ExSpiron 1Xi by Respiratory Motion Inc.

ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age.

ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

Minute Ventilation (MV)
Tidal volume (TV)
Respiratory rate (RR)
ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

Device Description

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate.

The ExSpiron 1Xi system consists of:
• Monitor:
The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
o Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.

o Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.

There are no hardware changes included in this submission.

Single-Patient Use ExSpiron Electrode PadSet:
• A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

AI/ML Overview

The acceptance criteria and study proving the device meets them are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Equivalence to NM3 within)	Reported Device Performance (Mean Measurement Accuracy Error)
Minute Ventilation (MV)	+/- 10%	11.9%
Tidal Volume (TV)	+/- 10%	12.0%
Respiratory Rate (RR)	+/- 10%	4.2% (0.6 breaths/min)

Note: The document states that the equivalence tests rejected the null hypothesis that the ExSpiron 1Xi and NM3 have different mean values and concluded with 90% power that the measurements of MV, TV, and RR from the ExSpiron 1Xi and NM3 are equivalent within +/-10%. This indicates that the device met the acceptance criteria despite the accuracy error values being slightly outside the 10% for MV and TV in the table. The "accuracy error" values seem to represent the deviation, while the "equivalence tests" are the primary mechanism for meeting the criteria.

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

Sample Size: 72 pediatric patients.
Data Provenance: Prospective observational study conducted at Children's Hospital of Boston, USA.

3. Number of Experts and Qualifications for Ground Truth:

The study utilized continuous respiratory data collected simultaneously from the ExSpiron 1Xi and a monitoring spirometer (Philips NM3, referred to as the reference device) placed in the respiratory circuit. The NM3 itself essentially served as the "expert" ground truth (or established reference) in this comparative study.
No human experts were explicitly mentioned as establishing a separate ground truth for the test set; the NM3 measurements were the reference.
The qualifications of the individuals operating the devices or interpreting the NM3 data are not specified, beyond general "healthcare professionals."

4. Adjudication Method:

No explicit adjudication method (like 2+1, 3+1) was mentioned. The study directly compared measurements from the ExSpiron 1Xi to the reference device (NM3).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted in the context of human readers improving with or without AI assistance. This study was focused on the standalone performance of the ExSpiron 1Xi against a reference device, not on assisting human readers.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone study was performed. The clinical performance testing described is a standalone evaluation of the ExSpiron 1Xi's ability to measure MV, TV, and RR compared to a recognized reference device (Philips NM3) without a human-in-the-loop component.

7. Type of Ground Truth Used:

The ground truth used was a reference device comparison. Specifically, the measurements from the Philips NM3 Respiratory Profile Monitor, a monitoring spirometer placed in the respiratory circuit, served as the reference standard for MV, TV, and RR.

8. Sample Size for the Training Set:

The device's algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort."
The exact sample size for the training set is not provided in the document, but it is described as a "large historical cohort."

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

The document states that the software algorithm calculates respiratory parameters using a model "trained with a dataset containing respiratory data from a large historical cohort."
It does not explicitly detail how the ground truth for this historical training dataset was established. However, given the context of a medical device measuring physiological parameters, it's highly probable that this training data would have been collected using established, accurate measurement methods, likely similar to (or including) reference spirometry or other validated respiratory monitoring techniques.

Summary

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March 16, 2018

Respiratory Motion Inc. Susan Hamann Director of Regulatory Affairs 411 Waverly Oaks Road, Building 1, Suite 150 Waltham, Massachusetts 02452

Re: K173181

Trade/Device Name: ExSpiron™ 1Xi Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK, BZQ Dated: February 8, 2018 Received: February 12, 2018

Dear Susan Hamann:

We have reviewed vour 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. 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.

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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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Tina Kiang -2

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173181

Device Name ExSpiron 1Xi

Indications for Use (Describe)

ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age.

ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

米 Minute Ventilation (MV)
- Tidal volume (TV)
- Respiratory rate (RR)

ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a pair of lungs against a black background. The lungs are translucent and blue, allowing the viewer to see their internal structure. The lungs are positioned side by side, with the trachea visible at the top. The image is likely a medical illustration or a representation of the human respiratory system.

