ExSpiron 2Xi 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 1 - year of age.

ExSpiron 2Xi 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 2Xi measurements are used as an adjunct to other clinical information.

Device Description

The ExSpiron 2Xi Respiratory Monitor System consists of:
Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
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.
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.
Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181
ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet.
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.

AI/ML Overview

The provided document describes the ExSpiron 2Xi Respiratory Monitor System, focusing on its substantial equivalence to a predicate device (ExSpiron 1Xi).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ExSpiron 2Xi are based on demonstrating substantial equivalence to its predicate (ExSpiron 1Xi). The key performance metric highlighted is Bench Accuracy for Minute Ventilation (MV), Tidal Volume (TV), and Respiratory Rate (RR), which serves as a surrogate for demonstrating equivalent performance.

Parameter	Acceptance Criteria (Predicate: ExSpiron 1Xi Performance)	Reported Device Performance (ExSpiron 2Xi)
Minute Ventilation (MV)	1.78%	1.57%
Tidal Volume (TV)	2.39%	2.28%
Respiratory Rate (RR)	1.38%	1.55%

The document states, "The accuracy of the proposed device is substantially equivalent to the predicate." This implies that the ExSpiron 2Xi's performance falling within a comparable range to the predicate's established performance fulfills the accuracy acceptance criterion.

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

The document does not specify a sample size for a particular "test set" in the context of clinical data for accuracy. Instead, it refers to "Bench Accuracy" testing. This suggests the primary testing for equivalence was done in a controlled, non-human, benchtop environment, rather than a clinical dataset of patients.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as the clinical testing was deemed "not required" for this Special 510(k). The "large historical cohort" mentioned for algorithm training is not further detailed.

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

This information is not provided as the primary performance evaluation relied on "Bench Accuracy" testing, not clinical studies requiring expert ground truth for medical imaging/diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human readers interpreting a test set requiring adjudication.

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

An MRMC study was not conducted for this submission. The submission is a "Special 510(k)" which typically relies on design control changes and verification/validation testing to demonstrate substantial equivalence, rather than new clinical trials or comparative effectiveness studies with human readers. The document explicitly states, "Clinical testing was not required."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The accuracy values provided for MV, TV, and RR are implied to be standalone performance metrics of the device itself, as they are derived from "Bench Accuracy" testing. There is no mention of human interaction influencing these reported accuracy percentages in the context of the device's output.

7. Type of Ground Truth Used

For the "Bench Accuracy" testing, the ground truth would likely be established through controlled measurements using calibrated testing equipment or simulated physiological models, where the true values of Minute Ventilation, Tidal Volume, and Respiratory Rate are known or precisely controlled. The document does not specify the exact nature of this "ground truth" for bench accuracy, but it would not be expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set

The document states that the software algorithm was trained with "a dataset containing respiratory data from a large historical cohort." A specific sample size for this training cohort is not provided.

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

The document mentions that the algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort." It does not explicitly state how the ground truth for this training data was established. It can be inferred that for the "respiratory data," ground truth would likely involve highly accurate reference measurements from other established monitoring methods (e.g., spirometry, capnography, or other gold standard methods) when the historical data was collected. However, this is conjecture based on typical medical device development, and not explicitly stated in the document.

Summary

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December 17, 2019

Respiratory Motion, Inc. Susan Hamann Director of Quality and Regulatory 80 Coolidge Hill Road Watertown, Massachusetts 02472

Re: K192595

Trade/Device Name: ExSpiron 2Xi Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK, BZO Dated: December 2, 2019 Received: December 3, 2019

Dear Susan Hamann:

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) K192595

Device Name ExSpiron 2Xi

Indications for Use (Describe)

ExSpiron 2Xi 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 1 - year of age.

ExSpiron 2Xi 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 2Xi 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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510(k) Summary – Special 510(k) K192595

510(k) Owner:	Respiratory Motion, Inc.
Address:	80 Coolidge Hill RoadWatertown, MA USA 02472
Phone:	781-373-1636
Fax:	781-373-1653
Contact person:	Jenny Freeman, MD
Date 510(k) Summary prepared and type of 510(k):	December 12, 2019 Special 510(k)
Trade name:	ExSpiron 2Xi
Common name:	Respiratory Monitoring System
Classifications:	Regulation Number: 21 CFR 868.1850

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Regulation Name:	Monitoring Spirometer
Regulatory Class:	II
Product Code:	BZK, BZQ
Predicate devices:	ExSpiron 1Xi Respiratory Monitor, marketed by Respiratory Motion, Inc, Watertown, MA (K173181).
Device Description:	The ExSpiron 2Xi Respiratory Monitor System consists of:Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.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.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.Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet.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.
Intended use:	ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as postoperative care and critical care units, to monitor breathing in patients at least one year of age. ExSpiron 2Xi 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 2Xi measurements are used as an adjunct to other clinical information

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Special 510(k) Summary Continued

