The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.

The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.

Device Description

Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients' status and alarm conditions when they are away from the patient and associated medical devices.

Digistat Smart Central connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices including patient monitors, ventilators, and infusion pumps. The user configures Digistat Smart Central to determine which information, including alarm notifications, is delivered to which users. Digistat Smart Central then formats the data for delivery to the display devices.

Digistat Smart Central is not in contact with the patient. It is intended to forward the information generated by the connected medical devices and systems and it does not generate patient related alarms. As such, the patient population and patient conditions are established by the medical devices and systems to which the product is connected.

AI/ML Overview

This document, a 510(k) Premarket Notification for the Digistat Smart Central, primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for an AI/ML algorithm. The product described is a medical device integration solution that forwards information and alarms, not an AI/ML diagnostic or predictive algorithm.

Therefore, many of the requested elements pertaining to AI/ML model validation (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance) are not applicable or detailed in this document. The document outlines performance testing more generally related to software development, cybersecurity, and usability engineering, rather than clinical performance metrics typical for AI/ML algorithms.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not present due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) akin to AI/ML device validation. Instead, the "Summary of Performance Testing" section indicates that the device's software and benchmark performance were verified and validated against:

Software Standards/Guidance:
- FDA guidance: "The content of premarket submissions for software contained in medical devices, 11 May 05."
- FDA guidance: "Off-the-shelf software use in medical devices, 09 Sep 99."
- FDA guidance: "General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02."
- FDA guidance: "Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14."
- "Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05."
- "Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17."
- IEC 62304: 2006, "Medical device software - Software life cycle processes."
Performance Testing – Bench (Usability):
- IEC 62366-1: 2015, "Medical devices – Application of usability engineering to medical devices."

Reported Device Performance:

The document states:

"Test results indicate that the Digistat Smart Central software complies with its predetermined specifications and the applicable guidance documents."
"Test results indicate that the Digistat Smart Central complies with its predetermined specifications and the applicable standards."
"The results of these activities demonstrate that the Digistat Smart Central is performs as well as the predicate devices."

This indicates qualitative confirmation of meeting specifications and standards rather than specific quantitative performance numbers (e.g., latency, throughput, error rates) that would typically be associated with performance acceptance criteria for an AI/ML device. The "acceptance criteria" here are compliance with software and usability standards, and the "performance" is that it did comply.

2. Sample sizes 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 in the document. As the device is a data forwarding system and not an AI/ML diagnostic tool, there's no mention of "test sets" in the context of patient data or clinical images/signals for AI/ML model evaluation. The "tests" mentioned are verification and validation of software and usability, which don't typically involve "sample sizes" of clinical data to the same extent an AI/ML model would.

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 applicable/provided. The device does not generate diagnostic interpretations or predictions that would require expert-established ground truth for performance evaluation in the context of AI/ML.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are used in studies involving human interpretation or uncertain ground truth, which is not the primary focus for a data forwarding device like Digistat Smart Central.

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

This information is not applicable/provided. MRMC studies are typically done for AI/ML devices that assist human interpretation (e.g., radiologists reading scans with vs. without AI assistance). The Digistat Smart Central is a messaging system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a "Smart Central" system that forwards information; its "performance" is its ability to reliably forward data and alarms, not to make a standalone diagnosis or prediction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. Ground truth, in the AI/ML sense, is not relevant for the type of device (data forwarding system) described in this document. The "truth" for this device would be whether the data was forwarded accurately and in a timely manner, which would be verified through system testing rather than clinical ground truth labels.

8. The sample size for the training set

This information is not applicable/provided. The Digistat Smart Central is not described as an AI/ML algorithm that requires a training set. Its "software" is rigorously engineered and verified/validated against specifications and standards, not "trained" on a dataset.

9. How the ground truth for the training set was established

This information is not applicable/provided. As the device is not an AI/ML algorithm requiring a training set, the concept of "ground truth for the training set" does not apply.

