(255 days)
Not Found
No
The document describes image processing and measurement capabilities but does not mention AI, ML, or related terms. The performance testing section refers to standard software validation and a clinical study on a predicate device, not AI/ML model training or validation.
No
The device is described as a software imaging system for processing, reviewing, displaying, and archiving medical images and data. It assists in diagnosis and evaluation but does not directly provide therapy or treatment.
No
The document explicitly states, "Diagnosis is not performed by the software but by qualified Physicians," and "UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes." While it processes images and assists in measurements for evaluation, it's not the device itself that makes the diagnosis.
Yes
The device description explicitly states "UltraLinq is a web-based software application" and the intended use describes its function as receiving, processing, reviewing, displaying, and archiving medical images and data, all of which are software-based activities. While it interfaces with hardware (imaging modalities, computers, mobile devices), the device itself is presented as the software system.
Based on the provided information, UltraLinq is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- UltraLinq's Function: UltraLinq primarily deals with medical images acquired from imaging modalities like Ultrasound and MRI. It processes, reviews, displays, and archives these images and associated data. While it performs some processing on echocardiographic images to assist in cardiac evaluation, this is done on already acquired images and not on biological specimens.
- Intended Use: The intended use clearly states that diagnosis is performed by qualified physicians, not by the software itself. The software is a tool to manage and view images and data.
- Lack of Specimen Analysis: There is no mention of UltraLinq analyzing any biological specimens.
Therefore, UltraLinq falls under the category of a medical image management and processing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UltraLinq is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US), and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer, iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to:
- · share reports and studies with other UltraLinq users,
- · review reports and studies,
- · download and save reports and studies,
- · send reports and studies to EMR and EHR systems, and
- · route reports and studies to other UltraLinq users.
UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation.
UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation.
This device is not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone.
UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians.
UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation.
UltraLinq conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (US), and Magnetic Resonance (MR)
Anatomical Site
Left ventricular wall (for cardiac evaluation based on echocardiographic images).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
UltraLinq is intended for use by a physician or other trained medical professionals. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
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)
UltraLinq Healthcare Solutions has conducted verification and validation on the UltraLinq software. Software validation has been satisfactorily completed and the software met its performance requirements and specifications. Software validation was completed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a device of moderate concern. Software Risk Analysis, Software Requirements Specification, Software Design Specifications, Traceability Analysis, Software Development Environment Description, and Revision History were completed in accordance with the guidance documents.
Performance testing of UltraLinq was conducted to validate that the device conforms to the defined user needs and intended uses.
UltraLinq integrates with DiACardio's LVivo EF to provide automated Ejection Fraction (EF) calculation. UltraLinq integrates the LVivo EF algorithm without changes. A Clinical Study was performed and submitted by DiACardio on the LVivo EF Software Application 510(k) K130779.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ULTRALINQ HEALTHCARE SOLUTIONS, INC. % Ms. Rita King CEO MethodSense. Inc. PO Box 110352 DURHAM NC 27709
Re: K143176 Trade/Device Name: UltraLing Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 15, 2015 Received: June 17, 2015
Dear Ms. King:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
July 17, 2015
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143176
Device Name UltraLinq
Indications for Use (Describe)
UltraLinq is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US), and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer, iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. UltraLinq is used to:
- · share reports and studies with other UltraLinq users,
- · review reports and studies,
- · download and save reports and studies,
- · send reports and studies to EMR and EHR systems, and
- · route reports and studies to other UltraLinq users.
UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes. The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation.
UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation.
This device is not to be used for mammography.
Additional Information (AI) to 510(k) - K143176
| 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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3
510(k) Summary
UltraLinq K143176
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | UltraLinq Healthcare Solutions, Inc.