Comparison to cleared device

	ExSpiron® 2Xi	ExSpiron® 1Xi (Predicate)
Characteristic	Proposed Device	(K173181)	Comment
Intended Use	ExSpiron 2Xi is indicated for use byhealthcare professionals inhealthcare facilities, such aspostoperative care and critical careunits, to monitor breathing inpatients at least one year of age.ExSpiron 2Xi 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 2Xi measurements areused as an adjunct to other clinicalinformation.	ExSpiron 1Xi is indicated for use byhealthcare professionals inhealthcare facilities, such aspostoperative care and critical careunits, to monitor breathing inpatients at least one 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.	Both the proposed device and thepredicate have identical IntendedUse
Technology	Measurement is by thoracicbioimpedance.	Measurement is by thoracicbioimpedance.	Both the proposed device and thepredicate have identical fundamentalscientific technology.
VolumeMeasurements	Tidal volumeMinute volumeVolume vs. time chart	Tidal volumeMinute volumeVolume vs. time chart	Both the proposed device and thepredicate measure the samerespiratory volumes.
RateMeasurements	Respiratory rate (breaths/min)	Respiratory rate (breaths/min)	Both the proposed device and thepredicate measure respiratory rate.
Safety	IEC 60601-1, including electricaland mechanical safety	IEC 60601-1, including electricaland mechanical safety	Both the proposed device and thepredicate have an equivalentelectrical safety profile and arecompliant with IEC 60601-1.
Energy Source	The bioimpedance output signal isgenerated internally to theExSpiron Monitor. It is a lowcurrent signal at approximately 50kHz.	The bioimpedance output signal isgenerated internally to theExSpiron Monitor. It is a lowcurrent signal at approximately 50kHz.	Both the proposed device and thepredicate have equivalent energysource.
PowerManagementBoard	Board is external to the tabletcomputer.	Board is internal to the tabletcomputer.	Functionality of Power ManagementBoard remains unchanged. The twoboards are substantially equivalent.
Data AcquisitionBoard	Digital Data Acquisition Board.	Analog Data Acquisition Board.	Updated Data Acquisition Boardperforms the same core functions asthe predicate along with built in NurseCall Circuitry and additional electricisolation. Safety and effectiveness ofdifferences have been addressed
			through relevant performance testing.
Algorithm	A software algorithm calculatesrespiratory parameters using aproprietary, non-linear,regressive model trainedwith a dataset containingrespiratory 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 thepredicate have the samefundamental algorithm
Enclosure	Injection molded plastic (ABS)housing, flame-retardant.	Formed plastic (ABS) housing,flame-retardant.	Both the proposed device and thepredicate have equivalent enclosurematerial.
Graphical UserInterface	Graphical User Interface allowedinput of demographic patients atleast 1 year of age.	Graphical User Interface allowedinput of demographic patients atleast 1 year of age.	The Graphical User Interface isdifferent in the proposed deviceowing to the different size of tabletsused in the devices, however thecontent is equivalent.
EMC/EMICompliance	IEC 60601-1-2 compliant	IEC 60601-1-2 compliant	Both the proposed device and thepredicate are 60601-1-2 compliant.
Electrode PadSet	Single-patient use,biocompatible, printed padset.	Single-patient use, biocompatible,printed padset.	Both the proposed device and thepredicate use the same electrodepadset.
ImpedanceMeasurementRange	15 Ohms to 180 Ohms	15 Ohms to 180 Ohms	Both the proposed device and thepredicate have the samemeasurement range.
Tablet Computer	Linux tablet computer.	Windows tablet computer.	The proposed device and thepredicate use different tabletcomputers. The functions of thetablet remain the same.
Nurse Call Relay	Nurse call relay is containedwithin the monitor.	Nurse call relay module is anaccessory to the monitor.	A nurse call relay has been integratedinto the monitor in the proposeddevice. Performance testing wasconducted to demonstratesubstantial equivalence.
Biocompatibility	Neither the Monitor nor thePatient Cable are intended forpatient contact. The ElectrodePadSet is biocompatible.	Neither the Monitor nor the PatientCable are intended for patientcontact. The Electrode PadSet isbiocompatible.	Both the proposed device and thepredicate are biocompatible.
Usability	IEC 60601-1-6 compliant	IEC 60601-1-6 compliant	Usability Testing was performed todemonstrate that the 2Xi is equivalentto the 1Xi when used by intendedusers in the intended environment.
Bench Accuracy
	MV 1.57%TV - 2.28%RR - 1.55%	MV 1.78%TV - 2.39%RR - 1.38%	The accuracy of the proposed deviceis substantially equivalent to thepredicate.

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Additional Information:

Summary of Performance and Bench Testing Performed – All the testing passed the verification and validation requirements. The list of tests performed is as follows:

1. Software Test Protocol
1. Accuracy Test Protocol
1. System Power Verification Test
1. System Battery Verification Test
1. Internal Usability Testing
1. Nurse Call Test
1. User Manual Verification Test
1. Do by Analysis Test This tests requirements that need static analysis, calculations, and visual inspection.

Summary of Clinical Testing performed –Design changes to device were confirmed and validated by performance and bench testing. Clinical testing was not required.

Summary of Biocompatibility testing - Additional testing was not required for the ExSpiron 2Xi. The Padset and cables are identical to previous submissions for the ExSpiron 1Xi. The monitor and patient cables are not intended for patient contact.

Conformance to Standards applicable to the device – The ExSpiron 2Xi met the applicable requirements specified in the standards. The standards used are:

1. ANSI AAMI IEC 60601-1:2005/(R)2012 And A1:2012 (Consolidated Text)
1. ANSI AAMI IEC 60601-1-6:2010/AMD1:2013
1. ANSI AAMI IEC 62304:2006/A1:2016
1. ANSI AAMI IEC 62366-1:2015
1. ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007)
ANSI AAMI IEC 62133-2:2017 8.

Conclusion: Based on the testing and evaluations performed on the ExSpiron 2Xi, the device is as safe, as effective, and is substantially equivalent to the predicate device.

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).