(187 days)
Not Found
No
The device description explicitly states that it "only matches data to Hospital-defined protocols" and "uses no proprietary algorithms." It functions as an alarm notification system based on pre-defined criteria, not learning or adapting from data.
No
The device is described as a 'Clinical Decision Support device' and an 'alarm notification system' intended to help clinical staff make timely, informed decisions and improve compliance with patient care protocols. It explicitly states it is "not intended to replace clinicians' judgement" and "not intended to be relied upon in deciding to take immediate clinical action," and it does not provide treatment or directly impact a patient's health condition. Its function is to match data to protocols and generate alarms/advisories to support decisions, not to provide therapy itself.
No
Explanation: The device description states that "+ACG provides no clinical recommendations, performs no assessment of patient conditions, and uses no proprietary algorithms." Its purpose is to match data to hospital-defined protocols to generate alarms and advisories, which is intended to support compliance with patient care protocols, not to diagnose conditions.
Yes
The device description explicitly states "+ACG software is an alarm notification system..." and "+ACG software only works with Talis EMR software." The performance studies mention testing of "Talis Hub hardware," but this appears to be a separate component (likely for data acquisition/transmission) that the software interacts with, not part of the +ACG device itself. The focus of the description and intended use is on the software's function of processing data and generating notifications based on defined protocols.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of +ACG clearly states it uses data from multiple sources including medical devices and healthcare information systems, and matches this data to hospital-defined protocols. It does not mention analyzing biological samples like blood, urine, or tissue.
- The intended use is clinical decision support based on existing patient data and protocols. The device generates alarms and advisories based on matching patient data to pre-defined criteria within the hospital's protocols. This is a different function than diagnosing a condition based on laboratory analysis of a specimen.
- The device description focuses on software functionality for data processing and notification. It describes how the software works with an EMR to acquire, transmit, store, and display patient information and generate notifications based on matching data to criteria. This aligns with clinical decision support systems, not IVDs.
Therefore, the function and intended use of +ACG do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
+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.
Product codes
MWI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians.
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)
Non-Clinical Tests – Harmonized Standards: Talis EMR with +ACG has passed all safety tests for demonstrated compliance with ANSI AAMI IEC 62304:2006/A1:2016 for Medical device software – Software life cycle processes.
Non-Clinical Tests - International Recognized Standard: Talis +ACG Alarm Notification System testing confirmed that the alarm and advisory signals comply with ISO 60601-1-8 Edition 2.2 2020-07 for 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.
Cybersecurity: Talis EMR with +ACG cybersecurity processes and controls demonstrate compliance with ISO 27001: 2017 (Information technology – Security techniques – Information security management systems – Requirements), as certified by TUV SUD and assessed by 3rd party vulnerability and penetration testing. MedISAO membership also supports identification of newly identified vulnerabilities.
Hardware Testing: Talis Hub hardware which functions as a non-device MDDS was tested to all applicable sections of IEC 60601-1 Edition 3.1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), as certified by UL.
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.
Conclusion: 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. 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.
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.
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
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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).
1
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
2
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 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
| 510(k) Summary | |||
|---|---|---|---|
| I. SUBMITTER | |||
| Date Prepared | March 15, 2024 | ||
| Submitter/Owner | Talis Clinical LLC | ||
| 650 Mondial Parkway | |||
| Streetsboro, OH 44241 USA | |||
| Phone: 1-234-284-2400 | |||
| Key Contact | William Murphy | ||
| VP Regulatory & Quality | |||
| william.murphy@getinge.com | |||
| 510(k) Submission Type | This is a traditional 510(k) for multi-function software as a | ||
| medical 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, and | |||
| Monitoring Devices (DHT2A) | |||
| 21 CFR 870.2300 Regulatory Class: Class II | |||
| Product Code: MWI | |||
| III. PREDICATE DEVICE | |||
| Predicate Device | 510(k) No. | Company Name | |
| Device 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 Capsule | |||
| Technologies, 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
4
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 +ACG | |
| Subject Device | +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. |
| K213335 | Capsule Surveillance is a clinical decision support device that
integrates, analyzes, and displays data from multiple sources
including medical devices and healthcare information systems. It |
5
| Capsule Technologies, SAS /
Capsule Tech Inc
Capsule Surveillance System
Predicate Device | uses standardized rules that are based on customers approved
clinical practices, protocols, and policies to create clinically
relevant alerts in health care facilities when used by clinical
physicians or appropriate medical staff under the direction of
physicians. It is not intended to replace clinicians' judgment, but
rather to assist clinicians in making timely, informed, higher
quality decisions.
Capsule Surveillance may be configured for secondary
monitoring and alerting intended to be relied upon in deciding to
take immediate clinical action.
Capsule Surveillance may also be configured for remote display
of physiological data and alerts not intended to be relied upon in
deciding 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-patient |
| display or access to detailed views of a single patient's data. | |
| Data Input | Both devices use input from multiple electronic sources including |
| EMRs and medical devices. | |
| Methods for Accessing the | |
| Application | Both devices allow access via a workstation or remotely via a web |
| browser | |
| Not intended to be relied upon in | |
| deciding to take immediate | |
| clinical action. | Both devices may be configured for remote display of |
| physiological data and alerts not intended to be relied upon in | |
| deciding 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 in | |
| deciding to take immediate action | Subject device is not intended to be relied upon in deciding to |
| take immediate clinical action. | |
| Clinical Surveillance | Subject device does not detect the onset of emergent, potentially |
| actionable conditions and inform the care team. | |
| Patient Monitoring | Subject device is not integrated with a predictive scoring system |
| that calculates a score quickly at the bedside (combining certain | |
| vitals and clinician observations) to help in identifying patients at | |
| risk of deterioration. | |
| Default Alarms or Advisories | Subject device does not support any clinical alarm or advisory |
| condition unless the medical facility identifies and defines the | |
| alarm or advisory condition and messages to the HCP. | |
| Clinical Surveillance | Subject device does not monitor patient conditions |
6
| Patient Monitoring | Subject device does not monitor, assess, diagnose, or predict
patient conditions. Software is limited to match patient data to
Medical Facility defined patient care protocols (guidances) |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended to be relied upon in
deciding to take immediate action | Subject device provides no alarms / advisories not understood by
HCP authorized to perform and trained to Medical Facility patient
care 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 | FDA
Recognition # | Title |
|--------------------------------------------------------------------|----------------------|------------------------------------------------------------------------------------------------------------|
| ANSI AAMI IEC
62304:2006/A1:2016 | 13-79 | Medical device software ">– Software life cycle processes
[Including Amendment 1 (2016)] |
| ANSI AAMI IEC
62366-
1:2015+AMDI:2020
(Consolidated Text) | 5-129 | Medical devices – Part 1 Application of usability engineering
to 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 for |
| basic safety and essential performance – Collateral standard: | |
| General requirements, tests, and guidance for alarm systems in | |
| medical 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 – Information |
| security management systems – Requirements (ISO/IEC | |
| 27001:2013 including Cor 1:2014 and Cor 2:2015) Released | |
| 2017-06 |
7
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 for |
| basic 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.