(126 days)
Not Found
Yes
The device description mentions a "smart virtual assistant" with "analytical functions" and a "conversational voice or text interface" that translates user requests. While not explicitly stating "AI" or "ML," these features strongly suggest the use of underlying AI/ML technologies for natural language processing, data analysis, and intelligent assistance. The "Parameter-Based Notification feature" also implies some level of data analysis and pattern recognition, which can be facilitated by ML.
No.
Graffiti is a software solution designed to retrieve and display patient information, facilitate team collaboration, and provide notifications. It is not intended to directly diagnose, treat, prevent, cure, or mitigate disease, nor does it affect the structure or any function of the body. Its primary function is informational support for healthcare providers.
No
The device is described as a software solution that retrieves, manages, and displays patient information, and includes collaboration tools and a smart assistant for notifications. It is not intended to diagnose or analyze medical conditions to identify diseases or problems.
Yes
The device description explicitly states "Graffiti is a software-only solution" and that it is intended to operate on "customer supplied smartphones," indicating no proprietary hardware is included. The performance studies focus on software verification, validation, and usability testing, further supporting its software-only nature.
Based on the provided information, Graffiti is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Graffiti's Function: Graffiti's primary function is to retrieve, manage, and display existing patient record information and data from hospital information systems. It also includes team collaboration tools and analytical functions for notifications based on this existing data.
- No Specimen Analysis: There is no mention of Graffiti analyzing any biological specimens or performing any tests on samples taken from the human body. Its operation is based on accessing and processing data that has already been generated and stored within the healthcare facility's information system.
Therefore, Graffiti falls outside the scope of an In Vitro Diagnostic device. It is a software solution designed to improve access to and management of existing patient data for healthcare providers.
No
The provided input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no mention or approval of a PCCP for this device.
Intended Use / Indications for 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.
Product codes
DQK
Device Description
Graffiti is a software-only solution that interfaces with a healthcare facility's information system to retrieve, manage and display patient information on a handheld mobile device. It integrates care team collaboration tools and a smart virtual assistant to retrieve patient data and information from the hospital information systems through a conversational voice or text interface.
The smart assistant also includes analytical functions to enable user-defined custom notifications including time-based, event-based and parameter-based notifications. When the condition for notification is met, Graffiti produces a notification on the user smartphone, thereby helping the user improve her situational awareness.
Graffiti is intended to operate on customer supplied smartphones.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Provider (HCP). 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.
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)
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of Graffiti:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Software Verification
• Software Validation
• Usability Testing
Design verification and validation testing was performed to confirm that software and user requirements have been met.
In particular, bench testing was conducted to confirm that the conversational interface can accurately translate user conversational requests into executable data requests or notification requests. Usability testing demonstrate that intended users can successfully operate the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Philips IntelliVue GuardianSoftware (K180534)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 |
| 9900 W Innovation Dr. | |
| Wauwatosa, WI 53226, USA | |
| Primary Contact | |
| Person: | Camille Vidal |
| Director of Regulatory Affairs Strategy | |
| GE Healthcare | |
| 240-280-5356 | |
| Camille.Vidal@ge.com | |
| Device Trade | |
| Name: | Graffiti™ |
| Common/Usual | |
| Name: | Programmable diagnostic computer |
| Classification | |
| Names: | |
| Product Code: | 21 CFR 870.1425 Programmable diagnostic computer |
| Class II | |
| DQK | |
| Predicate | |
| Device(s): | Philips IntelliVue GuardianSoftware (K180534) |
| Device | |
| Description: | Graffiti is a software-only solution that interfaces with a healthcare |
| facility's information system to retrieve, manage and display patient | |
| information on a handheld mobile device. It integrates care team | |
| collaboration tools and a smart virtual assistant to retrieve patient data | |
| and information from the hospital information systems through a | |
| conversational voice or text interface. |
The smart assistant also includes analytical functions to enable user-
defined custom notifications including time-based, event-based and
parameter-based notifications. When the condition for notification is
met, Graffiti produces a notification on the user smartphone, thereby
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
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. |
| Comparison to
Predicate Device: | Both Graffiti and its predicate device are clinical information software
that display patient information and data including vitals and lab results
on a mobile device, for access whenever it is needed by the care team.
Both systems are intended to be used by healthcare providers caring for
patients in a hospital or an acute care facility. Graffiti and its predicate
have the same intended use. |
| | Both systems interface with the facility information system to retrieve
and display patient information and data such as labs. Vitals presented
in Graffiti come from validated values recorded in the EMR, while
GuardianSoftware pulls data from patient monitoring systems at regular
intervals. |
| | Both devices include a customizable rule engine that produces
notifications to the user when the conditions for notification are fulfilled. |
| | The main technological difference between Graffiti and its predicate, is
in how the user interacts with the device. Graffiti includes a digital
personal assistant "Bot" which can retrieve data or set notifications at
the user request. Graffiti's conversational voice or text interface
facilitate access to data stored in the hospital information system
instead of the user having to go through the traditional menu selection
interface. |
| Clinical and Non-
Clinical Tests | Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the |
| | development of Graffiti:
• |
| | Risk Analysis |
| | ■ Requirements Reviews |
| | ■ Design Reviews |
| | ■ Software Verification |
| | ■ Software Validation |
| | ■ Usability Testing |
| | Design verification and validation testing was performed to confirm that
software and user requirements have been met. |
| | In particular, bench testing was conducted to confirm that the
conversational interface can accurately translate user conversational
requests into executable data requests or notification requests. Usability
testing demonstrate that intended users can successfully operate the
system. |
| Conclusion: | Graffiti with Parameter Based Notifications has the same intended use
as the predicate device. The main difference in technological
characteristics is in the conversational voice or text interface of Graffiti.
Human factor and usability evaluation shows that the intended users can
safely use Graffiti through its conversational voice or text interface. |
| | Graffiti is substantially equivalent to IntelliVue GuardianSoftware. |
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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
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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.