respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician

Patients should be hemodynamically stable.

The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

Device Description

BEACON Caresystem is an Intensive Care Unit (ICU) ventilation assist system. BEACON Caresystem will provide ICU clinicians with on-demand ventilator-dependent open-loop advice for ventilating adult patients.

BEACON Caresystem uses inputs measured by BEACON Caresystem and data inputs from the ventilator and manual data entry by the clinician into a computer program that has been designed to provide advice for changes to the ventilator settings for the individual patient undergoing mechanical ventilation.

BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators.

BEACON Caresystem consists of the following components:

BEACON Display Unit
BEACON Gas Module
BEACON Power Adaptor
NONIN XPOD SpO2 Analyzer

BEACON Caresystem utilizes the following cleared accessories:

BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult [K093080]
BEACON Water Trap (Adult) [K182075 & K171292]
NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285]
NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255]
NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285]

The BEACON Display Unit is a standard off-the-shelf tablet touch-screen computer. The BEACON display unit connects through a USB port to the NONIN XPOD SpO2 analyzer for pulse oximetry measurements and serial data ports for connection to the BEACON Gas Module and the connected ICU ventilator. The BEACON Display unit includes the BEACON Caresystem Software. The BEACON Gas Module performs measurement of patient airway flow and inspired and expired fractions of CO2 and O2 in the airway.

As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for:

Respiratory mechanics monitoring (i.e. airway flow/volume)
Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate
Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The BEACON Caresystem Software utilizes the monitored parameters above with data from the connected ICU ventilator and clinician entered values to generate on demand, open-loop advice for changes to the ventilator settings for an adult patient undergoing mechanical ventilation.

AI/ML Overview

The BEACON Caresystem is intended to provide respiratory mechanics monitoring and on-demand ventilator-dependent open-loop advice for mechanically ventilated adult patients in the Intensive Care Unit (ICU).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantifiable table with specific thresholds (e.g., accuracy > 90%). Instead, it describes a comparative approach where the BEACON Caresystem's performance is deemed "comparable" to a legally marketed predicate device.

Acceptance Criterion (Inferred from comparisons)	Reported Device Performance (as stated in the document)
Device Performance - Advice Generation:	A head-to-head test on a patient simulator showed that the BEACON advice generation is comparable to the predicate device. Three clinical studies concluded that BEACON Caresystem generated advice with high clinical practice agreement. One study showed that BEACON Caresystem responded appropriately to over and under support for spontaneous breathing patients. The fifth study evaluated BEACON advice and active clinicians in patient cases.
Device Performance - Gas and Flow Measurements:	Bench test comparisons with predicate and reference devices for End-tidal Carbon Dioxide (EtCO2), Alveolar Ventilation (VA), Respiratory Rate (RR), Oxygen Uptake (VO2), Carbon Dioxide Production (VCO2), and Energy Expenditure (EE) showed that the measurements of BEACON are comparable to the predicate or reference devices in the full ranges specified.
Compliance with Standards:	Designed and tested for compliance to IEC 60601-1:2012 Ed. 3.1, IEC 60601-1-2:2014 ed.4, IEC 80601-2-61:2017, AIM Standard 7351731 Rev. 2.00 2017-02-23, IEC 62304 Edition 1.1 2015-06, IEC 62366-1 Edition 1.0 2015-02, and ISTA 3A 2008.
Biocompatibility:	Not applicable for new testing, as patient-contacting accessories are FDA-cleared and legally marketed.

2. Sample Size Used for the Test Set and Data Provenance

The document states that five clinical studies were submitted, and these appear to form the basis of the test set for the advice generation. However, it does not explicitly state the sample size (number of patients or cases) for any of these clinical studies or for the bench tests.

The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The information provided does not specify the number of experts used to establish ground truth for the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it mentions "active clinicians" but does not detail their number or specific qualifications. For the study on spontaneous breathing patients, it mentions using an "esophageal catheter" as a reference technique, implying a technical measurement rather than expert consensus for that specific ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it states it was evaluated "blindly," but further details on adjudication are missing.

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

The provided text does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The clinical studies primarily focus on the agreement and appropriateness of the BEACON Caresystem's advice, not on human reader performance with or without the device. The fifth study did "evaluate blindly the BEACON Caresystem advice and active clinicians in patient cases," but it's not described as an MRMC comparative effectiveness study to measure improvement from AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone evaluation of the algorithm's performance (advice generation and measurement accuracy) appears to have been a significant part of the testing.

