(259 days)
Not Found
No
The summary describes a bioimpedance measurement system and standard signal processing on a Windows PC, with no mention of AI or ML techniques.
No.
The device is indicated for monitoring breathing and providing measurements, which is a diagnostic function, not a therapeutic one. It does not provide treatment or alleviate symptoms.
No
The device is indicated for monitoring breathing and its measurements are used as an adjunct to other clinical information sources, not for diagnosing conditions.
No
The device description explicitly states that the ExSpiron system consists of a "Bioimpedance measurement system" and a "Single Patient Use ExSpiron™ Electrode Lead Set," which are hardware components.
Based on the provided information, the ExSpiron device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the ExSpiron is used to "monitor breathing in adult patients" by measuring physiological parameters like tidal volume, respiratory rate, and minute ventilation. These are measurements taken directly from the patient's body.
- Device Description: The device description details a bioimpedance measurement system with electrodes placed on the torso. This is a non-invasive method of measuring physiological signals from the body.
- Lack of In Vitro Activity: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The ExSpiron does not perform any analysis on such specimens.
- Nature of Measurements: The measurements provided (tidal volume, respiratory rate, minute ventilation) are direct physiological measurements of respiratory function, not analyses of biological samples.
The ExSpiron is a patient monitoring device that uses non-invasive methods to assess respiratory status.
N/A
Intended Use / Indications for Use
ExSpiron 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 is a non-invasive system that graphically displays lung volume against time and reports an approximate value of: • Tidal volume, • Respiratory rate, and • Minute ventilation.
ExSpiron measurements are used as an adjunct to other clinical information sources.
Product codes (comma separated list FDA assigned to the subject device)
BZK, BZQ
Device Description
The ExSpiron™ consists of: Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.Panel PC: A Windows 7 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 volume, tidal volume, and respiratory rate.Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso (for electrode placement) / Lungs (for measurement)
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
A clinical study compared simultaneous measurements from the ExSpiron and the predicate, Wright spirometer. (Respiratory rate was calculated using a stop watch.) Twenty subjects representing a broad range of intended patients participated in the study. (Age range: 20-84, BMI range: 19.9-43.2, 11 female, 9 male) The study involved two sessions for each subject, an initial session in which electrodes were applied, the ExSpiron was calibrated to the individual, and each subject performed ten 60-second breathing tests. Tidal volume, minute ventilation, and respiratory rate were measured simultaneously by the ExSpiron and the Wright spirometer. Each subject returned twenty-four hours after the first session with the original electrodes still attached. Using the same individual calibration values, a second set of ten 60-second breathing tests was performed.
A similar study was performed comparing the Wright spirometer to the Morgan SpiroAir LT diagnostic spirometer. A different set of twenty subjects participated. (Age range: 20-60, BMI range: 19.0-28.0, 9 female, 11 male) Each subject participated in one session performing twenty 30-second breathing tests with volume measurements made simultaneously with the Wright spirometer and the Morgan diagnostic spirometer.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing:
A clinical study compared simultaneous measurements from the ExSpiron and the predicate, Wright spirometer.
Sample size: Twenty subjects (Age range: 20-84, BMI range: 19.9-43.2, 11 female, 9 male).
Key results:
ExSpiron-Wright study results:
Minute Ventilation: Overall Bias -2.1%, Overall Precision 10.5%, Overall Accuracy 10.7%
Tidal Volume: Overall Bias -1.9%, Overall Precision 10.3%, Overall Accuracy 10.4%
Respiratory Rate: Overall Bias -0.2%, Overall Precision 2.0%, Overall Accuracy 2.0%
The results indicate that the individual calibration is stable over a 24-hour period.
A similar study was performed comparing the Wright spirometer to the Morgan SpiroAir LT diagnostic spirometer.
Sample size: Twenty subjects (Age range: 20-60, BMI range: 19.0-28.0, 9 female, 11 male).