236 West 30th Street, 6th Floor
New York, NY 10001
Phone: 646-666-9576 |
| ------------ | ---------------------------------------------------------------------------------------------------------------------- |
|---|
- Primary Contact: Rita King, CEO MethodSense, Inc. Email: ritaking@methodsense.com Phone: 919-313-3961 Fax: 919-313-3979
- Company Contact: Stephen Farber Chief Executive Officer
- Date Prepared: June 15, 2015
Device Name and Classification
| Trade Name: | UltraLinq |
|---|---|
| Common Name: | Picture Archiving Communications System (PACS) |
| Classification: | Class II |
| Regulation Number: | 892.2050 – Picture Archiving and Communications System (PACS) |
| Classification Panel: | Radiology |
| Product Code: | LLZ |
Predicate Devices:
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| Trade Name | ASTRA | LVivo EF Software Application |
| Common Name | Picture Archiving Communications System | Picture Archiving Device |
| 510(k) Submitter / Holder | Candelis, Inc. | DiACardio, Ltd. |
| 510(k) Number | K111694 | K130779 |
| Regulation Number | 892.2050 | 892.2050 |
| Classification Panel | Radiology | Radiology |
| Product Code | LLZ | LLZ |
4
Device Description and Intended Use
UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone.
UltraLing is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians.
UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation.
UltraLing conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
Indications for Use
UltraLing is a software imagement system intended to receive, process, review, display, and archive medical images and data from imaging modalities (e.g. Ultrasound (US). and Magnetic Resonance (MR)). Images and data can be stored, communicated and displayed across computer systems and mobile devices. UltraLinq is a single system that can run on a web-enabled computer. iPad and iPhone and may be interfaced with other PACS systems. Diagnosis is not performed by the software but by qualified Physicians. Typical users of this system are trained and qualified professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
UltraLinq is used to:
- share reports and studies with other UltraLinq users,
- . review reports and studies,
- download and save reports and studies, ●
- send reports and studies to EMR and EHR systems, and ●
- . route reports and studies to other UltraLing users.
UltraLinq provides access to medical images on mobile devices for non-diagnostic viewing and referral purposes.
The mobile device access functionality is used for patient management by the medical community in order to access and display patient data, medical reports, and medical images. Mobile devices are not intended to replace full diagnostic workstations and should be used only when there is no access to a workstation.
UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular
5
function evaluation. This measurement, available on workstations only, can be used to assist the clinician in cardiac evaluation.
This device is not to be used for mammography.
Substantial Equivalence
UltraLinq is substantially equivalent to predicate devices currently on the market. These devices are:
- . ASTRA by Candelis, Inc - K111694 (primary predicate device)
- LVivo EF Software Application by DiACardio, Ltd K130779 (secondary predicate ● device)
UltraLinq has the same intended use and indications for use as the predicate devices. The table below provides a detailed comparison of UltraLinq to the predicate devices.
Detailed Comparison of the Subject and Predicate Devices
6
| Item | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
|---|---|---|---|---|
| Intended Use | UltraLinq | |||
| UltraLinq is intended for | ||||
| use by a physician or other | ||||
| trained medical | ||||
| professionals to receive, | ||||
| process, review, display | ||||
| and archive medical | ||||
| images and data from | ||||
| imaging modalities. |
UltraLinq is also intended
for non-invasive processing
of already acquired
echocardiographic images
in order to detect, measure,
and calculate the left
ventricular wall for left
ventricular function
evaluation. This
measurement, available on
workstations only, can be
used to assist the clinician
in a cardiac evaluation.
Diagnosis is not performed
by the software but by
qualified Physicians. | ASTRA
ASTRA is intended to be
used by trained
professionals, e.g.
Physicians, radiologists,
nurses, medical
technicians, and
assistants to receive,
process, review, display,
print and archive medical
images and data from
imaging modalities.
Diagnosis is not
performed by the software
but by Radiologists,
Clinicians or referring
Physicians. | LVivo EF Software
Application
LVivo EF Software
Application is intended
for non-invasive
processing of already
acquired
echocardiographic
images in order to
detect, measure, and
calculate the left
ventricular wall for left
ventricular function
evaluation. This
measurement can be
used to assist the
clinician in a cardiac
evaluation. | Identical to the LVivo EF
Software Application.
