(86 days)
Nonin Model 2500 Pulse Oximeter - 510(k) Number - K001930
No
The summary does not mention AI, ML, or related terms, and the device description and performance studies focus on traditional signal processing and accuracy metrics for pulse oximetry.
No
The device is described as a "noninvasive, arterial oxygen saturation and pulse rate monitor" intended for "non-continuous noninvasive monitoring." Its function is solely to measure and display SpO2 and pulse rate, not to deliver any specific therapy or treatment.
Yes
Explanation: The device is a pulse oximeter that monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo SET® Rad-5v Pulse Oximeter measures physiological parameters to assess a patient's condition, which aligns with the function of a diagnostic device.
No
The device description explicitly states it is a "Handheld Pulse Oximeter" and mentions "LED indicator bars," indicating it includes hardware components beyond just software.
Based on the provided information, the Masimo SET® Rad-5v Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Masimo SET® Rad-5v Pulse Oximeter is a noninvasive device that monitors physiological parameters (oxygen saturation and pulse rate) in vivo (on the body) using a sensor placed on the patient's finger, toe, or ear.
The device description and intended use clearly state that it is a noninvasive monitor and does not involve the analysis of biological specimens outside the body.
N/A
Intended Use / Indications for Use
The Masimo SET " RAD-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.
The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous nonitoring of functions of functions or indicated I he Rad-Sv Handleto Pulse Oxmleer is interest for the Rad-Sv Handheld Pulse Oxinere is indicated of arteral hellogiount (Spo?) and 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® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of inconal I II Masino SET " Rad Pri unse Oxiniver to Cased pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad Sv oxygell saluration of arterial acult, pediatric, and neonatal patients during both no motion and motion r use Oxfilions, and for patients who are well or porty perfused in hospital-type facilities, mobile, and home environments..
Product codes
DQA, DPZ
Device Description
The Masimo SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).
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, and mobile 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:
- Study Type: Bench testing
- Sample Size: Not specified
- Data Source: Simulator
- Annotation Protocol: Not specified
- Key Results: The Masimo SET* Rad-5v Pulse Oximeters returned the same sauracy values within = 2 digits and pulse rate values within ± 3 digits when compared to the simulators used.
Clinical tests:
- Study Type: Clinical studies using SET technology
- Sample Size: Healthy adult volunteer subjects, neonates
- Data Source: Arterial blood samples with a CO-Oximeter, ECG monitor
- Annotation Protocol: Not specified, but stated that studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Cuncal Studies Neve Charletee roll of Human Subjects and Part 56 - Institutional Review Boards.
- Key Results:
- For adults and pediatrics: Saturation accuracy ± 2 digits during no motion and ± 3 digits during motion conditions (compared to CO-Oximeter). Pulse rate accuracy ± 2 digits during no motion conditions and ± 5 digits during motion conditions (compared to ECG).
- For neonates: Saturation accuracy 70% - 100% within ± 3 digits during both motion and no motion conditions (compared to CO-Oximeter), with 1% added for fetal hemoglobin. Pulse rate accuracy ± 3 digits during no motion and ± 5 digits during motion conditions (compared to ECG).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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, Pediatrics: 70% - 100% ± 3 digit, 0% - 69% unspecified
- Neonates: 70% - 100% ± 3 digit, 0% - 69% unspecified
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%): - Saturation (% SpO2) ± 2 digits
- Pulse Rate ± 3 digits
Predicate Device(s)
Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and Cables K031330
Reference Device(s)
Nonin Model 2500 Pulse Oximeter - 510(k) Number - K001930
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 9 2004
510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo. The logo is a stylized wordmark with a small circle above the "i". Below the logo is the address "2852 Kelvin Avenue, Irvine, CA 92614". The phone number is "949-250-9688" and the fax number is "949-250-9686".
| 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: | February 18, 2004 |
| Trade Name | Masimo SET * Rad-5v 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
Nonin Model 2500 Pulse Oximeter - 510(k) Number - K001930 |
The Masimo SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).
Features and Benefits
ano Delleria
Clinically proven Masimo SETTM technology performance Applicable for use on neonate, pediatric and adult patients Proven for accurate monitoring in motion and low perfusion environments SpO2, pulse rate, alarm, and pulse amplitude index displays SQ 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
Intended use
The Masimo SET " RAD-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.
.
1
Indications for use
The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous nonitoring of functions of functions or indicated I he Rad-Sv Handleto Pulse Oxmleer is interest for the Rad-Sv Handheld Pulse Oxinere is indicated of arteral hellogiount (Spo?) and 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-5v pulse oximeter are that oxyhemoglobin and deoxyhemonion I he price of operation of the Mistino DE - - Las - Parterial blood in tissue (and hence, light absorption ther adsorpound of countine the pulse (specifical starterior renous shunting is highly variable and that fluctuating by mal blood is a major component of noise during the pulse. Because oxylemoglobin and deoxyhemoglobin and deoxyhemoglobin differ absorbance of yenous not is a najor computent of the blood is related to hemoglobin oxygen saturation. The in light at sur hour of readed minered tight aborder of and infraced pulsatile absorbance signal into an arterial included a noise component and calculates the ratio of the artist without noise. The ratio of the two arterial pulse-added a bsorbance signals and its value is used to find the SpO saturation in an empirically derived equation into the Masimo SET® Rad-Sv 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 Masino SET * Rad-Sv pulse oximeter is turned on. An oximetery sensor is attached to a patient's finger and of a patient cable is connected to the sensor and the other end connected to the Rad-5v pulse oximeter.
