The Rubicon screening device is a small battery-powered device designed to assess and record nasal and oral airflow in adult patient during sleep in the home setting. The device is intended as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

Device Description

The Rubicon Screening Device is comprised of 3 components and software. For the physical device. Rubicon is comprised of an Airflow sensor, cable connecting air flow sensor and a single inline module (SIM) as described below:

Airflow sensor: The airflow sensor is placed under the user's nose where it converts temperature and pressure changes to a voltage signal. Polarized Polyvinylidene Fluoride (PVDF) is a temperature-sensing material. PVDF generates a small electrical charge in response to temperature change. The sensor is permanently connected to the SIM via two lead wires. The temperature difference between patient exhaled air and ambient air, as well as airflow pressure on the sensor generates a small voltage signal, which can be recorded as airflow by recording equipment. The vibration of breath sounds (snoring) produces a small voltage signal, which can be recorded as snoring by recording equipment. As integrated into the Rubicon, the airflow sensor provides two channels of output data from the same PVDF sensor. One channel focuses on sinusoidal airflow waveforms for identification of airflow events, and the second channel provides snore data.

Cable: The lead wires are a typical cable pair. The lead wires were reviewed as part of the IEC 60601-1 safety evaluation. The lead wires transmit signals from the airflow sensor to the SIM and are permanently attached to the airflow sensor and the SIM.

SIM (Housing and PCB): The SIM's primary function is to collect raw electrical signals from the airflow sensor. These signals include airflow and snore analog data. These analog signals are filtered and acquired by the SIM's A/D converter, then transmitted in real time to a nearby Smartphone, which must be running the Rubicon companion app. The SIM PCB is powered by a small coin cell battery.

Software: The basic purpose of the software is to: Collect data from the sensor device by transmitting the data to a collection hub, which is a Smartphone + a mobile software application (app). Transmit data to a remote data center, which is accomplished via the cellular network. Store, process, and display data to a health care professional or end user via the Rubicon Analysis Software PC application and its report. The system consists of three major components: Sim Software (firmware), Rubicon App and Rubicon Desktop Software

AI/ML Overview

The Rubicon Screening Device is intended to assess and record nasal and oral airflow in adult patients during sleep in a home setting. It functions as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

The provided document, K200654, mainly focuses on establishing substantial equivalence to a predicate device (IMS-SleepCheck, K022294) and a reference device (Dymedix – Airflow Sensor, K040069). It describes the device's design, components, and indications for use, and outlines non-clinical testing performed (biocompatibility, electrical safety, electromagnetic compatibility, and comparative performance testing). However, it does not present a detailed study demonstrating specific acceptance criteria with reported performance metrics, nor does it provide the detailed information requested in points 2-9.

The document states, under "Comparative testing," that "Data and scoring compared to PSG collected and analyzed data and reviewed by independent sleep specialists." This implies a comparative study was conducted, likely to establish the performance of Rubicon in identifying airflow events relevant to sleep disorders. However, the results, sample sizes, and other specifics of this study are not provided in the submitted text.

Therefore, based on the provided text, a full answer to all your questions cannot be completed. Below is a summary of what can be extracted and what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and specific performance metrics for the Rubicon Screening Device are not explicitly stated in the provided document. The document mentions "comparative performance testing" and that "Data and scoring compared to PSG collected and analyzed data and reviewed by independent sleep specialists," but it does not present the results of this comparison or any pre-defined acceptance thresholds.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set in any comparative performance study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that data was "reviewed by independent sleep specialists" to establish ground truth through comparison with PSG. However, it does not specify the number of experts, nor their detailed qualifications (e.g., years of experience, board certifications).

4. Adjudication method for the test set

The adjudication method used for establishing ground truth from the "independent sleep specialists" is not described in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

The document mentions "comparative performance testing" where "Data and scoring [were] compared to PSG collected and analyzed data and reviewed by independent sleep specialists." This implies a comparison against PSG, which is typically considered the gold standard for sleep studies. However, it does not specify if this was an MRMC study designed to assess reader performance with and without AI assistance, nor does it provide an effect size for human reader improvement.

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

The document describes the device's components, including software for data collection, transmission, storage, processing, and display to a healthcare professional. The statement "We are not diagnosing but reporting detected airflow events for further consideration by the clinician" suggests that the device's output (airflow events) is intended to be used by a clinician, implying a human-in-the-loop scenario. It does not explicitly state whether a standalone algorithm performance study was done without human interpretation.

