(29 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 monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 - Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE SpO2-Masimo (module) is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE) to provide the ability to monitor Masimo pulse oximeters (SpO2 and PR). 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 equipped with the same Masimo Technology Board as the predicate device (K200494), which provides the Masimo SET Technology for the measurement and monitoring of pulse oximetry data.
The module is labeled CARESCAPE SpO2 – Masimo or GE CARESCAPE SpO2 – Masimo. Both versions are identical except for the labeling to distinguish the version distributed by Masimo. The purpose of this submission is to receive clearance to market CARESCAPE SpO2 - Masimo under its own 510(k).
The provided text describes the CARESCAPE SpO2 - Masimo device, whose 510(k) submission (K212876) is for a labeling update and to market the device under its own 510(k). The device itself is identical to the primary predicate device, GE CARESCAPE SpO2 – Masimo (part of K200494), with no changes to hardware, software, or performance. Therefore, new performance data was not generated for this submission.
The acceptance criteria provided in the document are the performance specifications of the device as previously cleared with the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this submission is for a device that is identical to a previously cleared predicate, the "reported device performance" refers to the previously established performance specifications which are considered met, as there are no changes to the device itself.
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (as per predicate) |
|---|---|---|
| Performance Specification (Arms) | ||
| SpO2, no motion (70-100%) | 2% (Adults, Pediatrics, Infants) | 2% (Adults, Pediatrics, Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| SpO2, motion (70-100%) | 3% (Adults, Pediatrics, Infants, Neonates) | 3% (Adults, Pediatrics, Infants, Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults, Pediatrics, Infants) | 2% (Adults, Pediatrics, Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| Pulse Rate, no motion (25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) |
| Pulse Rate, motion (25-240 bpm) | 5 bpm (Adults, Pediatrics, Neonates) | 5 bpm (Adults, Pediatrics, Neonates) |
| Pulse Rate, low perfusion (25-240 bpm) | 3 bpm (Adults, Pediatrics, Neonates) | 3 bpm (Adults, Pediatrics, Neonates) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the primary predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, no new test set was used for this particular submission. The performance data is derived from the testing conducted for the primary predicate device (K200494), but the details of that testing (sample size, data provenance) are not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this submission as no new testing was performed to establish ground truth.
4. Adjudication method for the test set
Not applicable for this submission as no new testing was performed to establish ground truth that would require 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. This device is an oximeter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The performance specifications listed are standalone performance metrics of the oximeter device. Details of the studies establishing these specifications were conducted for the predicate device, but are not described in this document.
7. The type of ground truth used
For an oximeter measuring SpO2 and Pulse Rate, the ground truth typically involves invasive blood gas analysis (for SpO2) and ECG or simultaneous direct measurement (for Pulse Rate) against which the device's measurements are compared. These methods would have been used during the original testing of the predicate device.
8. The sample size for the training set
Not applicable. This document is for a medical device (oximeter), not an AI model requiring a training set. The device operates on physical principles, not machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 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).