510(k) Summary – Traditional 510(k)

510(k) Owner:	Respiratory Motion, Inc.
Address:	411 Waverley Oaks RoadBuilding 1, Suite 150Waltham, Massachusetts 02452
Phone:	781-373-1636
Fax:	781-373-1653
Contactperson:	Jenny Freeman, MD
Date 510(k)Summary prepared andtype of 510(k):	March 15, 2018 – Traditional 510(k)
Trade name:	ExSpironTM 1Xi
Commonname:	Respiratory Monitoring System
Classifications:	Regulation Number: 21 CFR 868.1850Regulation Name: Monitoring SpirometerRegulatory Class: IIProduct Code: BZK, BZQ
Predicatedevices:	ExSpiron 1Xi Respiratory Monitor, marketed by Respiratory Motion, Inc, Waltham, MA(K162131).
ReferenceDevice	The Philips NM3 was chosen as a reference device in the clinical study because it measures thesame parameters as the ExSpiron 1Xi in a continuous and non-invasive manner, comparable toour device.
DeviceDescription:	The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displayslung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate.The ExSpiron 1Xi system consists of:• Monitor:The Monitor contains a bioimpedance measurement system and a tablet PC housed withina single enclosure.o Bioimpedance measurement system: The Monitor incorporates a stabilized highfrequency current generator and an adaptive circuit that conditions the resultingvoltage signal and converts it to digital form. Firmware within the Monitorperforms signal acquisition and relays data to the tablet PC.o Computer: A tablet PC performs signal processing and calibration, and runs thegraphical user interface (GUI). The PC takes user input from a touch screenthrough a virtual keyboard and mouse. The GUI is used for recording patient data
	and displaying the respiratory trace as well as scalar values and trends for minuteventilation, tidal volume, and respiratory rate.There are no hardware changes included in this submission.
	Single-Patient Use ExSpiron Electrode PadSet:• A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. Itdelivers current to, and records impedance measurements from, the skin. The ElectrodePadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.
Intended use:	ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such aspost-operative care and critical care units, to monitor breathing in patients at least one year ofage.ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time andreports an approximate value of:* Minute Ventilation (MV)* Tidal volume (TV)* Respiratory rate (RR)ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

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K173181 S002

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Nonclinicaltesting:	Nonclinical testing was performed to demonstrate the equivalence of the ExSpiron 1Xi tothe predicate. The FDA recognized tests that were completed are listed below. SeeSection 9.0; Declarations of Conformity and Summary Reports for details of the testing.- Basic Safety and Essential Performance (IEC 60601-1; Ed. 3.0) - Pass,- Immunity/Emissions (IEC 60601-1-2; Ed. 3.0) - Pass,- Usability (IEC 60601-1-6; 2010, A1:2013 and 62366;2007, A1:2014) - Pass, and- Alarms (IEC 60601-1-8; 2006) - Pass.
	Other tests which are not FDA recognized were also completed. The following non-FDArecognized tests were performed and each achieved favorable results:- Degrees of protection provided by enclosures (IEC code) (IEC 60529; 2004)- Packaged products weighing 150 lbs (68 kg) or less (ISTA Procedure1A; 2014)- ECG Trunk Cables and patient lead wires (ANSI EC53; 2013)
	The results of this testing demonstrate that the proposed device is equivalent to thepredicate in safety and essential performance.
Clinicalperformancetesting:	The device was tested on pediatric patients in a prospective observational study atChildren's Hospital of Boston.
	The aim of this study was to evaluate the capability of the ExSpiron 1Xi to accuratelymeasure tidal volume (TV), minute volume (MV), and respiratory rate (RR) in theperioperative setting in pediatric patients who were intubated and undergoing generalanesthesia.
	We studied pediatric patients between the ages of 1 year and 17 years, ASA status I to IIIscheduled to undergo a surgical procedure under general anesthesia at Boston Children'sHospital.
	Continuous respiratory data were collected simultaneously from the ExSpiron 1Xi and amonitoring spirometer placed in the respiratory circuit (NM3, Respironics NM3Respiratory Profile Monitor, Philips Healthcare, Amsterdam, Netherlands). Both theExSpiron 1Xi and NM3 provide real-time measurements of MV, TV, and RR.
	Data from 72 pediatric patients show the ExSpiron 1Xi mean measurement bias (ExSpiron1Xi – NM3 measurement) for MV was -3.8% (95% limits of agreement) (+/-1.96 SD):(-19.9% to 12.2%), for TV it was -4.9 (-21.0% to 11.3%), and for RR it was 1.1% (-4.1%to 6.2%). The mean measurement accuracy errors for MV, TV, and RR were 11.9%,12.0%, and 4.2% (0.6 breaths/min), respectively. Note that, lower accuracy values indicatehigher measurement agreement. The equivalence tests rejected the null hypothesis that theExSpiron 1Xi and NM3 have different mean values and conclude with 90% power that themeasurements of MV, TV, and RR from the ExSpiron 1Xi and NM3 are equivalent within+/-10%. These data demonstrate agreement between ExSpiron 1Xi and NM3measurements in the studied pediatric population.
Conclusionsregardingsafety andeffectiveness:	Based on the comparison of the intended use of the predicate and the proposed device, andon the results of nonclinical and clinical testing, the proposed ExSpiron 1Xi (Pediatric) issubstantially equivalent to the predicate and is as safe and as effective as the predicate.

