(88 days)
Not Found
No
The description focuses on remote communication and control features for ultrasound systems, with no mention of AI or ML for image analysis, diagnosis, or other functions.
No.
The device is used for remote diagnostic image viewing, review, consultation, guidance, support, and education; it does not directly apply treatment to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated for remote console access of the Philips ultrasound system for diagnostic image viewing and review". The "Device Description" further clarifies that it facilitates "remote diagnostic viewing and review" and mentions that "healthcare professionals using Reacts may provide clinical diagnoses from a remote location".
No
The device is described as a "software-based communication feature integrated in Philips Diagnostic Ultrasound Systems." This indicates it is a software component of a larger hardware system (the ultrasound system), not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: Collaboration Live is a software feature that facilitates remote communication and access to an ultrasound system for viewing, review, consultation, and control. It does not perform any tests on biological samples.
- Intended Use: The intended use is for remote access to an ultrasound system for diagnostic image viewing and review, consultation, guidance, support, and education. This is related to interpreting images generated by an ultrasound system, not analyzing biological samples.
- Device Description: The description focuses on the communication and remote control capabilities of the software, not on any analytical processes performed on biological materials.
- Input Modality: The input modality is Ultrasound, which is an imaging technique, not a method for analyzing biological samples.
Therefore, Collaboration Live falls under the category of medical imaging software or a communication/collaboration tool for medical professionals, not an In Vitro Diagnostic 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 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 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 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.
Mentions image processing
Common Name: System, Image Processing, Radiological
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
Qualified 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
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.
Key Metrics
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
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
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,
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) 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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3
Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a bright blue. The letters are evenly spaced and the word is horizontally aligned.
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 Name
and Address | Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact
Information | Colin S. Jacob
Senior Regulatory Affairs Specialist
TEL: +1 (425)-908-1209
EMAIL: colin.jacob@philips.com |
| Secondary Contact
Information | Benny Lam
Principal Regulatory Affairs Specialist
TEL: +1 (425)-215-3496 |
II. Device
I.
| Trade Name | Collaboration Live | ||
|---|---|---|---|
| Common Name | System, Image Processing, Radiological | ||
| Regulation Description | Picture archiving and communications system (Primary) | ||
| Ultrasonic pulsed doppler imaging system | |||
| Ultrasonic pulsed echo imaging system | |||
| Regulation Number | 892.2050 (Primary) | ||
| 892.1550 | |||
| 892.1560 | |||
| Product Code | LLZ (Primary) | ||
| IYN | |||
| IYO | |||
| Device Class | Class II | ||
| Review Panel | Radiology | ||
| Predicate Device |
Collaboration Live – Philips Ultrasound (K200179)
4
II. 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.
Indications for Use III.
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.
5
| Attribute | Collaboration Live
K201665
(Subject Device) | Collaboration Live
K200179
(Predicate) | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Ultrasound, Inc. | Philips Ultrasound, Inc. | Same |
| Regulation
Name | Picture Archiving and
Communications System
(PACS) | Picture Archiving and
Communications System
(PACS) | Same |
| Product
Code(s) | Primary: LLZ
Secondary: IYN, IYO | Primary: LLZ
Secondary: IYN, IYO | Same |
| 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. | 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. | Both device are
indicated for image
review and viewing at
remote location over the
Internet. They are
intended for ultrasound
image review and
viewing, remote control,
and communication in
real time.
The predicate is not
indicated for diagnostic
use. |
| Features | Image viewing and review
Text Chat
Voice Calling
Video Calling
Remote Asset Sharing
Remote Control | Image viewing and review
Text Chat
Voice Calling
Video Calling
Remote Asset Sharing
Remote Control | Same |
| Local System
Hardware | Philips EPIQ or Affiniti
ultrasound system | Philips EPIQ or Affiniti
ultrasound system | Same |
| Remote
System
Hardware | Commercially available off-
the-shelf computer hardware | Commercially available off-
the-shelf computer hardware | Same |
| Attribute | Collaboration Live
K201665
(Subject Device) | Collaboration Live
K200179
(Predicate) | Comparison |
| Supported
Imaging
Modalities | Ultrasound | Ultrasound | Same |
| Intended
Users | Qualified healthcare
professionals | Qualified healthcare
professionals | Same |
| Remote-client
Use
Environment | Clinical environment with
ambient light condition
consistent with the generally
accepted standards of the
clinical application. | Clinical environment | Subject device has an
additional requirement
for ambient light
condition. |
| Remote
Diagnostic
Use | Image visualized for
diagnostic review and
viewing on remote-client
Reacts | No | The predicate is not
indicated for diagnostic
use. |
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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