Braid

K200822 · Braid.Health · LLZ · Aug 13, 2020 · Radiology

Device Facts

• Record ID: K200822
• Device Name: Braid
• Applicant: Braid.Health
• Product Code: LLZ · Radiology
• Decision Date: Aug 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Braid is a web-based PACS platform for viewing, annotating, and reviewing DICOM-compliant medical images and reports. It ingests DICOM data, scheduling info, and text reports, storing them in an internal format for web-based access. Used by radiologists, physicians, and surgeons in hospitals and clinics. Operates on standard web browsers and mobile devices (iPhone/iPad). Features include grayscale rendering, window/level, zoom, pan, stack navigation, and advanced tools like MIP/MPR and measurements. Hardware-accelerated rendering via WebGL optimizes display. Healthcare providers use the interface to review images for primary diagnosis on cleared monitors or for reference/diagnostic viewing on mobile devices when workstations are inaccessible. Final diagnostic decisions remain with the physician, who assesses image quality suitability. Benefits include remote access to diagnostic-quality imaging and efficient workflow integration.

Clinical Evidence

Clinical validation involved board-certified radiologists evaluating Braid's image quality and features (including MPR) on FDA-cleared diagnostic monitors and mobile devices (iPhone 11, iPad Pro 3). Testing covered all intended modalities across various lighting conditions (office vs. bright). Results confirmed images were of appropriate diagnostic quality for clinical use.

Technological Characteristics

Web-based software PACS; utilizes WebGL for hardware-accelerated rendering. Database uses NoSQL (CouchDB, IndexedDB, LevelDB). Supports DICOM communication. Compatible with standard web browsers (Chrome, Safari). Mobile support for iOS. Software level of concern: moderate. No specific hardware materials; relies on off-the-shelf diagnostic monitors and mobile hardware.

Indications for Use

Indicated for use by qualified medical personnel to receive, store, and display DICOM images (CR, DX, CT, MR), scheduling info, and reports. Supports mobile diagnostic use for review/analysis when workstations are unavailable. Contraindicated for mammography image acquisition/display.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• BOX DICOM Viewer (K151957)
• Enterprise Imaging XERO Viewer 8.1 (K170434)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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<br>301 Rhode Island St. B10<br>San Francisco, CA 94103 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vivian Liu<br>Braid.Health<br>301 Rhode Island St. B10<br>San Francisco, CA 94103<br>[e-mail]<br>[phone] |
| 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<br>Viewer 8.1 |
| Manufacturer: | BOX INC. | Agfa HealthCare N.V. |
| 510(k) Number: | K151957 | K170434 |

K200822

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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

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- 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.

