(105 days)
K06120
No
The document describes standard pulse oximetry technology and does not mention AI or ML in the device description, intended use, or performance studies.
No.
The device is a monitoring tool that measures physiological parameters. It does not actively treat or mitigate a disease or condition.
Yes
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet)." These measurements provide information about the patient's physiological state, which can be used by a healthcare professional to identify or recommend a course of treatment, fitting the definition of a diagnostic device.
No
The device description clearly states it is a "Pulse CO-Oximeter" with an "LED display" and "output interfaces," indicating it is a hardware device that performs measurements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter is a noninvasive monitoring device. It measures physiological parameters (oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin) directly from the patient's body using sensors applied to the skin (fingertip, hand, foot). It does not analyze samples taken from the body.
Therefore, based on the provided information, the device's function clearly falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo Rainbow SET® 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, JKS
Device Description
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter (Rad 87) with Rainbow technology is noninvasive monitoring of arterial oxygen saturation (%SpO₂), pulse rate, carboxyhemoglobin saturation (%SpCO), and/or methemoglobin saturation (%SpMet). The Rad 87 features an LED display that continuously displays numeric values for %SpO₂ and pulse rate. Other information displayed by the Rad 87 include: %SpCO and/or %SpMet, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Rad 87 has output interfaces including Nurse Call analog output, RS-232 serial output, and optional wireless connection to Patient SafetyNet.
The Rad 87 is intended to be used with the following sensors:
- Masimo LNOP series of oximetery sensors .
- . Masimo LNCS series of oximetery sensors
- Masimo Rainbow series of (SpCO/SpMet) sensors .
The Rad 87 is also intended to be used with the Masimo patient cables, including Red and Rainbow patient cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed that Support a Determination of Substantial Equivalence.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and Accessories were subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the simulator under the range of oxygen saturation and pulse rates that the device specify.
Clinical Tests Performed that Support a Determination of Substantial Equivalence.
Clinical studies were performed using the Masimo Rainbow SET® Technology on healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a laboratory CO-oximeter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K06120
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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ు రాజాల
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
(949) 297-7000
FAX (949) 297-7001 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | James Cronin, Vice President of Regulatory Affairs |
| Contact for this Submission: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | October 24, 2007 |
| Trade Name | Masimo Rainbow SET® Rad 87 Pulse CO-Monitor and Accessories, |
| Common Name | Pulse Oximeter |
| Classification Name | Oximeter (74DQA) (870.2700) (JKS) |
| Substantially Equivalent Devices | Masimo SET® Radical 7 Pulse CO-Oximeter and Accessories
510(k) Number - K06120
Masimo Rainbow Adhesive Sensors
510(k) Number - K071024 |
Description of the Device and Its Intended Use
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter (Rad 87) with Rainbow technology is noninvasive monitoring of arterial oxygen saturation (%SpO₂), pulse rate, carboxyhemoglobin saturation (%SpCO), and/or methemoglobin saturation (%SpMet). The Rad 87 features an LED display that continuously displays numeric values for %SpO₂ and pulse rate. Other information displayed by the Rad 87 include: %SpCO and/or %SpMet, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Rad 87 has output interfaces including Nurse Call analog output, RS-232 serial output, and optional wireless connection to Patient SafetyNet.
The Rad 87 is intended to be used with the following sensors:
- Masimo LNOP series of oximetery sensors .
- . Masimo LNCS series of oximetery sensors
- Masimo Rainbow series of (SpCO/SpMet) sensors .
The Rad 87 is also intended to be used with the Masimo patient cables, including Red and Rainbow patient cables.
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Configurations
The Masimo SET® Rad 87 Pulse CO-Oximeter comes in four models:
- . Horizontal, without optional radio
- Horizontal, with optional radio .
- . Vertical, without optional radio
- Vertical, with optional radio .
Standard and Optional Features
Each of the four models mentioned above includes the following key standard features:
- SpO2 .
- . Pulse Rate
- Low Signal IQ .
- Perfusion Index .
The following key optional features are also available for each of these four models:
- . SpCO
- SpMet .