Equivalent to ASTRA
with the exception that
UltraLinq does not print
images. |
| Indications for Use | UltraLinq is a software
image management system
intended to receive,
process, review, display,
and archive medical | ASTRA is software image
management intended to
receive, process, review,
display, print and archive
medical images and data | LVivo EF Software
Application is intended
for non-invasive
processing of already
acquired | Identical to LVivo EF
Software Application
Equivalent to ASTRA
with the exception that |
| | | | | |
| images and data from | from imaging modalities | echocardiographic | UltraLinq does not print | |
| imaging modalities (e.g.
Ultrasound (US), and | (e.g. CR and DR). Images | images in order to | images and is not to be | |
| Magnetic Resonance | and data can be stored, | detect, measure, and | used for mammography. | |
| (MR)). Images and data | communicated, and | calculate the left | Also, equivalent to | |
| can be stored, | displayed within the | ventricular wall for left | ASTRA, UltraLinq | |
| communicated and | system or across | ventricular function | provides three different | |
| displayed across computer | computer systems. | evaluation. This | interfaces and runs on | |
| systems and mobile | ASTRA is comprised with | measurement can be | iPad and iPhone but | |
| devices. UltraLinq is a | three configurations | used to assist the | instead of 3 different | |
| single system that can run | depending upon the | clinician in a cardiac | configuration | |
| on a web-enabled | requirements of the user | evaluation. | implementations as | |
| computer, iPad and iPhone | and desired options:
ASTRA PLUS, ASTRA | | provided by ASTRA, | |
| and may be interfaced with | Lite, and ASTRA Mobile. | | UltraLinq is comprised of | |
| other PACS systems. | ASTRA runs on a PC | | a single configuration. | |
| Diagnosis is not performed | workstation, iPad, or | | | |
| by the software but by | iPhone and may be | | | |
| qualified Physicians. | interfaced with verified | | | |
| Typical users of this system | and validated image | | | |
| are trained and qualified | acquisition devices from | | | |
| professionals, e.g. | Candelis or other PACS | | | |
| physicians, radiologists, | systems. Diagnosis is not | | | |
| nurses, medical | performed by the software | | | |
| technicians, and assistants. | but by Radiologists,
Clinicians or referring | | | |
| UltraLinq is used to: | Physicians. Typical users | | | |
| • share reports and
studies with other
UltraLinq users, | of this system are trained
professionals, e.g. | | | |
| • review reports and
studies, | physicians, radiologists,
nurses, medical | | | |
| • download and save
reports and studies, | technicians, and
assistants. | | | |
| • send reports and studies
to EMR and EHR
systems, and | ASTRA Plus is used to:
share reports and studies | | | |
| • route reports and studies | with other ASTRA peers, | | | |
7
8
| to other UltraLinq users.
UltraLinq provides access
to medical images on
mobile devices for non-
diagnostic viewing and
referral purposes.
The mobile device access
functionality is used for
patient management by the
medical community in order
to access and display
patient data, medical
reports, and medical
images. Mobile devices are
not intended to replace full
diagnostic workstations and
should be used only when
there is no access to a
workstation.
UltraLinq is also intended
for non-invasive processing
of already acquired
echocardiographic images
in order to detect, measure,
and calculate the left
ventricular wall for left
ventricular function
evaluation. This
measurement, available on
workstation only, can be
used to assist the clinician
in cardiac evaluation.
This device is not to be
used for mammography. | review reports and
studies, download and
save reports, send reports
to local EMR, HER, RIS,
HIS or PACS systems
(HL7 send), route studies
to PACS, Workstations, or
other ASTRA peers.
ASTRA Lite is used to:
share reports and studies
with ASTRA peers, review
reports and studies,
download and save
reports, send reports to
local EMR, HER, RIS, HIS
or PACS system s (HL7
send).
