(136 days)
No reference devices are used in this submission.
No
The document describes a standard PACS viewer with image manipulation and display features. There is no mention of AI, ML, or any algorithms that would suggest automated analysis or interpretation of images beyond basic viewing tools.
No.
The device is a software teleradiology system for viewing and organizing medical images, intended for diagnostic and review purposes rather than direct therapeutic intervention.
Yes
Braid is described as a software system that allows users to view DICOM-compliant images for diagnostic and mobile-diagnostic purposes, and explicitly states it can be used for "primary diagnosis on FDA-cleared diagnostic monitors" and "diagnostic viewing on mobile devices." The "Intended Use / Indications for Use" section also notes it can be used for "mobile diagnostic use for review and analysis of CR, DX, CT, and MR images" when "images are reviewed and use as an element of diagnosis."
Yes
The device is described as a "web-based software platform" and a "picture archiving and communication system (PACS)". While it interacts with hardware like monitors and mobile devices, the core functionality and the device itself are defined as software. The performance studies include software verification and validation, and while they also test the performance on hardware, this is to ensure the software functions correctly on those platforms, not because the hardware is part of the regulated device itself.
Based on the provided information, Braid is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Braid's Function: Braid is a software system that handles, organizes, stores, and displays medical images (CR, DX, CT, MR) and associated reports. It is used for viewing, analysis, and potentially diagnosis based on these images. This process involves interpreting images of the body, not analyzing specimens taken from the body.
- Lack of Specimen Analysis: The description of Braid's intended use, device description, and features does not mention any analysis of biological specimens. Its focus is entirely on the handling and display of medical imaging data.
Therefore, Braid falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices.
Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis.
When images are reviewed and use as an element of diagnosis, it is the trained physician to determine if the image quality is suitable for their clinical application.
Contraindications: Braid is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
Product codes
LLZ
Device Description
Braid is a web-based software platform that allows a user to view DICOM-compliant images for diagnostic and mobile-diagnostic purposes. Braid may be used with FDA-cleared diagnostic monitors and mobile devices including iPhones, and iPads. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, and review of reports and demographic information. Braid allows for multispecialty viewing of medical images including Computed Radiography (CR), Computer Tomography (CT), Digital Radiography (DX), Magnetic Resonance (MR), as well as associated non-imaging data such as report text.
-
. Braid can be used for primary diagnosis on FDA-cleared diagnostic monitors. Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to review patient images, perform non-destructive manipulations, annotations, and measurements. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
-
. Braid can also be used for reference and diagnostic viewing on mobile devices. Braid diagnostic use on mobile devices is not intended to replace full diagnostic workstations and should only be used only be used for when there is no access to workstation. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
Braid has the following viewer technology and features:
- Grayscale Image Rendering
- Localizer Lines
- Localizer Point
- Orientation Markers
- Distance Markers
- Study Data Overlays
- Stack Navigation Tool
- Window/Level Tool
- Zoom Tool
- Panning Tool
- Color Inversion
- Text Annotation
- Maximum Intensity Projection
- Reslicing (MPR)
- Area Measurement Annotation
- Angle Measurement Annotation
In addition, Braid has:
- Added Hardware accelerated rendering
- Support for high resolution Retina displays
- Keyboard shortcuts for all tools and all annotation types
- Touchscreen support
- Quick image manipulation and navigation via multitouch gestures, on touchscreens or multitouch capable trackpads
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DX, CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices.
Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators.
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)
Software Verification and Validation Testing:
Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern.
Mobile Device Bench Testing:
Bench testing in accordance with AAPM Report No. 270 - Display Quality Assurance (2019) and AAPM on-line report No. 03, "Assessment of Display Performance for Medical Imaging Systems" was performed to evaluate the ability of the intended mobile device screens to support the proposed indications for use. This testing was conducted on the iPhone 11 and iPad Pro 3. The display performance characteristics evaluated included: Spatial Resolution, Luminance Response, DICOM GSDF, Artifacts, Temporal Response, Color & Greyscale Tracking, Reflection diffuse, Reflection specular, Ambient Light, and Uniformity. This bench testing demonstrated that the designated hardware platforms are appropriate for Braid's intended use and supports substantial equivalence of Braid to the predicate devices.
