Search Results

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.

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.

Ask a specific question about this device

The Masimo SafetyNet Opioid System is intended to monitor and alarm when a patient may be experiencing an opioid induced impairment of oxygenation.

The Masimo SafetyNet Opioid System is indicated for the non-invasive continuous monitoring of individuals 15 years and older for the identification of when they may be experiencing a substance induced impairment of oxygenation (e.g., opioid induced respiratory depression (OIRD) caused by oral or injectable opioids) in hospital and home environments.

The Masimo SafetyNet Opioid System (device) is a system intended for noninvasively and continuously monitoring opioid users 15 years and older to identify substance induced impairment of oxygenation that can lead to opioid induced respiratory depression (OIRD) caused by oral or injectable opioids in hospital or home use environments. The device functions using a pre-determined notification escalation policy that provides the ability for the user to receive alerts and to establish a network of emergency contacts who can be contacted based on the level of alert/alarm as determined by the device. These emergency contacts are notified after previous notifications sent to the device user do not resolve the desaturation condition. As a final action, the device can notify Emergency Medical Service (EMS) dispatch to trigger a wellness call. If assistance is needed or the device user does not respond, the dispatch will request that EMS (i.e., ambulance service) be sent to the device user's location.

The device consists of the following components:

• Bedside Station Device component that communicates monitoring data wirelessly from the medical technologies to provide visual/audible alerts.
• Masimo Sensor Wireless wearable pulse oximetry sensor that provides the monitoring data.
• Masimo SafetyNet Opioid App - Software application installed on a smart device that provides the graphical user interface to display live monitoring data (e.g., pulse rate (PR), pulse waveform) and alarm condition status.
• Opioid Halo Software that runs continuously to provide real-time detection of the severe OIRD risk based upon changes or patterns in oxygenation biomarker data (peripheral oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi)) found to be consistent with published understanding of physiological effects of OIRD.
• Notification Escalation Policy - Policy that is used to add levels of awareness through the notification of the device user, emergency contact, or contracted Emergency Responders.
• Masimo SafetyNet Cloud A server accessed over the internet that gathers and stores measured data communicated wirelessly from a Bedside Station.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The clinical performance validation summarized in the document focuses on the device's ability to detect opioid-induced respiratory depression (OIRD) with improved specificity and reduced non-actionable alarms compared to a traditional pulse oximeter with a fixed threshold alarm.

• Standard Pulse Oximeter (Benchmark): 80.6% Specificity
• Halo Level 1: 93.9% Specificity
• Halo Level 2: 97.5% Specificity
• Halo Level 3: 99.5% Specificity
  Subpopulation Specificity (Halo Level 2):
• Naïve: 99.3%
• Chronic: 98.4%
• Hospital: 97.2%
• Illicit: 93.5% |
  | Equivalent Sensitivity in OIRD Detection (compared to traditional oximeter) | Overall:
• Standard Pulse Oximeter (Benchmark): 99.2% Sensitivity
• Halo Level 1: 100.0% Sensitivity
• Halo Level 2: 100.0% Sensitivity
• Halo Level 3: 79.2% Sensitivity (Not equivalent for Level 3 overall, but with mitigating factors discussed in benefit/risk determination)
  Subpopulation Sensitivity (Halo Level 2):
• Naïve: 100.0%
• Chronic: 100.0%
• Hospital: 100.0%
• Illicit: 100.0% |
  | Reduction in Non-Actionable Alarms (compared to traditional oximeter) | Overall:
• Halo Level 1: 75.0% Reduction
• Halo Level 2: 89.0% Reduction
• Halo Level 3: 96.7% Reduction
  Subpopulation Alarm Reduction (Halo Level 2):
• Naïve: 96.3%
• Chronic: 93.0%
• Hospital: 88.0%
• Illicit: 61.0%
• Sleeping Non-opioid users: 61.6% |
  | Responsiveness of Halo alarms (Time from opioid injection to alarm - TFO, and Time from alarm to intervention - TTI) | Illicit Users:
• Benchmark: TFO 3.14 min, TTI 2.69 min
• Halo Level 1: TFO 3.42 min, TTI 2.40 min
• Halo Level 2: TFO 4.60 min, TTI 1.22 min
• Halo Level 3: TFO 4.80 min, TTI 1.06 min (Halo Level 2 and 3 show improved TTI despite slightly longer TFO) |
  | Performance in varied skin pigmentation | No clinically significant effect on performance due to use of Halo software and reliance on trends in data, even with a hypothesized 2% positive SpO2 bias in illicit users data. Specificity for illicit users with bias was 88.7% (L1), 95.1% (L2), 99.6% (L3) compared to 85.8% (L1), 93.5% (L2), 99.6% (L3) without bias. |
  | SpO2 Accuracy (hardware performance) | ARMS (%) for Radius PPG Sensors:
• 90-100% SpO2: 1.73%
• 80-90% SpO2: 1.80%
• 70-80% SpO2: 1.73%
• 70-100% SpO2: 1.75%
  Bias between Light and Dark subjects:
• Light (13 subjects): Bias 0.05, ARMS 1.79
• Dark (9 subjects): Bias 0.03, ARMS 1.75 |

