Collaboration Live is indicated for remote console access of the Philips ultrasound system for image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use.

Device Description

Collaboration Live is a new software feature integrated in Philips Epiq and Affiniti Diagnostic Ultrasound Systems (K182857). Collaboration Live enables two-way communication of text, voice, image, and video information between an ultrasound system operator and a remote user on a Windows desktop or laptop computer. Collaboration Live facilitates: 1) remote service support, 2) remote clinical training and education, and 3) remote peer-to-peer collaboration (non-diagnostic). Collaboration Live functionality includes a remote control feature in which the ultrasound system operator may grant a qualified remote user control of all ultrasound system parameters via a virtual control panel and virtual touch screen. The ultrasound system operator maintains the ability to take back system control at any time. The remote user interacts with the ultrasound system using the Collaboration Live remote application, which is called Reacts.

AI/ML Overview

The provided text describes the "Collaboration Live" device, a software feature for Philips ultrasound systems, and its substantial equivalence to a predicate device (GE Customer Remote Console). However, the document does not contain specific acceptance criteria, a detailed study proving performance, or the specific data requested in the prompt.

Instead, it broadly states: "Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use."

Without explicit acceptance criteria and corresponding performance data, it's impossible to fill out the requested table and answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, the answer below reflects the absence of this detailed information in the provided document.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for Philips Healthcare's "Collaboration Live" device states that "Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use."

However, the document does not explicitly define the specific acceptance criteria or present a detailed study report with quantitative performance metrics for Collaboration Live. No tables showing acceptance criteria alongside reported device performance are included. The description focuses on demonstrating substantial equivalence based on technological similarities and software verification, rather than a quantifiable performance study against predefined criteria.

Therefore, the following information cannot be extracted from the provided text:

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

Not provided in the document. The document only states that the device "meets the acceptance criteria" without specifying what those criteria are or presenting detailed performance data.

2. Sample size used for the test set and the data provenance:

Not provided in the document. The document mentions "Software verification" but does not detail the test set size, its composition, or its origin (e.g., country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. Since no specific performance study with a test set and ground truth establishment is detailed, this information is absent.

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

Not applicable / Not provided.

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:

Not performed / Not stated. The document explicitly states, "Collaboration Live did not require clinical testing to support a determination of substantial equivalence." This implies no clinical comparative effectiveness study, including MRMC studies, was conducted or reported. "Collaboration Live" is described as a remote access and collaboration tool, not an AI diagnostic aid that would typically involve human reader performance improvement studies.

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

Not performed / Not stated. The device is a collaboration tool, not an autonomous diagnostic algorithm, so standalone performance in the typical sense is not an applicable characteristic for this type of device.

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

Not applicable / Not provided. As no specific performance study against a ground truth is reported.

8. The sample size for the training set:

Not provided. The document does not describe any machine learning or AI model training, thus no training set information is available.

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

Not applicable / Not provided.

Summary

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February 18, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Healthcare % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K200179

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: November 25, 2019 Received: January 24, 2020

Dear Prithul Bom:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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) K200179

Device Name Collaboration Live

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety and Effectiveness (5)

Collaboration Live

The 510(k) summary of safety and effectiveness information is submitted in accordance with 21CFR $807.92. See Appendix D1.

1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy
  Bothell, WA 98021-8431

Contact person:	Paul Elias, Regulatory Affairs Specialist
Email:	Paul.Elias@philips.com
Tel:	425-482-8396
Fax:	425-487-8666
Secondary Contact:	Hebe Sun, Senior Regulatory Affairs Manage
Email:	Hebe.Sun@philips.com

Date prepared: November 20, 2019

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
  Picture archiving and communications system Common name: Proprietary name: Collaboration Live

Classification Name	21 CFR Section	Product Code
System, Image Processing, RadiologicalPicture archiving and communications system(PACS)	892.2050	LLZ
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO

As stated in 21 CFR parts 892.2050, 892.1550, and 892.1560, each of these types of devices has been classified as Class II.

3. Substantially Equivalent Devices

Philips Ultrasound believes that Collaboration Live is substantially equivalent to the following predicate device:

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Predicate Device	510(k)
GE Customer Remote Console	K150193

4. Device Description

5. Indications for Use

Collaboration Live is indicated for remote console access of the Philips ultrasound system for image viewing, image review, consultation, guidance, support, and education in real time. Access must be granted by the technologist operating the system. Images reviewed remotely are not for diagnostic use.

6. Technological Comparison to Predicate Device

Collaboration Live employs the same fundamental scientific technology as the predicate GE Customer Remote Console (CRC). Like CRC, Collaboration Live is a software feature that enables remote image viewing and real-time communication between the system operator and a remote user (on a laptop or desktop computer) for the purposes of service, training/education, and peer-to-peer collaboration. Collaboration Live also contains a remote control feature similar to CRC, in which a qualified remote user can control the system parameters when granted access by the system operator. Like CRC, remote control in Collaboration Live can be granted to only one remote user at a time and may be revoked at any time by the system operator.

7. Safety Considerations and Nonclinical Performance Testing

No performance standards for PACS systems or components have been issued under the authority of Section 514.

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Quality assurance measures applied to the product design and development included risk analysis, product specifications, design reviews, and verification testing.

Software verification supported a determination of substantial equivalence with the predicate GE Customer Remote Console (K150193), and demonstrated that Collaboration Live meets the acceptance criteria and is adequate for its intended use.

8. Clinical Data

Collaboration Live did not require clinical testing to support a determination of substantial equivalence.

9. Conclusion

The Collaboration Live software requirements have been successfully verified and cybersecurity vulnerability testing has been conducted to ensure product security. The differences between Collaboration Live and the predicate GE Customer Remote Console do not raise new questions of safety or effectiveness. With similar technology, features, and indications for use, Collaboration Live is substantially equivalent to the predicate GE Customer Remote Console (K150193).

514 Performance Standards

There are no Sec. 514 performance standards for Collaboration Live.

Prescription Status

Collaboration Live and the associated Epiq and Affiniti Diagnostic Ultrasound Systems are prescription devices. The prescription device statement appears in the labeling for the Collaboration Live feature and in the labeling for the Epiq and Affiniti Diagnostic Ultrasound Systems.

Sterilization Sites

Not applicable. Collaboration Live is a software feature.

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).