Clinical Validation Testing:
Clinical validation testing was conducted to support the diagnostic quality of Braid on mobile devices as well as the use of Braid features such as reslicing (MPR). Board-certified radiologists were asked to evaluate all braid features and to provide multiple scores for the quality of the Braid images on both an FDA-cleared diagnostic monitor as well as the intended mobile devices. Images were evaluated across all intended imaging modalities and in both office and bright lighting conditions. Results demonstrated that the images displayed by Braid were of appropriate diagnostic quality in all conditions. These performance data including image quality evaluations by qualified radiologists are adequate to support substantial equivalence of Braid to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices are used in this submission.
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
August 13, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Braid.Health % Ms. Vivian Liu Correspondent 301 Rhode Island St. SAN FRANCISCO CA 94103
Re: K200822
Trade/Device Name: Braid Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 16, 2020 Received: July 16, 2020
Dear Ms. Liu:
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) K200822
Device Name Braid
Indications for Use (Describe)
Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices.
Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis.
When images are reviewed and use as an element of diagnosis, it is the trained physician to determine if the image quality is suitable for their clinical application.
Contraindications: Braid is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
| 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
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for Braid™ is provided below:
SUBMITTER
| Submitter: | Braid.Health
301 Rhode Island St. B10
San Francisco, CA 94103 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Liu
Braid.Health
301 Rhode Island St. B10
San Francisco, CA 94103
vivian@braid.health
(617) 335-6866 |
| Date Prepared: | March 27, 2020 |
DEVICE
| Name of Device: | Braid | |
|---|---|---|
| Common or Usual Name: | Picture archiving and communications system | |
| Classification: | 21 CFR 892.2050 | |
| Regulatory Class: | Class II | |
| FDA Panel | Radiology | |
| Product Code: | LLZ - System, Image Processing, Radiological |
PREDICATE DEVICES 1.
| Primary | Secondary | |
|---|---|---|
| Predicate Device Name: | BOX DICOM Viewer™ | Enterprise Imaging XERO |
| Viewer 8.1 | ||
| Manufacturer: | BOX INC. | Agfa HealthCare N.V. |
| 510(k) Number: | K151957 | K170434 |
4
Reference Devices:
No reference devices are used in this submission.
DEVICE DESCRIPTION 2.
Braid is a web-based software platform that allows a user to view DICOM-compliant images for diagnostic and mobile-diagnostic purposes. Braid may be used with FDA-cleared diagnostic monitors and mobile devices including iPhones, and iPads . It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, and review of reports and demographic information. Braid allows for multispecialty viewing of medical images including Computed Radiography (CR), Computer Tomography (CT), Digital Radiography (DX), Magnetic Resonance (MR), as well as associated non-imaging data such as report text.
- . Braid can be used for primary diagnosis on FDA-cleared diagnostic monitors. Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to review patient images, perform non-destructive manipulations, annotations, and measurements. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
- . Braid can also be used for reference and diagnostic viewing on mobile devices. Braid diagnostic use on mobile devices is not intended to replace full diagnostic workstations and should only be used only be used for when there is no access to workstation. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
Braid has the following viewer technology and features:
- Grayscale Image Rendering
- Localizer Lines
- Localizer Point
- Orientation Markers
- Distance Markers
- Study Data Overlays
- Stack Navigation Tool
- Window/Level Tool
- Zoom Tool
- Panning Tool
- Color Inversion
- Text Annotation
5
- Maximum Intensity Projection
- Reslicing (MPR)
- Area Measurement Annotation
- Angle Measurement Annotation
In addition, Braid has:
-
Added Hardware accelerated rendering
-
Support for high resolution Retina displays
-
Keyboard shortcuts for all tools and all annotation types
-
Touchscreen support
-
Quick image manipulation and navigation via multitouch gestures, on touchscreens or multitouch capable trackpads
3. INDICATIONS FOR USE
Braid™ is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid™ is used by hospitals, clinics, imaging centers, and radiologist reading practices.
