(128 days)
Not Found
No
The document describes a standard pulse oximeter utilizing spectrophotometry and plethysmography principles. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on traditional accuracy metrics against established reference methods.
No.
The document indicates that the device is for monitoring purposes (continuous monitoring of functional oxygen saturation and pulse rate). It does not suggest any therapeutic intervention based on the readings.
Yes
The device is intended for continuous monitoring of functional oxygen saturation and pulse rate, providing data that can be used to assess a patient's physiological state and aid in diagnosis.
No
The device description explicitly states it is a "handheld pulse oximeter" and is "powered by 4 AA batteries," indicating it is a physical hardware device, not software only.
Based on the provided information, the Masimo SET® RAD-5 Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Masimo SET® RAD-5 Pulse Oximeter measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by using a sensor attached to the patient's body (finger or foot). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for continuous monitoring of physiological parameters (SpO2 and pulse rate) directly from the patient, not for analyzing samples in a laboratory setting.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Masimo SET® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.
The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.
The Masimo SET® Rads Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition 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
Device Description
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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
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Indicated Patient Age Range
Adult, pediatric, and neonatal patients
Intended User / Care Setting
Hospitals, hospital-type facilities, and mobile 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:
The Masimo SET® Rad-5 Pulse Oximeters was subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the simulator under the range of saturation and pulse rates that both devices specify. The results of the bench testing showed that the Masimo SET® Rad-5 Pulse Oximeters returned the same saturation accuracy values within ± 2 digits and pulse rate values within ± 3 digits when compared to the simulators used.
Clinical tests performed that support a determination of substantial equivalence:
Clinical studies were performed using the Masimo 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 CO-Oximeter.
Clinical studies were performed using the technology on neonates during no motion and motion conditions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using the technology on healthy adult volunteer subjects who were subjected to low perfusion conditions and 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.
Clinical studies were performed using the Masimo SET technology on neonates with low perfusion and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
The results from the clinical studies show that the Masimo SET® technology saturation accuracy values for adults and pediatrics within ± 2 digils during no motions and ± 3 digits during motion conditions when compared to the CO-Oximeter and the pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion compared to the ECG.
The specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with saturations down to 83% combined with clinical studies on adults to show that the Masimo SET® technology to be within ± 3 digits during both motion and no motion conditions when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates to be within ± 3 digits during no motion and ± 5 digits during motion conditions when compared to the ECG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Saturation (% SpO2) - During No Motion Conditions1: Adults, Pediatrics: 70% - 100% ± 2 digit, Neonates: 70% - 100% ± 3 digit
- Saturation (% SpO2) - During Motion Conditions2,3: Adults, Pediatrics2: 70% - 100% ± 3 digit, Neonates3: 70% - 100% ± 3 digit
- Pulse Rate (bpm) - During No Motion Conditions1: Adults, Pediatric, Neonates: 25 to 240 ± 3 digits
- Pulse Rate (bpm) - During Motion Conditions233: Adults, Pediatric, Neonates: 25 to 240 ± 5 digits
- Low Perfusion Performance4: Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits
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
Image /page/0/Picture/1 description: The image shows the text string "K033296" in a handwritten style. The text is oriented diagonally, running from the lower-left to the upper-right corner of the image. The characters appear to be written with a thick marker or pen, giving them a bold appearance.
FEB 1 9 2004
| Submitted by: | Masimo Corporation |
|---|---|
| 2852 Kelvin Ave | |
| Irvine, CA 92614-5826 | |
| (714) 250-9688 | |
| FAX (714) 250-9686 | |
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | December 5, 2003 |
| Trade Name | Masimo SET® Rad-5 Pulse Oximeter |
| Common Name | Pulse Oximeter |
| Classification Name | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and |
| Cables | |
| 510(k) Number - K031330 | |
| Features and Benefits | |
| Clinically proven Masimo SET TM technology performance | |
| Applicable for use on neonate, pediatric and adult patients | |
| Proven for accurate monitoring in motion and low perfusion environments | |
| SpO 2 , pulse rate, alarm, and perfusion index displays | |
| Signal IQ TM for signal identification and quality indication | |
| Lightweight, convenient handheld design | |
| Long battery life: over 36 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 TM | |
| Three sensitivity levels - Max, Normal and APOD TM | |
| Adjustable alarm volume |
Adjustable averaging 2 to 16 seconds
Intended use
The Masimo SET® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.
1
Indications for use
The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.
Principles of Operation
The principles of operation of the Masimo SET® Rad-Spulse oximeter are that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomery), the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography), and that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed to hemoglobin oxygen saturation. The Masimo SET® Rad-Spulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arterial signals without noise. The ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2 saturation into the Masimo SET Rad-5 software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions.
Method of Operation
The Masimo SET® Rad-5 pulse 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-5 pulse oximeter.
