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 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.

AI/ML Overview

Please note: The provided document is a 510(k) summary for the "Collaboration Live" device. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the change to allow diagnostic use for remote viewing. While it mentions "validation testing with pre-determined criteria," it does not provide the specific details of the acceptance criteria or the full study report. It only states that such testing was conducted and that the labeling was updated based on the findings.

Therefore, much of the requested information regarding detailed acceptance criteria, specific reported performance, sample sizes, ground truth establishment, expert qualifications, and MRMC study details cannot be fully extracted from this document alone.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions "pre-determined criteria" for validation testing but does not explicitly list them or the quantitative reported device performance against these criteria. It broadly states that "remote display specifications and network bandwidth requirements for equivalent image quality for diagnostic viewing were determined."

Given the limited information, a hypothetical table based on the statement "equivalent image quality for diagnostic viewing" might look like this, but these are inferred and not explicitly stated criteria or performance metrics in the document:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Equivalent image quality for diagnostic viewing compared to local ultrasound system	Met (stated that "equivalent image quality for diagnostic viewing were determined")
Adherence to remote display specifications	Met (stated that "remote display specifications... were determined")
Adherence to network bandwidth requirements	Met (stated that "network bandwidth requirements... were determined")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified in the provided document.
Data provenance: Not specified in the provided document. The document only mentions "Validation testing... was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention an MRMC comparative effectiveness study, nor does it refer to AI assistance. The device is a "software-based communication feature" for remote viewing and control of ultrasound systems, not an AI-driven image analysis tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device "Collaboration Live" is explicitly designed for "remote console access" and "two-way communication... between an ultrasound local system operator and a remote healthcare professional." It's a system for human users to interact remotely with an ultrasound machine. Therefore, a "standalone algorithm only" performance study, without human involvement, would not be applicable to this type of device. The study implicitly involves human users making diagnostic decisions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in the provided document beyond implying an evaluation of "equivalent image quality for diagnostic viewing." This would typically require expert assessment of image quality and diagnostic accuracy, but the specifics are not detailed.

8. The sample size for the training set

Not applicable. The "Collaboration Live" device is a software communication feature for remote access and viewing, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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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 (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

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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: benny.lam@philips.com

I. Submitter

Manufacturer Nameand Address	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431
ContactInformation	Colin S. JacobSenior Regulatory Affairs SpecialistTEL: +1 (425)-908-1209EMAIL: colin.jacob@philips.com
Secondary ContactInformation	Benny LamPrincipal Regulatory Affairs SpecialistTEL: +1 (425)-215-3496

II. Device

Trade Name	Collaboration Live
Common Name	System, Image Processing, Radiological
Regulation Description	Picture archiving and communications system (Primary)Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging system
Regulation Number	892.2050 (Primary)892.1550892.1560
Product Code	LLZ (Primary)IYNIYO
Device Class	Class II
Review Panel	Radiology
Predicate Device

Collaboration Live – Philips Ultrasound (K200179)

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II. Device Description

Indications for Use III.

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Attribute	Collaboration LiveK201665(Subject Device)	Collaboration LiveK200179(Predicate)	Comparison
Manufacturer	Philips Ultrasound, Inc.	Philips Ultrasound, Inc.	Same
RegulationName	Picture Archiving andCommunications System(PACS)	Picture Archiving andCommunications System(PACS)	Same
ProductCode(s)	Primary: LLZSecondary: IYN, IYO	Primary: LLZSecondary: IYN, IYO	Same
Indicationsfor Use	Collaboration Live isindicated for remote consoleaccess of the Philipsultrasound system fordiagnostic image viewingand review, consultation,guidance, support, andeducation in real time.Access must be granted bythe healthcare professionalsoperating the ultrasoundsystem. Compliance with thetechnical and operatorrequirements specified in theUser Manual is required.It is the responsibility of thehealthcare professionals atthe remote client to ensureimage quality, displaycontrast, and ambient lightconditions are consistentwith the generally acceptedstandards of the clinicalapplication.	Collaboration Live isindicated for remote consoleaccess of the Philipsultrasound system for imageviewing, image review,consultation, guidance,support, and education inreal time. Access must begranted by the technologistoperating the system. Imagesreviewed remotely are notfor diagnostic use.	Both device areindicated for imagereview and viewing atremote location over theInternet. They areintended for ultrasoundimage review andviewing, remote control,and communication inreal time.The predicate is notindicated for diagnosticuse.
Features	Image viewing and reviewText ChatVoice CallingVideo CallingRemote Asset SharingRemote Control	Image viewing and reviewText ChatVoice CallingVideo CallingRemote Asset SharingRemote Control	Same
Local SystemHardware	Philips EPIQ or Affinitiultrasound system	Philips EPIQ or Affinitiultrasound system	Same
RemoteSystemHardware	Commercially available off-the-shelf computer hardware	Commercially available off-the-shelf computer hardware	Same
Attribute	Collaboration LiveK201665(Subject Device)	Collaboration LiveK200179(Predicate)	Comparison
SupportedImagingModalities	Ultrasound	Ultrasound	Same
IntendedUsers	Qualified healthcareprofessionals	Qualified healthcareprofessionals	Same
Remote-clientUseEnvironment	Clinical environment withambient light conditionconsistent with the generallyaccepted standards of theclinical application.	Clinical environment	Subject device has anadditional requirementfor ambient lightcondition.
RemoteDiagnosticUse	Image visualized fordiagnostic review andviewing on remote-clientReacts	No	The predicate is notindicated for diagnosticuse.

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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Regulation Number and Section

§ 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).