(187 days)
+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems.
Medical Facilities use their clinical protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility < clinical physicians or appropriate medical staff under the direction of physicians.
+ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.
lt is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions.
+ACG is not intended to be used for secondary monitoring.
+ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action.
+ACG only works with Talis EMR Products.
Talis EMR software is an Electronic Medical Record intended to support patient care documentation compliant with patient care record and billing requirements. Talis EMR leverages a non-device MDDS to acquire, transmit, store, and display electronic patient information available from multiple electronic sources including other EMRs and medical devices. Talis EMR provides no clinical recommendations, performs no assessment of patient conditions, and uses no proprietary algorithms. Display or access to patient data is not intended to influence the judgement of the healthcare professional user. Talis EMR software functions are either non-device software functions or software functions for which FDA has determined to exercise enforcement discretion.
+ACG software is an alarm notification system which may be configured to notify health care professionals when alarm or advisory conditions are identified based on patient data matching the Medical Facility defined alarm or advisory condition criteria. +ACG alarm/advisory notifications are limited to alarm or advisory conditions defined by the Medical Facility.
Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.
+ACG software only works with Talis EMR software.
The provided text does not contain information about specific acceptance criteria and a study that proves the device meets those criteria in the traditional sense of a clinical performance study with predefined metrics (e.g., sensitivity, specificity, accuracy).
Instead, this document is a 510(k) Premarket Notification from the FDA, which focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety.
Here's an analysis of what is present in the document related to "acceptance criteria" and "proof":
The document indicates that the Talis EMR with +ACG device has undergone non-clinical testing to demonstrate compliance with various harmonized and international standards, which can be seen as the "acceptance criteria" for its safety, software lifecycle, usability, cybersecurity, and electrical safety.
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of quantitative acceptance criteria (e.g., "sensitivity > X%", "specificity > Y%") and reported performance metrics for the device's core function (+ACG alarm notification) as one might expect from a diagnostic or AI-driven decision support system that provides specific diagnoses or predictions.
Instead, the "acceptance criteria" are compliance with established regulatory and technical standards. The "reported device performance" is that the device has passed these tests.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Software Lifecycle: ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software – Software life cycle processes) | Has passed all safety tests for demonstrated compliance. Certified. |
| Usability Engineering: ANSI AAMI IEC 62366-1:2015+AMDI:2020 (Medical devices – Part 1 Application of usability engineering to medical devices) | Has passed all safety tests for demonstrated compliance. Certified. Human factors and usability testing completed. |
| Alarm Systems: ISO 60601-1-8 Edition 2.2 2020-07 (Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems.) | Alarm and advisory signals comply with the international standard. |
| Information Security Management Systems: ISO 27001: 2017 (Information technology – Security techniques – Information security management systems – Requirements) | Cybersecurity processes and controls demonstrate compliance, certified by TUV SUD, assessed by 3rd party vulnerability and penetration testing. |
| Electrical Equipment Safety: IEC 60601-1 Edition 3.1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) (for Talis Hub hardware) | Tested to all applicable sections of the standard, certified by UL. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Talis EMR with +ACG, like the predicate device, did not require clinical trials." It details non-clinical tests (standards compliance, software validation, usability validation, risk management). Therefore, there is no specific "test set" sample size with patient data in the context of clinical performance evaluation mentioned. The testing focused on technical compliance, not clinical outcomes from a patient dataset.
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)
Since no clinical test set (i.e., patient data requiring independent ground truth establishment) was used, this information is not applicable and not provided. The "ground truth" for this device's function would be the accurate implementation of hospital-defined protocols and the correct generation of alarms/advisories based on inputted data, which is verified through software validation and functional testing against those pre-defined rules, rather than expert interpretation of patient cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical test set requiring expert adjudication was used.
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
No MRMC comparative effectiveness study was done or reported. The device is a "Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories." It is explicitly stated: "It is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions." And "+ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action." This indicates it's not a diagnostic or primary monitoring tool that would typically be evaluated with MRMC studies for improved human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the device's function is algorithm-only in matching data to protocols, the "performance" described is about its compliance with technical standards and its ability to generate alarms based on configured rules, rather than a standalone clinical performance evaluation against a diagnostic ground truth. The document does not describe such a standalone performance study with clinical outcomes metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional aspect of the +ACG software, the "ground truth" would be the hospital-defined protocols and criteria for generating alarms and advisories. The device's "performance" is its ability to accurately implement these pre-defined rules. The document implies verification and validation activities were performed against these defined rules, as part of software validation.
8. The sample size for the training set
Not applicable. The +ACG software is described as a "Clinical Decision Support device that only matches data to Hospital-defined protocols." This indicates a rule-based expert system or a system configured with user-defined logic, rather than a machine learning model that requires a "training set" of data for learning patterns.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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April 1, 2024
Talis Clinical, LLC William Murphy Vice President Regulatory & Quality 650 Mondial Parkway Streetsboro, Ohio 44241
Re: K233133
Trade/Device Name: Talis EMR with +ACG Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: February 23, 2024 Received: February 26, 2024
Dear William Murphy:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 W. Shih -S
Jennifer Shih Kozen 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
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Indications for Use
510(k) Number (if known)
Device Name
Talis EMR with +ACG
Indications for Use (Describe)
+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems.
