(90 days)
No
The description mentions a "computer program" that uses inputs to provide "advice," but there is no mention of AI, ML, or any learning algorithms. The advice generation appears to be based on pre-programmed logic or rules derived from clinical practice, rather than a system that learns from data.
No.
The device provides respiratory mechanics monitoring and on-demand ventilator-dependent open-loop advice, making it a diagnostic and assistive device, but it does not directly treat a disease or condition.
No
The BEACON Caresystem is described as an "Intensive Care Unit (ICU) ventilation assist system" that provides "on-demand ventilator-dependent open-loop advice" and "respiratory mechanics monitoring." Although it monitors physiological parameters (airway flow/volume, CO2/O2, SpO2), its primary purpose is to provide advice for ventilator settings, not to diagnose a disease or condition. It acts as an adjunct to mechanical ventilation rather than a diagnostic tool.
No
The device description explicitly lists hardware components such as the BEACON Display Unit, BEACON Gas Module, BEACON Power Adaptor, and NONIN XPOD SpO2 Analyzer, in addition to software.
Based on the provided text, the BEACON Caresystem is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- BEACON Caresystem's Function: The BEACON Caresystem directly monitors physiological parameters from the patient's airway (flow, CO2, O2) and arterial hemoglobin (SpO2). It uses these real-time, in-vivo measurements, along with ventilator data and clinician input, to provide advice on ventilator settings. It does not analyze specimens taken from the body.
The device is a respiratory monitoring and ventilation assist system used in a clinical setting, not a laboratory setting for analyzing biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZK
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. 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]. ●
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] ●
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Properly trained clinicians in the Intensive Care Unit (ICU)
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 Performance Tests:
- BEACON Caresystem has been designed and tested for compliance to the following recognized standards: IEC 60601-1:2012 Ed. 3.1, IEC 60601-1-2:2014, 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, ISTA 3A 2008.
- 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.
Clinical Tests:
- Five clinical studies where the advice generation of BEACON Caresystem were tested have been submitted.
- 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.
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.
Philips NM3 Respiratory Monitor with VentAssist (K103578)
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.
GE Healthcare Datex-Ohmeda S/5TM Compact Airway Module (model family E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CC (K051092)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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.
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3
K192584 510(K) SUMMARY
MERMAID CARE
510(k) Summary in accordance with 21 CFR 807.92
| Submitted by: | Mermaid Care A/S
Hedelund 1
DK-9400 Noerresundby
Denmark | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------|
| | 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 Usual
Name: | 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 and
accessories: | GE Healthcare Datex-Ohmeda S/5TM Compact Airway Module (model
family E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CC
(K051092) | | |
| Reference Product
Codes: | 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 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. 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] ●
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.
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].