(168 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 indicative of a machine learning approach used for calculating respiratory parameters.
No.
The device is a monitoring system that displays physiological parameters but does not provide any treatment or therapeutic function.
No.
The ExSpiron 1Xi is a non-invasive monitor that measures and displays respiratory parameters (Minute Ventilation, Tidal Volume, Respiratory Rate) and is indicated for "monitoring breathing." While it provides data, the text explicitly states its measurements "are used as an adjunct to other clinical information," and does not indicate it is used to diagnose a disease or condition.
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. These are hardware components, making it a hardware and software system, not software-only.
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 taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ExSpiron 1Xi Function: The ExSpiron 1Xi is a non-invasive monitor that measures respiratory parameters (Minute Ventilation, Tidal Volume, Respiratory Rate) by applying electrodes to the patient's torso and using bioimpedance. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it monitors breathing in patients, which is a direct measurement of a physiological function, not an analysis of a biological specimen.
Therefore, the ExSpiron 1Xi falls under the category of a non-invasive physiological monitoring device, not an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a 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 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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's torso
Indicated Patient Age Range
patients at least one year of age.
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.
Description of the test set, sample size, data source, and annotation protocol
The device was tested on pediatric patients in a prospective observational study at Children's Hospital of Boston.
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).
Data from 72 pediatric patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing:
Study type: Prospective observational study.
Sample size: 72 pediatric patients.
Key results: 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.
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.
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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/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)
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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. |