(29 days)
The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.
The CARESCAPE SpO2 – Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended to be used with compatible Philips Intellivue Patient Monitors.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, infant, and neonatal patients during no motion conditions.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of respiratory rate (RRa) for adult and pediatric patients during no motion conditions.
The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.
The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The purpose of this submission is to add Radius PPG as a compatible accessory to the Carescape SpO2 -Masimo (K221953) and Masimo rainbow SET IntelliVue (K162675). The description of the subject devices is provided below:
Carescape SpO2 - Masimo: The Carescape SpO2 – Masimo is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE, K213234) 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.
Masimo rainbow SET IntelliVue: The Masimo rainbow SET IntelliVue is a module intended to compatible patient monitors (e.g., Philips IntelliVue, K221348) to provide continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). 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.
This FDA premarket notification (K232389) describes the addition of the Radius PPG as a compatible accessory to two existing devices: the Carescape SpO2 - Masimo (K221953) and the Masimo rainbow SET IntelliVue (K162675). The notification states that "there were no hardware or software changes made to the subject devices as part of this submission from the previous clearances." Therefore, the performance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed for the primary devices themselves in this document, but rather for the accessory's clinical performance.
The provided document focuses on demonstrating that the addition of the Radius PPG accessory does not raise new questions of safety and effectiveness, and that the clinical performance of the Radius PPG on patients of different skin pigmentations is equivalent.
Here's an analysis of the provided information, focusing on the Radius PPG accessory's clinical performance criteria as outlined:
1. A table of acceptance criteria and the reported device performance
The document provides clinical performance data for SpO2 monitoring with the Radius PPG across different skin pigmentations. The acceptance criteria for SpO2 accuracy in oximeters are typically expressed as the "Arms" (Accuracy Root Mean Square) value. Although a specific acceptance criterion is not stated as a numerical target in the document for this submission, the reported "Arms" values are compared, implicitly seeking to demonstrate acceptable accuracy across patient populations. Standard SpO2 accuracy for oximeters without motion is usually around 2% Arms.
| Feature | Acceptance Criteria (Implied by context and typical SpO2 device performance) | Reported Device Performance (Radius PPG) |
|---|---|---|
| SpO2 Accuracy (Arms, Overall) | Around 2% or better (Typical for pulse oximeters) | 1.75 |
| SpO2 Accuracy (Arms, Light Skin) | Around 2% or better | 1.79 |
| SpO2 Accuracy (Arms, Dark Skin) | Around 2% or better | 1.75 |
The reported Arms values of 1.75, 1.79, and 1.75 suggest that the Radius PPG accessory meets or exceeds typical accuracy expectations for pulse oximetry.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (for Radius PPG clinical data):
- Subjects: 22
- Samples: 762 (Overall)
- Light Skin Samples: 449
- Dark Skin Samples: 313
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical data for such devices is typically collected prospectively in controlled settings to assess accuracy.
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 type of device (pulse oximeter) does not rely on expert interpretation for ground truth. The ground truth for SpO2 measurement is typically established using a reference co-oximeter connected to arterial blood samples (invasi
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For pulse oximetry, the ground truth is derived from objective measurements (arterial blood gas analysis with a co-oximeter), so such adjudication methods are not applicable.
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
No, an MRMC comparative effectiveness study was not done. This device is a measurement device (a pulse oximeter accessory), not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, this type of study and effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical data presented (Bias, Precision, Arms) represents the standalone performance of the Radius PPG accessory in measuring SpO2. Pulse oximeters inherently operate in a "standalone" fashion by directly measuring physiological parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for SpO2 measurements is typically established through arterial blood gas analysis using a laboratory co-oximeter. This provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2), against which the non-invasive SpO2 readings from the device are compared. While not explicitly stated in this summary, this is the standard method for validating pulse oximeter accuracy.
8. The sample size for the training set
The document does not explicitly mention a "training set" for the Radius PPG accessory. For traditional medical devices like pulse oximeters, the device's algorithms are developed and refined using empirical data during the R&D phase. The clinical data presented here is for validation, not training.
9. How the ground truth for the training set was established
As noted in point 8, a specific "training set" with ground truth establishment is not detailed in the context of this submission for a pulse oximeter accessory. The device's underlying technology (Masimo SET and rainbow SET Pulse Oximetry) would have been developed and validated with substantial data, and its core principles rely on the physics of light absorption by different hemoglobin species.
§ 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).