(126 days)
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.
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.
I am sorry, but the provided text does not contain information about the specific acceptance criteria for the device "Graffiti" or a detailed study proving its performance against these criteria.
The document is a 510(k) premarket notification summary for the device "Graffiti", indicating that it has been deemed substantially equivalent to a predicate device (Philips IntelliVue GuardianSoftware).
Here's what I can extract from the provided text regarding the testing and evaluation:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document states "Design verification and validation testing was performed to confirm that software and user requirements have been met." and "bench testing was conducted to confirm that the conversational interface can accurately translate user conversational requests into executable data requests or notification requests." However, it does not list specific acceptance criteria or quantitative performance metrics against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "bench testing" and "usability testing" but does not detail the sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A MRMC comparative effectiveness study is not mentioned as part of the submission. The document focuses on showing substantial equivalence based on the device's functionality and safety, not on comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states "bench testing was conducted to confirm that the conversational interface can accurately translate user conversational requests into executable data requests or notification requests." This implies some level of standalone testing on the algorithm's ability to interpret queries. However, no specific performance metrics or detailed methodology for this "standalone" test are provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for the "bench testing" or "usability testing." For the conversational interface, the "ground truth" would likely be the correct interpretation and execution of the user's request.
8. The sample size for the training set
This information is not provided. The document describes the device as a "software-only solution" with a "digital personal assistant 'Bot'" and includes "analytical functions to enable user-defined notifications." While such systems would typically involve a training phase, the details of the training set are not included in this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided.
In summary, the provided 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and technology. It mentions various quality assurance measures and testing, but it does not delve into the detailed, quantitative performance studies against specific acceptance criteria that you are requesting.
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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
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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
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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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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, LLC9900 W Innovation Dr.Wauwatosa, WI 53226, USA |
| Primary ContactPerson: | Camille VidalDirector of Regulatory Affairs StrategyGE Healthcare240-280-5356Camille.Vidal@ge.com |
| Device TradeName: | Graffiti™ |
| Common/UsualName: | Programmable diagnostic computer |
| ClassificationNames:Product Code: | 21 CFR 870.1425 Programmable diagnostic computerClass IIDQK |
| PredicateDevice(s): | Philips IntelliVue GuardianSoftware (K180534) |
| DeviceDescription: | Graffiti is a software-only solution that interfaces with a healthcarefacility's information system to retrieve, manage and display patientinformation on a handheld mobile device. It integrates care teamcollaboration tools and a smart virtual assistant to retrieve patient dataand information from the hospital information systems through aconversational voice or text interface.The smart assistant also includes analytical functions to enable user-defined custom notifications including time-based, event-based andparameter-based notifications. When the condition for notification ismet, Graffiti produces a notification on the user smartphone, therebyhelping 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 collaborationtools and a smart assistant for the retrieval and display of patient recordinformation 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 smartassistant is also intended to keep track of changes in patientinformation, 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 systemor any patient monitoring or central station devices. | |
| Comparison toPredicate Device: | Both Graffiti and its predicate device are clinical information softwarethat display patient information and data including vitals and lab resultson a mobile device, for access whenever it is needed by the care team.Both systems are intended to be used by healthcare providers caring forpatients in a hospital or an acute care facility. Graffiti and its predicatehave the same intended use. |
| Both systems interface with the facility information system to retrieveand display patient information and data such as labs. Vitals presentedin Graffiti come from validated values recorded in the EMR, whileGuardianSoftware pulls data from patient monitoring systems at regularintervals. | |
| Both devices include a customizable rule engine that producesnotifications to the user when the conditions for notification are fulfilled. | |
| The main technological difference between Graffiti and its predicate, isin how the user interacts with the device. Graffiti includes a digitalpersonal assistant "Bot" which can retrieve data or set notifications atthe user request. Graffiti's conversational voice or text interfacefacilitate access to data stored in the hospital information systeminstead of the user having to go through the traditional menu selectioninterface. | |
| 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 thatsoftware and user requirements have been met. | |
| In particular, bench testing was conducted to confirm that theconversational interface can accurately translate user conversationalrequests into executable data requests or notification requests. Usabilitytesting demonstrate that intended users can successfully operate thesystem. | |
| Conclusion: | Graffiti with Parameter Based Notifications has the same intended useas the predicate device. The main difference in technologicalcharacteristics is in the conversational voice or text interface of Graffiti.Human factor and usability evaluation shows that the intended users cansafely use Graffiti through its conversational voice or text interface. |
| Graffiti is substantially equivalent to IntelliVue GuardianSoftware. |
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GE Healthcare 510(k) Premarket Notification Submission
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§ 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).