(92 days)
No
The document describes a pulse co-oximeter using established Masimo SET and Rainbow technology, focusing on signal processing and measurement accuracy. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is a continuous non-invasive monitor for arterial oxygen saturation, pulse rate, carboxyhemoglobin, and methemoglobin saturation. While it provides diagnostic information, its primary function is monitoring, not therapy.
Yes
The device continuously monitors physiological parameters like oxygen saturation, pulse rate, carboxyhemoglobin, and methemoglobin levels, providing information about a patient's health status. This direct measurement of physiological indicators for assessing health and potential abnormalities aligns with the definition of a diagnostic device.
No
The device description explicitly mentions "Handheld Pulse CO-Oximeters" and their features, including a display, LED indicators, and the need for specific sensors and cables. This indicates a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Masimo SET® Rad-57 cm and m Pulse CO-Oximeters are noninvasive devices. They measure physiological parameters (oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin) by placing sensors on the patient's body (fingertip, hand, foot).
- No Sample Analysis: The device does not analyze samples taken from the body. It directly measures parameters on the body.
Therefore, while it's a medical device used for diagnosis and monitoring, it falls under the category of noninvasive physiological monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Masimo SET" Rad-57 cm and m Pulse CO-Oximeters and accessories are indivated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO), pulse rate (measured by an SpOn sensor), carboxyhemoglobin, and/or methemoglobin saturation (measured by an SpCO/SpMet sensor) for adult, pediative, and neonaal patients in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Rad-57 cm 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) momently of famoronal on Jyon and methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 cm Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Rad-57 m 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) momering of antinental ation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 m 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DSA, JKS
Device Description
The Rad-57 cm and m Handheld Pulse CO-Oximetesr with Rainbow technology are noninvasive, arterial oxygen saturation and pulse rate monitor that also measure Carboxyhemoglobin. The Rad-ST featurena multicologies and Indicelosmallion display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal (Q Indicator (Low SIQ) included LED) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO) and/or Methemoglobin saturation(%21). alarm status, alarm silence, battery life and SpCO/SpMet sensor connected. The Masino SET Rad-57 cm and and Photo (10-Oximeters are intended to be used with Masimo's LNOP and LNCS series of oximelery sensors and patient ables and Masimo is Rainbow SpCO/SpMet sensors and Rainbow 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
Hospitals, hospital-type facilities, mobile, and home environments.
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)
Nonclinical tests performed that support a determination of substantial equivalence:
Bench testing using a simulator that determined the performance accuracy of the instruments against the range of saturation and pulse rates that both devices specify.
Results: The Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeter and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
1. The Masimo SET Technology with LNOP Adt sensors:
- Validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor.
- This variation equals plus or minus one standard deviation which encompasses 68% of the population.
2. The Masimo SET Technology with LNOP Adt sensors:
- Validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor.
- This variation equals plus or minus one standard deviation which encompasses 68% of the population.
3. The Masimo SET Technology with LNOP Neo sensors:
- Validated for neonatal motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor.
- 1% has been added to the saturation accuracy to account for the effects of fetal hemoglobin.
- This variation equals plus or minus one standard deviation which encompasses 68% of the population.
4. The Masimo SET Rainbow Technology with Rainbow DC-dc sensors:
- Validated in human blood on healthy adult volunteers against a laboratory CO-oximeter from 1-40% for carboxyhemoglobin and 1-15% for methemoglobin.
- This variation equals plus or minus one standard deviation which encompasses 68% of the population.
5. The Masimo SET Technology:
- Validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%.
- This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Clinical tests performed that support a determination of substantial equivalence.
Clinical studies were performed using the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeter on healthy adult volunteer subjects during no 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 CO-Oximeter.
