Collaboration Live

K201665 · Philips Ultrasound, Inc. · LLZ · Sep 15, 2020 · Radiology

Device Facts

• Record ID: K201665
• Device Name: Collaboration Live
• Applicant: Philips Ultrasound, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Collaboration Live is indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education in real time. Access must be granted by the healthcare professionals operating the ultrasound system. Compliance with the technical and operator requirements specified in the User Manual is required. It is the responsibility of the healthcare professionals at the remote client to ensure image quality, display contrast, and ambient light conditions are consistent with the generally accepted standards of the clinical application.

Device Story

Collaboration Live is a software-based communication feature integrated into Philips Diagnostic Ultrasound Systems (EPIQ or Affiniti). It enables real-time, two-way exchange of text, voice, image, and video between a local ultrasound operator and a remote healthcare professional using a Windows-based remote client (Reacts). The system includes a remote control feature allowing the local operator to grant the remote user control of ultrasound parameters via a virtual control panel and touch screen. Used in clinical environments, it facilitates remote diagnostic viewing, clinical training, peer collaboration, and service support. By enabling remote diagnostic review, the device expands access to ultrasound expertise and helps limit exposure risks for patients and staff during infectious disease outbreaks (e.g., COVID-19). Healthcare professionals at the remote site are responsible for ensuring that display and ambient light conditions meet clinical standards.

Clinical Evidence

Bench testing only. Validation testing evaluated remote viewing and review performance against local ultrasound systems. Remote display specifications and network bandwidth requirements were established to ensure image quality equivalent to local diagnostic viewing. Labeling was updated to specify requirements for safe remote diagnostic use.

Technological Characteristics

Software-based communication feature integrated into Philips EPIQ/Affiniti ultrasound systems. Operates via network connection between local ultrasound system and remote Windows-based client. Features include real-time text, voice, video, remote asset sharing, and remote control of system parameters. Requires specific ambient light and display contrast conditions for diagnostic use.

Indications for Use

Indicated for remote console access of Philips ultrasound systems for diagnostic image viewing, review, consultation, guidance, support, and education by qualified healthcare professionals.

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

• Collaboration Live - Philips Ultrasound (K200179)

Submission Summary (Full Text)

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September 15, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

Philips Ultrasound, Inc. % Mr. Colin S. Jacob Senior Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021

Re: K201665

Trade/Device Name: Collaboration Live Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, IYN, IYO Dated: August 10, 2020 Received: August 11, 2020

Dear Mr. Jacob:

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) K201665

Device Name Collaboration Live

## Indications for Use (Describe)

Collaboration Live is indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education in real time. Access must be granted by the healtheare professionals operating the ultrasound system. Compliance with the technical and operator requirements specified in the User Manual is required.

It is the responsibility of the healthcare professionals at the remote image quality, display contrast, and ambient light conditions are consistent with the generally accepted standards of the clinical application.

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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Traditional 510(k) Collaboration Live

# K201665

## 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: September 14, 2020

EMAIL: [e-mail]

### I. Submitter

| Manufacturer Name<br>and Address | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact<br>Information | Colin S. Jacob<br>Senior Regulatory Affairs Specialist<br>TEL: [phone]<br>EMAIL: [e-mail] |
| Secondary Contact<br>Information | Benny Lam<br>Principal Regulatory Affairs Specialist<br>TEL: [phone] |

#### II. Device

I.

| Trade Name | Collaboration Live | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Common Name | System, Image Processing, Radiological | | |
| Regulation Description | Picture archiving and communications system (Primary)<br>Ultrasonic pulsed doppler imaging system<br>Ultrasonic pulsed echo imaging system | | |
| Regulation Number | 892.2050 (Primary)<br>892.1550<br>892.1560 | | |
| Product Code | LLZ (Primary)<br>IYN<br>IYO | | |
| Device Class | Class II | | |
| Review Panel | Radiology | | |
| Predicate Device | | | |

Collaboration Live – Philips Ultrasound (K200179)

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#### II. Device Description

Collaboration Live is software-based communication feature integrated in Philips Diagnostic Ultrasound Systems. Collaboration Live together with remote-client Reacts enables two-way communication of text, voice, image, and video information between an ultrasound local system operator and a remote healthcare professional on a Windows device. Collaboration Live-Reacts facilitates: 1) remote diagnostic viewing and review, 2) remote clinical training and education, 3) remote peer collaboration, and 4) remote service support. Collaboration Live functionality includes a remote control feature in which the ultrasound local system operator may grant a qualified remote user control of the ultrasound system parameters via a virtual control panel and virtual touch screen. By meeting the technical, operator, and environment requirements specified in the User Manual, healthcare professionals using Reacts may provide clinical diagnoses from a remote location as they would directly on the ultrasound system.

