(23 days)
No
The document describes a software-based communication feature for remote access and collaboration on ultrasound systems. It focuses on real-time viewing, communication, and remote control, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as software for remote communication and control of an ultrasound system for diagnostic viewing, consultation, and education, rather than directly applying therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device 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." More importantly, the "Device Description" states, "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." This indicates its use in the diagnostic process.
Yes
The device is described as "software-based communication feature integrated with Philips Diagnostic Ultrasound Systems" and "together with remote-client Reacts software". It facilitates communication and remote control of an existing ultrasound system, but the device itself is the software component enabling this remote interaction. The description focuses entirely on the software's functionality and compatibility with various platforms.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states "remote console access of the Philips ultrasound system for diagnostic image viewing and review... 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." This clearly indicates the device is intended to be used for diagnostic purposes, which is a key characteristic of IVD devices.
- Device Description: The description reinforces the diagnostic intent by mentioning "remote diagnostic viewing and review."
- Input Imaging Modality: The device works with Ultrasound, which is a diagnostic imaging modality.
While the device is primarily a communication and remote access tool, its intended use for facilitating clinical diagnoses from remote locations using diagnostic images places it within the scope of IVD devices. The fact that it enables healthcare professionals to provide diagnoses remotely, as if they were directly using the ultrasound system, is a strong indicator of its diagnostic function.
It's important to note that the term "IVD" specifically refers to devices used to examine specimens taken from the human body. However, the regulatory definition of IVD can be broad and encompass devices that provide information for diagnostic purposes, even if they don't directly analyze biological samples. In this case, the device is facilitating the interpretation of diagnostic images, which is a crucial part of the diagnostic process.
Therefore, based on the provided text, the device's intended use for remote diagnostic image viewing, review, and the ability for healthcare professionals to provide clinical diagnoses remotely strongly suggests it is an IVD device.
N/A
Intended Use / 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.
Product codes
LLZ, IYN, IYO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals operating the ultrasound system and remote healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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
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). 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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. 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 | ||
| Address | Philips Ultrasound, Inc. | |
| 22100 Bothell Everett Hwy | ||
| Bothell, WA 98021-8431 | ||
| Contact Information | Courtney Nix | |
| Senior Regulatory Affairs Specialist | ||
| Secondary Contact | Tamara Daniels | |
| Senior 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 892.2050 | |
| IYN; System, Imaging, Pulsed Doppler, Ultrasonic; 21 CFR 892.1550 | ||
| 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 | |
| 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).