
| OS | Microsoft Windows | | Microsoft Windows 7
and above. | Yes |
D. Brief Discussion of Test Results Submitted:
Bench Testing
The test plan covers all aspects of the functionality, exercising every user interface, all menus and submenus, as well as the measurement tools.
The software was tested according to the company's Design Control process. Risks were analyzed according to ISO 14971 to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. Hence, no measures are considered essential performance characteristics. The software is also verified for compliance with the DICOM standard.
Clinical Testing
7
ASCEND Image Viewer was tested in US city-hospital environments throughout the development cycle. Clinical testers consisted of resident cardiologists, cardiology fellows, and sonographers. The clinical test results showed ASCEND Image Viewer performed effectively its intended use. Where the functionality of ASCEND Image Viewer intersected with the predicate device, it was found to be substantially equivalent. No late-arising risks or other safety concerns were recorded during clinical testing.
- E. Conclusions from Test Results:
The Graphic User Interface conforms to the ASCEND Image Viewer functional specification.
The comparison ASCEND Image Viewer with the predicate devices shows that the ASCEND Image Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Verification and validation activities ensure that the design specifications are met, and that ASCEND Image Viewer does not introduce new issues concerning safety and effectiveness. Hence ASCEND Image Viewer is substantial equivalent to the predicate device.