The RespiraSense is indicated for continuous, non-invasive, and real-time monitoring of respiratory rate. RespiraSense is indicated for patients 18 years and older in hospital-type facilities and while patients are mobile (e.g., walking). RespiraSense is not intended to be an apnoea monitor.

Device Description

The RespiraSense (RS) monitors respiratory rate by directly measuring displacements of the chest and abdomen that occur during breathing which are analogous of respiratory rate. This is measured using piezoelectric film elements that output a varying voltage when displaced. The RS device is a non-invasive, wireless, respiratory rate (RR) monitor that is worn on the body of the patient. It is internally-powered, and enables continuous RR monitoring from a single application for up to four days. It is designed to enhance the ability of medical staff to reliably measure respiratory rate remotely. The RS Device is comprised of the RespiraSense Lobe (hereafter the Lobe), the reusable component that houses the RS Device's electronics, a single use adhesive RespiraSense Sensor (hereafter the Sensor) and Cradle. The Lobe and Sensor connect via a secured flat cable and are mechanically fastened together using a plastic Cradle. The Lobe and Sensor are placed on the left-hand side of a patient's torso. The Lobe transmits wirelessly via Bluetooth to an iPad running PMDs RS App for display, control and alert functionality. The RS App allows for Configuring the Lobe, Displaying respiration rate, Display SpO2 and Pulse rate from a connected Nonin device (optional), Configuring alert limits. The RS application can also connect to and display information from multiple Lobes simultaneously. The Lobe is rechargeable. It is designed to be charged using the supplied Charging Station. Charging must be done outside of the immediate patient environment. Charging cannot occur while the device is in operation. Up to six Lobes can be charged at one time. The Sensor is the only patient-contacting device and is secured to the patient with medical grade adhesive.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the RespiraSense device:

Acceptance Criteria and Device Performance

Acceptance Criteria (Performance Specification)	Reported Device Performance
Range: 6 - 60 breaths per minute (bpm)	Range: 6 - 60 breaths per minute
Resolution: 1 breath per minute (bpm)	Resolution: 1 breath per minute
Accuracy: $\pm$ 3 breaths per minute (bpm)	Accuracy: $\pm$ 3 bpm at a 95% confidence level (compared to gold standard EtCO2)

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

Sample Size: A total of 56 subjects were evaluated.
Data Provenance: The study was a multi-site comparative clinical testing in the intended population and environment. This suggests the data was collected prospectively for this specific clinical trial. The document does not specify the country of origin, but given it's an FDA submission, it's likely the clinical sites were in the US or followed international standards acceptable to the FDA.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document states, "A total of 56 subjects were evaluated by manual counting and / or comparison to a FDA cleared end-tidal CO2 monitor with the observer blinded to the EtCO2 monitor."
The "manual counting" suggests human observers, but the exact number of experts or their qualifications (e.g., specific clinical experience) are not explicitly stated in this summary.

3. Adjudication Method for the Test Set:

The document mentions "manual counting and / or comparison to a FDA cleared end-tidal CO2 monitor with the observer blinded to the EtCO2 monitor." This implies a comparison to a referent standard.
The summary does not detail an explicit adjudication method (like 2+1 or 3+1 consensus) for the manual counting or for resolving discrepancies between manual counts and the EtCO2 monitor, if any. The primary ground truth appears to be the EtCO2 monitor.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:

This device, RespiraSense, is a breathing frequency monitor and not an AI-assisted diagnostic imaging device (like those often requiring MRMC studies).
The study described is a comparative clinical study evaluating the accuracy of the device against a gold standard, not a study assessing the impact of AI on human reader performance. Therefore, an MRMC comparative effectiveness study was not performed in this context, and there's no mention of human reader improvement with AI assistance.

5. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

The entire clinical study for the RespiraSense device focuses on its standalone performance in measuring respiratory rate. It operates as a continuous, non-invasive monitor, directly providing a measurement. Humans use the device, but its core function (measuring RR) is algorithmic.
So, the clinical test effectively assesses the standalone performance of the device's algorithm in measuring respiratory rate.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The primary ground truth used was a "gold standard EtCO2" (End-Tidal Carbon Dioxide) monitor which is an FDA-cleared device for measuring respiratory rate.
Additionally, manual counting was also performed, serving as a secondary or confirmatory ground truth measure.

7. The Sample Size for the Training Set:

The document does not specify a separate training set size. This 510(k) summary focuses on the clinical performance of the completed device. For a medical device utilizing an algorithm, training data would have been used during development, but its size is not typically disclosed in the 510(k) summary (which focuses on the final validation/test data).