Bench Tests: Gas and flow measurements (EtCO2, VA, RR, VO2, VCO2, EE) were evaluated in "bench test comparisons with predicate and reference devices." This suggests a standalone evaluation of the device's measurement accuracy against established standards without direct human-in-the-loop influence on the measurement results.
Patient Simulator Test: A "head-to-head test comparing the advice presented by BEACON and the predicate device was performed on a patient simulator." This is a standalone evaluation of the advice generation algorithm.
Clinical Studies: The clinical studies primarily assessed the advice generated by the BEACON Caresystem ("agreement of BEACON Caresystem advice," "effect of the applied advice," "ability of BEACON Caresystem advice to find appropriate breathing effort levels"), implying an evaluation of the device's output.

7. The Type of Ground Truth Used

The ground truth for different aspects of the device's performance appears to vary:

Advice Generation: Ground truth appears to be established through:
- Comparison with the predicate device's advice on a patient simulator.
- "Clinical practice agreement" in three clinical studies, suggesting agreement with established medical best practices or expert clinical judgment (though details on how this was established are scarce).
- Reference technique (esophageal catheter) for breathing effort levels in one study.
- Comparison with "active clinicians" in patient cases in the fifth study.
Gas and Flow Measurements: Ground truth was established by comparison with predicate and reference devices in bench tests.

8. The Sample Size for the Training Set

The provided text does not contain any information about the training set for the BEACON Caresystem software or algorithm. This document focuses on the S510(k) submission, which typically emphasizes testing of the final product rather than describing the development and training phases.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about the training set (see point 8), there is no information on how its ground truth was established.

Summary

{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.

December 18, 2019

Mermaid Care A/S Claus Lindholt Chief Technology Officer Hedelund 1 Norresundby, DK DK-0400

Re: K192584

Trade/Device Name: BEACON Caresystem, Model 00002144 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK Dated: September 16, 2019 Received: September 19, 2019

Dear Claus Lindholt:

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

{1}------------------------------------------------

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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192584

Device Name

BEACON Caresystem, Model 00002144

Indications for Use (Describe)

The intended use of the BEACON Caresystem is to provide

· respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
· on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician

Patients should be hemodynamically stable.

The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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}------------------------------------------------

K192584 510(K) SUMMARY

MERMAID CARE

510(k) Summary in accordance with 21 CFR 807.92

Submitted by:	Mermaid Care A/SHedelund 1DK-9400 NoerresundbyDenmark
	Tel.: +45 70 23 70 15
Contact Person:	Claus Lindholt, CTO
Date of Summary:	September 16, 2019
Device Trade Name:	BEACON Caresystem, Model 00002144
Common or UsualName:	Monitoring Spirometer (Product code: BZK)
Classification Name:	Spirometer, Monitoring (W/Wo Alarm) [21 C.F.R. §868.1850]
Class:	II
Predicate Device:	Philips NM3 Respiratory Monitor with VentAssist (K103578)
Reference Device andaccessories:	GE Healthcare Datex-Ohmeda S/5TM Compact Airway Module (modelfamily E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CC(K051092)
Reference ProductCodes:	Code:	Regulatory Description:	Regulation Number:
	BZL	Oxygen uptake computer	21 C.F.R. §868.1730
	DQA	Oximeter	21 C.F.R. §870.2700
	CCK	Carbon dioxide gas analyzer	21 C.F.R. §868.1400
	CCI	Oxygen gas analyzer	21 C.F.R. §868.1720

Device Description:

BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators. Currently supported mechanical ventilators are:

Maquet Servo I [K073179] ●
Dräger Evita XL [K083050]
Dräger Infinity V500 [K093633] .
Puritan Bennett PB840 [K001646]
Puritan Bennett PB940 [K131252] ●
Hamilton G5 [K070513]. ●

{4}------------------------------------------------

BEACON Caresystem consists of the following components:

BEACON Display Unit
BEACON Gas Module
BEACON Power Adaptor ●
NONIN XPOD SpO2 Analyzer .