Key results:
Wright-Morgan study results:
Minute Ventilation: Bias 0.4%, Accuracy 3.9%
Tidal Volume: Bias 0.4%, Accuracy 3.9%
Combining the results of the ExSpiron-Wright study and the Wright-Morgan study provided calculated estimates of ExSpiron bias and accuracy with respect to the Morgan diagnostic spirometer:
ExSpiron-Morgan results:
Minute Ventilation: Bias -1.7%, Accuracy 9.9%
Tidal Volume: Bias -1.5%, Accuracy 9.6%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bias, Precision, Accuracy
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 a black and white drawing of a pair of lungs. The lungs are connected to the trachea, which is the tube that carries air to and from the lungs. The lungs are the main organs of the respiratory system, and they are responsible for taking in oxygen and releasing carbon dioxide. The image is a simple illustration of the lungs and trachea.
SEP 2 6 2012
510(k) Summary
| 510(k) Owner: | Respiratory Motion, Inc. |
|---|---|
| Address: | 305 Second Avenue, Suite B |
| Waltham, Massachusetts 02451 | |
| Phone: | 781-373-1636 |
| Fax: | 781-373-1653 |
| Contact person: | Jenny Freeman, MD |
| Date 510(k) | |
| Summary prepared: | September 20, 2012 |
| Trade name: | ExSpiron™ |
| Common name: | Respiratory Monitor |
| Classifications: | Monitoring spirometer |
| Product code: BZK | |
| Regulation: 21 CFR 868.1850 |
Breathing frequency monitor
Product code BZQ
Regulation: 21 CFR 868.2375 |
| Predicate devices: | For product code BZK, nSpire Wright/Haloscale Respirometer, marketed by
nSpire Health, Inc. of Longmont, CO 510(k) K091853
For product code BZQ, Philips MPn0 Intellivue Patient Monitors, marketed by
Philips Healthcare 510(k) K060541 |
| Device Description: | The ExSpiron™ consists of:
Bioimpedance measurement system: A stabilized high frequency
current generator is connected to two outer electrodes. The inner four
electrodes are connected to an adaptive circuit that conditions the
resulting voltage signal and converts it to digital form. Firmware
performs signal acquisition and relays data to the panel PC.Panel PC: A Windows 7 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 volume, tidal volume, and respiratory
rate.Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead
set containing six electrodes to be placed on the torso. It delivers current
and records impedance measurements. The electrode lead set is also used
to perform subsystem checks prior to patient measurements. |
1
| Intended use: | ExSpiron™ 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™ is a non-invasive system that graphically displays lung volume
against time and reports an approximate value of:
• Tidal volume,
• Respiratory rate, and
• Minute ventilation
ExSpiron™ measurements are used as an adjunct to other clinical information
sources. | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
technological
characteristics: | Characteristic | ExSpiron™ | nSpire | Philips
Intellivue
Monitor | Comment |
| | Intended Use | See above. | See K091853 | See K060541 | The clinical application of the
ExSpiron™ is equivalent to that of
the nSpire.
The comparison to the intended
use of the Philips monitor is
restricted to monitoring of
respiration rate.
ExSpiron™ has no alarm function.
