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 with Philips Diagnostic Ultrasound Systems. Collaboration Live, together with remote-client Reacts software, 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, iOS, Android, or Chrome platform. Collaboration Live-Reacts facilitates: 1) remote diagnostic viewing and review, 2) remote clinical training and education, 3) remote peer-topeer 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

The provided text describes a 510(k) premarket notification for Philips Ultrasound, Inc.'s "Collaboration Live" device, and its substantial equivalence to a predicate device. However, the document does not contain the specific details about acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical validation study.

The document states:

"Validation testing was completed and produced under Philips's design controls procedures that comply with 21 CFR 820.30. Validation Testing, with pre-determined criteria, was conducted to evaluate and demonstrate the equivalency of Collaboration Live used on Windows, iOS, Android, and Chrome platforms."
"The results of the design control activities support that the software, which expands the compatible platforms and adds three features, does not raise new questions of safety or effectiveness. In addition to labeling, testing performed demonstrates that the Collaboration Live software meets the defined requirements and performance claims and are substantially equivalent to the predicate software (K201665)."

This implies that some form of validation against pre-determined criteria was performed, but the specifics of those criteria (e.g., quantitative performance metrics like accuracy, sensitivity, specificity, resolution, latency, etc., for diagnostic image viewing and review), the study design, sample sizes, ground truth establishment, or expert involvement are not included in this FDA 510(k) summary document.

The 510(k) summary focuses on demonstrating substantial equivalence, primarily by expanding compatible platforms and adding new features (Network Indicator, Remote Image Quality, Remote User Measurement) while maintaining the original indications for use. It asserts that these changes do not raise new questions of safety or effectiveness.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and what is missing:

Acceptance Criteria and Device Performance:

1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms within this document. The document refers to "pre-determined criteria" and "defined requirements and performance claims" but does not list them. Given the device's function (remote console access for diagnostic image viewing and review, consultation, guidance, support, and education), the acceptance criteria would likely relate to image quality (resolution, clarity, color representation), latency, reliability of connection, and functionality of remote control features, all assessed for clinical applicability.
- Reported Device Performance: The document only states that "testing performed demonstrates that the Collaboration Live software meets the defined requirements and performance claims." Specific performance metrics are not provided.

Study Details:

2. Sample sizes used for the test set and the data provenance: Not provided in the document.
- Data Provenance: Not provided.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The document mentions "healthcare professionals at the remote client" being responsible for ensuring image quality, but this refers to the user's responsibility, not the study's ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 explicitly stated and highly unlikely for this device. This device is a remote access/collaboration tool, not an AI diagnostic algorithm intended to improve human reader performance on a diagnostic task. Its validation would focus on the fidelity and functionality of the remote access.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is inherently a human-in-the-loop system for real-time collaboration. The "alone" aspect would be assessing the technical performance of the remote viewing and control, which is implied by "Validation Testing, with pre-determined criteria, was conducted to evaluate and demonstrate the equivalency of Collaboration Live used on Windows, iOS, Android, and Chrome platforms."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a device like this, ground truth would likely involve technical performance metrics (e.g., objective image quality assessments, latency measurements, functional tests of remote controls) alongside subjective assessments by clinicians regarding its usability and diagnostic adequacy when viewing images remotely.
8. The sample size for the training set: Not applicable and not provided. This is not an AI/ML device that requires a "training set" in the typical sense for learning patterns from data. Its development involves software engineering and functional testing.
9. How the ground truth for the training set was established: Not applicable and not provided.

Summary of Device and its Purpose:

Device Name: Collaboration Live
Manufacturer: Philips Ultrasound, Inc.
Regulation Name: Medical image management and processing system
Regulatory Class: Class II (Product Codes: LLZ, IYN, IYO)
Indications for Use: 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.
Key Features (as per this submission): Expansion of compatible platforms (Windows, iOS, Android, Chrome) and addition of Network Indicator, Remote Image Quality, Remote User Measurement.
Predicate Device: Collaboration Live – Philips Ultrasound (K201665, cleared September 15, 2020)

In conclusion, while the document confirms that validation testing demonstrating equivalency and meeting defined requirements was performed, it does not disclose the specific acceptance criteria or the detailed results of that study, which is typical for a 510(k) summary as it focuses on establishing substantial equivalence rather than providing a full clinical validation report.

Summary

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Philips Ultrasound, Inc. % Tamara Daniels Sr. Regulatory Affairs Manager 22100 Bothell Everett Highway BOTHELL WA 98201

September 24, 2021

Re: K212777

Trade/Device Name: Collaboration Live Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, IYN, IYO Dated: August 27, 2021 Received: September 1, 2021

Dear Tamara Daniels:

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,

Jessica Lamb

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) K212777

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

510(K) #: K212777

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

Date Prepared: September 21, 2021

I.	Submitter
	Manufacturer Name andAddress	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431
	Contact Information	Courtney NixSenior Regulatory Affairs Specialist
	Secondary Contact	Tamara DanielsSenior Regulatory Affairs Manager
II.	Device
	Trade Name	Collaboration Live
	Common Name	System, Image Processing, Radiological
	Product Code;Regulation Description;Regulation Number	LLZ; System, Image Processing, Radiological; 21 CFR 892.2050IYN; System, Imaging, Pulsed Doppler, Ultrasonic; 21 CFR 892.1550IYO; System, Imaging, Pulsed Echo, Ultrasonic; 21 CFR 892.1560
	Device Class	Class II
	Review Panel	Radiology
	Predicate Device	Collaboration Live – Philips Ultrasound (K201665, clearedSeptember 15, 2020)

III. Device Description

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IV. Indications for Use

V. Comparison of Technological Characteristics with the Predicate Device

The primary purpose of the submission is to expand the compatible platforms for Collaboration Live:

Predicate (K201665): Windows O
O This submission: Windows, iOS, Android, and Chrome

Additional features have been introduced into the proposed software:

Network Indicator O
Remote Image Quality O
Remote User Measurement O

The intended users, use environment, indications for use, and intended use are unchanged as compared to the predicate.

VI. Validation Testing Summary

Validation testing was completed and produced under Philips's design controls procedures that that comply with 21 CFR 820.30. Validation Testing, with pre-determined criteria, was conducted to evaluate and demonstrate the equivalency of Collaboration Live used on Windows, iOS, Android, and Chrome platforms.

VII. Conclusion

The results of the design control activities support that the software, which expands the compatible platforms and adds three features, does not raise new questions of safety or effectiveness. In addition to labeling, testing performed demonstrates that the Collaboration Live software meets the defined requirements and performance claims and are substantially equivalent to the predicate software (K201665).

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).