(198 days)
The Masimo Rad 5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad 5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5v Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad 8 Pulse Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rainbow Rad 8 Pulse Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rad 57 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring 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 Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter end accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The Masimo Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). The Masimo Rad 87 Pulse CO- . Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitaltype facilities, mobile, and home environments.
The Masimo LNCS/M-LNCS Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo ReSposable SpO2 Series Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Masimo SET® and Masimo rainbow SET® Pulse Oximeter instruments and sensors provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR). The Masimo rainbow SET technology also provides nonitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa).
This 510(k) is being submitted to support modifications to the device labeling to incorporate the results of clinical trials described in peer-reviewed publications regarding the use of Masimo pulse oximeters and sensors intended to screen newborn patients for critical congenital heart disease (CCHD). These modifications include the published newborn screening protocol for CCHD recommended by a work group selected by SACHDNC, AAP, ACCF and AHA (the "CCHD Workgroup"), and instructions regarding proper use of the subject Masimo devices to implement this protocol.
These labeling changes are being made in direct response to action taken by HHS in September 2011 adding pulse oximeter screening of newborns for CCHD to the Federal Recommended Uniform Screening Panel (RUSP) Guidelines. These guidelines recommend use of devices that a) are motion-tolerant, b) report functional oxygen saturation, c) have been validated in low perfusion conditions; and d) have been cleared by the FDA for use in newborns, criteria that are fully met by the subject Masimo devices.
Here's an analysis of the acceptance criteria and the studies that support the device's performance, based on the provided 510(k) summary:
Masimo SET® and Masimo rainbow SET® Pulse Oximeters and Sensors (K120657)
This 510(k) pertains to labeling modifications for existing Masimo pulse oximeters and sensors to incorporate their use in screening newborns for Critical Congenital Heart Disease (CCHD), based on peer-reviewed clinical studies. It is not a de novo submission for a new device, nor does it present new performance data specific to the device itself within the 510(k) document. Instead, it leverages existing clinical evidence gathered on the predicate devices.
The acceptance criteria for this specific 510(k) submission are implicit: demonstrating that the existing Masimo devices meet the criteria established by the CCHD Workgroup and that there is sufficient clinical evidence (from published studies) to support the expanded labeling for CCHD screening.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for labeling modifications based on existing clinical evidence, the "acceptance criteria" are derived from the CCHD Workgroup's recommendations for suitable devices. The "reported device performance" refers to the capabilities of the Masimo devices as described in the submission and implicitly demonstrated in the cited clinical studies.
| Acceptance Criteria (from CCHD Workgroup) | Reported Device Performance (by Masimo) / Implied in Studies |
|---|---|
| Device is motion-tolerant | Fully met by subject Masimo devices (per submission) |
| Reports functional oxygen saturation | Fully met by subject Masimo devices (per submission) |
| Has been validated in low perfusion conditions | Fully met by subject Masimo devices (per submission) |
| Cleared by the FDA for use in newborns | Masimo devices are already FDA-cleared for use in neonatal patients (per existing indications for use) |
| Effective for screening for low blood oxygen saturation to detect CCHD | Supported by two independent prospective clinical studies cited (see below) |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" here refers to the populations in the two clinical studies cited as evidence for CCHD screening.
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Study 1 (Sweden):
- Sample Size: 39,821 newborn subjects
- Data Provenance: Prospective clinical study, conducted at 5 maternity centers in Sweden.
- Device Used: Masimo Radical pulse oximeter (Masimo Rad 5, Rad 5v, and Rad 8 systems incorporate the same Masimo SET technology).
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Study 2 (UK):
- Sample Size: 20,055 newborn subjects
- Data Provenance: Prospective clinical study, conducted at 6 maternity centers in the UK.
- Device Used: Masimo Radical 7 pulse CO-Oximeter (Masimo Rad 57 and Rad 87 systems incorporate the same Masimo rainbow SET technology).
The submission does not specify a separate "test set" in the context of a typical algorithm validation for a new device. Instead, these are real-world prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not detail the number or qualifications of experts used to establish ground truth for the two cited clinical studies. These studies were published in peer-reviewed literature, implying that their methodologies, including ground truth establishment, would have been subject to scientific vetting. For CCHD screening, ground truth typically involves a combination of echocardiography, clinical examination, and tracking of health outcomes.
4. Adjudication Method for the Test Set
The 510(k) summary does not specify any adjudication method for establishing ground truth within the cited clinical studies. This information would typically be found within the full peer-reviewed publications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, as this submission is for a medical device (pulse oximeter) that provides direct measurements, not an AI interpretation that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The clinical studies cited, while involving human operators for device application and data interpretation in a clinical setting, evaluate the performance of the device's measurement algorithm (Masimo SET and Masimo rainbow SET technology) in detecting low oxygen saturation in newborns, which is the direct output of the algorithm. The "standalone" performance here refers to the accuracy and reliability of the oximeter's readings in a real-world screening scenario, as published in the referenced studies.
7. The Type of Ground Truth Used
The specific type of ground truth used in the two cited clinical studies is not explicitly detailed in the 510(k) summary. However, for CCHD screening studies, the ground truth for "critical congenital heart disease" is typically established through:
- Confirmed diagnosis by echocardiography: This is often considered the gold standard for diagnosing structural heart defects.
- Clinical outcomes: This includes diagnosis during hospitalization, surgical intervention, or adverse events related to undiagnosed CCHD.
- Expert clinical diagnosis: Based on a thorough medical evaluation by pediatric cardiologists or neonatologists.
The studies found "sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD," implying that the ground truth used allowed for this correlation to be made.
8. The Sample Size for the Training Set
This 510(k) is for existing devices, and the studies cited are validation studies for the application of CCHD screening, not studies used to develop or train the pulse oximetry algorithms themselves. The Masimo SET and Masimo rainbow SET technologies were developed prior to these studies. Therefore, no specific "training set" for the oximeter's core algorithm (which measures SpO2, PR, etc.) is discussed in the context of this 510(k) for labeling changes. The pulse oximetry technology itself would have gone through its own development and validation using various physiological models and human subject data.
9. How the Ground Truth for the Training Set was Established
As mentioned above, this 510(k) does not describe the specific training set or how ground truth was established for the development of the Masimo pulse oximetry algorithms. The technology was already developed and cleared prior to these CCHD screening studies. Typically, ground truth for pulse oximeter algorithm development involves:
- Controlled desaturation studies: Where subjects' oxygen saturation is precisely controlled and measured directly via arterial blood gas analysis (co-oximetry) while simultaneous pulse oximeter readings are taken.
- Physiological models: Use of simulators or animal models.
§ 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).