(186 days)
The Multi-Parameter Mobile CareGuide™ 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party device, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB or CAN connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter has not been demonstrated in disease states.
The Multi-Parameter Mobile CareGuide 3100 Oximeter sensor uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm). The Multi-Parameter Mobile CareGuide 3100 Oximeter is a multiple parameter oximeter. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to a 30 party display or patient monitor through a proprietary protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 310 party display/patient monitor. The sensor is identical to the predicate (K122645) Mobile CareGuide 2100 Oximeter hardware containing six major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2 and pHm; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Multi-Parameter Mobile CareGuide 3100 Oximeter uses the same disposable element as the Mobile CareGuide 2100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for SmO2 or pHm performance. Instead, it relies on demonstrating that the device's accuracy is "comparable" to a predicate device through a "bridging study." The accuracy of the Multi-Parameter CareGuide 3100 was established by comparing its values against direct blood measurements using a laboratory analyzer.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable to predicate device (Paratrend 7 Sensor (pH) (K970906)) | "Accuracy of the CareGuide 3100 was established via a bridging study, comparing CareGuide 3100 values against direct blood measurements using a laboratory analyzer." "the accuracy of the CareGuide 3100 is comparable to that predicate device." |
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the sample size used for the "bridging study" that established accuracy, nor does it specify the country of origin or whether the data was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the document. The accuracy was established by comparing to "direct blood measurements using a laboratory analyzer," implying that the ground truth was derived from laboratory testing, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on direct blood measurements from a laboratory analyzer, not expert consensus that would require adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or implied. The focus was on the standalone performance of the device against a laboratory reference.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "bridging study" compared the device's outputs (SmO2 and pHm) directly against "direct blood measurements using a laboratory analyzer," indicating an evaluation of the algorithm's performance without human intervention in interpreting the device's output.
7. Type of Ground Truth Used
The ground truth used was based on direct blood measurements using a laboratory analyzer. This is akin to using a gold standard reference method for comparing the device's measurements.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size for a training set. The descriptions focus on the comparison study rather than the development and training of the device's algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. The document notes that "The same software quantitative algorithm for SmO2 is used in both devices" (referring to the predicate device), suggesting a pre-existing algorithm, but does not detail its development or the ground truth used for its training.
§ 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).