(259 days)
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.
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.
The provided 510(k) summary for the ExSpiron™ device includes information about its acceptance criteria and the study performed to demonstrate its performance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the calculation of bias and accuracy. The specific pass/fail thresholds for these metrics are not explicitly stated as "acceptance criteria" but are presented as the device's performance against a reference.
| Metric | Acceptance Criteria (Implied by Predicate Comparison) | Reported ExSpiron™ Performance (vs. Wright spirometer) | Reported ExSpiron™ Performance (Calculated vs. Morgan diagnostic spirometer) |
|---|---|---|---|
| Minute Ventilation | Expected to be comparable to predicate (Wright spirometer and indirectly Morgan diagnostic spirometer) | Bias: -2.1% (Overall), -2.3% (Day 1), -1.9% (Day 2) Accuracy: 10.7% (Overall), 10.4% (Day 1), 10.9% (Day 2) | Bias: -1.7% Accuracy: 9.9% |
| Tidal Volume | Expected to be comparable to predicate (Wright spirometer and indirectly Morgan diagnostic spirometer) | Bias: -1.9% (Overall), -1.7% (Day 1), -2.0% (Day 2) Accuracy: 10.4% (Overall), 9.8% (Day 1), 11.0% (Day 2) | Bias: -1.5% Accuracy: 9.6% |
| Respiratory Rate | Expected to be comparable to predicate (Wright spirometer) | Bias: -0.2% (Overall), -0.6% (Day 1), 0.2% (Day 2) Accuracy: 2.0% (Overall), 2.4% (Day 1), 1.6% (Day 2) | N/A (Not directly compared to Morgan for RR) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for ExSpiron-Wright study: 20 subjects
- Sample Size for Wright-Morgan study: 20 subjects (a different set of subjects)
- Data Provenance: The document does not explicitly state the country of origin, but it is a 510(k) submission to the FDA, suggesting the study was conducted to support US market approval. The study design (clinical comparison) implies prospective data collection for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a measurement device, and its performance is compared directly against existing medical devices (Wright spirometer and Morgan SpiroAir LT diagnostic spirometer), which are considered the reference or "ground truth" for these measurements. There is no mention of human experts establishing ground truth for individual measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth was established by direct measurement from predicate devices, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The ExSpiron™ is a medical device for monitoring physiological parameters (tidal volume, minute ventilation, respiratory rate), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical performance testing describes a standalone assessment of the ExSpiron™ device. Its measurements were compared directly and simultaneously with those from the predicate devices (Wright spirometer and, indirectly, Morgan diagnostic spirometer). The output of the ExSpiron (tidal volume, minute ventilation, respiratory rate) is generated solely by the device based on its bioimpedance measurements and internal algorithms, without human intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth used was measurement from predicate medical devices:
- Wright spirometer: for tidal volume, minute ventilation, and respiratory rate. Respiratory rate was calculated using a stopwatch in conjunction with the Wright spirometer.
- Morgan SpiroAir LT diagnostic spirometer: for tidal volume and minute ventilation in a separate comparative study with the Wright spirometer. This allowed for an indirect comparison between the ExSpiron and the Morgan device.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The ExSpiron™ uses a "Bioimpedance measurement system" with "Firmware performs signal acquisition and relays data to the panel PC. Panel PC: A Windows 7 PC performs signal processing and calibration." It also states "the ExSpiron was calibrated to the individual" in the clinical study. This suggests a traditional signal processing approach with individual calibration, rather than a large dataset-based machine learning training paradigm. Therefore, a specific "training set sample size" as understood in AI development is not provided or likely applicable in the conventional sense for this device.
9. How the Ground Truth for the Training Set was Established
Similar to the point above, a traditional "training set ground truth" is not explicitly described. Instead, the device undergoes individual calibration for each subject against known physiological signals or reference measurements at the time of use. The clinical study details that "electrodes were applied, the ExSpiron was calibrated to the individual, and each subject performed ten 60-second breathing tests." This initial calibration likely establishes the individual's baseline and correlation for the bioimpedance measurements before subsequent monitoring.