Braid™ can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. Braid™ mobile diagnostic use is not intended for the display of mammography images for diagnosis.
When images are reviewed and use as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application.
Contraindications: Braid™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 4. WITH THE PREDICATE DEVICE
Table 1 below compares the key technological features of the subject devices to the predicate devices BOX DICOM Viewer 10 (K151957) and Enterprise Imaging XERO Viewer 8.1, (K170434). While there are several differences in the technological features of Braid1M compared to the predicate devices, these differences do not raise new questions of safety and effectiveness and are supported by performance testing in order to establish substantial equivalence.
6
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device
Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Applicant | Braid.Health | OTech, Inc | Agfa HealthCare N.V. | |
| 2 | Device Name | BraidTM | BOX DICOM ViewerTM | Enterprise Imaging
XERO Viewer 8.1 | |
| 3 | Product Code | LLZ | LLZ | LLZ | Same |
| 4 | Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| 5 | Indications for
Use | BraidTM is a software
teleradiology system
used to receive
DICOM images,
scheduling
information and
textual reports,
organize and store
them in an internal
format, and to make
that information
available across a
network via web.
BraidTM is used by
hospitals, clinics,
imaging centers, and
radiologist reading
practices.
BraidTM can optionally
be used for mobile
diagnostic use for
review and analysis of
CR, DX, CT, and MR
images and medical
reports. Braid mobile
diagnostic use is not
intended to replace full
diagnostic
workstations and
should only be used
when there is no
access to a
workstation. BraidTM
mobile diagnostic use
is not intended for the
display of
mammography images
for diagnosis.
When images are
reviewed and use as an | The BOX DICOM
ViewerTM is a software
Teleradiology system used
to receive DICOM
images, scheduling
information and textual
reports, organize and store
them in an internal format,
and to make that
information available
across a network via web
and customized user
interfaces. The BOX
DICOM ViewerTM is used
by hospitals, imaging
centers, radiologist
reading practice.
Contraindications: The
BOX DICOM ViewerTM
is not intended for the
acquisition of
mammographic image
data and is meant to be
used by qualified medical
personnel only who are
qualified to create and
diagnose radiological
image data. | Agfa HealthCare's
Enterprise Imaging
XERO Viewer 8.1 is a
software application
used for reference and
diagnostic viewing of
multi-specialty medical
imaging and non-
imaging data with
associated reports and
documents and, as such,
fulfills a key role in the
Enterprise Imaging
Solution. XERO
Viewer 8.1 enables
healthcare
professionals, including
(but not limited to)
physicians, surgeons,
nurses, and
administrators to
receive and view patient
images, documents and
data from multiple
departments and
organizations within
one multi-disciplinary
viewer. XERO Viewer
8.1 allows users to
perform image
manipulations
(including
window/level, markups,
3D visualization) and
measurements.
When images are
reviewed and use as an
element of diagnosis, it
is the responsibility of
the trained physician to
determine if the image | The proposed
indications for use
are similar to both
predicates. The
indications include
mobile diagnostic
indications which
are present in the
secondary predicate
but absent in the
primary predicate.
Mobile diagnostic
use is supported by
performance testing
in order to establish
substantial
equivalence. |
7
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device
Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | element of diagnosis,
it is the responsibility
of the trained
physician to determine
if the image quality is
suitable for their
clinical application.
Contraindications:
BraidTM is not
intended for the
acquisition of
mammographic image
data and is meant to be
used by qualified
medical personnel
only who are qualified
to create and diagnose
radiological image
data. | | quality is suitable for
their clinical
application. Lossy
compressed
mammography images
and digitized film
images should not be
used for primary image
interpretation.