- . Pleth Variability Index
Indications for Use/ Intended Use
The Masimo SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® 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.
Specifications and Ranges
| Range | Oxygen Saturation (%SpO2) | 0 - 100% |
|---|---|---|
| Carboxyhemoglobin Saturation (%SpCO) | 0 - 99% | |
| Methemoglobin Saturation (%SpMet) | 0 - 99.9% | |
| Pulse Rate (bpm) | 25 - 240 | |
| Perfusion Index | 0.02 - 20% | |
| Pleth Variability Index | 0 - 100% | |
| Accuracy | ||
| Oxygen Saturation (%SpO2) - During No Motion Conditions | ||
| Adults, Pediatrics, Infants, Neonates | 60% - 80% ± 3% | |
| Adults, Pediatrics, Infants, Neonates | 70% - 100% ± 2% | |
| Adults, Pediatrics, Infants, Neonates | 0% - 69% unspecified | |
| Oxygen Saturation (% SpO2) - During Motion Conditions | ||
| Adults, Pediatrics, Infants, Neonates | 70% - 100% + 3% |
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| Oxygen Saturation (%SpO₂) - During Low Perfusion Conditions | Adults, Pediatrics, Infants, Neonates | 70% - 100% ± 2% |
|---|---|---|
| Adults, Pediatrics, Infants, Neonates | 0% - 69% unspecified | |
| Carboxyhemoglobin Saturation (% SpCO) | 0% - 40% ± 3% | |
| Methemoglobin Saturation (% SpMet) | 0% - 15% ± 1% | |
| Pulse Rate (bpm) - During No Motion Conditions | ||
| Adults, Pediatric, Neonates | 25 - 240 ± 3 bpm | |
| Pulse Rate (bpm) - During Motion Conditions | ||
| Adults, Pediatric, Neonates | 25 - 240 ± 5 bpm | |
| Pulse Rate (bpm) - During Low Perfusion Conditions | ||
| Adults, Pediatric, Neonates | 25 to 240 ± 3 bpm | |
| Resolution |
Oxygen Saturation (% SpO2) 1% Carboxyhemoglobin Saturation (% SpCO), digital display 1% Methemoglobin Saturation (% SpMet), digital display 0.1% Pulse Rate (bpm) 1
Interfering Substances
Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.
SpO2 is empirically calibrated to functional arterial oxygen saturation in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter can not measure elevated levels of COHb or MetHb. Increases in either COHb or MetHb will affect the accuracy of the SpO2 measurement.
For increased COHb: COHb levels above normal tend to increase the level of SpO2. The level of increase is approximately equal to the amount of COHb that is present. NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be preformed.
For increased MetHb: the SpO2 may be decreased by levels of MetHb of up to approximately 10% to 15%. At higher levels of MetHb, the SpO2 may tend to read in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be preformed.
Power
AC Power Rechargeable battery 100 - 240 VAC, 47-63 Hz, 15VA Sealed lead acid
Environmental
Operating Temperature Storage Temperature Relative Humidity Operating Altitude
41°F to + 104°F (5°C to +40°C) -40°F to + 158°F (-40°C to +70°C) 5% to 95% non-condensing 500 mbar to 1060 mbar pressure -1,000 ft to 18,000 ft (-304 m to 5,486 m)
Or~.
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Circuitry
Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of parameters Automatic alarm messages
Display
Type Data Displayed LED
SpO2 %, Pulse Rate, % SpCO and/or %SpMet. alarm status, status messages, Signal IQ, perfusion index, pleth variability index, APOD, sensitivity, wireless radio connection, system status light
Audio indicators Adjustable volume Alarm silence Sensor condition alarms
System failure and battery low alarms
Physical characteristics
Dimensions: Weight:
8.2" x 6.0" x 3.0" (20.8cm x 15.2cm x 7.6cm) 2.1 lbs (0.908 kg)
Modes
Averaging mode: Sensitivity
2, 4, 8, 10, 12, and 16 seconds Normal, Maximum, APOD
Principles of Operation
SpO2 General Description
Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects to the pulse oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in two ways: 1) as a percent value for arterial oxygen saturation (SpO2), and 2) as a pulse rate (PR).
