(125 days)
ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients.
ExSpiron 1xi is a non-invasive 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.
The ExSpiron 1xi system 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.
Computer: 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. 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™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.
The ExSpiron™ 1xi respiratory monitor is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in adult (at least 21 years old) patients. It is a non-invasive system that graphically displays lung volume against time and reports approximate values for Tidal Volume, Respiratory Rate, and Minute Ventilation. The measurements are used as an adjunct to other clinical information sources.
The provided documentation does not contain a table of acceptance criteria or reported device performance for this specific 510(k) submission (K130170). The submission is a Special 510(k) where the manufacturer states that "No clinical testing was performed for this 510(k). The measurement algorithm and software are unchanged from the predicate. Measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087." This means that the device's performance relies on the data submitted for its predecessor, the ExSpiron Respiratory Monitor (K120087).
However, based on the information provided for K130170:
1. Table of Acceptance Criteria and Reported Device Performance:
As stated above, no specific acceptance criteria or reported performance for the ExSpiron™ 1xi is provided in this document as it references the predicate device. For the predicate device, K120087, the performance statistics would have been determined through clinical trials. Without access to K120087, these specific details cannot be provided here.
The document states that changes for K130170 were related to:
- Software Verification & Validation
- Safety Testing - IEC 60601-1 2nd Edition
- Electromagnetic Compatibility - IEC 60601-1-2
- ExSpiron 1Xi System Test Plan
- Patient Cable Design Verification (AAMI / ANSI EC53:1995/(R) 2008)
- Electrode PadSet Design Verification (AAMI / ANSI EC12:2000/(R)2010, AAMI / ANSI EC53:1995/(R) 2008)
- Electrode - Biocompatibility - ANSI/AAMI/ISO 10993-1
All performance testing for these modifications was reported as successful, raising no new safety or efficacy concerns and demonstrating substantial equivalence to the predicate device.
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087.
- Data Provenance: Not applicable for this specific 510(k). For the predicate device (K120087), this information would be detailed in its submission. It's likely that the data would be prospective, given the nature of clinical trials for device performance. Country of origin not specified in the current document.
3. Number of Experts and Qualifications for Ground Truth - Test Set:
- Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The ground truth for the predicate device's clinical trials (K120087) would have been established through a reference standard method, but the number and qualifications of experts are not described in this document.
4. Adjudication Method for the Test Set:
- Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done for this specific 510(k) (K130170). The device is a monitor that reports values, not an AI for interpretation requiring human readers.
6. Standalone (Algorithm Only) Performance Study:
- Yes, implicitly. The statement that "The measurement algorithm and software are unchanged from the predicate" implies that the core algorithm's performance was evaluated in a standalone manner during the clinical trials for the predicate device (K120087). This 510(k) (K130170) focuses on modifications to hardware components and software updates that do not alter the fundamental measurement algorithm.
7. Type of Ground Truth Used:
- For the performance statistics referenced from the predicate K120087, the ground truth for respiratory measurements (Tidal Volume, Respiratory Rate, Minute Ventilation) would typically be established using a gold standard reference measurement system (e.g., highly accurate spirometry, capnography, or volumetric respirators) rather than expert consensus on images or pathology. The document does not specify the exact ground truth method used in the predicate study.
8. Sample Size for the Training Set:
- Not applicable for this 510(k) (K130170). The clinical trials for the predicate device (K120087) would have involved a patient sample. The document does not provide this information.
9. How Ground Truth for the Training Set Was Established:
- Not applicable for this 510(k) (K130170). For the predicate device's clinical trials, the ground truth would have been established using a gold standard reference measurement system, as mentioned in point 7.
§ 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).