7. The type of ground truth used

The ground truth for the comparative testing was established by comparing the device's collected and analyzed data and scoring to Polysomnography (PSG), reviewed by independent sleep specialists. PSG is generally considered the gold standard for diagnosing sleep disorders.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This submission focuses on substantial equivalence and non-clinical testing rather than detailed algorithm development and validation.

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

As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary

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July 22, 2020

Dymedix Diagnostics, Inc. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K200654

Trade/Device Name: Rubicon Screening Device Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: June 24, 2020 Received: June 25, 2020

Dear Paul Dryden:

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

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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 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 (QS) 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 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,

for Michael Ryan Division 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

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Indications for Use

510(k) Number (if known)

K200654

Device Name

Rubicon Screening Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_XX Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

Page 1 of 1

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Page 1 of 5
Date Prepared:	22-Jul-2020
I Submitter	Dymedix Diagnostics, Inc.5985 Rice Creek Pkwy.Shoreview, MN 55126T - 888-212-1100
Official Contact:	Jim Moore, CEO
Submission Correspondent:	ProMedic, LLCPaul Dryden, President131 Bay Point Dr. NESt. Petersburg, FL 33704E - paul.dryden@promedic.ccT - 239-307-6061
II Device
Proprietary or Trade Name:	Rubicon Screening Device
Common/Usual Name:	Ventilatory Effort Recorder
Classification Name:	21CFR 868.2375MNR - Ventilatory Effort RecorderClass II
III Predicate Device:	K022294- IMS-SleepCheck
Reference Device:	K040069 – Dymedix – Airflow Sensor

IV Device Description:

Airflow sensor

The airflow sensor is placed under the user's nose where it converts temperature and pressure changes to a voltage signal. Polarized Polyvinylidene Fluoride (PVDF) is a temperature-sensing material. PVDF generates a small electrical charge in response to temperature change.

The sensor is permanently connected to the SIM via two lead wires.

The temperature difference between patient exhaled air and ambient air, as well as airflow pressure on the sensor generates a small voltage signal, which can be recorded as airflow by recording equipment. The vibration of breath sounds (snoring) produces a small voltage signal, which can be recorded as snoring by recording equipment.

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As integrated into the Rubicon, the airflow sensor provides two channels of output data from the same PVDF sensor. One channel focuses on sinusoidal airflow waveforms for identification of airflow events, and the second channel provides snore data.

Cable

The lead wires are a typical cable pair. The lead wires were reviewed as part of the IEC 60601-1 safety evaluation. The lead wires transmit signals from the airflow sensor to the SIM and are permanently attached to the airflow sensor and the SIM.

SIM (Housing and PCB)

The SIM's primary function is to collect raw electrical signals from the airflow sensor. These signals include airflow and snore analog data. These analog signals are filtered and acquired by the SIM's A/D converter, then transmitted in real time to a nearby Smartphone, which must be running the Rubicon companion app. The SIM PCB is powered by a small coin cell battery.

Software

The basic purpose of the software is to:

Collect data from the sensor device by transmitting the data to a collection hub, which is a Smartphone + a mobile software application (app).
Transmit data to a remote data center, which is accomplished via thecellular network. ●
. Store, process, and display data to a health care professional or end user via the Rubicon Analysis Software PC application and its report.

The system consists of three major components: Sim Software (firmware), Rubicon App and Rubicon Desktop Software

V Indications for use:

Patient Population: This device is used only by adults during their sleep

Environments of use: Home settings

The following table presents the comparison to support substantial equivalence.

Table 1 compares the key features of the proposed Rubicon with the identified predicate -K022294- IMS SleepCheck and reference K040069 - Dymedix Air Flow Sensor and demonstrates that this proposed device can be found substantially equivalent.

In summary, one can conclude that substantial equivalence is met based upon the following:

Indications for Use – The Indications for Use are similar. The subject device is only a screening tool which is detecting airflow events based upon airflow characteristics, whereas the predicate also collects airflow data and reports apnea and hypopnea breathing events and is considered a screening tool.

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We are not diagnosing but reporting detected airflow events for further consideration by the clinician.

Technology and construction - The technology and construction are similar to predicate in that we are utilizing an airflow sensor to detect breathing events. The employed airflow sensor is identical to the reference. K040069, device which has been cleared for the same intended use. There are no differences in the breathing event detection technology.

The subject device transmits data via BLE to an app. However, transmission of data via wireless technology is not new or novel and does not change the risk profile beyond what is already recognized by FDA as acceptable when applicable testing has been provided.