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).

Comparison oftechnological	Characteristic	ExSpiron 1Xi with Pediatric(Proposed Device)	ExSpiron™1Xi(Predicate) K162131	Comment
characteristics:	Intended Use	ExSpiron 1Xi is indicated for use byhealthcare professionals inhealthcare facilities, such as post-operative care and critical care units,to monitor breathing in patients atleast 1-year of age.ExSpiron 1Xi is a non-invasivemonitor that graphically displayslung volume against time andreports an approximate value of:Minute Ventilation (MV)Tidal volume (TV)Respiratory rate (RR)●ExSpiron 1Xi measurements areused as an adjunct to other clinicalinformation sources.	ExSpiron 1Xi is indicated for use byhealthcare professionals inhealthcare facilities, such as post-operative care and critical care units,to monitor breathing in adult (atleast 21 years old) patients.ExSpiron 1Xi is a non-invasivemonitor that graphically displayslung volume against time andreports an approximate value of:Minute Ventilation (MV)Tidal volume (TV)Respiratory rate (RR)ExSpiron 1Xi measurements areused as an adjunct to other clinicalinformation.	The proposed device has a new indication for use. Patientpopulations will be expanded to include pediatric patients at least 1-year old.
	Technology	Measurement is by thoracicbioimpedance.	Measurement is by thoracicbioimpedance.	Both the proposed device and the predicate have identicaltechnology.
	VolumeMeasurements	Tidal volumeMinute volumeVolume vs. time chart	Tidal volumeMinute volumeVolume vs. time chart	Both the proposed device and the predicate measure the samerespiratory volumes.
	RateMeasurements	Respiratory rate (breaths/min)	Respiratory rate (breaths/min)	Both the proposed device and the predicate measure respiratory rate.
	Safety	IEC 60601-1, including electricaland mechanical safety	IEC 60601-1, including electricaland mechanical safety	Both the proposed device and the predicate have the same electricalsafety profile and are compliant with IEC 60601-1.
	Energy Source	The bioimpedance output signal isgenerated internally to the ExSpironMonitor. It is a low current signal atapproximately 50 kHz.	The bioimpedance output signal isgenerated internally to the ExSpironMonitor. It is a low current signal atapproximately 50 kHz.	Both the proposed device and the predicate have the same energysource.
	Algorithm	A software algorithm calculatesrespiratory parameters using aproprietary, non-linear, regressivemodel trained with a datasetcontaining respiratory data from alarge historical cohort.	A software algorithm calculatesrespiratory parameters using aproprietary, non-linear, regressivemodel trained with a datasetcontaining respiratory data from alarge historical cohort.	Both the proposed device and the predicate have the samealgorithm.
	Enclosure	Formed plastic (ABS) housing,flame-retardant.	Formed plastic (ABS) housing,flame-retardant.	Both the proposed device and the predicate have the same enclosurematerial.
Graphical UserInterface	Graphical User Interface allowedinput of demographic patients atleast 1 year of age.	Graphical User Interface allowedinput of demographic patients atleast 21 years of age.	Both the proposed device and the predicate have the same hardware,firmware, and core software functionality. The proposed device hasseveral changes to the GUI as well as disabling of the "BasicMonitoring" functionality when used for pediatric patients since thisfunctionality has not been validated in this population.
EMC/EMICompliance	IEC 60601-1-2 compliant	IEC 60601-1-2 compliant	Both the proposed device and the predicate are 60601-1-2compliant.
ElectrodePadSet	Single-patient use, biocompatible,printed padset.	Single-patient use, biocompatible,printed padset.	Both the proposed device and the predicate use the same electrodepadset.
ImpedanceMeasurementRange	15 Ohms to 180 Ohms	15 Ohms to 180 Ohms	Both the proposed device and the predicate have the samemeasurement range.
TabletComputer	Windows tablet computer.	Windows tablet computer.	Both the proposed device and the predicate use the same tabletcomputer.
Biocompatibility	Neither the Monitor nor the PatientCable are intended for patientcontact. The Electrode PadSet isbiocompatible.	Neither the Monitor nor the PatientCable are intended for patientcontact. The Electrode PadSet isbiocompatible.	Both the proposed device and the predicate have identicalbiocompatibility.
Usability	ISO 60601-1-6 compliant	ISO 60601-1-6 compliant	Both the proposed device and the predicate have the same usabilitywhen used in the Volume Synchronization and Percent Baselinemodes of operation. Basic Monitoring is disabled in PediatricMode.
Accuracy	MV - 11.9%TV - 12.0%RR - 4.2%	MV - 11.5%TV - 11.4%RR - 0.1%	Details of the accuracy of the proposed device versus the predicateare included in the Clinical. Performance section of this summary.