The montor will begin continuously displaying the patient's pulse rate. and SpO2 value. The practitioner can then use the I Intention 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 deternines the patient no longer requires monitoring, the cable is disconnected from the oxinetty 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-5v 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, Pediatrics | 70% - 100% ± 3 digit | |
| 0% - 69% unspecified | ||
| Neonates | 70% - 100% ± 3 digit | |
| 0% - 69% unspecified | ||
2
| Pulse Rate (bpm) - During No Motion Conditions1 | 25 to 240 ± 3 digits |
|---|---|
| Adults, Pediatric, Neonates | |
| Pulse Rate (bpm) - During Motion Conditions2,3 | 25 to 240 ± 5 digits |
| Adults, Pediatric, Neonates | |
| Resolution | |
| Saturation (% SpO₂) | 1% |
| Pulse Rate (bpm) | |
|---|---|
| Low Perfusion Performance4 |
0.02% Pulse Amplitude | Saturation (% SpO2) ± 2 digits |
| and % Transmission > 5% | Pulse Rate ± 3 digits |
Interfering Substances
Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the Carousynemoglobin may erroreasily in 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
: 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、 、
11 - 1 - 1 - - -
Type Data Displayed LED, 7-segment Pulse Rate, SpO2 %, Aların status, alarnı silenced status, Pulse Amplitude Index Bar. Signal Quality Bar. and Battery Status.
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 Alam silence (120 seconds): all mute (continuous silence) Sensor condition alarms System failure and battery low alarms
3
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
8 seconds Normal
- 1 The Masimo SET Technology with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunters in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory coo studies on nearly admit roluneers in internet equals plus or minus one standard deviation which encompasses 68% of the population.
- ule population.
2 The Masimo SET Technology with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunters in induced hypoxia studies while performing rubbing and tapping motions, at 2 lo 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 specifical saturation accuracy from 70% 100% for neonates is based on the results from clinical studies on adult volunteers and 1% was added to account for the properties of fetal hemoglobin to be within ± 3 digits during both voluneers and 170 was added to when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates more and no no include on and ± 5 digits during motion conditions when compared to the ECG. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- The Masico SET Technology has been validated for low perfusion accuracy in bench top testing against a Brotek Index 2 simulator and Masino'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. ה
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.
Nonclinical tests performed that support a determination of substantial equivalence.
The Masimo SET " Rad-5v 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-5v Pulse Oximeters returned the same sauracy 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 sudies were performed using SET technology on healthy adult volunteer subjects during no motion and motions 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 Masimo SET* technology on neonates during no 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 SET* 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 mstruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
4
Clinical studies were performed using SET® technology on neonates with low perfusion conditions and neasuring 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 -Cuncal Studies Neve Charletee roll of Human Subjects and Part 56 - Institutional Review Boards.
The results from the clinical studies show that the Masino SET* technology saturation accuracy values for adults and pediatrics r it is a 2 digits during no motions and ± 3 digits during motion conditions when compared to the CO-Oxineer and the whan = 2 digits dating no motion conditions and = 5 digits during motion conditions when conditions when compared to the ECG.
The specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies on adult volunteers and 1% was added to account for the properties of fetal hemoglobin to be within ± 3 digits during both notion and no notion 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
:24:00 来
The results of the environmetal testing demonstrated that the Masimo SET* Rad-5vPulse Oximeter met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.
The results of the bench testing demonstrates that the Masimo SET * Rad-5v Pulse Oximeters met its performance requirements.
The results of the clinical testing demonstrates that the Masino 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 Masino SET* Rad-5v Pulse Oximeters is safe, effective.
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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 a stylized symbol of an eagle with three wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
Mr. James Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Ave. Irvine, CA 92614-5826
Re: K033998
Trade/Device Name: Masimo SET Rad 5v Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DPZ Dated: December 22, 2003 Received: December 24, 2003
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 he 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.
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
6
Page 2 -- Mr. James Cronin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordlict radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro revi marketing your device as described in your Section 510(k) I ms letter witi anow you to ought inding of substantial equivalence of your device to a legally premarket notineation: "The stars 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 If you attire 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 other general micronational 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.
Sincercly yours,
Chris 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
7
510(k) Number (if known):
Masimo SET Rad 5v Pulse Oximeter Device Name:
Indications For Use:
The Masimo SET® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of inconal I II Masino SET " Rad Pri unse Oxiniver to Cased pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad Sv oxygell saluration of arterial acult, pediatric, and neonatal patients during both no motion and motion r use Oxfilions, and for patients who are well or porty 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)
thi
Anesthesiology, G
510(k) Number
0020