Who is the manufacturer of ExSpiron 1Xi?

Respiratory Motion, Inc. filed the 510(k) submission for ExSpiron 1Xi (K162131).

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 (K162131) 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 (K130170).

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

K162131 · Respiratory Motion, Inc. · BZK · May 9, 2017 · Anesthesiology

Device Facts

Record ID	K162131
Device Name	ExSpiron 1Xi
Applicant	Respiratory Motion, Inc.
Product Code	BZK · Anesthesiology
Decision Date	May 9, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1850
Device Class	Class 2
Attributes	AI/ML, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K162131 · May 9, 2017	ExSpiron 1Xi	Respiratory Motion, Inc.	Historical clinical cohort data; Multi-year patient population respiratory data	The device's proprietary, non-linear, regressive model was trained and refined using a large historical cohort of respiratory data collected over three years across diverse patient populations to improve accuracy.	Algorithm training; Historical cohort; Retrospective data

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Historical Cohort Training Dataset; Retrospective analysis of historical clinical data; Follow-up/Duration: 3 years; Study Period: 3 years	Diverse patient populations; Sample Size: Thousands of data points	Not applicable for this study	Algorithm accuracy for respiratory parameters (MV, TV, RR)

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Minute Ventilation	Non-linear regressive model	—	11.5% (Overall Accuracy)	Large historical cohort and thousands of additional data points	—	Clinical study in Waltham, MA: 20 subjects	—
Tidal Volume	Non-linear regressive model	—	11.4% (Overall Accuracy)	Large historical cohort and thousands of additional data points	—	Clinical study in Waltham, MA: 20 subjects	—
Respiratory Rate	Non-linear regressive model	—	0.08% (Overall Accuracy)	Large historical cohort and thousands of additional data points	—	Clinical study in Waltham, MA: 20 subjects	—

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 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.

Device Story

ExSpiron 1Xi is a non-invasive respiratory monitoring system for use in healthcare facilities by clinicians. It utilizes thoracic bioimpedance to measure respiratory parameters. A single-patient use electrode padset applied to the patient's torso delivers a low-current (50 kHz) signal and records impedance changes. The monitor enclosure contains a high-frequency current generator and signal conditioning circuitry; a tablet PC performs signal processing, calibration, and GUI display. The device provides real-time graphical traces of lung volume over time and scalar values for minute ventilation, tidal volume, and respiratory rate. These measurements serve as an adjunct to other clinical information, assisting healthcare providers in assessing patient respiratory status. The system eliminates the need for patient-specific calibration required by the predicate, improving usability in basic monitoring modes.

Clinical Evidence

Clinical study (n=20, age 22-80, BMI 19-42) compared ExSpiron 1Xi to the predicate device. Subjects performed 20 breathing tests in two sessions (24 hours apart). Primary endpoints included bias, precision, and accuracy for Minute Ventilation, Tidal Volume, and Respiratory Rate. Overall accuracy was 11.5% for MV, 11.4% for TV, and 0.08% for RR. Results demonstrate clinically relevant accuracy over a 24-hour period.

Technological Characteristics

Thoracic bioimpedance sensing; 50 kHz low-current signal. Formed ABS plastic housing. Single-patient use biocompatible electrode padset. Windows tablet PC for processing/GUI. Compliant with IEC 60601-1 (safety), IEC 60601-1-2 (EMC/EMI), IEC 60601-1-6/62366 (usability), and IEC 60601-1-8 (alarms).

Indications for Use

Indicated for adult patients (≥21 years) in healthcare facilities (e.g., post-operative, critical care) for non-invasive monitoring of breathing parameters.