Uncompressed or non-
lossy compressed "for
presentation" images
may be used for
diagnosis or screening
on monitors that are
FDA-cleared for their
intended use.
XERO Viewer 8.1 can
optionally be
configured for Full
Fidelity Mobile, which
is intended for mobile
diagnostic use, review
and analysis of CR, DX,
CT, MR, US, ECG
images and medical
reports. XERO Viewer
Full Fidelity Mobile is
not intended to replace
full diagnostic
workstations and should
only be used when there
is no access to
workstation. XERO
Viewer Full Fidelity
Mobile is not intended
for the display of
mammography images
for diagnosis. | |
| 6 | Modalities | CR, DX, CT, MR | CT, MR, US, PET | CR, DX, CT, MR, US,
ECG | BraidTM offers a
subset of the
imaging modalities
when compared to
the secondary
predicate. The
absence of these
modalities does not
raise any issues of
substantial
equivalence, and
performance data is
provided to support
those modalities that
are included. |
8
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|-------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7 | Communication | DICOM | DICOM | DICOM | Same |
| 8 | Network Access | Web Browser | Web Browser | Web Browser | Same |
| 9 | Web Browser
Software | Google Chrome,
Safari | Google Chrome for all
features. Microsoft Internet
Explorer & Mozilla Firefox for
features except the DICOM Viewer. | Microsoft Internet
Explorer, Google Chrome,
Safari, Mozilla Firefox | Similar — each product offers a list
of compatible internet browsers.
The proposed browsers for Braid
are supported by performance testing. |
| 10 | Mobile
Platforms | iPhones, iPads | None | iPads | Similar — both Braid and Xero have
designated mobile platforms that
they support. This functionality is
supported by performance testing
for the intended mobile platforms. |
| 11 | User
Interface/Input | Mouse and keyboard,
Touchscreens | Mouse and keyboard | Mouse and keyboard,
Touchscreens | Similar, Braid and Xero both provide
touchscreen functionality. This
function is supported by
performance testing to support
substantial equivalence. |
| 12 | Drag and Drop
Import | Yes | Yes | Yes | Same |
| 13 | Image Storage | Yes | Yes | Yes | Same |
| 14 | Database
Software | CouchDB,
IndexedDB, LevelDB | MySQL | unknown | IndexedDB is an alternative to the
WebSQL (deprecated) database, and
relational databases such as MySQL.
Such as LevelDB and CouchDB, it is
a key-value pair NoSQL database,
which can provide the same
functionalities. IndexedDB is now
the native and high-performance |
9
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device
Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|------------------------------|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 15 | Grayscale image
rendering | Yes | Yes | Yes | Same |
| 16 | RGB image
rendering | No | Yes | Yes | Braid does not have
this feature, but the
absence of this
feature does not
raise questions of
safety and
effectiveness or
affect the intended
use of the device. |
| 17 | Distance
Markers | Yes | Yes | Yes | Same |
| 18 | Study Data
Overlays | Yes | Yes | Yes | Similar - both Braid
and BOX DICOM
offer overlays with
study data, while
Xero includes this
information in a
header bar. This
difference does not
impact safety or
effectiveness. |
| 19 | Stack navigation | Yes | Yes | NA | Same |
| 20 | Window Level | Yes | Yes | Yes | Same |
| 21 | Zoom in on
Image | Yes | Yes | Yes | Same |
| 22 | Panning | Yes | Yes | Yes | Same |
| 23 | Invert Image | Yes | Yes | Yes | Same |
| 24 | Text Annotation | Yes | Yes | Yes | Same |
| 25 | MIP/MPR
Reconstruction | Yes | No | Yes | Braid offers MIP
and MPR
reconstruction as
does the Xero
Viewer predicate.