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device<br>Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Applicant | Braid.Health | OTech, Inc | Agfa HealthCare N.V. | |
| 2 | Device Name | BraidTM | BOX DICOM ViewerTM | Enterprise Imaging<br>XERO Viewer 8.1 | |
| 3 | Product Code | LLZ | LLZ | LLZ | Same |
| 4 | Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| 5 | Indications for<br>Use | BraidTM is a software<br>teleradiology system<br>used to receive<br>DICOM images,<br>scheduling<br>information and<br>textual reports,<br>organize and store<br>them in an internal<br>format, and to make<br>that information<br>available across a<br>network via web.<br>BraidTM is used by<br>hospitals, clinics,<br>imaging centers, and<br>radiologist reading<br>practices.<br>BraidTM can optionally<br>be used for mobile<br>diagnostic use for<br>review and analysis of<br>CR, DX, CT, and MR<br>images and medical<br>reports. Braid mobile<br>diagnostic use is not<br>intended to replace full<br>diagnostic<br>workstations and<br>should only be used<br>when there is no<br>access to a<br>workstation. BraidTM<br>mobile diagnostic use<br>is not intended for the<br>display of<br>mammography images<br>for diagnosis.<br>When images are<br>reviewed and use as an | The BOX DICOM<br>ViewerTM is a software<br>Teleradiology system used<br>to receive DICOM<br>images, scheduling<br>information and textual<br>reports, organize and store<br>them in an internal format,<br>and to make that<br>information available<br>across a network via web<br>and customized user<br>interfaces. The BOX<br>DICOM ViewerTM is used<br>by hospitals, imaging<br>centers, radiologist<br>reading practice.<br>Contraindications: The<br>BOX DICOM ViewerTM<br>is not intended for the<br>acquisition of<br>mammographic image<br>data and is meant to be<br>used by qualified medical<br>personnel only who are<br>qualified to create and<br>diagnose radiological<br>image data. | Agfa HealthCare's<br>Enterprise Imaging<br>XERO Viewer 8.1 is a<br>software application<br>used for reference and<br>diagnostic viewing of<br>multi-specialty medical<br>imaging and non-<br>imaging data with<br>associated reports and<br>documents and, as such,<br>fulfills a key role in the<br>Enterprise Imaging<br>Solution. XERO<br>Viewer 8.1 enables<br>healthcare<br>professionals, including<br>(but not limited to)<br>physicians, surgeons,<br>nurses, and<br>administrators to<br>receive and view patient<br>images, documents and<br>data from multiple<br>departments and<br>organizations within<br>one multi-disciplinary<br>viewer. XERO Viewer<br>8.1 allows users to<br>perform image<br>manipulations<br>(including<br>window/level, markups,<br>3D visualization) and<br>measurements.<br>When images are<br>reviewed and use as an<br>element of diagnosis, it<br>is the responsibility of<br>the trained physician to<br>determine if the image | The proposed<br>indications for use<br>are similar to both<br>predicates. The<br>indications include<br>mobile diagnostic<br>indications which<br>are present in the<br>secondary predicate<br>but absent in the<br>primary predicate.<br>Mobile diagnostic<br>use is supported by<br>performance testing<br>in order to establish<br>substantial<br>equivalence. |

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device<br>Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | element of diagnosis,<br>it is the responsibility<br>of the trained<br>physician to determine<br>if the image quality is<br>suitable for their<br>clinical application.<br>Contraindications:<br>BraidTM is not<br>intended for the<br>acquisition of<br>mammographic image<br>data and is meant to be<br>used by qualified<br>medical personnel<br>only who are qualified<br>to create and diagnose<br>radiological image<br>data. | | quality is suitable for<br>their clinical<br>application. Lossy<br>compressed<br>mammography images<br>and digitized film<br>images should not be<br>used for primary image<br>interpretation.<br>Uncompressed or non-<br>lossy compressed "for<br>presentation" images<br>may be used for<br>diagnosis or screening<br>on monitors that are<br>FDA-cleared for their<br>intended use.<br>XERO Viewer 8.1 can<br>optionally be<br>configured for Full<br>Fidelity Mobile, which<br>is intended for mobile<br>diagnostic use, review<br>and analysis of CR, DX,<br>CT, MR, US, ECG<br>images and medical<br>reports. XERO Viewer<br>Full Fidelity Mobile is<br>not intended to replace<br>full diagnostic<br>workstations and should<br>only be used when there<br>is no access to<br>workstation. XERO<br>Viewer Full Fidelity<br>Mobile is not intended<br>for the display of<br>mammography images<br>for diagnosis. | |
| 6 | Modalities | CR, DX, CT, MR | CT, MR, US, PET | CR, DX, CT, MR, US,<br>ECG | BraidTM offers a<br>subset of the<br>imaging modalities<br>when compared to<br>the secondary<br>predicate. The<br>absence of these<br>modalities does not<br>raise any issues of<br>substantial<br>equivalence, and<br>performance data is<br>provided to support<br>those modalities that<br>are included. |

