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Masimo Rad-67™ Pulse CO-Oximeter

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

rainbow DCI-mini sensor

The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

The Masimo Rad-67™ Pulse CO-Oximeter is a handheld device that includes the Masimo Rainbow SET measurements.

The Rad-67™ has the same measurement technology and intended use as the cleared predicate, Pronto (K091057). The Rad-67™ includes Masimo Rainbow SET measurement technology, which enables the Rad-67™ to provide noninvasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi) and total hemoglobin concentration (SpHb®). The Rad-67™ can communicate through a wired or wireless connection to transfer data to external applications and devices.

The rainbow DCI-mini sensor, compatible accessory to the Rad-67™, is a reusable sensor that is compatible with Masimo rainbow SET technology and is intended for spot-check monitoring of functional oxygen saturation (SpO2), pulse rate (PR) and total hemoglobin (SpHb®).

Here's a breakdown of the acceptance criteria and the study details for the Masimo Rad-67™ Pulse CO-Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• SpHb Clinical Validation Study: 317 adult subjects.
• SpO2 No Motion Clinical Validation Study: "healthy, adult volunteers" (specific number not provided, but implies a cohort used for inducing desaturation).
• SpO2 Motion Clinical Validation Study: "healthy, adult volunteers" (specific number not provided).
• Data Provenance: The document does not specify the country of origin. It indicates these were prospective clinical studies performed by Masimo on Rad-67™ and rainbow DCI-mini sensors.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The ground truth for SpHb was established by a "HiCN reference method." For SpO2, the comparison is directly against actual arterial oxygen saturation levels achieved by inducing desaturation in volunteers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The studies focus on the device's standalone accuracy against physiological measurements, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance studies. They evaluate the accuracy of the Rad-67™ Pulse CO-Oximeter (which incorporates Masimo's Rainbow SET technology) in measuring SpO2 and SpHb directly against reference methods, without human-in-the-loop interpretation or assistance.

7. Type of Ground Truth Used

• SpHb: "HiCN reference method" (Hemiglobincyanide method, a laboratory gold standard for total hemoglobin concentration).
• SpO2: The context implies that the ground truth for SpO2 was derived from actual arterial blood oxygen saturation measured during controlled desaturation episodes in volunteers. This is typical for oximetry validation studies, often referred to as arterial blood gas (ABG) analysis or similar lab-based measurements.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is common for medical devices where the underlying algorithm is typically developed by the manufacturer, and the regulatory submission focuses on the validation (test set) performance.

9. How the Ground Truth for the Training Set Was Established

As no training set information is provided, there is no information on how ground truth for a training set would have been established.

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The Masimo Rainbow SET® Radical 7R 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 Rainbow SET® Radical 7R 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. In addition, the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories (Radical 7R) include the MX board with Masimo Rainbow SET technology. The Radical 7R provides noninvasive monitoring of arterial oxygen saturation (%SpO-), pulse rate (PR), carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa). Other information displayed by the Radical 7R includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Hematocrit (SpHct), Signal Identification Quality (SIQa), Respiration Indicator (RI), alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7R has output interfaces include: SatShare connection to multiparameter monitors, Nurse Call analog output, and RS-232 serial output.

Here's a breakdown of the acceptance criteria and study information for the Masimo Rainbow SET® Radical 7R CO-Oximeter, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

1. Sample size used for the test set and the data provenance:

   • SpO2, SpCO, SpMet (Adults): "healthy adult volunteers" (specific number not provided).
   • SpO2, SpMet (Neonates): 16 neonatal NICU patients.
   • SpHb (Adults/Pediatrics): "healthy adult volunteers and on surgical patients with light to dark skin pigmentation" (specific number not provided).
   • Data Provenance: The text does not explicitly state the country of origin. It indicates "healthy adult volunteers," "surgical patients," and "neonatal NICU patients," implying prospective clinical studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this type of device and study. The ground truth was established using a laboratory CO-Oximeter (a reference medical device), not human expert consensus.

3. Adjudication method:

   • Not applicable as the ground truth was derived from a laboratory CO-Oximeter.

