Who is the manufacturer of ExSpiron 1Xi?

Respiratory Motion, Inc. filed the 510(k) submission for ExSpiron 1Xi (K173181).

What is the FDA product code for ExSpiron 1Xi?

BZK. It is classified under 21 CFR 868.1850 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for ExSpiron 1Xi?

510(k) clearance (submission type: Traditional).

Does ExSpiron 1Xi use AI or machine learning?

Yes. ExSpiron 1Xi (K173181) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for ExSpiron 1Xi?

ExSpiron 1Xi Respiratory Monitor (K162131).

Who can help prepare an FDA 510(k) submission like ExSpiron 1Xi?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like ExSpiron 1Xi get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

ExSpiron 1Xi

K173181 · Respiratory Motion, Inc. · BZK · Mar 16, 2018 · Anesthesiology

Device Facts

Record ID	K173181
Device Name	ExSpiron 1Xi
Applicant	Respiratory Motion, Inc.
Product Code	BZK · Anesthesiology
Decision Date	Mar 16, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1850
Device Class	Class 2
Attributes	AI/ML, Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Minute Ventilation (MV)	Proprietary non-linear regressive model	Equivalent within +/- 10%	Mean measurement bias -3.8%; mean accuracy error 11.9%	Large historical cohort	—	Prospective observational study at Children's Hospital of Boston: 72 pediatric patients	—
Tidal Volume (TV)	Proprietary non-linear regressive model	Equivalent within +/- 10%	Mean measurement bias -4.9%; mean accuracy error 12.0%	Large historical cohort	—	Prospective observational study at Children's Hospital of Boston: 72 pediatric patients	—
Respiratory Rate (RR)	Proprietary non-linear regressive model	Equivalent within +/- 10%	Mean measurement bias 1.1%; mean accuracy error 4.2%	Large historical cohort	—	Prospective observational study at Children's Hospital of Boston: 72 pediatric patients	—

Indications for Use

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 Story

ExSpiron 1Xi is a non-invasive respiratory monitor for use by healthcare professionals in clinical settings. It utilizes thoracic bioimpedance to measure respiratory parameters; a stabilized high-frequency current generator (approx. 50 kHz) delivers current via a single-patient-use electrode padset placed on the patient's torso. An adaptive circuit conditions the resulting voltage signal, which is converted to digital form. A tablet PC processes these signals using a proprietary, non-linear, regressive model to calculate and display real-time lung volume, minute ventilation, tidal volume, and respiratory rate. The device provides clinicians with continuous respiratory data as an adjunct to other clinical information, aiding in patient assessment. The system includes a graphical user interface for data visualization and trend monitoring. No hardware changes were made for this pediatric indication expansion; however, specific monitoring modes are disabled for pediatric patients.

Clinical Evidence

Prospective observational study of 72 pediatric patients (ages 1-17, ASA I-III) undergoing general anesthesia. Compared ExSpiron 1Xi against Philips NM3 spirometer. Results: Mean measurement bias for MV was -3.8% (-19.9% to 12.2%), TV -4.9% (-21.0% to 11.3%), and RR 1.1% (-4.1% to 6.2%). Mean accuracy errors: MV 11.9%, TV 12.0%, RR 4.2%. Equivalence tests rejected the null hypothesis of different mean values, concluding with 90% power that measurements are equivalent within +/-10%.

Technological Characteristics

Thoracic bioimpedance sensing; 50 kHz low current signal. Formed ABS plastic enclosure. Tablet PC-based processing. Single-patient-use biocompatible electrode padset. Compliant with IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC/EMI), and IEC 60601-1-8 (alarms). Proprietary non-linear regressive software algorithm.

Indications for Use

Indicated for patients at least 1 year of age in healthcare facilities (e.g., post-operative, critical care) for monitoring breathing parameters (MV, TV, RR).

Regulatory Classification

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.

Predicate Devices

ExSpiron 1Xi Respiratory Monitor (K162131)