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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 BWaltham, 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 spirometerProduct code: BZKRegulation: 21 CFR 868.1850Breathing frequency monitorProduct code BZQRegulation: 21 CFR 868.2375 |
| Predicate devices: | For product code BZK, nSpire Wright/Haloscale Respirometer, marketed bynSpire Health, Inc. of Longmont, CO 510(k) K091853For product code BZQ, Philips MPn0 Intellivue Patient Monitors, marketed byPhilips Healthcare 510(k) K060541 |
| Device Description: | The ExSpiron™ consists of:Bioimpedance measurement system: A stabilized high frequencycurrent generator is connected to two outer electrodes. The inner fourelectrodes are connected to an adaptive circuit that conditions theresulting voltage signal and converts it to digital form. Firmwareperforms 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 froma touch screen through a virtual keyboard and mouse. The GUI is usedfor recording patient data and displaying the respiratory trace as well asscalar values and trends for minute volume, tidal volume, and respiratoryrate.Single Patient Use ExSpiron™ Electrode Lead Set: An electrode leadset containing six electrodes to be placed on the torso. It delivers currentand records impedance measurements. The electrode lead set is also usedto perform subsystem checks prior to patient measurements. |
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| 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 (atleast 21 years old) patients.ExSpiron™ is a non-invasive system that graphically displays lung volumeagainst time and reports an approximate value of:• Tidal volume,• Respiratory rate, and• Minute ventilationExSpiron™ measurements are used as an adjunct to other clinical informationsources. | ||||
|---|---|---|---|---|---|
| Comparison oftechnologicalcharacteristics: | Characteristic | ExSpiron™ | nSpire | PhilipsIntellivueMonitor | Comment |
| Intended Use | See above. | See K091853 | See K060541 | The clinical application of theExSpiron™ is equivalent to that ofthe nSpire.The comparison to the intendeduse of the Philips monitor isrestricted to monitoring ofrespiration rate.ExSpiron™ has no alarm function.All devices are used by healthcareprofessionals. | |
| Technology | Measurement isby thoracicbioimpedance. | Measurement isby in-lineturbine flowmeter. | Measurementis bybioimpedance. | ||
| VolumeMeasurements | Tidal volumeMinute volumeVolume vs. timechart | Tidal volumeMinute volume | None | The time function for theminute volume measurement ofthe nSpire is provided by auser's stopwatch. | |
| RateMeasurements | Respiratory rate(breaths/min) | None | Respiratoryrate | ||
| Safety | IEC 60601-1,includingelectrical andmechanicalsafety | Mechanicalonly. Safetyspecificationsare not given inthe user manualor 510(k)summary. | IEC 60601-1,etc. | ||
| Nonclinicalperformance | Performance testing confirmed essential performance by IEC 60601-1 and IEC60601-1-2 tests and confirmed usability by simulated use by physicians and |
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| Clinicalperformancetesting: | A clinical study compared simultaneous measurements from the ExSpiron and thepredicate, Wright spirometer. (Respiratory rate was calculated using a stopwatch.) Twenty subjects representing a broad range of intended patientsparticipated in the study. (Age range: 20-84, BMI range: 19.9-43.2, 11 female, 9male) The study involved two sessions for each subject, an initial session inwhich electrodes were applied, the ExSpiron was calibrated to the individual, andeach subject performed ten 60-second breathing tests. Tidal volume, minuteventilation, and respiratory rate were measured simultaneously by the ExSpironand the Wright spirometer. Each subject returned twenty-four hours after the firstsession with the original electrodes still attached. Using the same individualcalibration values, a second set of ten 60-second breathing tests was performed. | |||||
|---|---|---|---|---|---|---|
| The results of ExSpiron-Wright study were: | ||||||
| ExSpiron-Wright | MinuteVentilation | TidalVolume | RespiratoryRate | |||
| 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 MorganSpiroAir LT diagnostic spirometer. (The closed cell construction of the Morganspirometer limits the breathing test time to 30 seconds. A direct comparison ofthe ExSpiron to the Morgan spirometer is suboptimal.) A different set of twentysubjects participated. (Age range: 20-60, BMI range: 19.0-28.0, 9 female, 11male) Each subject participated in one session performing twenty 30-secondbreathing tests with volume measurements made simultaneously with the Wrightspirometer and the Morgan diagnostic spirometer. | ||||||
| Wright-Morgan | MinuteVentilation | Tidal Volume | ||||
| Bias | 0.4% | 0.4% | ||||
| Accuracy | 3.9% | 3.9% | ||||
| Continued on next page. |
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| Clinicalperformancetesting:Continued fromprevious page | Combining the results of the ExSpiron-Wright study and the Wright-Morganstudy provided calculated estimates of ExSpiron bias and accuracy with respect tothe Morgan diagnostic spirometer: | ||
|---|---|---|---|
| ExSpiron-Morgan | MinuteVentilation | Tidal Volume | |
| Bias | -1.7% | -1.5% | |
| Accuracy | 9.9% | 9.6% | |
| Conclusionsregarding safetyand effectiveness: | Based on the comparisons of intended use, and results of nonclinical and clinicaltesting, the ExSpironTM is substantially equivalent in intended use, safety, andeffectiveness to the nSpire Respirometer and to the breathing frequency monitorfunction of the Philips Intellivue Patient Monitors. |
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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.
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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
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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:_
§ 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).