ASTRA Mobile is used to:
share reports with other
ASTRA peers, review
reports, download and
save reports, send reports
to local EMR, HER, HIS
or PACS systems (HL7
send).
Only pre-processed
DICOM for presentation
images can be interpreted
by primary image
diagnosis in
mammography. Lossy
compressed
Mammographic images | |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
9
| | | and digitized film screen
images may only be
interpreted using and FDA
approved monitor that
offers at least 5 Megapixel
resolution and meets
other technical
specifications reviewed
and accepted by FDA. | | |
|-------------------------------------------------------------------------------------------------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------|
| Internet Based
Software | Yes | Yes | No | Equivalent to ASTRA |
| Receive, store,
retrieve, process,
review, and/or
display Medical
Images | Yes | Yes | Yes | Equivalent to ASTRA
and LVivo EF Software
Application |
| Receives DICOM
images from
Imaging
modalities. | Yes | Yes | Yes | Equivalent to ASTRA
and LVivo EF Software
Application. |
| Cloud-based
computing and
storage for
transfer and
sharing of studies,
images and
reports | Yes | Yes | No | Equivalent to ASTRA. |
| Software operates
on off-the-shelf
hardware | Yes | Yes | Yes | Equivalent to ASTRA
and LVivo EF Software
Application |
| Image storage and
archive server | Yes | Yes | No | Equivalent to ASTRA |
| Displays images
on mobile devices | Yes | Yes | No | Equivalent to ASTRA |
| Conforms to
DICOM Standard | Yes | Yes | Yes | Equivalent to ASTRA
and LVivo EF Software |
| for interoperability
with other DICOM
compliant systems | | | | Application |
| Routing of images | Yes | Yes | No | Equivalent to ASTRA |
| Transmits images
using lossy
compression | Yes | Yes | No | Equivalent to ASTRA |
| Stores images
using lossy
compression | Yes | Unknown | No | Equivalent to ASTRA |
| Automated
calculation of Left
Ventricular Wall
Boundary from
Echocardiographic
Videos | Yes | No | Yes | Identical to LVivo EF
Software Application. |
| Calculation of
ejection fraction
based on
computer
ventricular wall
boundaries | Yes | No | Yes | Identical to LVivo EF
Software Application. |
| Scaling (Zoom
In/Out) | Yes | Yes | No | Equivalent to ASTRA |
| Adjusting the
brightness level | Yes | Yes | No | Equivalent to ASTRA |
| Panning | Yes | Yes | No | Equivalent to ASTRA |
| Adjusting contrast
level | Yes | Yes | No | Equivalent to ASTRA |
| Window- level
function | Yes | Yes | No | Equivalent to ASTRA |
10
11
Testing
UltraLinq Healthcare Solutions has conducted verification and validation on the UltraLinq software. Software validation has been satisfactorily completed and the software met its performance requirements and specifications. Software validation was completed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a device of moderate concern. Software Risk Analysis, Software Requirements Specification, Software Design Specifications, Traceability Analysis, Software Development Environment Description, and Revision History were completed in accordance with the guidance documents.
Performance testing of UltraLinq was conducted to validate that the device conforms to the defined user needs and intended uses.
UltraLinq integrates with DiACardio's LVivo EF to provide automated Ejection Fraction (EF) calculation. UltraLinq integrates the LVivo EF algorithm without changes. A Clinical Study was performed and submitted by DiACardio on the LVivo EF Software Application 510(k) K130779.
Substantial Equivalence Conclusions
In conclusion, the intended use for the UltraLing device is the same as that of the predicate devices. The comparison demonstrates UltraLing has similar device functions and other technological characteristics, and testing shows these functions perform as intended. This demonstrates that UltraLinq is substantially equivalent to the predicate devices and assures that UltraLinq is as safe and effective as the predicate devices.
Conclusion
The 510(k) Pre-market Notification for UltraLing contains adequate information and data to determine that UltraLing is as safe and effective as the legally marketed predicate devices.