Reference Devices

Philips NM3 Respiratory Profile Monitor

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 Road Building 1, Suite 150 Waltham, Massachusetts 02452 | | Phone: | 781-373-1636 | | Fax: | 781-373-1653 | | Contact person: | Jenny Freeman, MD | | Date 510(k) Summary prepared and type of 510(k): | March 15, 2018 – Traditional 510(k) | | Trade name: | ExSpironTM 1Xi | | Common name: | Respiratory Monitoring System | | Classifications: | Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK, BZQ | | Predicate devices: | ExSpiron 1Xi Respiratory Monitor, marketed by Respiratory Motion, Inc, Waltham, MA (K162131). | | Reference Device | The Philips NM3 was chosen as a reference device in the clinical study because it measures the same parameters as the ExSpiron 1Xi in a continuous and non-invasive manner, comparable to our device. | | 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. | | Intended use: | 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. | {4}------------------------------------------------ {5}------------------------------------------------ | Comparison of technological | Characteristic | ExSpiron 1Xi with Pediatric (Proposed Device) | ExSpiron™1Xi (Predicate) K162131 | Comment | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | characteristics: | Intended Use | 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 1-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 sources. | 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 adult (at least 21 years old) patients. 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. | The proposed device has a new indication for use. Patient populations will be expanded to include pediatric patients at least 1- year old. | | | Technology | Measurement is by thoracic bioimpedance. | Measurement is by thoracic bioimpedance. | Both the proposed device and the predicate have identical technology. | | | Volume Measurements | Tidal volume Minute volume Volume vs. time chart | Tidal volume Minute volume Volume vs. time chart | Both the proposed device and the predicate measure the same respiratory volumes. | | | Rate Measurements | Respiratory rate (breaths/min) | Respiratory rate (breaths/min) | Both the proposed device and the predicate measure respiratory rate. | | | Safety | IEC 60601-1, including electrical and mechanical safety | IEC 60601-1, including electrical and mechanical safety | Both the proposed device and the predicate have the same electrical safety profile and are compliant with IEC 60601-1. | | | Energy Source | The bioimpedance output signal is generated internally to the ExSpiron Monitor. It is a low current signal at approximately 50 kHz. | The bioimpedance output signal is generated internally to the ExSpiron Monitor. It is a low current signal at approximately 50 kHz. | Both the proposed device and the predicate have the same energy source. | | | Algorithm | A software algorithm calculates respiratory parameters using a proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort. | A software algorithm calculates respiratory parameters using a proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort. | Both the proposed device and the predicate have the same algorithm. | | | Enclosure | Formed plastic (ABS) housing, flame-retardant. | Formed plastic (ABS) housing, flame-retardant. | Both the proposed device and the predicate have the same enclosure material. | | Graphical User Interface | Graphical User Interface allowed input of demographic patients at least 1 year of age. | Graphical User Interface allowed input of demographic patients at least 21 years of age. | Both the proposed device and the predicate have the same hardware, firmware, and core software functionality. The proposed device has several changes to the GUI as well as disabling of the "Basic Monitoring" functionality when used for pediatric patients since this functionality has not been validated in this population. | | | EMC/EMI Compliance | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant | Both the proposed device and the predicate are 60601-1-2 compliant. | | | Electrode PadSet | Single-patient use, biocompatible, printed padset. | Single-patient use, biocompatible, printed padset. | Both the proposed device and the predicate use the same electrode padset. | | | Impedance Measurement Range | 15 Ohms to 180 Ohms | 15 Ohms to 180 Ohms | Both the proposed device and the predicate have the same measurement range. | | | Tablet Computer | Windows tablet computer. | Windows tablet computer. | Both the proposed device and the predicate use the same tablet computer. | | | Biocompatibility | Neither the Monitor nor the Patient Cable are intended for patient contact. The Electrode PadSet is biocompatible. | Neither the Monitor nor the Patient Cable are intended for patient contact. The Electrode PadSet is biocompatible. | Both the proposed device and the predicate have identical biocompatibility. | | | Usability | ISO 60601-1-6 compliant | ISO 60601-1-6 compliant | Both the proposed device and the predicate have the same usability when used in the Volume Synchronization and Percent Baseline modes of operation. Basic Monitoring is disabled in Pediatric Mode. | | | 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 predicate are included in the Clinical. Performance section of this summary. | | {6}------------------------------------------------ K173181 S002 {7}------------------------------------------------ | Nonclinical testing: | Nonclinical testing was performed to demonstrate the equivalence of the ExSpiron 1Xi to the predicate. The FDA recognized tests that were completed are listed below. See Section 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-FDA recognized 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 Procedure 1A; 2014) - ECG Trunk Cables and patient lead wires (ANSI EC53; 2013) | | | The results of this testing demonstrate that the proposed device is equivalent to the predicate in safety and essential performance. | | Clinical performance testing: | The device was tested on pediatric patients in a prospective observational study at Children's Hospital of Boston. | | | The aim of this study was to evaluate the capability of the ExSpiron 1Xi to accurately measure tidal volume (TV), minute volume (MV), and respiratory rate (RR) in the perioperative setting in pediatric patients who were intubated and undergoing general anesthesia. | | | We studied pediatric patients between the ages of 1 year and 17 years, ASA status I to III scheduled to undergo a surgical procedure under general anesthesia at Boston Children's Hospital. | | | Continuous respiratory data were collected simultaneously from the ExSpiron 1Xi and a monitoring spirometer placed in the respiratory circuit (NM3, Respironics NM3 Respiratory Profile Monitor, Philips Healthcare, Amsterdam, Netherlands). Both the ExSpiron 1Xi and NM3 provide real-time measurements of MV, TV, and RR. | | | Data from 72 pediatric patients show the ExSpiron 1Xi mean measurement bias (ExSpiron 1Xi – 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 indicate higher measurement agreement. The equivalence tests rejected the null hypothesis that the ExSpiron 1Xi and NM3 have different mean values and conclude with 90% power that the measurements of MV, TV, and RR from the ExSpiron 1Xi and NM3 are equivalent within +/-10%. These data demonstrate agreement between ExSpiron 1Xi and NM3 measurements in the studied pediatric population. | | Conclusions regarding safety and effectiveness: | Based on the comparison of the intended use of the predicate and the proposed device, and on the results of nonclinical and clinical testing, the proposed ExSpiron 1Xi (Pediatric) is substantially equivalent to the predicate and is as safe and as effective as the predicate. |

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