BEACON Caresystem utilizes the following cleared accessories:

BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult ● [K0930801
BEACON Water Trap (Adult) [K182075 & K171292] .
NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285] .
NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255]
NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285] ●

As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for:

. Respiratory mechanics monitoring (i.e. airway flow/volume)
. Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate
. Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

Indications for Use:

The intended use of the BEACON Caresystem is to provide

respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician

Patients should be hemodynamically stable.

The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

The Indications for Use statement for the BEACON Caresystem is not identical to the predicate device; however, the differences do not alter the intended clinical use of they affect the substantial equivalence to the predicate.

Comparison of the technological characteristics with the Predicate Device and Reference Device:

BEACON Caresystem and the predicate device both continuously measure pulse oximetry, inspiratory and expiratory air flow and gas and provide on-demand advice on ventilator settings based on the patient specific measurements on a display unit.

{5}------------------------------------------------

At a high level, the subject and predicate devices are based on the following same technological elements:

. Pulse oximetry
. Respiratory flow and carbon dioxide gas measurements and signal processing
. Advice generation of mechanical ventilator settings
Graphical display of measurements and advice for the user ●

The following technological differences exist between the subject and predicate devices:

Subject device measures respiratory Oxygen gas fraction
Subject device requires connection to a supported mechanical ventilator for advice generation, . whereas ventilator connectivity is optional in predicate device

The Reference Device has been included to account for the addition of Oxygen measurements in the subject device. The subject and reference devices uses similar measurement technologies and testing has shown comparable performance.

Non-Clinical Performance Tests Submitted:

BEACON Caresystem has been designed and tested for compliance to the following recognized standards:

. IEC 60601-1:2012 Ed. 3.1, Medical electrical equipment-Part1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, ed.4. Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility Requirements and tests.
. IEC 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
. AIM Standard 7351731 Rev. 2.00 2017-02-23. Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
IEC 62304 Edition 1.1 2015-06, Medical Device Software Software Life Cycle Processes. .
IEC 62366-1 Edition 1.0 2015-02, Medical Devices Part 1: Application Of Usability Engineering To ● Medical Devices [Including Corrigendum 1 (2016)].
. ISTA 3A 2008, Packaged-Products For Parcel Delivery System Shipment 70 Kg (150 Lb) Or Less.

A head-to-head test comparing the advice presented by BEACON and the predicate device was performed on a patient simulator and the results showed that the BEACON advice generation is comparable to the predicate device.

Gas and flow measurements in BEACON has been evaluated in bench test comparisons with predicate and reference devices. End-tidal Carbon Dioxide (EtCO2), Alveolar Ventilation (VA), Respiratory Rate (RR) measurements were tested against the predicate device. Oxygen Uptake (VO2), Carbon Dioxide Production (VCO2) and Energy Expenditure (EE) measurements were tested against the reference device. All tests showed that the measurements of BEACON is comparable to the predicate or reference devices in the full ranges specified.

BEACON Caresystem has two patient contacting accessories, which are both FDA-cleared and legally marketed, so no new biocompatibility testing was performed.

Clinical Tests Submitted:

Five clinical studies where the advice generation of BEACON Caresystem were tested have been submitted.

{6}------------------------------------------------

Three studies evaluated the clinical agreement of BEACON Caresystem advice and the effects of the applied advice to the patients' respiration and oxygenation. The studies concluded that BEACON Caresystem generated advice with high clinical practice agreement.

One study evaluated the ability of BEACON Caresystem advice to find appropriate breathing effort levels for spontaneous breathing patients. The reference technique esophageal catheter was used to estimate breathing effort. The study concluded that BEACON Caresystem responded appropriately to over and under support.

The fifth study evaluated blindly the BEACON Caresystem advice and active clinicians in patient cases.

Conclusion:

The BEACON Caresystem utilizes equivalent technology and has similar technical specifications as the predicate device and the reference device, the Philips NM3 Respiratory Monitor with VentAssist and Reference Device, the GE Healthcare Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX and accessories), respectively.

The detailed comparison and the submitted non-clinical performance testing and clinical data demonstrate that the BEACON Caresystem performs comparably to the predicate and reference device and is therefore substantially equivalent to the legally marketed predicate device, Philips NM3 Respiratory Monitor with VentAssist [K103578].

Regulation Number and Section

§ 868.1850 Monitoring spirometer.

(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).