Environment of Use - The environments of use are similar - home settings.

Patient Population - The patient population is similar to the predicate namely, adults.

Non-Clinical Testing Summary -

Biocompatibility

ISO 10993 designates the sensor as external communicating through tissue contact, and surface contact for a limited duration of use (< 24 hrs.). The cytotoxicity, irritation, sensitization, acute systemic toxicity, and material-mediated pyrogen tests were conducted as per ISO 10993.

Bench testing

Electrical safety, electromagnetic compatibility and comparative performance testing were conducted.

Substantial Equivalence Conclusion -

All testing demonstrated that the proposed device is substantially equivalent to the predicate device.

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Table 1

Device Comparison	Proposed deviceRubicon SA system	IMS – SleepCheckK022294	ReferenceDymedix - Sensor K040069
Classification	MNRVentilatory Effort RecorderCRF 868.2375	MNRVentilatory Effort RecorderCRF 868.2375	MNRVentilatory Effort RecorderCRF 86,2375
Model	Rubicon Screening Device	SleepCheck	Reusable Airflow/Snore Sensor
Indications for Use	The Rubicon screening device is a smallbattery-powered device designed toassess and record nasal and oral airflowin adult patient during sleep in the homesetting. The device is intended as ascreening device to determine the needfor clinical diagnosis and evaluation bypolysomnography (PSG) based on thepatient's test data.	The SleepCheck is a small monitordesigned to assess nasal and oral airflow.Apnea breathing events are countedbased on a reduction in airflow. Thedevice is intended for use as a screeningdevice to determine the need for clinicaldiagnosis and evaluation bypolysomnography based on the patient'sscore.	The DYMEDIX Airflow Sensor is usedwith existing recording devices insupport of diagnostic recording of nasal,oral airflow and breathing sounds(snore). The sensors are used withpatients who require a sleep study.
Target Population	Adult	Adult	Adult
Environment of Use	Home	Home	Home and clinical
OTC or Rx	Rx	Rx	Rx
Design	Main unitAirflow Sensor	Main UnitAirflow sensor - pressure	Air flow sensor measuring temperaturechanges
Device Components	Single Patient, single useAirflow sensorLead wireSIM with BLE transmissionSmartphone app	Single-Patient, single-use3 prong cannula with sensorsMain unitData reviewed by clinician	ReusableAir flow sensor
Sensor Placement Site	Rests over the lip, under the nose	Rests over the lip, under the nose	Rests over the lip, under the nose
Means of measuringairflow	Airflow sensor has 2 channels, detectschanges in airflow and noise (snoring)which is converted to a voltage signal	Airflow sensor	Air flow sensor has 2 channels, detectschanges in air flow and noise (snoring)which is connected to a recorder
Device Comparison	Proposed deviceRubicon screening	IMS - SleepCheckK022294	ReferenceDymedix - Sensor K040069
Measures snoring	Yes	No	Yes
Measures	Airflow events	Apnea Hypopnea	No
Calculation of Airflow event	Signal decrease of 10 sec. or longer	Signal decrease of 10 sec. or longer	Sensor only
Records and Presents data	Airflow events (AFE)AFE IndexEstimated Sleep TimeEstimated Sleep EfficiencyThis is a screening tool only	Apnea and HypopneaAHITotal apnea eventsNumeric readoutBreathing indicator - moving bar displayThis is a screening tool only	Sensor only
Data transmission	Bluetooth between SIM and Smartphone	Data viewed by clinician	Sensor only
Specifications			Sensor only
Sampling rate	Respiratory flow and breathing sounds:100 Hz	10 Hz	Sensor only
Nights of monitoring	Up to 2	Single night	Sensor only
Power source	Battery - coin sized20-hour maximum usage (2 tests)	Alkaline battery	Sensor only
Dimensions of main unit	Width: 114mmHeight: 70mmDepth: 25mm	Small wearable main unit	Sensor only
Safety and EMC	ES 60601-1IEC 60601-1-2IEC 60601-1-11	ES 60601-1IEC 60601-1-2EC 60601-1-4	Sensor only
Biocompatibility	Airflow sensor consideredExternally communicating and Surface contactLimited duration testing	Airflow sensor consideredExternally communicating and Surface contactLimited duration testing	Sensor only
Comparative testing	Data and scoring compared to PSGcollected and analyzed data and reviewedby independent sleep specialists	PSG comparison	Sensor only

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K200654

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).