(121 days)
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No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The technology described is based on signal extraction and oximetry, which are traditional signal processing techniques.
No
This device is a diagnostic and monitoring tool, measuring physiological parameters like oxygen saturation, pulse rate, and carboxyhemoglobin. It does not provide any therapy or treatment.
Yes
Explanation: The device is described as a "Pulse CO-Oximeter" that continuously monitors functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and carboxyhemoglobin saturation (SpCO). These measurements provide clinicians with information about a patient's physiological state, aiding in the diagnosis and monitoring of conditions related to oxygenation and carbon monoxide exposure. The "Intended Use / Indications for Use" section explicitly states its use for "continuous monitoring" which is a key aspect of diagnostic devices.
No
The device description clearly states it is a "Handheld Pulse CO-Oximeter" and mentions physical components like an LED display, indicators, and the need for specific sensors and cables, indicating it is a hardware device with integrated software.
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 Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter is a noninvasive device that measures physiological parameters (oxygen saturation, pulse rate, and carboxyhemoglobin saturation) directly from the patient's body using sensors applied to the skin (fingertip, hand, foot). It does not analyze samples taken from the body.
- Intended Use: The intended use describes continuous monitoring of these parameters, not the analysis of biological samples.
- Device Description: The description emphasizes noninvasive monitoring and the use of sensors applied to the patient.
- Performance Studies: The performance studies involve bench testing with a simulator and clinical studies on human subjects, measuring parameters directly from the body and comparing them to arterial blood samples analyzed by a laboratory CO-Oximeter (which is an IVD). The device itself is not performing the analysis of the blood samples.
Therefore, the Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter falls under the category of a noninvasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masino Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (neasured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an Sp CO sensor) for adult, pediatric, and neonatal patients in hospital-type facilities, mobile, and home environments.
The Masino Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an SpCO sensor). The Masimo Rainbow SET® Rad 57 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.
Product codes
DQA
Device Description
The Rad-57 Handheld Pulse CO-Oximeter with Rainbow technology is a noninvasive, arterial oxygen saturation, pulse rate, and carboxyhemoglobin monitor. The Rad-57 features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal IQ Indicator (Low SIQ) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO). The Masimo SET Rad 57 Signal Extraction Pulse CO-Oximeter is intended to be used with Masimo's LNOP. LNOP. LNOPv, and LNCS series of oximetery sensors and patient cables and Masimo's Rainbow oximetery/HbCO sensors and Rainbow cables.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates.
Indicated Patient Age Range
Adult, pediatric, and neonatal patients
Intended User / Care Setting
Hospital-type facilities, mobile, and home environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests performed that support a determination of substantial equivalence.
Study Type: Bench testing
Sample Size: Not specified
Key Results: The results of the bench testing showed that the Masimo Rainbow SET® Rad 57 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 deternination of substantial equivalence.
Study Type: Clinical studies
Sample Size: Not specified (healthy adult volunteers for Masimo SET Technology and Masimo SET Rainbow Technology)
Key Results:
- The Masimo SET Technology with LNOP, LNOP v, and LNCS sensors has been validated for no motion accuracy in 1 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.
- The Masinto SET Technology with LNOP, LNOP, and LNCS sensors has been validated for motion accuracy in 2 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.
- The Masino SET Technology with I.NOP, I.NOPv, and LNCS Neo sensors has been validated for neonatal motion stability of econology on healthy adult voluneers 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 and tapping monons, at 2 to 1 the range of 70-100% SpO2 against a laboratory CO-oximster and FCCG wontor. 1% has been added to the saturation accuracy to account for the effects of fetal hemoglobin. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- The Masimo SET Rainbow Technology with Rainbow DC-1-dc sensors have been validated in human blood on বা healthy adult volunteers against a laboratory CO-oximeter from 1-40%. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek 5 Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of rnater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- The clinical testing demonstrates that the Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories meet its performance requirements during no motion conditions and low perfusion conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
0
JAN 1 9 2005 510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows the logo and contact information for Masimo. The logo features the company name in a bold, sans-serif font with a stylized "M". Below the logo is the address "40 Parker, Irvine, CA 92618", followed by the telephone number "949-297-7000" and fax number "949-297-7001".
| 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 17, 2004 |
| Trade Name | Masimo Rainbow SET ™ Rad 57 Pulse CO-Oximeter 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 5 Pulse Oximeter and accessories
510(k) Number - K033296
Radiometer America, Inc OSM3 Hemoximeter
510(k) Number - K853990 |
Description of Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter
The Rad-57 Handheld Pulse CO-Oximeter with Rainbow technology is a noninvasive, arterial oxygen saturation, pulse rate, and carboxyhemoglobin monitor. The Rad-57 features a multicolored LED display that continuously displays numeric values for SpO2 and pulse rate, a Low Signal IQ Indicator (Low SIQ) indicator bars for Perfusion Index (PI) and Carboxyhemoglobin saturation (%SpCO). The Masimo SET Rad 57 Signal Extraction Pulse CO-Oximeter is intended to be used with Masimo's LNOP. LNOP. LNOPv, and LNCS series of oximetery sensors and patient cables and Masimo's Rainbow oximetery/HbCO sensors and Rainbow cables.
Features and Benefits
Clinically proven Masimo SETTM technology performance Applicable for use on neonate, infant, pediatric and adult patients Proven for accurate monitoring in motion and low perfusion environments SpO2, pulse rate, alarm, Perfusion Index and %SpCO displays Low Signal IQ (SIQ) indicator Lightweight, convenient handheld design Long battery life: over 8 hours on 4 "AA" alkaline batteries Audible Alarm for sensor-off and low battery Alarms for Hi/Low saturation and Hi/Low pulse rate FastSat™
1
Three sensitivity levels - Max, Normal and APOD™ 72 hours of trending memory Adiustable alarm volume Adjustable averaging 2 to 16 seconds.