Medical Facilities use their clinical protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility < clinical physicians or appropriate medical staff under the direction of physicians.
+ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.
lt is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions.
+ACG is not intended to be used for secondary monitoring.
+ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action.
+ACG only works with Talis EMR Products.
| 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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| 510(k) Summary | |||
|---|---|---|---|
| I. SUBMITTER | |||
| Date Prepared | March 15, 2024 | ||
| Submitter/Owner | Talis Clinical LLC650 Mondial ParkwayStreetsboro, OH 44241 USAPhone: 1-234-284-2400 | ||
| Key Contact | William MurphyVP Regulatory & Qualitywilliam.murphy@getinge.com | ||
| 510(k) Submission Type | This is a traditional 510(k) for multi-function software as amedical device. | ||
| II. DEVICE | |||
| Trade Name | Talis EMR with +ACG | ||
| Common Name | Alarm Notification System | ||
| Classification Name | Panel & Name: Cardiovascular (OHT2)Subpart & Division: Cardiac Electrophysiology, Diagnostics, andMonitoring Devices (DHT2A)21 CFR 870.2300 Regulatory Class: Class IIProduct Code: MWI | ||
| III. PREDICATE DEVICE | |||
| Predicate Device | 510(k) No. | Company NameDevice Name | Product Code |
| K213335 | Capsule Technologies, SAS / Capsule Tech Inc.Capsule Surveillance System | MWI | |
| The Talis EMR with +ACG is substantially equivalent to the legally marketed predicate CapsuleTechnologies, SAS / Capsule Tech Inc.'s Capsule Surveillance System (K213335). |
IV. DEVICE DESCRIPTION
Talis EMR with +ACG - description of device per 21 CFR 807.92(a)(4)
Talis EMR software is an Electronic Medical Record intended to support patient care documentation compliant with patient care record and billing requirements. Talis EMR leverages a non-device MDDS to acquire, transmit, store, and display electronic patient information available from multiple electronic sources including other EMRs and medical devices. Talis EMR provides no clinical recommendations, performs no assessment of patient conditions, and uses no proprietary algorithms. Display or access to patient data is not intended to influence the judgement of the healthcare professional user. Talis EMR software functions are either non-device software functions or software functions for which FDA has determined to exercise enforcement discretion.
+ACG software is an alarm notification system which may be configured to notify health care professionals when alarm or advisory conditions are identified based on patient data matching the
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Medical Facility defined alarm or advisory condition criteria. +ACG alarm/advisory notifications are limited to alarm or advisory conditions defined by the Medical Facility.
Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.
+ACG software only works with Talis EMR software.
INDICATIONS FOR USE V.
Intended Use as required per 21 CFR 807.92(a)(5)
+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems.
Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives.
It is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions.
+ACG is not intended to be used for secondary monitoring.
+ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action.
+ACG only works with Talis EMR Products.
| Comparison of Intended Uses for Subject Device and Predicate | |
|---|---|
| Name | Indications for Use/Intended Use |
| Talis EMR with +ACGSubject Device | +ACG is a Clinical Decision Support device that only matchesdata to Hospital-defined protocols to generate Alarms andAdvisories. +ACG uses data from multiple sources includingmedical devices and healthcare information systems.Medical Facilities use their clinical practices, protocols, andpolicies to define clinically relevant alarms and advisory criteria.Talis then configures Alarms and Advisories within +ACG to beused by the Medical Facility's clinical physicians or appropriatemedical staff under the direction of physicians.+ACG is intended to support the Medical Facility's efforts toimprove compliance to their patient care protocols andachievement of their quality initiatives.It is not intended to replace clinicians' judgement, but rather toassist clinicians in making timely, informed decisions.+ACG is not intended to be used for secondary monitoring.+ACG Alarms are not intended to be relied upon in deciding totake immediate clinical action.+ACG only works with Talis EMR Products. |
| K213335 | Capsule Surveillance is a clinical decision support device thatintegrates, analyzes, and displays data from multiple sourcesincluding medical devices and healthcare information systems. It |
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| Capsule Technologies, SAS /Capsule Tech IncCapsule Surveillance SystemPredicate Device | uses standardized rules that are based on customers approvedclinical practices, protocols, and policies to create clinicallyrelevant alerts in health care facilities when used by clinicalphysicians or appropriate medical staff under the direction ofphysicians. It is not intended to replace clinicians' judgment, butrather to assist clinicians in making timely, informed, higherquality decisions.Capsule Surveillance may be configured for secondarymonitoring and alerting intended to be relied upon in deciding totake immediate clinical action.Capsule Surveillance may also be configured for remote displayof physiological data and alerts not intended to be relied upon indeciding to take immediate clinical action. |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Similarities | |
|---|---|