The Masino SET Rainbow Technology with Rainbow DC-dc sensors have been validated in human blood on healthy adult volunteers against a laboratory CO-oximeter from 1-40% for carboxyhemoglobin and 1-15% for methenoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Oxygen Saturation (% SpO2) - During No Motion Conditions:
Adults, Pediatrics: 70% - 100% ± 2 digits; 0% - 69% unspecified
Neonates: 70% - 100% ± 3 digits; 0% - 69% unspecified
Oxygen Saturation (% SpO2) - During Motion Conditions:
Adults, Pediatrics: 70% - 100% ± 3 digits; 0% - 69% unspecified
Neonates: 70% - 100% ± 3 digits; 0% - 69% unspecified
Carboxyhemoglobin Saturation (% SpCO): 0% - 40% ± 3 digits
Methemoglobin Saturation (% SpMet): 0% - 15% ± 1 digits
Pulse Rate (bpm) - During No Motion Conditions:
Adults, Pediatric, Neonates: 25 to 240 ± 3 digits
Pulse Rate (bpm) - During Motion Conditions:
Adults, Pediatric, Neonates: 25 to 240 ± 5 digits
Low Perfusion Performance:
Oxygen Saturation (% SpO2) ± 2 digits
Pulse Rate ± 3 digits (for > 0.02% Pulse Amplitude and % Transmission > 5%)
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.
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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1053477
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011
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
(714) 297-7000
FAX (714) 297-7001 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | December 13, 2005 |
| Trade Name | Masimo Rainbow SET* Rad-57 cm and m Pulse CO-Oximeters and accessories |
| Common Name | Pulse Oximeter and Sensor |
| Classification Name | Oximeter (74DQA)
Transducer and Electrode Cable (including connector) (74DSA)
Carbon monoxide test system (JKS)(862.3220) |
| Substantially Equivalent Devices | Masimo SET Rad-57 Pulse CO-Oximeter and accessories
510(k) Number K042536
Radiometer America, Inc OSM3 Hemoximeter
510(k) Number – K853990 |
Description of Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters
The Rad-57 cm and m Handheld Pulse CO-Oximetesr with Rainbow technology are noninvasive, arterial oxygen saturation and pulse rate monitor that also measure Carboxyhemoglobin. The Rad-ST featurena multicologies and Indicelosmallion display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal (Q Indicator (Low SIQ) included LED) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO) and/or Methemoglobin saturation(%21). alarm status, alarm silence, battery life and SpCO/SpMet sensor connected. The Masino SET Rad-57 cm and and Photo (10-Oximeters are intended to be used with Masimo's LNOP and LNCS series of oximelery sensors and patient ables and Masimo is Rainbow SpCO/SpMet sensors and Rainbow cables.
Features and Benefits Clinically proven Masimo SETTN technology performance Applicable for use on neonate, infant, pediatric and adult patients Proven for accurate monitoring in motion and low perfusion environments Sp()2, pulse rate, alarm, Perfusion Index, % SpCO and/or SpMet displays Low Signal IQ (SIQ) indicator Lightweight, convenient handheld design Up to 8 hours continuous use on 4 "AA" alkaline batteries Visual battery life indicator
Masimo Corporation -
1
Audible Alarm for sensor-off and low battery Alarms for Hi/Low saturation and Hi/Low pulse rate, SpCO, SpMet FastSat™ (for SpO2 measurement) Three sensitivity levels - Max, Normal and APOD™ (for SpO2 measurement) 72 hours of trending memory Adjustable alarm volume Adjustable averaging 2 to 16 seconds
Intended use
The Masimo SET" Rad-57 cm and m Pulse CO-Oximeters and accessories are indivated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO), pulse rate (measured by an SpOn sensor), carboxyhemoglobin, and/or methemoglobin saturation (measured by an SpCO/SpMet sensor) for adult, pediative, and neonaal patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use
The Masimo SET® Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for the continuous noninvasive montoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO-sensor) and carboxyhenoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SoMet sepsor). The Masimo SFFT Rad-57 cm and m Pulse CO-Oximeters and accessories are indicated for use with adult, pediatric, and neouatal 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.
