(281 days)
Not Found
Yes
The description explicitly mentions a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort," which is a characteristic of machine learning algorithms.
No
The device is a non-invasive monitor that measures respiratory parameters, such as minute ventilation, tidal volume, and respiratory rate, and graphically displays lung volume against time. Its intended use is for monitoring breathing and the measurements are used as an adjunct to other clinical information, not for treating or preventing a disease or condition.
Yes
The device "is indicated...to monitor breathing" and "graphically displays lung volume against time and reports an approximate value of: Minute Ventilation (MV), Tidal volume (TV), Respiratory rate (RR)." These functions are used to assess physiological parameters, which is a diagnostic purpose. The text also states that it provides "clinically relevant accuracy."
No
The device description explicitly states the system consists of a Monitor containing a bioimpedance measurement system and a tablet PC, and a Single-Patient Use Electrode PadSet, indicating significant hardware components beyond just software.
Based on the provided information, the ExSpiron 1Xi is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ExSpiron 1Xi Function: The ExSpiron 1Xi is a non-invasive monitor that measures breathing parameters (Minute Ventilation, Tidal Volume, Respiratory Rate) by applying electrodes to the patient's skin. It does not analyze biological specimens.
- Intended Use: The intended use is to monitor breathing in adult patients, not to perform diagnostic tests on samples.
Therefore, the ExSpiron 1Xi falls under the category of a non-invasive physiological monitoring device, not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZK, BZQ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
Input Imaging Modality
Not Found
Anatomical Site
Patient's torso (skin)
Indicated Patient Age Range
adult (at least 21 years old) patients
Intended User / Care Setting
healthcare professionals in healthcare facilities, such as post-operative care and critical care units
Description of the training set, sample size, data source, and annotation protocol
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.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 indicate clinically relevant accuracy over a 24-hour period.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Proposed ExSpiron 1Xi /Predicate ExSpiron 1Xi Comparison
Minute Ventilation: Overall Bias 2.2%, Overall Precision 7.0%, Overall Accuracy 11.5%
Tidal Volume: Overall Bias 2.2%, Overall Precision 6.9%, Overall Accuracy 11.4%
Respiratory Rate: Overall Bias 0.01%, Overall Precision 0.08%, Overall Accuracy 0.08%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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;
- 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. | | | | |