The monitor will begin continuously displaying the patient's pulse . The practitioner can adjust the high and low alarm limits to their desired value, if required. The practitioner can then use the information that is continuously displayed on the monitor, and hear if an alarm limit is reached, 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 Masimo SET® Rad 5 pulse oximeter is powered by 4 AA batteries with an operating time of 36 hours'.
Specifications and Operating Ranges
| Range | |
|---|---|
| Saturation (% SpO2) | 1% - 100% |
| Pulse Rate (bpm) | 25 - 240 |
| Perfusion | 0.02% - 20% |
| Accuracy | |
| Saturation (% SpO2) - During No Motion Conditions1 | |
| Adults, Pediatrics | 70% - 100% ± 2 digit |
| 0% - 69% unspecified | |
| Neonates | 70% - 100% ± 3 digit |
| 0% - 69% unspecified | |
| Saturation (% SpO2) - During Motion Conditions2,3 | |
| Adults, Pediatrics2 | 70% - 100% ± 3 digit |
| 0% - 69% unspecified | |
| Neonates3 | 70% - 100% ± 3 digit |
2
0% - 69% unspecified
| Pulse Rate (bpm) - During No Motion Conditions1 | |
|---|---|
| Adults, Pediatric, Neonates | 25 to 240 ± 3 digits |
Pulse Rate (bpm) - During Motion Conditions233 25 to 240 ± 5 digits Adults, Pediatric, Neonates
Resolution
| Saturation (% SpO2) | 1% |
|---|---|
| Pulse Rate (bpm) | 1 |
Low Perfusion Performance4
0.02% Pulse Amplitude and % Transmission > 5%
Saturation (% SpO2) ± 2 digits Pulse Rate ± 3 digits
Interfering Substances
Carboxyhemoglobin may erroneously increase 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 %, Alarm status, alarm silenced status, Perfusion |
| Index Bar, Signal IO 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) Pulse rate out-of-limits alarm SpO2 level out-of limits alarm Sensor condition alarms System failure and battery low alarms
3
| 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) |
Modes
Averaging mode: Sensitivity
2, 4, 8, 10, 12, and 16 seconds Normal, APOD, and MAX
- 1 The Masimo SET Technology with LNOP Adt sensors has been 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 cooximeter 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 has been 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 and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm 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 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.
- રે This represents approximate run time at lowest indicator brightness, using a new, fully charged battery.
Environmental Testing
Applicable environmetal testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed.
Nonclinical tests performed that support a determination of substantial equivalence.
The Masimo SET® Rad-5 Pulse Oximeters was subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the simulator under the range of saturation and pulse rates that both devices specify.
The results of the bench testing showed that the Masimo SET® Rad-5 Pulse Oximeters returned the same saturation accuracy values within ± 2 digits and pulse rate values within ± 3 digits when compared to the simulators used.
Clinical tests performed that support a determination of substantial equivalence.
Clinical studies were performed using the Masimo 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 CO-Oximeter.
Clinical studies were performed using the technology on neonates during no motion and motion conditions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using the technology on healthy adult volunteer subjects who were subjected to low perfusion conditions and 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.
4
Clinical studies were performed using the Masimo SET technology on neonates with low perfusion and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
The results from the clinical studies show that the Masimo SET® technology saturation accuracy values for adults and pediatrics within ± 2 digils during no motions and ± 3 digits during motion conditions when compared to the CO-Oximeter and the pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion compared to the ECG.
The specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with saturations down to 83% combined with clinical studies on adults to show that the Masimo SET® technology to be within ± 3 digits during both motion and no motion conditions when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates to be within ± 3 digits during no motion and ± 5 digits during motion conditions when compared to the ECG.
Conclusions
The results of the environmetal testing demonstrated that the Masmo SET® Rad-5Pulse Oximeter of Reviewers Guidance for Premarket Submissions - November 1993.
The results of the bench testing demonstrates that the Masimo SET® Rad-5 Pulse Oximeters met its performance requirements.
The results of the clinical testing demonstrates that the Masimo SET® technology meets its performance requirements during no motion and motion conditions and low perfusion conditions.
The non-clinical and clinical testing performed demonstrates that the Masimo SET® Rad-5 Pulse Oximeters is safe, effective.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2004
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614-5826
Re: K033296
Trade/Device Name: Masimo SET RAD-5 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 23, 2004 Received: January 26, 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.
6
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 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 (301) 594-4646. 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,
Chris
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
7
Indications for Use
510(k) Number (if known): K033296
Masimo SET Rad 5 Pulse Oximeter Device Name:
Indications For Use:
The Masimo SET® Rads Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition 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 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)
h
Anesthesiology, General Hospital, Intection Control. Der
510(k) Number:
1080