Study Details

1. Sample Size and Data Provenance:

   • Test Set (Clinical Performance Validation):
     • Algorithmic Performance (OIRD Detection, Sensitivity/Specificity): 40,322 data segments from 641 study participants.
       • 135 prescription home opioid users (naïve, chronic)
       • 242 hospitalized opioid users
       • 264 illicit opioid users
     • Alarm Reduction: Data from 936 cases (the same 641 opioid users + an additional 295 sleeping non-opioid users).
     • Timing Data (TFO/TTI): 17 illicit opioid rescue cases.
     • Skin Pigmentation Analysis: Data from 264 illicit users (original and modified with 2% SpO2 bias).
     • SpO2 Performance Validation (Hardware): 26 healthy male and female volunteer subjects with varying skin pigmentation (13 Light, 9 Dark for analysis, 4 excluded).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but the context of an FDA de novo submission typically implies a controlled clinical study environment, likely prospective. The reference to "prescription home opioid (i.e., naïve, chronic)", "hospitalized opioid", and "illicit opioid" suggests a mix of settings.
   • Training Set Sample Size: Not explicitly stated in the provided text.

2. Number of Experts for Ground Truth & Qualifications:

   • The document implies clinical experts were involved in establishing the "ground truth" for OIRD events, particularly mentioning "critical data were available to lead to development of a sufficiently rigorous ground truth comparator" and "for in-hospital patients who may be experiencing other physiologic perturbations not related to OIRD, it is uncertain what other data was available for the clinical experts to lay ground truth of an OIRD event."
   • However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of OIRD events from the study data. It refers to "clinical experts" establishing the ground truth, but the process (e.g., individual expert, consensus, adjudicated by a third expert in case of disagreement) is not detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. The study assessed the device's algorithmic performance (Halo software) in detecting OIRD and reducing alarms compared to a traditional pulse oximeter (benchmark), not human readers. The clinical validation focused on the device's ability to improve detection and reduce nuisance alarms.

5. Standalone Performance (Algorithm Only):

   • Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The published sensitivity and specificity values for the Halo software (Level 1, 2, 3) directly represent the algorithm's performance in identifying OIRD events and non-OIRD events without human interpretation or intervention affecting the classification, only alarm generation. The comparison to a "traditional pulse oximeter with a fixed threshold alarm" also implies an algorithmic comparison.

6. Type of Ground Truth Used:

   • The ground truth for OIRD detection appears to be based on expert consensus/clinical assessment (implied by "critical data were available to lead to development of a sufficiently rigorous ground truth comparator" and "clinical experts to lay ground truth of an OIRD event"). It is not stated to be pathology or direct outcomes data, but rather clinical determination of OIRD based on available patient data segments.

7. Sample Size for the Training Set:

   • The document does not provide the sample size for the training set. It only states: "For devices using algorithms based on machine learning, the clinical validation must be completed using a dataset that is separate from the training dataset". This confirms the test set described (40,322 data segments from 641 participants) was distinct from the training data, but the size of the training data is not given.

8. How Ground Truth for the Training Set Was Established:

   • The document does not specify how the ground truth for the training set was established. It only mentions the requirement that "the clinical validation must be completed using a dataset that is separate from the training dataset." Based on the description for the test set, it's highly probable the training set's ground truth was established similarly through clinical expert assessment, but this is not explicitly confirmed.

Ask a specific question about this device