| Item of Comparison | Description/Rationale |
| Target Populations | Both devices are intended to be used by trained clinicians. |
| Environment of Use | Both devices are intended to be used in medical facility settings. |
| Matrix and Detailed Views | Both devices allow for matrix or simultaneous multi-patientdisplay or access to detailed views of a single patient's data. |
| Data Input | Both devices use input from multiple electronic sources includingEMRs and medical devices. |
| Methods for Accessing theApplication | Both devices allow access via a workstation or remotely via a webbrowser |
| Not intended to be relied upon indeciding to take immediateclinical action. | Both devices may be configured for remote display ofphysiological data and alerts not intended to be relied upon indeciding to take immediate clinical action. |
| Differences | |
| Item of Comparison | Description/Rationale |
| Secondary Monitoring | Subject device is not intended for secondary monitoring |
| Intended to be relied upon indeciding to take immediate action | Subject device is not intended to be relied upon in deciding totake immediate clinical action. |
| Clinical Surveillance | Subject device does not detect the onset of emergent, potentiallyactionable conditions and inform the care team. |
| Patient Monitoring | Subject device is not integrated with a predictive scoring systemthat calculates a score quickly at the bedside (combining certainvitals and clinician observations) to help in identifying patients atrisk of deterioration. |
| Default Alarms or Advisories | Subject device does not support any clinical alarm or advisorycondition unless the medical facility identifies and defines thealarm or advisory condition and messages to the HCP. |
| Clinical Surveillance | Subject device does not monitor patient conditions |
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| Patient Monitoring | Subject device does not monitor, assess, diagnose, or predictpatient conditions. Software is limited to match patient data toMedical Facility defined patient care protocols (guidances) |
|---|---|
| Intended to be relied upon indeciding to take immediate action | Subject device provides no alarms / advisories not understood byHCP authorized to perform and trained to Medical Facility patientcare protocols. |
Substantial Equivalence Summary
Both devices provide clinical decision support. Both may be configured to support Medical Facility defined alarms / advisories condition criteria. Both have the ability to send alarm notification signals to HCP as identified by the Medical Facility. Operational and technological characteristics form the basis for the determination of substantial equivalence of the Talis EMR with +ACG software with the legally marketed predicate device (K213335). Talis EMR with +ACG is substantially equivalent to the predicate device.
VI. Performance Data
Non-Clinical Tests – Harmonized Standards
Talis EMR with +ACG has passed all safety tests for demonstrated compliance with the harmonized standards below.
| Standard | FDARecognition # | Title |
|---|---|---|
| ANSI AAMI IEC62304:2006/A1:2016 | 13-79 | Medical device software ">– Software life cycle processes[Including Amendment 1 (2016)] |
| ANSI AAMI IEC62366-1:2015+AMDI:2020(Consolidated Text) | 5-129 | Medical devices – Part 1 Application of usability engineeringto medical devices, including Amendment 1 |
Non-Clinical Tests - International Recognized Standard
Talis +ACG Alarm Notification System testing confirmed that the alarm and advisory signals comply with the international standard below.
| Standard | Title |
|---|---|
| ISO 60601-1-8 Edition 2.2 2020-07 | Medical electrical equipment – Part 1-8: General requirements forbasic safety and essential performance – Collateral standard:General requirements, tests, and guidance for alarm systems inmedical electrical equipment and medical electrical systems. |
Talis EMR with +ACG cybersecurity processes and controls demonstrate compliance with the recognized standard below, as certified by TUV SUD and assessed by 3th party vulnerability and penetration testing. MedISAO membership also supports identification of newly identified vulnerabilities.
| Standard | Title |
|---|---|
| ISO 27001: 2017 | Information technology – Security techniques – Informationsecurity management systems – Requirements (ISO/IEC27001:2013 including Cor 1:2014 and Cor 2:2015) Released2017-06 |
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Talis Hub hardware which functions as a non-device MDDS was tested to all applicable sections of the standard below, as certified by UL.
| Standard | Title |
|---|---|
| IEC 60601-1 Edition 3.1 | Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance |
Human factors and usability testing has been completed, as well as certification to IEC 62304 for software lifecycle and IEC 62366. No new issues of safety or effectiveness as compared to the predicate are introduced as a result of using this device.
Clinical Studies
Talis EMR with +ACG, like the predicate device, did not require clinical trials.
FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the Talis EMR with +ACG.
Based upon the design, intended use, indications for use, classification, usability, and safety testing the Talis EMR with +ACG is substantially equivalent to the listed predicate device.
VII. CONCLUSIONS
The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors and usability testing demonstrate that Talis EMR with +ACG does not raise new questions of safety and effectiveness when compared to the predicate device, performs as intended, and has performance characteristics that are substantially equivalent to the Capsule Surveillance System predicate device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).