(80 days)
The 750C monitor is intended to continuously calculate and display the following physiological vital signs: end tidal carbon dioxide, respiration rate, capnograph waveform, functional arterial oxygen saturation, pulse rate, plethysmograph waveform and an optional non-invasive blood pressure measurement of systolic, diastolic, mean arterial pressures along with pulse rate derived from a NIBP pressure waveform. The 750C is intended for monitoring of adult, pediatric and neonatal patients in the care of health care professionals.
The CAS 750C Series Monitor is a multi-parameter patient monitor based on the exterior design and platform of the CAS 740 Vital Signs Monitor. The 750C features a capnograph equivalent to the Oridion Polaris 2004 End-Tidal C02 for the continuous non-invasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath. Monitors in the series also have a choice of MasimoSET® or Nellcor® OxiMAX® Sp02 technology, and CAS MAXNIBP®. All four monitors in the 750C series have end-tidal C02 and a pulse oximeter. Two of the four have an additional third parameter consisting of noninvasive blood pressure. Blood pressure measurement is based on the CAS oscillometric technology, and is identical to that which is found in the CAS 740 series vital signs monitors (K033048).
The 750C monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, its features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and a backlit LCD display with both waveform and a numeric display.
The provided 510(k) summary (K050844) describes the CAS 750C Series Monitor, a multi-parameter patient monitor. The submission primarily focuses on establishing substantial equivalence to predicate devices, particularly concerning its capnography and pulse oximetry components, and demonstrating compliance with various safety and performance standards.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table format as one might expect for a new diagnostic or AI device comparing performance metrics. Instead, it refers to compliance with established medical device standards and the demonstrated accuracy of OEM modules. The "performance" is implicitly demonstrated through adherence to these standards and the equivalence to predicate devices.
| Parameter/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Capnography (EtCO2) | Meet requirements of EN 864 Capnometers for use with Humans Particular Requirements; Equivalent to Oridion Polaris 2004 clinical performance. | Uses OEM modules (Oridion Polaris 2004 equivalent) which have demonstrated successful clinical performance in their own premarket submissions. Fully configured model 750 devices were sent to OEM module manufacturer for performance testing, implying successful integration and comparable performance. |
| Pulse Oximetry (SpO2) | Meet requirements of EN 865 Pulse Oximeters Particular Requirements; Equivalent to Masimo SET 2000 or Nellcor N-595 clinical performance. | Uses OEM modules (Masimo SET® or Nellcor® OxiMAX®) which have demonstrated successful clinical performance in their own premarket submissions. Fully configured model 750 devices were sent to OEM module manufacturer for performance testing, implying successful integration and comparable performance. |
| Non-Invasive Blood Pressure (NIBP) | Meet accuracy requirements of ANSI/AAMI SP10:2002 -- Electric or Automated Sphygmomanometers (accuracy, performance and environmental); Equivalent to CAS 740 Series performance. | The NIBP parameter uses CAS oscillometric technology, identical to that found in the CAS 740 series (K033048). Clinical accuracy of NIBP parameter has been demonstrated to meet AAMI SP10: 2002. |
| Electrical Safety | UL60601-1 (w/ CSA 22.2 No. 60601-1); IEC60601-1; EN60601-1-2:2001; IEC60601-1-4. | Will be tested in accordance with these standards prior to market release. (The 510(k) process accepts planned testing for compliance as sufficient, rather than requiring completed test reports in all cases, especially for off-the-shelf components). |
| Mechanical Robustness | IEC68-2-6, -27 and -34 Mechanical Shock and Vibration. | Will be tested in accordance with these standards prior to market release. |
| EMC | EN60601-1-2:2001. | Will be tested in accordance with this standard prior to market release. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a new algorithm evaluation with a specific sample size. Instead, it relies on:
- Clinical data from OEM module manufacturers: The submission states that OEM parameter suppliers for EtCO2 and SpO2 have demonstrated successful clinical performance in their own premarket submissions. This implies their original submissions included clinical data, though specific sample sizes, provenance, or retrospective/prospective nature for those studies are not provided in this K050844 document.
- NIBP parameter: "The NIBP parameter has been demonstrated to meet the clinical accuracy of AAMI SP10: 2002." AAMI SP10 outlines requirements for clinical testing, usually involving a sample of human subjects (e.g., typically 85 subjects with specific gender and age distributions for accuracy studies). However, the specific sample size, country of origin, or retrospective/prospective nature for the CAS NIBP testing is not detailed here, only that it "meets" the standard.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physiological monitor, not an interpretive diagnostic device that requires expert consensus for ground truth. The "ground truth" for the physiological parameters (e.g., CO2 concentration, SpO2, blood pressure) would have been established by reference methods or validated equipment during the OEM module development and NIBP validation.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a physiological monitoring device, not an imaging or interpretive diagnostic device that would typically involve a multi-reader, multi-case study to compare human performance with and without AI assistance.
6. Standalone Performance
The performance described for the EtCO2, SpO2, and NIBP components refers to their inherent measurement capabilities. The submission implies standalone performance of the OEM modules and the CAS NIBP technology, which were then integrated into the 750C monitor. "Fully configured model 750 devices were sent to each OEM module manufacturer for performance testing," which suggests verification of the integrated system's performance, but the fundamental "standalone" performance benchmarks belong to the individual components.
7. Type of Ground Truth Used
- Capnography (EtCO2): Likely a reference gas analyzer or a highly accurate laboratory instrument.
- Pulse Oximetry (SpO2): Likely a co-oximeter (which measures arterial oxygen saturation directly from a blood sample) as the reference, often paired with controlled hypoxia studies.
- Non-Invasive Blood Pressure (NIBP): AAMI SP10 typically requires comparison against direct intra-arterial measurements or auscultatory measurements conducted by trained observers (auscultator ground truth) using a mercury sphygmomanometer.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device in the contemporary sense that would require a "training set" for an algorithm to learn from data. Its functionality is based on established physiological measurement principles and signal processing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).