Graffiti

K202189 · Ge Medical Systems Information Technologies, Inc. · DQK · Dec 8, 2020 · Cardiovascular

Device Facts

• Record ID: K202189
• Device Name: Graffiti
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Graffiti is a software solution that includes integrated team collaboration tools and a smart assistant for the retrieval and display of patient record information and data whenever needed by a Healthcare Provider (HCP). The smart assistant also includes analytical functions to enable user-defined notifications. When the Parameter-Based Notification feature is enabled, the smart assistant is also intended to keep track of changes in patient information, data and status. Graffiti may be used by members of the patient care team while on duty physically at the hospital or while on call, which could be remotely. Graffiti is not intended to replace the Electronic Medical Record system or any patient monitoring or central station devices.

Device Story

Software-only solution; interfaces with hospital information systems to retrieve/display patient data (vitals, labs) on handheld mobile devices. Features integrated team collaboration tools and smart virtual assistant; utilizes conversational voice or text interface for data retrieval and notification setup. Enables time-based, event-based, and parameter-based notifications. Used by healthcare providers in hospitals or remotely while on call. Output displayed on user smartphone; improves situational awareness by providing timely access to patient status. Does not replace EMR or central monitoring stations.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed software and user requirements. Usability testing demonstrated intended users can successfully operate the system. Bench testing confirmed the conversational interface accurately translates user requests into executable data or notification requests.

Technological Characteristics

Software-only solution; operates on customer-supplied smartphones. Features conversational voice/text interface ('Bot') for data retrieval and notification management. Includes customizable rule engine for time, event, and parameter-based notifications. Interfaces with hospital information systems to pull EMR data. No physical materials or energy sources.

Indications for Use

Indicated for healthcare providers (HCP) and patient care team members in hospital or acute care settings, including remote on-call scenarios, for retrieval and display of patient records and data, and for user-defined notifications based on patient information changes.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Philips IntelliVue GuardianSoftware (K180534)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 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.

December 8, 2020

GE Medical Systems Information Technologies, Inc. Camille Vidal Director Regulatory Affairs Strategy 9900 W Innovation Dr. Wauwatosa, Wisconsin 53226

Re: K202189

Trade/Device Name: Graffiti Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 6, 2020 Received: November 9, 2020

Dear Camille Vidal:

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

{1}------------------------------------------------

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K202189

Device Name Graffiti

#### Indications for Use (Describe)

Graffiti is a software solution that includes integrated team collaboration tools and a smart assistant for the retrieval and display of patient record information and data whenever needed by a Healthcare Provider (HCP). The smart asso includes analytical functions to enable user-defined notifications.

When the Parameter-Based Notification feature is enabled, the smart assistant is also intended to keep track of changes in patient information, data and status.

Graffiti may be used by members of the patient care team while on duty physically at the hospital or while on call, which could be remotely.

Graffiti is not intended to replace the Electronic Medical Record system or any patient monitoring or central station devices.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X 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/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three curved lines emanating from the circle, resembling water droplets or stylized flames. The logo is simple and recognizable, representing the company's brand identity.

## 510(k) Summary

### K202189

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | November 6, 2020 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies, LLC<br>9900 W Innovation Dr.<br>Wauwatosa, WI 53226, USA |
| Primary Contact<br>Person: | Camille Vidal<br>Director of Regulatory Affairs Strategy<br>GE Healthcare<br>240-280-5356<br>[e-mail] |
| Device Trade<br>Name: | Graffiti™ |
| Common/Usual<br>Name: | Programmable diagnostic computer |
| Classification<br>Names:<br>Product Code: | 21 CFR 870.1425 Programmable diagnostic computer<br>Class II<br>DQK |
| Predicate<br>Device(s): | Philips IntelliVue GuardianSoftware (K180534) |
| Device<br>Description: | Graffiti is a software-only solution that interfaces with a healthcare<br>facility's information system to retrieve, manage and display patient<br>information on a handheld mobile device. It integrates care team<br>collaboration tools and a smart virtual assistant to retrieve patient data<br>and information from the hospital information systems through a<br>conversational voice or text interface.<br><br>The smart assistant also includes analytical functions to enable user-<br>defined custom notifications including time-based, event-based and<br>parameter-based notifications. When the condition for notification is<br>met, Graffiti produces a notification on the user smartphone, thereby<br>helping the user improve her situational awareness. |
| | |
| | Graffiti is intended to operate on customer supplied smartphones. |
| Indications for use | Graffiti is a software solution that includes integrated team collaboration<br>tools and a smart assistant for the retrieval and display of patient record<br>information and data whenever needed by a Healthcare Provider (HCP).<br>The smart assistant also includes analytical functions to enable user-<br>defined notifications.<br>When the Parameter-Based Notification feature is enabled, the smart<br>assistant is also intended to keep track of changes in patient<br>information, data and status.<br>Graffiti may be used by members of the patient care team while on duty |
| | physically at the hospital or while on call, which could be remotely.<br>Graffiti is not intended to replace the Electronic Medical Record system<br>or any patient monitoring or central station devices. |
| Comparison to<br>Predicate Device: | Both Graffiti and its predicate device are clinical information software<br>that display patient information and data including vitals and lab results<br>on a mobile device, for access whenever it is needed by the care team.<br>Both systems are intended to be used by healthcare providers caring for<br>patients in a hospital or an acute care facility. Graffiti and its predicate<br>have the same intended use. |
| | Both systems interface with the facility information system to retrieve<br>and display patient information and data such as labs. Vitals presented<br>in Graffiti come from validated values recorded in the EMR, while<br>GuardianSoftware pulls data from patient monitoring systems at regular<br>intervals. |
| | Both devices include a customizable rule engine that produces<br>notifications to the user when the conditions for notification are fulfilled. |
| | The main technological difference between Graffiti and its predicate, is<br>in how the user interacts with the device. Graffiti includes a digital<br>personal assistant "Bot" which can retrieve data or set notifications at<br>the user request. Graffiti's conversational voice or text interface<br>facilitate access to data stored in the hospital information system<br>instead of the user having to go through the traditional menu selection<br>interface. |
| Clinical and Non-<br>Clinical Tests | Summary of Non-Clinical Tests:<br>The following quality assurance measures were applied to the |
| | development of Graffiti:<br>• |
| | Risk Analysis |
| | ■ Requirements Reviews |
| | ■ Design Reviews |
| | ■ Software Verification |
| | ■ Software Validation |
| | ■ Usability Testing |
| | Design verification and validation testing was performed to confirm that<br>software and user requirements have been met. |
| | In particular, bench testing was conducted to confirm that the<br>conversational interface can accurately translate user conversational<br>requests into executable data requests or notification requests. Usability<br>testing demonstrate that intended users can successfully operate the<br>system. |
| Conclusion: | Graffiti with Parameter Based Notifications has the same intended use<br>as the predicate device. The main difference in technological<br>characteristics is in the conversational voice or text interface of Graffiti.<br>Human factor and usability evaluation shows that the intended users can<br>safely use Graffiti through its conversational voice or text interface. |
| | Graffiti is substantially equivalent to IntelliVue GuardianSoftware. |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The circle has small, teardrop-shaped elements around its perimeter, giving it a slightly decorative appearance. The logo is colored in a light blue hue.

# GE Healthcare 510(k) Premarket Notification Submission

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is often used to represent the company's brand.