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 (K130170)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 9, 2017 Respiratory Motion, Inc. Susan Hamann Director of Quality and Regulatory 411 Waverly Oaks Road, Building 1, Suite 150 Waltham, Massachusetts 02452 Re: K162131 Trade/Device Name: ExSpiron™ 1Xi Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK, BZQ Dated: April 5, 2017 Received: April 10, 2017 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tina Kiang -s 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) K162131 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 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. 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/2 description: The image shows a pair of human lungs against a black background. The lungs are translucent and colored in shades of blue, giving them a somewhat ethereal appearance. The anatomical structure of the lungs is visible, including the lobes and some of the branching airways. The lighting and color choice create a visual effect that highlights the shape and form of the lungs. ## 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): | May 9, 2017 – 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 (K130170). | | 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. 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. | {4}------------------------------------------------ | | 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 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. | | | | | {5}------------------------------------------------ | Comparison of technological characteristics: | Characteristic | ExSpiron 1 (Proposed Device) | ExSpironTM1Xi (Predicate) K130170 | Comment | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | | 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 adult (at least 21 years old) patients | 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 | Both the proposed device and the predicate have an identical intended use. | | | | Each ExSpiron 1Xi is a noninvasive system that graphically displays lung volume against time and reports an approximate value of: • Tidal volume • Respiratory rate, and • Minute ventilation. | Each ExSpiron 1Xi is a noninvasive system that graphically displays lung volume against time and reports an approximate value of: • Tidal volume • Respiratory rate, and • Minute ventilation. | | | | | ExSpiron 1Xi measurements are used as an adjunct to other clinical information sources. | ExSpiron 1Xi measurements are used as an adjunct to other clinical information sources. | | | | 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. The algorithm was refined for the ExSpiron 1Xi- using thousands of additional data points collected over the last 3 years in a wide variety of patient populations. With the additional training data, the algorithm now provides accurate respiratory volumes without patient-specific | 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 essentially the same firmware, except the proposed device has been refined with thousands of additional data points that result in a more accurate estimate of respiratory parameters than the predicate. | | | Enclosure | calibration. Formed plastic (ABS) housing, flame-retardant. | Formed plastic (ABS) housing, flame-retardant. | Both the proposed device and the predicate have the same enclosure material. | | | 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. | Following FDA clearance of the predicate (K130170), a "letter to file" change was made to substitute an equivalent Windows tablet computer in the device (See "Letter to File" changes; Section 21b in this 510(k) filing). | | | 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. In the Basic Monitoring mode that has been introduced in the proposed device, the calibration step that was required for the predicate device has been eliminated. | | | Accuracy | MV - 11.5% TV - 11.4% RR - 0.1% | MV - 10.7% TV - 10.4% RR - 0.1% | Details of the accuracy of the proposed device versus the predicate are included in Section 20: Performance Testing - Clinical. | | {6}------------------------------------------------ T {7}------------------------------------------------ | Respiratory Motion, Inc. | | | 09 May 2017 | | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------|-----------------|---------------------| | 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: | A clinical study was conducted in Waltham MA, USA to compare simultaneous measurements from the ExSpiron 1Xi and the predicate device. Twenty subjects representing a broad range of intended patients participated in the study. (Age range: 22- 80, BMI range: 19-42 with 9 female, 11 male). The study involved two sessions for each subject, an initial session in which electrodes were applied and each subject performed twenty breathing tests. Tidal volume, minute ventilation, and respiratory rate were measured and processed by both the Predicate and the Proposed device. Each subject returned twenty-four hours after the first session with the original electrodes still attached. A second set of twenty breathing tests were performed. | | | | | | | The results of the clinical study were: | | | | | | | | Proposed ExSpiron 1Xi /Predicate ExSpiron 1Xi Comparison | Minute Ventilation | Tidal Volume | Respiratory Rate | | | Bias | Overall | 2.2% | 2.2% | 0.01% | | | | Day 1 | 3.4% | 3.4% | 0.02% | | | | Day 2 | 1.1% | 1.1% | 0.00% | | | Precision | Overall | 7.0% | 6.9% | 0.08% | | | | Day 1 | 5.2% | 5.1% | 0.11% | | | | Day 2 | 5.1% | 5.1% | 0.00% | | | Accuracy | Overall | 11.5% | 11.4% | 0.08% | | | | Day 1 | 10.1% | 10.1% | 0.11% | | | | Day 2 | 12.3% | 12.3% | 0.00% | | | The results indicate clinically relevant accuracy over a 24-hour period. | | | | | | 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 is substantially equivalent to the predicate and is as safe and as effective as the predicate. | | | | |

ExSpiron 1Xi

Device Facts

Real-World Evidence

Clinical Evidence

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

ExSpiron 1Xi

Device Facts

Real-World Evidence

Clinical Evidence

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!