(281 days)
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 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.
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.
Acceptance Criteria and Device Performance for ExSpiron™ 1Xi
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the proposed device (ExSpiron 1Xi) to a predicate device (ExSpiron™ 1Xi, K130170). The comparison focuses on various characteristics, including accuracy. While explicit "acceptance criteria" for accuracy are not stated as numerical thresholds, the document presents the accuracy results of the proposed device. The implied acceptance is that the proposed device performs at least as well as, or better than, the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed ExSpiron 1Xi) |
|---|---|---|
| Accuracy | ||
| Minute Ventilation (MV) | 10.7% | 11.5% (Overall) |
| Tidal Volume (TV) | 10.4% | 11.4% (Overall) |
| Respiratory Rate (RR) | 0.1% | 0.08% (Overall) |
| Bias | (Not explicitly stated for predicate) | MV: 2.2%, TV: 2.2%, RR: 0.01% (Overall) |
| Precision | (Not explicitly stated for predicate) | MV: 7.0%, TV: 6.9%, RR: 0.08% (Overall) |
| Intended Use | Identical to predicate | Identical to predicate |
| Technology | Thoracic bioimpedance | Thoracic bioimpedance |
| Volume Measurements | Tidal volume, Minute volume, Volume vs. time chart | Tidal volume, Minute volume, Volume vs. time chart |
| Rate Measurements | Respiratory rate (breaths/min) | Respiratory rate (breaths/min) |
| Safety | IEC 60601-1 compliant | IEC 60601-1 compliant |
| Energy Source | Low current signal at approximately 50 kHz | Low current signal at approximately 50 kHz |
| EMC/EMI Compliance | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant |
| Electrode PadSet | Single-patient use, biocompatible, printed padset | Single-patient use, biocompatible, printed padset |
| Impedance Measurement Range | 15 Ohms to 180 Ohms | 15 Ohms to 180 Ohms |
| Biocompatibility | Electrode PadSet is biocompatible; Monitor and Patient Cable not for patient contact | Electrode PadSet is biocompatible; Monitor and Patient Cable not for patient contact |
| Usability | ISO 60601-1-6 compliant (with calibration) | ISO 60601-1-6 compliant (without calibration in Basic Monitoring mode) |
The document notes that 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," leading to "more accurate respiratory volumes than the predicate." However, the accuracy percentages show a slight decrease in accuracy (higher percentage value) for MV and TV compared to the predicate in this summary document. This might be due to presenting overall clinical study results for the proposed device, while the predicate's numbers might be from a specific lab setting or a different calculation method for its initial clearance. The conclusion explicitly states the proposed device "is as safe and as effective as the predicate."
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 20 subjects
- Age range: 22-80
- BMI range: 19-42
- Gender: 9 female, 11 male
- Data Provenance:
- Country of Origin: Waltham, MA, USA (clinical study conducted there)
- Retrospective or Prospective: Prospective. The study was conducted specifically to compare simultaneous measurements from the ExSpiron 1Xi and the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth for this clinical study, nor does it specify their qualifications. The study focused on comparing the performance of the proposed device against a predicate device through simultaneous measurements. This implies the predicate device's measurements or another recognized standard served as the comparative reference, rather than a separate "ground truth" established by experts for each breath.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. It states that simultaneous measurements were taken from both the proposed device and the predicate device, implying a direct comparison rather than a need for expert adjudication of independent measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical study comparing simultaneous measurements of the proposed device and a predicate device on patients, not a study evaluating human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance aspect is implied. The "Accuracy" section of the comparison table and the clinical study results (Bias, Precision, Accuracy) directly assess the performance of the device's algorithms in measuring respiratory parameters (MV, TV, RR) without explicitly mentioning human intervention in the real-time measurement process. The device provides "approximate values" of these parameters.
7. Type of Ground Truth Used
The ground truth for the clinical study was established by simultaneous measurements from a legally marketed predicate device (ExSpiron™ 1Xi, K130170). The study aimed to show equivalence or improvement compared to an already cleared device.