Summary

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November 23, 2018

ASCOM UMS srl unipersonale % Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland. Colorado 80466

Re: K180430

Trade/Device Name: Digistat Smart Central Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, PHC Dated: October 24, 2018 Received: October 25, 2018

Dear Thomas Kroenke:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Arielle Drummond -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K180430

Device Name: Digistat Smart Central

Indications For Use: The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.

The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Page 1 of 1

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Submission Date:	07 November 2018
SubmissionNumber:	K180430
Submitter:	ASCOM UMS srl unipersonaleVia Amilcare Ponchielli 2950018 Scandicci (FI), Italy
SubmitterCorrespondents	Mr. Paolo BurchiettiPhone: +011 39 055 051 2161Email: paolo.burchietti@ascom.comMr. Ivan LiljegrenPhone +011 (46) 31 55 93 11Email: ivan.liljegren@ascom.com
ApplicationCorrespondent	Speed To Market, Inc.PO Box 3018Nederland, CO 80466Mr. Thomas KroenkePhone: +1 (303) 956-4232Email: tkroenke@speedtomarket.net
Manufacturing Site:	ASCOM UMS srl unipersonaleVia Amilcare Ponchielli 2950018 Scandicci (FI), Italy
Trade Name:	Digistat Smart Central
PrimaryClassificationName, Regulation,and Product Code:	System, Network and Communication, Physiological Monitors21 CFR §870.2300MSX
SecondaryClassificationName, Regulation,and Product Code:	Infusion Safety Management Software21 CFR §880.5725PHC

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New Ascom Model	Predicate510(k) Number	PredicateManufacturer / Model
Digistat Smart Central	K103634	Ascom (US), Inc. /ClinicalConneX Cardiomax
	K130208(Reference)	CardiopulmonaryCorporation / BernoulliEnterprise Software
	K130707(Reference)	iSirona, LLC / iSironaMagellan

Device Description: Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients' status and alarm conditions when they are away from the patient and associated medical devices.

Digistat Smart Central connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices including patient monitors, ventilators, and infusion pumps. The user configures Digistat Smart Central to determine which information, including alarm notifications, is delivered to which users. Digistat Smart Central then formats the data for delivery to the display devices.

Digistat Smart Central is not in contact with the patient. It is intended to forward the information generated by the connected medical devices and systems and it does not generate patient related alarms. As such, the patient population and patient conditions are established by the medical devices and systems to which the product is connected.

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Indications for Use: The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.

The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.

Technology Comparison:

The Digistat Smart Central employs the same technological characteristics as the predicate device.

Characteristic	Predicate Device	Proposed Device
Serves as secondary means ofannunciating patient events	Yes	Same.
Relays information from themedical devices to desktopsand mobile caregivers	Yes, patient monitors	Yes, patient monitors,ventilators, infusionpumps, hemodialysismachines, and infantincubators.
Caregiver is alerted viaaudible and/or vibratorytones when mobile displaydevice receives an alarmevent transmission	Yes	Same
Alarm event notifications canbe stored on display devicefor later reference	Last 10 - 50 storeddepending upon displaydevice.	Complete history ofevents is stored in theproduct database.Display devices can showfull history of the eventsfor the patient.Default filter shows justthe last hour of events.
Type of alarm	Yes	Same.
Vital signs	Yes	Same.
Waveform data	No	Same.

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Summary of Performance Testing:

Summary of Performance Testing:
Software	The Digistat Smart Central software is MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2006, Medical device software - Software life cycle processes Test results indicate that the Digistat Smart Central software complies with its predetermined specifications and the applicable guidance documents.
PerformanceTesting – Bench	The Digistat Smart Central was tested for performance in accordance with internal requirements and the following standards: IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Test results indicate that the Digistat Smart Central complies with its predetermined specifications and the applicable standards.
Conclusion	Verification and validation activities were conducted to establish the performance and safety characteristics of the Digistat Smart Central. The results of these activities demonstrate that the Digistat Smart Central is performs as well as the predicate devices.Therefore, the Digistat Smart Central is considered substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).