8. How the Ground Truth for the Training Set was Established:

As the training set details are not provided, information on how its ground truth was established is not available in this document. It is generally presumed that during the development phase, manufacturers would use similar robust methods (e.g., comparison to calibrated instruments or expert observations) to establish ground truth for their training data.

Summary

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October 7, 2022

PMD Solutions % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K220111

Trade/Device Name: RespiraSense Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BOZ Dated: August 30, 2022 Received: August 30, 2022

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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icies. You must comply with all the Act's

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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K220111

Device Name RespiraSense

Indications for Use (Describe)

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)

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510(K) SUMMARY

PMD Solutions RespiraSense

Date Summary was prepared: October 6, 2022

I. SPONSOR

PMD Solutions Bishoptown House Model Farm Road Cork, Ireland T12 T922 Tel - +353 (0) 212428760

Sponsor Contact:	Myles Murray - President
------------------	--------------------------

Submission Correspondent:	Paul Dryden
	ProMedic, LLC
	131 Bay Point Dr NE
	St. Petersburg, FL 33704

II. DEVICE

Name of the device:	RespiraSense
Common Name:	Breathing Frequency Monitor
Classification CFR:	21 CFR 868.2375
Classification Name:	Monitor, Breathing Frequency
Product Code:	BZQ

III. PREDICATE DEVICE AND REFERENCE DEVICE

Predicate Device:	Philips Intellivue CL Respiration Pod (K122223)
Common/Usual Name:	Breathing Frequency Monitor
Classification CFR:	21 CFR 868.2375
Classification Code:	BZQ / DRG / MSX
Classification Name:	Monitor, Breathing Frequency / Transmitters and Receivers,Physiological Signal, Radio Frequency / System, Network andCommunication, Physiological Monitors
Reference Device:	Masimo Rainbow SET Acoustic Monitoring sensor (K120984)
Common/Usual Name:	Oximeter
Classification CFR:	21 CFR 870.2700
Classification Name:	Oximeter / Monitor, Breathing Frequency
Product Code:	DQA / BZQ

IV. DEVICE DESCRIPTION

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The RS device is a non-invasive, wireless, respiratory rate (RR) monitor that is worn on the body of the patient. It is internally-powered, and enables continuous RR monitoring from a single application for up to four days. It is designed to enhance the ability of medical staff to reliably measure respiratory rate remotely.

The RS Device is comprised of the RespiraSense Lobe (hereafter the Lobe), the reusable component that houses the RS Device's electronics, a single use adhesive RespiraSense Sensor (hereafter the Sensor) and Cradle. The Lobe and Sensor connect via a secured flat cable and are mechanically fastened together using a plastic Cradle. The Lobe and Sensor are placed on the left-hand side of a patient's torso.

The Lobe transmits wirelessly via Bluetooth to an iPad running PMDs RS App for display, control and alert functionality. The RS App allows for

Configuring the Lobe ●
Displaying respiration rate ●
Display SpO2 and Pulse rate from a connected Nonin device (optional)
Configuring alert limits .

The RS application can also connect to and display information from multiple Lobes simultaneously.

The Lobe is rechargeable. It is designed to be charged using the supplied Charging Station. Charging must be done outside of the immediate patient environment. Charging cannot occur while the device is in operation. Up to six Lobes can be charged at one time.

The Sensor is the only patient-contacting device and is secured to the patient with medical grade adhesive.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND REFERENCE DEVICE

The table below outlines the features of the Respiratory Rate Monitor and compares it to the predicate devices to establish substantial equivalence.