SpCO and SpMet General Description
Pulse CO-oximetry is a continuous and non-invasive method of measuring the levels of carbon monoxide concentration (SpCO) and oxidized hemoglobin concentration (SpMet) in arterial blood. It relies on the same principles of pulse oximetry to make its SpCO/SpMet measurements. The measurements are taken by placing a sensor on a patient, usually on the fingertip for adults. The sensor connects directly to the pulse CO-oximetry instrument or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument displays the calculated data as percentage value for the SpCO and the SpMet. The Rad 87 is a combined SpO2, SpCO, and/or SpMet monitor with the same setup as that of a pulse oximeter and can display SpO2 in percentage values, pulse rate in beats per minute, SpCO in percentage values, and/or SpMet in percentage values.
Pulse oximetry is governed by the following principles:
-
- Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), and methemoglobin (blood with oxidized hemoglobin content) species differ in their absorption of visible and infrared light.
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-
- The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Rad 87 Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, and blood with oxidized hemoglobin content. Signal data is obtained by passing various visible and infrared lights (LED's, 400 to 1000nm) through a capillary bed (for example, a fingertip, a hand, a foot), and measuring changes in light absorption during the blood pulsatile cycle. The photodetector receives the light, converts it into an electronic signal and sends it to the Rad 87 for calculation.
- The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
Once the Rad 87 receives the signal from the sensor, it utilizes Masimo SET signal extraction technology to calculate the patient's functional oxygen saturation, fractional concentrations of carboxyhemoglobin and methemoglobin, and pulse rate. The SpCO and the SpMet measurements rely on multiwavelength calibration equations to estimate the percentages of carboxyhemoglobin and methemoglobin in arterial blood.
Method of Operation
:
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter (Rad 87) is turned on, An oximetry sensor is attached to a patient's finger and one end of a patient cable is connected to the sensor and the other end connected to the Rad 87 Pulse CO-Oximeter.
The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. If the Rad 87 is configured for SpCO and/or SpMet monitoring and the Rainbow sensor is attached to the patient's finger, then SpCO and/or SpMet values are also continuously displayed. The practitioner can then use the information that is continuously displayed on the monitor to help assess the condition of the patient and as an aide in determining if any intervention is required by the practitioner.
Once the practitioner determines the patient no longer requires monitoring, the cable is disconnected from the sensor, the CO-oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.
Description of Device Design Requirements
The Rad 87 was designed in accordance to the requirements of the following standards:
- . Electrical Safety requirements per BS EN 60601-1
- Performance requirements per ISO 9919 .
Identification of the Risk Analysis Method
Risk analysis was performed on the Rad 87 in accordance with ISO 14971 for the assessment of both general and specific device's design. The results of the risk analysis are included in this filing,
Discussion of the Device Characteristics
The Rad 87 characteristics include performance that meets or exceeds the requirements of ISO 9919. Additionally, the device is designed to be electrically safe for the patient and the operator in accordance with BS EN 60601-1. Verification and validation tests were completed whenever possible to mitigate risks identified in the device. For inherent risks that cannot be mitigated through product testing, the user will be notified through the product labeling.
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Description of the Performance Aspects
Non-Clinical Tests Performed that Support a Determination of Substantial Equivalence.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and Accessories were subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the simulator under the range of oxygen saturation and pulse rates that the device specify.
Clinical Tests Performed that Support a Determination of Substantial Equivalence.
Clinical studies were performed using the Masimo Rainbow SET® Technology on healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a laboratory CO-oximeter.
Conclusion
The information in this 510(k) submission demonstrates that the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories is substantially equivalent to the predicate device.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB -8 2008
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
Re: K073024
Trade/Device Name: Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and Accessories Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, JKS Dated: January 9, 2008 Received: January 10, 2008
Dear Ms. Marguerite Thomlinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Marguerite Thomlinson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely yours.
ORS
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and Accessories
Indications For Use:
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQz), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo Rainbow SET® 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 hospital-type facilities, mobile, and home environments.
Prescription Use _ X (Per 21 CFR 801.109 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073024