(255 days)
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.
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.
This document is a 510(k) Pre-market Notification for the UltraLinq device, which is a Picture Archiving Communications System (PACS) with an added feature for echocardiographic image analysis. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and detailed performance data in the format requested.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, and expert qualifications for a standalone performance study is not explicitly available within the provided text. The document refers to "Software validation" and "Performance testing" but does not detail the specific criteria or results in a measurable, quantifiable way for all functionalities.
However, it does describe the analytical validation for the echocardiographic measurement feature by referencing the predicate device.
Here's an attempt to answer your questions based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance for all functionalities of UltraLinq. Instead, it states that "Software validation has been satisfactorily completed and the software met its performance requirements and specifications."
For the specific functionality of automated calculation of Left Ventricular Wall Boundary and Ejection Fraction, UltraLinq integrates the LVivo EF algorithm without changes. The performance of this specific function relies on a prior clinical study submitted by DiACardio for the LVivo EF Software Application (K130779). The document does not provide the acceptance criteria or reported performance results of that study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text for UltraLinq's overall performance.
For the echocardiographic measurement functionality, it refers to "A Clinical Study was performed and submitted by DiACardio on the LVivo EF Software Application 510(k) K130779." Details of the sample size and data provenance for that study are not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text for UltraLinq's overall performance.
For the echocardiographic measurement functionality, it would have been established by the clinical study for the predicate device (LVivo EF Software Application), but those details are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned for UltraLinq. The document describes UltraLinq as a "software imagement system" that assists clinicians, explicitly stating "Diagnosis is not performed by the software but by qualified Physicians." This implies it's not a diagnostic AI in the sense that would typically require an MRMC study comparing human performance with and without AI assistance for improved diagnostic accuracy. Its role for most features is image management and display.
The only "AI-like" feature is the automated calculation of left ventricular wall boundary and ejection fraction. Even for this, the device states it "can be used to assist the clinician," not to replace their judgment. The document does not describe an MRMC study for this specific feature either, but rather relies on the predicate device's validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
For the core PACS functionalities (receiving, processing, reviewing, displaying, archiving, sharing, routing, etc.), these are inherent functions of the software itself and would be assessed in a standalone manner against technical and functional specifications. The document states, "Performance testing of UltraLinq was conducted to validate that the device conforms to the defined user needs and intended uses." However, specific metrics of "standalone performance" beyond functional correctness are not provided.
For the automated echocardiographic measurements, the document states: "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." This implies that the standalone performance of the EF algorithm was likely established by the DiACardio study, but the details are not replicated here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text for UltraLinq's general performance.
For the echocardiographic measurement functionality, the ground truth would have been established in the predicate device's clinical study (K130779), but the type of ground truth is not specified in the provided text. Typically for such measurements, it would involve measurements by expert sonographers/cardiologists.
8. The sample size for the training set
This information is not available in the provided text. The document refers to software validation and performance testing but does not detail the machine learning model development process or training set specifics. Since the device is a PACS system with an integrated measurement algorithm, explicit "training sets" might not be applicable in the same way as for a deep learning diagnostic algorithm, except potentially for the LVivo EF component.
9. How the ground truth for the training set was established
This information is not available in the provided text.