Intended use
The Masino Rainbow SET" Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (neasured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an Sp CO sensor) for adult, pediatric, and neonatal patients in hospital-type facilities, mobile, and home environments.
Indications For Use:
The Masino Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and carboxyhemoglobin saturation (measured by an SpCO sensor). The Masimo Rainbow SET® Rad 57 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.
Principles of Operation
SpO2 General Description
Pulse oxinetry 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 oximent 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). The following figure shows the general monitoring setup.
SpCO General Description
Pulse ( O-oximetry is a continuous and non-invasive method of measuring the levels of carbon monoxide concentration (SpCO) in arterial blood. It relies on the same principles of pulse its SpCO measurement. The measurement is 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 Rad-57 is a combined SpO2 and SpCO monitor with the same setup as that of a pulse oximeter and can display a percentage value for SpCO as well as SpO2 and pulse rate.
Pulse oximetry is governed by the following principles:
- l . Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood) and carboxyhemoglobin (blood with carbon monoxide content) species differ in their absorption of visible and infrared light.
-
- 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-57 handheld Pulse CO-Oximeter uses a multi-wavelength sensor to distinguish between oxygenated blood, and blood with carbon monoxide content. Signal data is obtained by passing various visible and infrared lights (LED's, 400 to 1000mm) 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-57 for calculation.
Once the Rad-57 receives the signal from the sensor, it utilizes Masimo SET signal extraction technology to calculate the patient's functional exygen saturation, fractional concentration of carboxyhemoglobin, and pulse rate. The SpCO measurement relies on a nultiwavelength calibration equation to estimate the percentage of carbon-monoxide in arterial blood.
2
Method of Operation
The Masimo Rainbow SET% Rad 57 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 Pulse CO-Oximeter.
The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. The practitioner can then use the r including with ogen continuously eligently and montor 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 discomected 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 Masino Rainbow SET® Rad 57 Pulse CO-Oximeter is powered 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% | |
| 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 | |
| Pulse Rate (bpm) - During No Motion Conditions1 | ||
| Adults, Pediatric, Neonates | 25 to 240 ± 3 digits | |
| 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% | |
| Carboxyhemoglobin Saturation (% SpCO), continuous bar display | 5% | |
| Pulse Rate (bpm) | 1 |
3
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 erroneous 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 | LED, 7-segment |
|---|---|
| Data Displayed | Pulse Rate, SpO2 %, %SpCO, % SpCO bar, Alarm status, alarm |
| silenced status, Perfusion Index Bar, Battery Status, APOD, FastSat. |
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:
Weight:
6.2" x 3.0" x 1.4" (15.8 cm x 7.6cm x 3.6 cm) 13oz. (0.32 kg)
Modes
Averaging mode: Sensitivity
2, 4, 8, 10, 12, and 16 seconds Normal, APOD, and MAX
- The Masimo SET Technology with LNOP, LNOP v, and LNCS sensors has been validated for no motion accuracy in 1 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.
- The Masinto SET Technology with LNOP, LNOP, and LNCS sensors has been validated for motion accuracy in 2 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.
4
- The Masino SET Technology with I.NOP, I.NOPv, and LNCS Neo sensors has been validated for neonatal motion در r ne stability of econology on healthy adult voluneers 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 and tapping monons, at 2 to 1 the range of 70-100% SpO2 against a laboratory CO-oximster and FCCG wontor. 1% has been added to the saturation accuracy to account for the effects of fetal hemoglobin. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- The Masimo SET Rainbow Technology with Rainbow DC-1-dc sensors have been validated in human blood on বা healthy adult volunteers against a laboratory CO-oximeter from 1-40%. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- ard de Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek 5 Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of rnater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one stand ard deviation which encompasses 68% of the population.
- This represents approximate run time at lowest indicator brightness, using a new, fully charged battery. 6.
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 patien 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 Masino Rainbow SETiv Rad 57 Pulse CO-Oximeter and accessories was subjected to bench testing using a simulator that decermined 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 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 deternination of substantial equivalence.
Cinical studies were performed using the Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial henoglobin 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%. 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 Pulse CO-Oximeter 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-10993-1. 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).
5
The results of the bench testing demonstrates that the Masino Rainbow SFT® Rad 57 Pulse CO-Oximeter meets its performance requirements
The results of the clinical testing demonstrates that the Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories meet its 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 Pulse CO-Oximeter and accessories is safe, effective, and performs as well as the predicate device, the Masimo SET® Rad 5 Pulse Oximeter, and therefore, it is substantially equivalent to the Masimo SET® Rad 5 Pulse Oximeter.
6
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
JAN 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618
Re: K042536
Trade/Device Name: Masimo Rainbow SET Rad 57 Pulse CO-Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 17, 2004 Received: December 21, 2004
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.
7
Page 2 - Mr. 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 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/industry/support/index.html.
Sincerely vours,
Chih-Lin, Ph.D.
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 3 - Indications for Use
510(k) Number (if known): K042536
Masimo Rainbow SET Rad 57 Pulse CO-Oximeter Device Name:
Indications For Use:
The Masino Rainbow SET® Rad 57 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive I he Masmo Rambow SET Rad 97 t mise CO Oxinecer and point (SpO2) and pulse rate (measured by an Species of any and monitoring of functional oxygen saturation of atterner nemogroum (oped) as the Rad 57 and 2008) and 12 and 10 and 10 and 10 and and for use with adult, pediative of an oped sellering both no motion and notion conditions, and for indicated for use will addit, pediality, and novations canage of the
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cum Sylum
(Division Sign Division of Anesthesioloo Infection Control, De
510(k) Number: K042536