Rubicon SA System
Device Facts
| Record ID | K200654 |
|---|---|
| Device Name | Rubicon SA System |
| Applicant | Dymedix Diagnostics, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Jul 22, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Indications for Use
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 Story
Rubicon Screening Device assesses/records nasal/oral airflow and snoring during sleep in home settings; intended for adult patients. System components: PVDF airflow sensor, single inline module (SIM), smartphone app, and PC analysis software. Sensor converts temperature/pressure changes into voltage signals; SIM filters/digitizes signals; transmits via Bluetooth to smartphone; smartphone transmits data via cellular network to remote data center. Healthcare professionals use PC software to view reports of airflow events (AFE), AFE index, estimated sleep time, and efficiency. Device acts as screening tool; results assist clinicians in determining need for formal PSG diagnosis. Benefits include home-based screening convenience.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogen) performed per ISO 10993. Electrical safety and EMC testing conducted per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Comparative performance testing involved data and scoring compared to PSG, with data analyzed and reviewed by independent sleep specialists.
Technological Characteristics
Components: PVDF airflow sensor, SIM (PCB with A/D converter), smartphone app, PC software. Sensing: PVDF material generates voltage from temperature/pressure changes. Connectivity: Bluetooth (SIM to smartphone), cellular (smartphone to cloud). Power: Coin cell battery (20-hour max). Sampling rate: 100 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility: ISO 10993 (external communicating, surface contact, <24 hrs).
Indications for Use
Indicated for adult patients for assessment and recording of nasal and oral airflow during sleep in home settings to determine the need for clinical diagnosis and evaluation by polysomnography.
Regulatory Classification
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.
Predicate Devices
- IMS-SleepCheck (K022294)
Reference Devices
- Dymedix Airflow Sensor (K040069)
Submission Summary (Full Text)
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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)
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.
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)
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| Page 1 of 5 | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 22-Jul-2020 |
| I Submitter | Dymedix Diagnostics, Inc.<br>5985 Rice Creek Pkwy.<br>Shoreview, MN 55126<br>T - 888-212-1100 |
| Official Contact: | Jim Moore, CEO |
| Submission Correspondent: | ProMedic, LLC<br>Paul Dryden, President<br>131 Bay Point Dr. NE<br>St. Petersburg, FL 33704<br>E - paul.dryden@promedic.cc<br>T - 239-307-6061 |
| II Device | |
| Proprietary or Trade Name: | Rubicon Screening Device |
| Common/Usual Name: | Ventilatory Effort Recorder |
| Classification Name: | 21CFR 868.2375<br>MNR - Ventilatory Effort Recorder<br>Class II |
| III Predicate Device: | K022294- IMS-SleepCheck |
| Reference Device: | K040069 – Dymedix – Airflow Sensor |
#### IV 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.
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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:
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.
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 device<br>Rubicon SA system | IMS – SleepCheck<br>K022294 | Reference<br>Dymedix - Sensor K040069 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | MNR<br>Ventilatory Effort Recorder<br>CRF 868.2375 | MNR<br>Ventilatory Effort Recorder<br>CRF 868.2375 | MNR<br>Ventilatory Effort Recorder<br>CRF 86,2375 |
| Model | Rubicon Screening Device | SleepCheck | Reusable Airflow/Snore Sensor |
| Indications for Use | The Rubicon screening device is a small<br>battery-powered device designed to<br>assess and record nasal and oral airflow<br>in adult patient during sleep in the home<br>setting. The device is intended as a<br>screening device to determine the need<br>for clinical diagnosis and evaluation by<br>polysomnography (PSG) based on the<br>patient's test data. | The SleepCheck is a small monitor<br>designed to assess nasal and oral airflow.<br>Apnea breathing events are counted<br>based on a reduction in airflow. The<br>device is intended for use as a screening<br>device to determine the need for clinical<br>diagnosis and evaluation by<br>polysomnography based on the patient's<br>score. | The DYMEDIX Airflow Sensor is used<br>with existing recording devices in<br>support of diagnostic recording of nasal,<br>oral airflow and breathing sounds<br>(snore). The sensors are used with<br>patients 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 unit<br>Airflow Sensor | Main Unit<br>Airflow sensor - pressure | Air flow sensor measuring temperature<br>changes |
| Device Components | Single Patient, single use<br>Airflow sensor<br>Lead wire<br>SIM with BLE transmission<br>Smartphone app | Single-Patient, single-use<br>3 prong cannula with sensors<br>Main unit<br>Data reviewed by clinician | Reusable<br>Air 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 measuring<br>airflow | Airflow sensor has 2 channels, detects<br>changes in airflow and noise (snoring)<br>which is converted to a voltage signal | Airflow sensor | Air flow sensor has 2 channels, detects<br>changes in air flow and noise (snoring)<br>which is connected to a recorder |
| Device Comparison | Proposed device<br>Rubicon screening | IMS - SleepCheck<br>K022294 | Reference<br>Dymedix - 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)<br>AFE Index<br>Estimated Sleep Time<br>Estimated Sleep Efficiency<br>This is a screening tool only | Apnea and Hypopnea<br>AHI<br>Total apnea events<br>Numeric readout<br>Breathing indicator - moving bar display<br>This 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:<br>100 Hz | 10 Hz | Sensor only |
| Nights of monitoring | Up to 2 | Single night | Sensor only |
| Power source | Battery - coin sized<br>20-hour maximum usage (2 tests) | Alkaline battery | Sensor only |
| Dimensions of main unit | Width: 114mm<br>Height: 70mm<br>Depth: 25mm | Small wearable main unit | Sensor only |
| Safety and EMC | ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | ES 60601-1<br>IEC 60601-1-2<br>EC 60601-1-4 | Sensor only |
| Biocompatibility | Airflow sensor considered<br>Externally communicating and Surface contact<br>Limited duration testing | Airflow sensor considered<br>Externally communicating and Surface contact<br>Limited duration testing | Sensor only |
| Comparative testing | Data and scoring compared to PSG<br>collected and analyzed data and reviewed<br>by independent sleep specialists | PSG comparison | Sensor only |
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K200654
