(30 days)
The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility.
The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patient at a time.
The CARESCAPE SpO2 – Masimo is indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.
The Masimo CARESCAPE SpO2 – Masimo with SpHb ("CARESCAPE SpO2 – Masimo") is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.
The CARESCAPE SpO2 – Masimo is the same module cleared as the GE CARESCAPE SpO2 – Masimo as part of the secondary predicate device (K213234), which provides the Masimo SET and rainbow SET Technology for the measurement and monitoring of pulse oximetry data. The only difference between the two modules is that the subject device is labeled for distribution by Masimo, and the secondary predicate is labeled for distribution by GE Healthcare. The difference between the subject device and primary predicate is the activation of the SpHb feature, the same as what was cleared as part of the secondary predicate (K213234).
This document is a 510(k) premarket notification for the "Masimo CARESCAPE SpO2 - Masimo with SpHb" device. The submission claims substantial equivalence to previously cleared predicate devices (K212876 and K213234). The primary change in the subject device is the activation of the SpHb (total hemoglobin concentration) feature, which was already cleared as part of the secondary predicate (K213234).
Therefore, the performance data presented is largely a restatement of the specifications of the equivalent devices, rather than new testing specific to this submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are the performance specifications for accuracy (Arms - Accuracy Root Mean Squared) listed in Table 1 and Table 4-1. The reported device performance is indicated as meeting these specifications by virtue of being the same device as the predicates.
| Feature | Acceptance Criteria (Specification - Arms) | Reported Device Performance (as stated in submission for equivalent device) |
|---|---|---|
| SpO2, No Motion (70-100%) | 2% (Adults, Pediatrics, and Infants) | 2% (Adults, Pediatrics, and Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| SpO2, Motion (70-100%) | 3% (Adults, Pediatrics, Infants and Neonates) | 3% (Adults, Pediatrics, Infants and Neonates) |
| SpO2, Low Perfusion (70-100%) | 2% (Adults, Pediatrics, and Infants) | 2% (Adults, Pediatrics, and Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, and Neonates) |
| Pulse Rate, Motion (25-240 bpm) | 5 bpm (Adults, Pediatrics, and Neonates) | 5 bpm (Adults, Pediatrics, and Neonates) |
| Pulse Rate, Low Perfusion (25-240 bpm) | 3 bpm (Adults, Pediatrics, and Neonates) | 3 bpm (Adults, Pediatrics, and Neonates) |
| SpHb (8-17 g/dL) | 1 g/dL (Adults and Pediatrics) | 1 g/dL (Adults and Pediatrics) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "As there were no performance changes made to the subject device from its latest clearance as part of the CARESCAPE ONE (K213234), no performance bench testing was included in this submission." This indicates that no new performance testing was conducted for this specific submission (K221953) to establish the device's performance directly. The performance specifications are derived from previous clearances of essentially the same device. Therefore, the sample size and data provenance for the original studies that established these specifications are not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text, as no new performance testing was conducted for this submission. The performance claims rely on prior clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text, as no new performance testing was conducted for this submission.
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
The device is an oximeter for continuous non-invasive monitoring of SpO2, PR, and SpHb. It is not an AI-assisted diagnostic device, nor does it involve human "readers" or image interpretation. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's performance specifications (e.g., Arms accuracy) are akin to a "standalone" performance, in the sense that they describe the accuracy of the device's measurements compared to a reference standard, without human interpretation as part of the primary measurement. The document states that the physical module and its underlying Masimo SET and rainbow SET Technology are the same as previously cleared. So, the stated performance specifications are effectively the standalone performance of the device's algorithms for SpO2, PR, and SpHb. No new standalone testing was conducted for this submission, relying on previous clearances.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For oximeters, the ground truth for SpO2 and SpHb measurements is typically established through direct blood gas analysis (e.g., co-oximetry) from arterial blood samples. The document does not explicitly state the ground truth method but this is the standard for such devices. This information also would have been detailed in the original submissions for the predicate devices.
8. The sample size for the training set
This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context. The device relies on established physiological principles and signal processing techniques (Masimo SET and rainbow SET Technology).
9. How the ground truth for the training set was established
This is not applicable as the document does not describe the development or training of an AI algorithm or a "training set" in that context.
§ 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).