All devices are used by healthcare
professionals. |
| | Technology | Measurement is
by thoracic
bioimpedance. | Measurement is
by in-line
turbine flow
meter. | Measurement
is by
bioimpedance. | |
| | Volume
Measurements | Tidal volume
Minute volume
Volume vs. time
chart | Tidal volume
Minute volume | None | The time function for the
minute volume measurement of
the nSpire is provided by a
user's stopwatch. |
| | Rate
Measurements | Respiratory rate
(breaths/min) | None | Respiratory
rate | |
| | Safety | IEC 60601-1,
including
electrical and
mechanical
safety | Mechanical
only. Safety
specifications
are not given in
the user manual
or 510(k)
summary. | IEC 60601-1,
etc. | |
| Nonclinical
performance | Performance testing confirmed essential performance by IEC 60601-1 and IEC
60601-1-2 tests and confirmed usability by simulated use by physicians and | | | | |
2
| Clinical
performance
testing: | A clinical study compared simultaneous measurements from the ExSpiron and the
predicate, Wright spirometer. (Respiratory rate was calculated using a stop
watch.) Twenty subjects representing a broad range of intended patients
participated in the study. (Age range: 20-84, BMI range: 19.9-43.2, 11 female, 9
male) The study involved two sessions for each subject, an initial session in
which electrodes were applied, the ExSpiron was calibrated to the individual, and
each subject performed ten 60-second breathing tests. Tidal volume, minute
ventilation, and respiratory rate were measured simultaneously by the ExSpiron
and the Wright spirometer. Each subject returned twenty-four hours after the first
session with the original electrodes still attached. Using the same individual
calibration values, a second set of ten 60-second breathing tests was performed. | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|-----------------------|-----------------|---------------------|
| | The results of ExSpiron-Wright study were: | | | | | |
| | | ExSpiron-Wright | | Minute
Ventilation | Tidal
Volume | Respiratory
Rate |
| | Bias | Overall | | -2.1% | -1.9% | -0.2% |
| | | Day 1 | | -2.3% | -1.7% | -0.6% |
| | | Day 2 | | -1.9% | -2.0% | 0.2% |
| | Precision | Overall | | 10.5% | 10.3% | 2.0% |
| | | Day 1 | | 10.2% | 9.7% | 2.3% |
| | | Day 2 | | 10.8% | 10.8% | 1.6% |
| | Accuracy | Overall | | 10.7% | 10.4% | 2.0% |
| | | Day 1 | | 10.4% | 9.8% | 2.4% |
| | | Day 2 | | 10.9% | 11.0% | 1.6% |
| The results indicate that the individual calibration is stable over a 24-hour period.
A similar study was performed comparing the Wright spirometer to the Morgan
SpiroAir LT diagnostic spirometer. (The closed cell construction of the Morgan
spirometer limits the breathing test time to 30 seconds. A direct comparison of
the ExSpiron to the Morgan spirometer is suboptimal.) A different set of twenty
subjects participated. (Age range: 20-60, BMI range: 19.0-28.0, 9 female, 11
male) Each subject participated in one session performing twenty 30-second
breathing tests with volume measurements made simultaneously with the Wright
spirometer and the Morgan diagnostic spirometer. | | | | | | |
| | | Wright-
Morgan | | Minute
Ventilation | Tidal Volume | |
| | | Bias | | 0.4% | 0.4% | |
| | | Accuracy | | 3.9% | 3.9% | |
| Continued on next page. | | | | | | |
3
| Clinical
performance
testing:
Continued from
previous page | Combining the results of the ExSpiron-Wright study and the Wright-Morgan
study provided calculated estimates of ExSpiron bias and accuracy with respect to
the Morgan diagnostic spirometer: | | |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------|
| | ExSpiron-
Morgan | Minute
Ventilation | Tidal Volume |
| | Bias | -1.7% | -1.5% |
| | Accuracy | 9.9% | 9.6% |
| Conclusions
regarding safety
and effectiveness: | Based on the comparisons of intended use, and results of nonclinical and clinical
testing, the ExSpironTM is substantially equivalent in intended use, safety, and
effectiveness to the nSpire Respirometer and to the breathing frequency monitor
function of the Philips Intellivue Patient Monitors. | | |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Respiratory Motion, Incorporated C/O Mr. Chas Burr Chas Burr QR Services 11 Mystic Avenue Winchester, Massachusetts 01890
Re: K120087
Trade/Device Name: ExSpiron™ Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ, BZK Dated: September 20, 2012 Received: September 21, 2012
Dear Mr. Burr:
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.
5
Page 2- Mr. Burr
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
far.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Indications For Use
510(k) Number (if known): K120087 Device Name: ExSpiron Indications for Use:
ExSpiron 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 of age) patients.
ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
- Tidal volume, .
- . Respiratory rate, and
- Minute ventilation. ●
ExSpiron measurements are used as an adjunct to other clinical information sources.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar. M21
(Division Sign-Off (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Antol, Dental Devices
510(k) Number:_