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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
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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
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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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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 FloorNew York, NY 10001Phone: 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 |
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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
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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
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| Item | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
|---|---|---|---|---|
| Intended Use | UltraLinqUltraLinq is intended foruse by a physician or othertrained medicalprofessionals to receive,process, review, displayand archive medicalimages and data fromimaging modalities.UltraLinq is also intendedfor non-invasive processingof already acquiredechocardiographic imagesin order to detect, measure,and calculate the leftventricular wall for leftventricular functionevaluation. Thismeasurement, available onworkstations only, can beused to assist the clinicianin a cardiac evaluation.Diagnosis is not performedby the software but byqualified Physicians. | ASTRAASTRA is intended to beused by trainedprofessionals, e.g.Physicians, radiologists,nurses, medicaltechnicians, andassistants to receive,process, review, display,print and archive medicalimages and data fromimaging modalities.Diagnosis is notperformed by the softwarebut by Radiologists,Clinicians or referringPhysicians. | LVivo EF SoftwareApplicationLVivo EF SoftwareApplication is intendedfor non-invasiveprocessing of alreadyacquiredechocardiographicimages in order todetect, measure, andcalculate the leftventricular wall for leftventricular functionevaluation. Thismeasurement can beused to assist theclinician in a cardiacevaluation. | Identical to the LVivo EFSoftware Application.Equivalent to ASTRAwith the exception thatUltraLinq does not printimages. |
| Indications for Use | UltraLinq is a softwareimage management systemintended to receive,process, review, display,and archive medical | ASTRA is software imagemanagement intended toreceive, process, review,display, print and archivemedical images and data | LVivo EF SoftwareApplication is intendedfor non-invasiveprocessing of alreadyacquired | Identical to LVivo EFSoftware ApplicationEquivalent to ASTRAwith 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 andstudies with otherUltraLinq users, | of this system are trainedprofessionals, e.g. | |||
| • review reports andstudies, | physicians, radiologists,nurses, medical | |||
| • download and savereports and studies, | technicians, andassistants. | |||
| • send reports and studiesto EMR and EHRsystems, and | ASTRA Plus is used to:share reports and studies | |||
| • route reports and studies | with other ASTRA peers, |
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| to other UltraLinq users.UltraLinq provides accessto medical images onmobile devices for non-diagnostic viewing andreferral purposes.The mobile device accessfunctionality is used forpatient management by themedical community in orderto access and displaypatient data, medicalreports, and medicalimages. Mobile devices arenot intended to replace fulldiagnostic workstations andshould be used only whenthere is no access to aworkstation.UltraLinq is also intendedfor non-invasive processingof already acquiredechocardiographic imagesin order to detect, measure,and calculate the leftventricular wall for leftventricular functionevaluation. Thismeasurement, available onworkstation only, can beused to assist the clinicianin cardiac evaluation.This device is not to beused for mammography. | review reports andstudies, download andsave reports, send reportsto local EMR, HER, RIS,HIS or PACS systems(HL7 send), route studiesto PACS, Workstations, orother ASTRA peers.ASTRA Lite is used to:share reports and studieswith ASTRA peers, reviewreports and studies,download and savereports, send reports tolocal EMR, HER, RIS, HISor PACS system s (HL7send).ASTRA Mobile is used to:share reports with otherASTRA peers, reviewreports, download andsave reports, send reportsto local EMR, HER, HISor PACS systems (HL7send).Only pre-processedDICOM for presentationimages can be interpretedby primary imagediagnosis inmammography. LossycompressedMammographic images | |
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
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| and digitized film screenimages may only beinterpreted using and FDAapproved monitor thatoffers at least 5 Megapixelresolution and meetsother technicalspecifications reviewedand accepted by FDA. | ||||
|---|---|---|---|---|
| Internet BasedSoftware | Yes | Yes | No | Equivalent to ASTRA |
| Receive, store,retrieve, process,review, and/ordisplay MedicalImages | Yes | Yes | Yes | Equivalent to ASTRAand LVivo EF SoftwareApplication |
| Receives DICOMimages fromImagingmodalities. | Yes | Yes | Yes | Equivalent to ASTRAand LVivo EF SoftwareApplication. |
| Cloud-basedcomputing andstorage fortransfer andsharing of studies,images andreports | Yes | Yes | No | Equivalent to ASTRA. |
| Software operateson off-the-shelfhardware | Yes | Yes | Yes | Equivalent to ASTRAand LVivo EF SoftwareApplication |
| Image storage andarchive server | Yes | Yes | No | Equivalent to ASTRA |
| Displays imageson mobile devices | Yes | Yes | No | Equivalent to ASTRA |
| Conforms toDICOM Standard | Yes | Yes | Yes | Equivalent to ASTRAand LVivo EF Software |
| for interoperabilitywith other DICOMcompliant systems | Application | |||
| Routing of images | Yes | Yes | No | Equivalent to ASTRA |
| Transmits imagesusing lossycompression | Yes | Yes | No | Equivalent to ASTRA |
| Stores imagesusing lossycompression | Yes | Unknown | No | Equivalent to ASTRA |
| Automatedcalculation of LeftVentricular WallBoundary fromEchocardiographicVideos | Yes | No | Yes | Identical to LVivo EFSoftware Application. |
| Calculation ofejection fractionbased oncomputerventricular wallboundaries | Yes | No | Yes | Identical to LVivo EFSoftware Application. |
| Scaling (ZoomIn/Out) | Yes | Yes | No | Equivalent to ASTRA |
| Adjusting thebrightness level | Yes | Yes | No | Equivalent to ASTRA |
| Panning | Yes | Yes | No | Equivalent to ASTRA |
| Adjusting contrastlevel | Yes | Yes | No | Equivalent to ASTRA |
| Window- levelfunction | Yes | Yes | No | Equivalent to ASTRA |
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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.
§ 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).