Compared to the
BOX predicate this
is an additional
feature. This feature
does not raise new
questions of safety |
10
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device
Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|--------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | and effectiveness,
but required
performance data to
support its function. |
| 26 | Area
Measurement
Annotation | Yes | Yes | Yes | Same |
| 27 | Angle
Measurement
Annotation | Yes | Yes | Yes | Same |
| 28 | User Interface
Text Styles,
colors, Fonts
and Icons | None | BOX Styles | None | BOX offers custom
styling for user
preference, whereas
the proposed device
and Xero do not.
This is a user
preference that has
no impact on safety
or effectiveness. |
| 29 | WebGL
rendering
optimization | Yes | Yes | Unknown | Hardware
acceleration is used.
WebGL (Web
Graphics Library) is
a JavaScript API for
rendering
interactive 3D
computer graphics
and 2D graphics
within any
compatible web
browser without the
use of plug-ins. The
user of this
technology raises no
new questions of
safety and
effectiveness and is
supported by
performance testing. |
| 30 | Support for high
resolution
Retina display | Full pixel density on
all displays | Full pixel density on all
displays | Full Fidelity Mode | Both Braid and Box
display the full pixel
density of the saved
image, while the
Xero Viewer has an
optional full fidelity
mode. This
difference does not
impact safety and
effectiveness, as the
reduced resolution
option on the Xero
viewer is just a user
preference that may
reduce loading
times when full
fidelity is not
desired |
11
| No. | Function | Subject Device
(BraidTM) | Primary Predicate Device
BOX DICOM ViewerTM
(K151957) | Secondary Predicate
Device
Enterprise Imaging
XERO Viewer 8.1
(K170434) | Function
Comparison |
|-----|-----------------------|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------|
| 31 | Keyboard
shortcuts | Yes | Yes | Yes | Same |
PERFORMANCE DATA ട്.
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern.
Mobile Device Bench Testing
Bench testing in accordance with AAPM Report No. 270 - Display Quality Assurance (2019) and AAPM on-line report No. 03, "Assessment of Display Performance for Medical Imaging Systems" was performed to evaluate the ability of the intended mobile device screens to support the proposed indications for use. This testing was conducted on the iPhone 11 and iPad Pro 3. The following display performance characteristics were evaluated:
- Spatial Resolution ●
- Luminance Response ●
- DICOM GSDF ●
- Artifacts ●
- Temporal Response ●
- Color & Greyscale Tracking ●
- Reflection diffuse ●
- Reflection specular ●
- Ambient Light ●
- Uniformity .
This bench testing demonstrated that the designated hardware platforms are appropriate for Braid™'s intended use and supports substantial equivalence of Braid™ to the predicate devices.
Clinical Validation Testing
12
Clinical validation testing was conducted to support the diagnostic quality of Braid™ on mobile devices as well as the use of Braid™ features such as reslicing (MPR). Board-certified radiologists were asked to evaluate all braid features and to provide multiple scores for the quality of the Braid™ images on both an FDA-cleared diagnostic monitor as well as the intended mobile devices. Images were evaluated across all intended imaging modalities and in both office and bright lighting conditions. Results demonstrated that the images displayed by Braid™ were of appropriate diagnostic quality in all conditions. These performance data including image quality evaluations by qualified radiologists are adequate to support substantial equivalence of Braid 1 to the predicate devices.
CONCLUSIONS 6.
Braid™ has the same intended use as a picture archiving and communication system as both predicate devices, BOX DICOM Viewer™ (K151957) and Enterprise Imaging XERO Viewer 8.1 (K170434). Braid™ has similar technological characteristics as both predicates, but differs in some features when compared to each, such as diagnostic use on mobile platforms when there is no access to a diagnostic workstation, the specific imaging modalities, or features such as reslicing. These differences do not raise new questions of safety and effectiveness, but are supported by performance testing including software verification testing, bench testing, and clinical validation testing. Based on the acceptable results of the performance testing, it is determined that Braid™ is substantially equivalent to the predicate devices.