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Parameter	Subject Device RespiraSense(K220111)	Predicate DevicePhilips Intellivue CL Respiration Pod (K122223)	Reference DeviceMasimo Rainbow SET AcousticMonitoring sensor (K120984)	Comparison
ClassificationName	Breathing Frequency Monitor	Breathing Frequency Monitor	Breathing Frequency Monitor	Similar
Indications forUse	The RespiraSense is indicated forcontinuous, non-invasive, and real-timemonitoring of respiratory rate.RespiraSense is indicated for patients18 years and older in hospitals,hospital-type facilities and while patientsare mobile (e.g., walking). RespiraSenseis not intended to be an apnoea monitor.	The IntelliVue CL Respiration Pod is indicated foruse by health care professionals whenever there is aneed for intermittent or spot-check acquisition andmonitoring of physiological patient parametersrespiration rate and pulse rate wirelessly in specifichospital areas. The IntelliVue CL Respiration Podis mainly indicated for use in general medical andsurgery wards and in waiting areas of emergencyrooms. It is not indicated for use in hospital areas inwhich continuous patient monitoring is needed,such as intensive care units or operating rooms.The intended use of the IntelliVue CL RespirationPod when used together with a patient monitor isfor intermittent or spot-check monitoring andrecording of, and to generate alarms for,respiration rate and pulse rate of adult patients.The IntelliVue CL Respiration Pod is alsointended for acquisition of respiration rate andpulse rate data of adult patients for a clinicalinformation management system.The Intellivue CL Respiration Pod is intended foruse by health care professionals. It is not intendedfor home use. It is not a therapeutic device.The IntelliVue CL Respiration Pod is not intendedfor use on patients with extremely high values forrespiration rate (above 60 rpm).The IntelliVue CL Respiration Pod is not intendedfor use on acutely ill cardiac patients with thepotential to develop life threatening arrhythmias,e.g. very fast atrial fibrillation or ventriculartachycardia (rapid irregular pulse rate). Formonitoring of these patients, a device forcontinuous ECG monitoring is necessary. TheIntelliVue CL Respiration Pod is not a substitutefor an ECG monitor.	The Rainbow® AcousticMonitoring sensors and cables areindicated for continuous,noninvasive monitoring ofrespiratory rate (RRa).The RAS- 125 is indicated for adultpatients in hospitals, hospital-typefacilities, mobile and homeenvironments.The RAS- 125c is indicated foradult and pediatric patients inhospitals, hospital-type facilities,mobile and home environments.	Similar to bothpredicate andreference formeasuring respiratoryrate in the intendedpopulation andenvironment.
Parameter	Subject Device RespiraSense(K220111)	Predicate DevicePhilips Intellivue CL Respiration Pod(K122223)	Reference DeviceMasimo Rainbow SET AcousticMonitoring sensor (K120984)	Comparison
MeasurementPrinciple	Thoracic and abdominal movementsfrom respiratory effort. Bending of thepiezo sensor caused by chest andabdomen movements during breathingproduce a voltage signal, from whichrespiration rate is derived. Integratedaccelerometer provides means tocorrect artefacts.	Thoracic movements from respiratory effort -Inclination changes of the incorporatedaccelerometer sensor, caused by chest andabdomen movements during breathing and heartcontraction, produce a voltage signal, from whichrespiration and pulse rate signals are derived.	Use of piezoelectric sensor elementfor the purpose of non-invasiverespiratory rate monitoring. As airflows, the acoustic vibrations aremeasured by the sensors andprocessed to determined respiratoryrate.	Similar principle ofoperations, sensortechnology of subjectdevice is differentfrom predicate butsimilar to referencedevice.
Patient Interface	Lobe attached to sensor. Sensoradhesively attached to patient's chest.	Pod attached to strap. Strap adhesively attached topatient.	Sensor adhered to the neck of thepatient, close to the windpipe. Acable connects the sensor toa nearby monitor.	Similar
PatientPopulation	Patients aged 18 or over	Adult	Adult and pediatric patients	Similar
Prescriptive	Yes	Yes	Yes	Similar
Environment	Hospital, hospital-type facilities, andmobile	Hospital	Hospitals, hospital-type facilities,mobile and home environments.	Similar
Hardware	Small body-worn device with adhesiveattachment, data is sent to theRespiraSense Software Application.Lobe hardware consists of a battery andan electronic module with the embeddedprocessor, accelerometer, dsPICmicrocontroller, Bluetooth Low Energy(BLE) transceiver, Sounder and LED.Encased in a plastic housing.	Small body-worn pod with adhesiveattachment, data is sent to an assignedcompatible IntelliVue Patient Monitor orIntelliVue Guardian Software.Pod hardware consists of a battery and anelectronic module with the embedded processor,accelerometer, SRR transceiver and speaker.Encased in a plastic housing.	A small piezoelectric sensor stripadhered to the neck of the patientand connected via a Masimo RDcables from the sensor to aperipheral bedside patient monitor.	Similar
Software	The RespiraSense Lobe provides andcommunicates measurement valuesand other information (e.g., batterystate) wirelessly as encrypted data viaan encrypted BLE wireless protocol tothe RespiraSense Software Applicationon a iPad. The RespiraSenseApplication manages bidirectionalcommunication between Lobe and theRespiraSense Application installed ona COTS Tablet Computer	The CL Respiration Pod provides andcommunicates measurements values and otherinformation (e.g., battery state) wirelessly via ShortRange Radio (SRR) to an assigned compatibleIntelliVue Patient Monitor or IntelliVue GuardianSoftware.The CL Respiration Pod can be controlled fromthe assigned IntelliVue Patient Monitor orIntelliVue Guardian Software run on PC orserver.	All software is managed by theperipheral bedside patient monitorto which the sensor is connected to.The Bedside patient monitorprovides power to the sensor.	Similar
Parameter	Subject Device RespiraSense(K220111)	Predicate DevicePhilips Intellivue CL Respiration Pod(K122223)	Reference DeviceMasimo Rainbow SET AcousticMonitoring sensor (K120984)	Comparison
PerformanceSpecification	Range: 6 - 60 breaths per minuteResolution: 1 breath per minuteAccuracy: $\pm$ 3 breaths per minute	Range: 5-60 breaths per minute Resolution: 1 breath per minute Accuracy: $\pm$ 1 breath per minute	Range: 4-70 breaths per minuteResolution: 1 breath per minuteAccuracy $\pm$ 1 breaths per minute	Difference on thelower range ofrespiration has noimpact on safety orefficacy. For accuracythere is referenceBiobeat K212153which has BPMaccuracy of $\pm$ 3 bpmto supportequivalence.
WirelessConnectivity	Bluetooth 4.2	Short Range Radio	N/A	Similar principleof operation
Power Source	Rechargeable Lithium-Ion battery	Rechargeable Lithium-Ion battery	Peripheral Bedside Monitor	Similar
Patientcontacting parts	Adhesive attaching device topatient's chest.	Adhesive attaching device to patient's chest.	Adhesive attaching device to thepatient's neck.	Similar
Safety and EMCStandards	AAMI ANSI ES 60601-1 :2015+A1:2012IEC 60601-1-2:2014IEC 60601-1-8:2012ANSI 63.27-2017AIM 735173	AAMI ANSI ES 60601-1:2005IEC 60601-1-2:2007IEC 60601-1-8:2006	IEC 60601-1IEC 60601-1-2	Subject devicecomplies with thecurrent versions ofthe applicablestandards.
Dimensions	57 mm x 98 mm x 18 mm (withoutsensor)	Pod: 53.5 mm x 27 mm x 65 mm ±5% (2.1 in x1.1 in x 2.6 in ±5%) (without cradle and sensor)	Sensor: 135 mm x 22mm x 3 mmaccompanied by a 3-3.5m cable	Similar
Weight	57 g	80 g ±10% (2.8 oz ±10%)	<20g (excluding cable)	Similar