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|-------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7 | Communication | DICOM | DICOM | DICOM | Same |
| 8 | Network Access | Web Browser | Web Browser | Web Browser | Same |
| 9 | Web Browser<br>Software | Google Chrome,<br>Safari | Google Chrome for all<br>features. Microsoft Internet<br>Explorer & Mozilla Firefox for<br>features except the DICOM Viewer. | Microsoft Internet<br>Explorer, Google Chrome,<br>Safari, Mozilla Firefox | Similar — each product offers a list<br>of compatible internet browsers.<br>The proposed browsers for Braid<br>are supported by performance testing. |
| 10 | Mobile<br>Platforms | iPhones, iPads | None | iPads | Similar — both Braid and Xero have<br>designated mobile platforms that<br>they support. This functionality is<br>supported by performance testing<br>for the intended mobile platforms. |
| 11 | User<br>Interface/Input | Mouse and keyboard,<br>Touchscreens | Mouse and keyboard | Mouse and keyboard,<br>Touchscreens | Similar, Braid and Xero both provide<br>touchscreen functionality. This<br>function is supported by<br>performance testing to support<br>substantial equivalence. |
| 12 | Drag and Drop<br>Import | Yes | Yes | Yes | Same |
| 13 | Image Storage | Yes | Yes | Yes | Same |
| 14 | Database<br>Software | CouchDB,<br>IndexedDB, LevelDB | MySQL | unknown | IndexedDB is an alternative to the<br>WebSQL (deprecated) database, and<br>relational databases such as MySQL.<br>Such as LevelDB and CouchDB, it is<br>a key-value pair NoSQL database,<br>which can provide the same<br>functionalities. IndexedDB is now<br>the native and high-performance |

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device<br>Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|------------------------------|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 15 | Grayscale image<br>rendering | Yes | Yes | Yes | Same |
| 16 | RGB image<br>rendering | No | Yes | Yes | Braid does not have<br>this feature, but the<br>absence of this<br>feature does not<br>raise questions of<br>safety and<br>effectiveness or<br>affect the intended<br>use of the device. |
| 17 | Distance<br>Markers | Yes | Yes | Yes | Same |
| 18 | Study Data<br>Overlays | Yes | Yes | Yes | Similar - both Braid<br>and BOX DICOM<br>offer overlays with<br>study data, while<br>Xero includes this<br>information in a<br>header bar. This<br>difference does not<br>impact safety or<br>effectiveness. |
| 19 | Stack navigation | Yes | Yes | NA | Same |
| 20 | Window Level | Yes | Yes | Yes | Same |
| 21 | Zoom in on<br>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<br>Reconstruction | Yes | No | Yes | Braid offers MIP<br>and MPR<br>reconstruction as<br>does the Xero<br>Viewer predicate.<br>Compared to the<br>BOX predicate this<br>is an additional<br>feature. This feature<br>does not raise new<br>questions of safety |

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device<br>Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|--------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | and effectiveness,<br>but required<br>performance data to<br>support its function. |
| 26 | Area<br>Measurement<br>Annotation | Yes | Yes | Yes | Same |
| 27 | Angle<br>Measurement<br>Annotation | Yes | Yes | Yes | Same |
| 28 | User Interface<br>Text Styles,<br>colors, Fonts<br>and Icons | None | BOX Styles | None | BOX offers custom<br>styling for user<br>preference, whereas<br>the proposed device<br>and Xero do not.<br>This is a user<br>preference that has<br>no impact on safety<br>or effectiveness. |
| 29 | WebGL<br>rendering<br>optimization | Yes | Yes | Unknown | Hardware<br>acceleration is used.<br>WebGL (Web<br>Graphics Library) is<br>a JavaScript API for<br>rendering<br>interactive 3D<br>computer graphics<br>and 2D graphics<br>within any<br>compatible web<br>browser without the<br>use of plug-ins. The<br>user of this<br>technology raises no<br>new questions of<br>safety and<br>effectiveness and is<br>supported by<br>performance testing. |
| 30 | Support for high<br>resolution<br>Retina display | Full pixel density on<br>all displays | Full pixel density on all<br>displays | Full Fidelity Mode | Both Braid and Box<br>display the full pixel<br>density of the saved<br>image, while the<br>Xero Viewer has an<br>optional full fidelity<br>mode. This<br>difference does not<br>impact safety and<br>effectiveness, as the<br>reduced resolution<br>option on the Xero<br>viewer is just a user<br>preference that may<br>reduce loading<br>times when full<br>fidelity is not<br>desired |

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| No. | Function | Subject Device<br>(BraidTM) | Primary Predicate Device<br>BOX DICOM ViewerTM<br>(K151957) | Secondary Predicate<br>Device<br>Enterprise Imaging<br>XERO Viewer 8.1<br>(K170434) | Function<br>Comparison |
|-----|-----------------------|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------|
| 31 | Keyboard<br>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

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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.