Principles of Operation
SpO2 General Description
Palse oxinctry 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 neovates. The sensor connects to the pulse oximent with a patient cable. The sensor collects signal data from the patient and sculs it to the instrument. The instrument displays the calculated data in two ways: 1) as a percent value for arterial oxygen saturation (Sp()2). 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 velies 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. The instrument displays the calculated data as percentage value for the SpCO and the SpMet. The Rad 57 cm is a combined SpO2, SpCO, and SpMet monitor with the same setup as that of a pulse oximeter and can display percentage values for SpCO and SpMet as well as SpO2 and pulse rate.
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.
- The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, is the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Rad-57 cm handheld 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.
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The photodetector receives the light, converts it into an electronic signal and sends it to the Rad-57 cm for calculation.
Once the Rad-57 cm 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-57 cm or m Pulse CO-Oximeter is turned on. An oximetery 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-57 cm or m Pulse CO-Oximeter.
The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. The practitioner can then use the information that is continuously displayed on the montor to help assess the condition of the patient and as an aide in decermining if any intervention is required by the practitioner.
Once the practitioner determines the patient no longer requires monitoring, the cable is disconnected from the oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.
Power Source
The Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oxincters are powcred by 4 AA batteries with an operating time of 8 hours".
Specifications and Operating Ranges
| Range | ||
|---|---|---|
| Oxygen Saturation (% SpO2) | 1% - 100% | |
| Carboxyhemoglobin Saturation (% SpCO) | 1-99% | |
| Methemoglobin Saturation (% SpMet) | 1-99.9% | |
| Pulse Rate (bpm) | 25 - 240 | |
| Perfusion | 0.02% - 20% | |
| Accuracy | ||
| Oxygen Saturation (% SpO2) - During No Motion Conditions1 | ||
| Adults, Pediatrics | 70% - 100% ± 2 digits | |
| 0% - 69% unspecified | ||
| Neonates | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Oxygen Saturation (% SpO2) - During Motion Conditions2,3 | ||
| Adults, Pediatrics | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Neonates3 | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Carboxyhemoglobin Saturation (% SpCO)4 | 0% - 40% ± 3 digits | |
| Methemoglobin Saturation (% SpMet)4 | 0% - 15% ± 1 digits | |
| Pulse Rate (bpm) - During No Motion Conditions1 | ||
| Adults, Pediatric, Neonates | 25 to 240 ± 3 digits |
3
| Pulse Rate (bpm) - During Motion Conditions2,3
| Adults, Pediatric, Neonates | 25 to 240 ± 5 digits |
|---|---|
| Low Perfusion Performance4 | |
| > 0.02% Pulse Amplitude | |
| and % Transmission > 5% | Oxygen Saturation (% SpO2) ± 2 digits |
| Pulse Rate ± 3 digits | |
| Resolution | |
| Oxygen Saturation (% SpO2) | 1% |
| Carboxyhemoglobin Saturation (% SpCO), digital display | 1% |
| Methemoglobin Saturation (% SpMet), digital display | 0.1% |
| Carboxyhemoglobin Saturation (% SpCO), continuous bar display | 5% |
| Carboxyhemoglobin Saturation (% SpMet), continuous bar display | .5, 1-5, 7.5, 10, 15, >20% |
| Pulse Rate (bpm) | 1 |
Interfering Substances
Carboxyhemoglobin may erroneously increase oxygen saturation readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroncous readings.
