Collaboration Live

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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. 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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 {1}------------------------------------------------ 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). 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212777 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 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The overall impression is clean and modern, reflecting the brand's identity. ## 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 and<br>Address | Philips Ultrasound, Inc.<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 | | | Contact Information | Courtney Nix<br>Senior Regulatory Affairs Specialist | | | Secondary Contact | Tamara Daniels<br>Senior Regulatory Affairs Manager | | II. | Device | | | | Trade Name | Collaboration Live | | | Common Name | System, Image Processing, Radiological | | | Product Code;<br>Regulation Description;<br>Regulation Number | LLZ; System, Image Processing, Radiological; 21 CFR 892.2050<br>IYN; System, Imaging, Pulsed Doppler, Ultrasonic; 21 CFR 892.1550<br>IYO; System, Imaging, Pulsed Echo, Ultrasonic; 21 CFR 892.1560 | | | Device Class | Class II | | | Review Panel | Radiology | | | Predicate Device | Collaboration Live – Philips Ultrasound (K201665, cleared<br>September 15, 2020) | ### III. 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and centered. ### IV. Indications for 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. ### 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).