#### Indications for Use III.

Collaboration Live is indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education in real time. Access must be granted by the healthcare professionals operating the ultrasound system. Compliance with the technical and operator requirements specified in the User Manual is required.

It is the responsibility of the healthcare professionals at the remote client to ensure image quality, display contrast, and ambient light conditions are consistent with the generally accepted standards of the clinical application.

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| Attribute | Collaboration Live<br>K201665<br>(Subject Device) | Collaboration Live<br>K200179<br>(Predicate) | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Same |
| Regulation<br>Name | Picture Archiving and<br>Communications System<br>(PACS) | Picture Archiving and<br>Communications System<br>(PACS) | Same |
| Product<br>Code(s) | Primary: LLZ<br>Secondary: IYN, IYO | Primary: LLZ<br>Secondary: IYN, IYO | Same |
| Indications<br>for Use | Collaboration Live is<br>indicated for remote console<br>access of the Philips<br>ultrasound system for<br>diagnostic image viewing<br>and review, consultation,<br>guidance, support, and<br>education in real time.<br>Access must be granted by<br>the healthcare professionals<br>operating the ultrasound<br>system. Compliance with the<br>technical and operator<br>requirements specified in the<br>User Manual is required.<br>It is the responsibility of the<br>healthcare professionals at<br>the remote client to ensure<br>image quality, display<br>contrast, and ambient light<br>conditions are consistent<br>with the generally accepted<br>standards of the clinical<br>application. | Collaboration Live is<br>indicated for remote console<br>access of the Philips<br>ultrasound system for image<br>viewing, image review,<br>consultation, guidance,<br>support, and education in<br>real time. Access must be<br>granted by the technologist<br>operating the system. Images<br>reviewed remotely are not<br>for diagnostic use. | Both device are<br>indicated for image<br>review and viewing at<br>remote location over the<br>Internet. They are<br>intended for ultrasound<br>image review and<br>viewing, remote control,<br>and communication in<br>real time.<br>The predicate is not<br>indicated for diagnostic<br>use. |
| Features | Image viewing and review<br>Text Chat<br>Voice Calling<br>Video Calling<br>Remote Asset Sharing<br>Remote Control | Image viewing and review<br>Text Chat<br>Voice Calling<br>Video Calling<br>Remote Asset Sharing<br>Remote Control | Same |
| Local System<br>Hardware | Philips EPIQ or Affiniti<br>ultrasound system | Philips EPIQ or Affiniti<br>ultrasound system | Same |
| Remote<br>System<br>Hardware | Commercially available off-<br>the-shelf computer hardware | Commercially available off-<br>the-shelf computer hardware | Same |
| Attribute | Collaboration Live<br>K201665<br>(Subject Device) | Collaboration Live<br>K200179<br>(Predicate) | Comparison |
| Supported<br>Imaging<br>Modalities | Ultrasound | Ultrasound | Same |
| Intended<br>Users | Qualified healthcare<br>professionals | Qualified healthcare<br>professionals | Same |
| Remote-client<br>Use<br>Environment | Clinical environment with<br>ambient light condition<br>consistent with the generally<br>accepted standards of the<br>clinical application. | Clinical environment | Subject device has an<br>additional requirement<br>for ambient light<br>condition. |
| Remote<br>Diagnostic<br>Use | Image visualized for<br>diagnostic review and<br>viewing on remote-client<br>Reacts | No | The predicate is not<br>indicated for diagnostic<br>use. |

### IV. Comparison of Technological Characteristics with the Predicate Device

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#### V. Validation Testing Summary

Validation testing with pre-determined criteria was conducted to evaluate the equivalency of remote viewing and review comparing to local ultrasound systems using Collaboration Live and remote-client Reacts. Remote display specifications and network bandwidth requirements for equivalent image quality for diagnostic viewing were determined. Labeling materials have been updated to inform the users regarding the requirements for safe and effective remote diagnostic review and viewing.

#### VI. Conclusion

The device functionalities, intended users, and performance of the subject Collaboration Live software, remote-client Reacts, and Philips diagnostic ultrasound systems, which Collaboration Live runs on, remain unchanged comparing to the predicate.

The change in indications for use of ultrasound images to be viewed and reviewed remotely for diagnostic purpose on remote-client Reacts, increases options to image patients inside of healthcare facilities, expands the number of healthcare professionals capable of performing ultrasound imaging technique, which could help limit the risk of exposure for healthcare workers and patients to the infectious diseases such as COVID-19.

The results of the design control activity suggest that the subject device does not raise new questions of safety or effectiveness. The validation testing and labeling are adequate to support the substantial equivalent determination to the predicate device.

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