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VII. PERFORMANCE DATA:

Bench testing - Bench testing was performed that includes:

Shelf-life / Aging ●
Software Verification and Validation Guidance for the Content of Premarket Submissions . for Software Contained in Medical Devices
AAMI ANSI ES 60601-1:2015+A1:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-1-2:2014 Collateral standard: Electromagnetic Disturbances Requirements ● and Tests
IEC 60601-1-8 2012 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless ● Coexistence
AIM 7351731 Rev. 2.00 Medical Electrical Equipment and System Electromagnetic ● Immunity Test for Exposure to Radio Frequency Identification Readers
Cybersecurity Content of Premarket Submissions for Management of Cybersecurity in Medical devices

Discussion - The subject device meets the applicable standards similar to the predicate device.

Biocompatibility - The adhesive of the sensor is applied to intact skin with a prolonged duration (up to 4 days). Testing was performed per:

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
. ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization

Discussion - Both devices use single-use disposable biocompatible adhesive compliant with applicable parts of the ISO 10993-1 Biological Evaluation standard to adhere to intact skin.

Clinical Testing

We performed a multi-site comparative clinical testing in the intended population and the environment comparing the subject device to the gold standard EtCO2. A total of 56 subjects were evaluated by manual counting and / or comparison to a FDA cleared end-tidal CO2 monitor with the observer blinded to the EtCO2 monitor. The subject covered the age range of > 18 years old and split by gender. The statistical analysis showed that the subject device are substantially equivalent to the gold standard of + 3 bpm at a 95% confidence level. The results supported the claims of substantial equivalence for the intended use.

VII. CONCLUSION:

The testing performed and comparison to the predicate demonstrate that the subject device is substantially equivalent to the predicate.

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).