Power
Internally powered by 4 "AA" Alkaline batteries
Isolation
No external power or ground connection, internally powered only
Environmental
| Operating Temperature | 41°F to 104°F (5°C to +40°C) |
|---|---|
| Storage Temperature | -40°F to + 158°F (-40°C to -70°C) |
| Relative Humidity | 5% to 95% noncondensing |
| Operating Altitude | 500 mbar to 1060 mbar pressure |
| -1.000 ft to 18.000 ft (-304 m to 5.486 m) |
Circuitry
Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of parameters Automatic alarm messages
Display
Type Data Displayed
LED, 7-segment
Pulse Rate, SpO2 %, % SpCO, % SpCO bar, %SpMet, %SpMet bar, alarm status, alarm silenced status, low Signal IQ, battery statusand SpCO/SpMet connected
]
Audio indicators
Adjustable volume audible pulse: OFF and 33% to 100% in 3 steps Adjustable volume audible alarm tone: levels and 33% to 100% in 3 steps Alarm silence (120 seconds); all mute (continuous silence) Sensor condition alarms System failure and battery low alarms
Physical characteristics
Dimensions: 6.2" x 3.0" x 1.4" (15.8 cm x 7.6cm x 3.6 cm) Weight: 13oz. (0.32 kg)
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Modes
Averaging mode: Sensitivity
2, 4, 8, 10, 12, and 16 seconds Normal, APOD, and MAX
- The Masimo SET Technology with LNOP Adt sensors has been validated for no motion accuracy in human blood l studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG montor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- The Masimo SET Technology with LNOP Adt sensors has been validated for motion accuracy in human blood 2 studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an anylitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- r ; The Masimo SET Technology with LNOP Neo sensors has been validated for neonatal motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an anplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. 1% has been added to the saturation accuracy to account for the effects of fetal hemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the population ..
- 4 The Masino SET Rainbow Technology with Rainbow DC-dc sensors have been validated in human blood on healthy adult volunteers against a laboratory CO-oximeter from 1-40% for carboxyhemoglobin and 1-15% for methemoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 5 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- This represents approximate run time at lowest indicator brightness, using a new, fully charged battery. ు.
Environmental Testing
Applicable environmental testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical. mechanical and environmental were performed and all tests passed.
Biocompatibility Testing
All patient contact materials were tested as Surface Devices with skin contact duration (>24 hr to 30 days) as defined ISO-10993-1: 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests. All patient contacting material passed.
Nonclinical tests performed that support a determination of substantial equivalence.
The Masimo Rainbow SET% Rad-57 cm and in Pulse CO-Oximeter and accessories was subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the range of saturation and pulse rates that both devices specify.
The results of the bench testing showed that the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeter and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
Clinical tests performed that support a determination of substantial equivalence.
5
Clinical studies were performed using the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeter on healthy adult volunteer subjects during no 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 CO-Oximeter.
The Masino SET Rainbow Technology with Rainbow DC-dc sensors have been validated in human blood on healthy adult volunteers against a laboratory CO-oximeter from 1-40% for carboxyhemoglobin and 1-15% for methenoglobin. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Conclusions
The results of the environmental testing demonstrated that the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters and accessories met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.
The results of the biocompatibility testing demonstrates the all patient contacting material met the requirements of ISO-1093-1. 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests for Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days).
The results of the bench testing demonstrates that the Masimo Rainbow SET® Rad-57 cm and ni Pulse CO-Oximeters meet them performance requirements.
The results of the clinical testing demonstrates that the Masimo Rainbow SET® Rad-57 cm and m Pulse CO-Oximeters and accessories meet their performance requirements during no motion conditions and low perfusion conditions.
The non-clinical and clinical testing performed demonstrates that the Masimo Rainbow SET & Rad-57 cm and m Pulse CO-Oximeters and accessories are safe, effective, and performs as well as the predicate device, the Masino SET® Rad-57 Pulse CO-Oximeter, and therefore, it is substantially equivalent to the Masimo SET® Rad-57 Pulse CO-Oximeter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2008
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618
Re: K053477
Trade/Device Name: Masimo SET Rad 57 cm and m Pulse CO-Oximeters Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 13, 2005 Received: December 14, 2005
Dear Mr. Cronin:
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 - Mr. James J. Cronin
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 Orth 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Oare
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
8
Section 4 - Indications for Use
510(k) Number (if known):
Masimo SET Rad 57 cm and m Pulse CO-Oximeters Device Name:
Indications For Use:
The Masimo SET® Rad-57 cm 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) momently of famoronal on Jyon and methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 cm Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Rad-57 m 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) momering of antinental ation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 m 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 _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
thl Mhal
General Hosp
ental Devices
1053477