8. Sample Size for the Training Set
- The predicate device's algorithm was "trained with a dataset containing respiratory data from a large historical cohort."
- The proposed device's 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." The exact numerical sample size ("thousands") is not specified beyond this qualitative description.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly detail how the ground truth for the "large historical cohort" or the "thousands of additional data points" used for algorithm training/refinement was established. However, given the nature of a spirometer, it is highly probable that the ground truth for training data would have been established using:
- Reference Spirometry: Directly measured, highly accurate respiratory volumes and rates from calibrated gold-standard spirometry equipment.
- Other established physiological measurement techniques that provide accurate respiratory parameters.
The purpose of the training data is to allow the device's proprietary, non-linear, regressive model to accurately calculate respiratory parameters "without patient-specific calibration" for the proposed device.
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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.
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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 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
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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)
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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 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): | May 9, 2017 – 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 (K130170). |
| 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 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. |
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| 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 adult (at least 21 years old)patients.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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| Comparison oftechnologicalcharacteristics: | Characteristic | ExSpiron 1 (Proposed Device) | ExSpironTM1Xi(Predicate) K130170 | Comment |
|---|---|---|---|---|
| Intended Use | ExSpiron 1Xi is indicated for useby healthcare professionals inhealthcare facilities, such as post-operative care and critical careunits, to monitor breathing in adult(at least 21 years old) patients | 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 | Both the proposed device and the predicate have an identical intendeduse. | |
| Each ExSpiron 1Xi is anoninvasive system thatgraphically displays lung volumeagainst time and reports anapproximate value of:• Tidal volume• Respiratory rate, and• Minute ventilation. | Each ExSpiron 1Xi is a noninvasivesystem that graphically displayslung volume against time andreports an approximate value of:• Tidal volume• Respiratory rate, and• Minute ventilation. | |||
| ExSpiron 1Xi measurements areused as an adjunct to other clinicalinformation sources. | ExSpiron 1Xi measurements areused as an adjunct to other clinicalinformation sources. | |||
| Technology | Measurement is by thoracicbioimpedance. | Measurement is by thoracicbioimpedance. | Both the proposed device and the predicate have identical technology. | |
| 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 theExSpiron Monitor. It is a lowcurrent signal at approximately 50kHz. | 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. Thealgorithm was refined for theExSpiron 1Xi- using thousands ofadditional data points collectedover the last 3 years in a widevariety of patient populations.With the additional training data,the algorithm now providesaccurate respiratory volumeswithout patient-specific | 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 essentially the samefirmware, except the proposed device has been refined with thousandsof additional data points that result in a more accurate estimate ofrespiratory 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 enclosurematerial. | |
| EMC/EMICompliance | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant | Both the proposed device and the predicate are 60601-1-2 compliant. | |
| 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. | Following FDA clearance of the predicate (K130170), a "letter to file"change was made to substitute an equivalent Windows tabletcomputer in the device (See "Letter to File" changes; Section 21b inthis 510(k) filing). | |
| 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 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. In the Basic Monitoring mode that has beenintroduced in the proposed device, the calibration step that wasrequired 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 areincluded in Section 20: Performance Testing - Clinical. |
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| Respiratory Motion, Inc. | 09 May 2017 | ||||
|---|---|---|---|---|---|
| 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: | A clinical study was conducted in Waltham MA, USA to compare simultaneousmeasurements from the ExSpiron 1Xi and the predicate device. Twenty subjectsrepresenting 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 eachsubject, an initial session in which electrodes were applied and each subject performedtwenty breathing tests. Tidal volume, minute ventilation, and respiratory rate weremeasured and processed by both the Predicate and the Proposed device. Each subjectreturned 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 /PredicateExSpiron 1Xi Comparison | MinuteVentilation | TidalVolume | RespiratoryRate | ||
| 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. | |||||
| 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 is substantiallyequivalent to the predicate and is as safe and as effective as the predicate. |
§ 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).