4. 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 involving human readers and AI assistance was not mentioned. The studies described focus on the device's accuracy against a reference standard.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the clinical studies describe the standalone performance of the device's algorithm against a laboratory CO-Oximeter for various physiological parameters (SpO2, SpCO, SpMet, SpHb).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Reference Medical Device: A laboratory CO-Oximeter was used as the ground truth for SpO2, SpCO, SpMet, and SpHb measurements. This is considered a gold standard for these physiological parameters.

7. The sample size for the training set:

   • The document does not explicitly state the sample size used for the training set. It describes the clinical studies used to validate performance, which would be considered the test set.

8. How the ground truth for the training set was established:

   • This information is not provided in the summary. Typically, training data for medical devices like this would be collected similarly to validation data, using reference instrumentation, but the specifics are not detailed here.

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The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.

The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.

Here's a breakdown of the acceptance criteria and study information for the Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The RadCheck performance is equivalent to those of the Rad 57t," implying that these specifications are met by the RadCheck device as well. The accuracy values provided are stated as "specifications" for the device, and the "Studies" section confirms its validation against these.

Study Information Proving Device Meets Acceptance Criteria

The document uses several "human blood studies" and "bench-top testing" to validate the accuracy claims.

1. Sample Size Used for the Test Set and Data Provenance:

   • SpO2 Accuracy (No Motion): "healthy adult volunteers" (specific number not provided). Data provenance: Human blood studies.
   • SpO2 Accuracy (No Motion) (extended 70-100% range): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
   • SpO2 Accuracy (Motion): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
   • SpO2 Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
   • Pulse Rate Accuracy (No Motion): Not explicitly detailed for no motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
   • Pulse Rate Accuracy (Motion): Not explicitly detailed for motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
   • Pulse Rate Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
   • SpHb Accuracy (No Motion): "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (specific number not provided). Data provenance: Human subjects.
   • For all human studies: The country of origin for the data is not specified in the provided text. The studies appear to be prospective as they involve induced hypoxia or direct measurement against a laboratory method.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not applicable in the context of this device. The ground truth relies on laboratory instruments (CO-Oximeter, ECG monitor) and simulators, not human expert consensus for interpreting device output.

3. Adjudication Method:

   • Not applicable. Ground truth is established by quantitative measurements from reference devices.

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

   • No. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers make assessments. This device is a measurement device.

5. Standalone (Algorithm only without human-in-the-loop performance) Study:

   • Yes. The accuracy claims are for the device's measurements (SpO2, Pulse Rate, SpHb) directly against laboratory references or simulators, which represents the standalone performance of the algorithm and sensor.

6. Type of Ground Truth Used:

   • Laboratory CO-Oximeter: Used as the ground truth for SpO2 and SpHb measurements.
   • ECG monitor: Used as the ground truth for pulse rate during human blood studies.
   • Biotek Index 2 simulator and Masimo's simulator: Used as the ground truth for SpO2 (low perfusion) and Pulse Rate (bench-top testing).

7. Sample Size for the Training Set:

   • The document describes validation studies, not necessarily specific training sets for a machine learning model. The underlying "Rainbow SET technology, MX-1 Board/Circuitry" implies significant prior development and data but the size of a distinct "training set" is not provided here.

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

   • Not explicitly detailed for a "training set" in this document. During product development and prior iterations (e.g., for the predicate device Masimo Rainbow SET Rad 57t), ground truth would have been established using the same reference methods as the validation studies (laboratory CO-Oximeters, ECG monitors, and simulators).

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The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Adhesive Sensors 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 Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI and Direct Connect (Reusable) Sensors in the K080238 filing and the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing.

The Rainbow Adhesive Sensors in this filing have the same intended use/indications for use and performance specifications as the Rainbow Reusable Sensors in the K080238 filing. However, The Rainbow Adhesive Sensors in this filing are similar in construction to the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing. The main difference is that the sensors in the K071024 filing have 8wavelengths and the sensors in this filing have 12-wavelengths.

Similar to the 8-wavelength sensors in this filing include the emitter and detector assemblies connecting to the flex circuit, and an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. Sensor sizing for use with adult, pediatric, infant, and neonatal patients are the same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.

Here's a breakdown of the acceptance criteria and the study details for the Rainbow Adhesive Pulse CO-Oximeter Sensors (K081659):

1. Table of Acceptance Criteria and Reported Device Performance

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