(30 days)
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No
The document describes standard pulse oximetry technology and does not mention AI, ML, or related concepts. The "Masimo SET Technology" and "Signal IQ" are proprietary signal processing techniques, not explicitly AI/ML.
No.
The device's stated intended use is for continuous noninvasive monitoring of physiological parameters (oxygen saturation and pulse rate), not for treatment or therapy.
Yes
The device is indicated for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used for diagnostic purposes in patients.
No
The device description explicitly mentions "Lightweight, convenient handheld design" and "Audible alarm for sensor-off and low battery," which are physical hardware components. The device is a pulse oximeter, which requires hardware to measure SpO2 and pulse rate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate". This is a measurement taken directly from the patient's body using a sensor, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description focuses on the features of a pulse oximeter, which is a non-invasive monitoring device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Masimo SET® Rad-8 Pulse Oximeter is a non-invasive patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Masimo SET® Rad-8 Pulse 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). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have the following features and benefits:
- Clinically proven Masimo SET 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 perfusion index displays .
- Signal IQ™ for signal identification and quality indication .
- · Lightweight, convenient handheld design
- · Audible alarm for sensor-off and low battery
- Alarms for Hi/Low saturation and pulse rate .
- Trauma and FastSat™ .
- Three sensitivity levels Max, Normal and APOD™ .
- · Adjustable alarm volume
- · Adjustable averaging 2 to 16 seconds
- · Trend data storage and output
- · Two models: Horizontal or Vertical position
The Rad 8 in this filing is substantially equivalent to the predicate device (K053269). The reason for this filing is to revise the upper limit of the pulse rate accuracy range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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)
- 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 co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
- The Masimo SET Technology with LNOP Blue sensors has been validated for no motion accuracy in human blood studies in the range of 60 - 100% on neonates, infants and pediatric patients with congenital cyanotic cardiac lesions.
- 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% SpO2against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
- The Masimo SET Technology with LNOP-Neo and Neo Pt sensors for neonatal motion accuracy is based on human blood studies for adults (see Notes 1 and 2 above), with added 1% to adult accuracy specifications.
- 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. Plus or minus one standard deviation encompasses approximately 68% of the population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2, No Motion Conditions:
Pediatrics, Infants, Neonates: 60 - 80% + 4%
Adults, Pediatrics: 70% - 100% ± 2%
Neonates: 70% - 100% ± 3%
SpO2, Motion Conditions:
Adults, Pediatrics, Neonates: 0% - 69% unspecified
Adults, Pediatrics, Neonates: 70% - 100% ± 3%
SpO2, Low Perfusion:
Adults, Pediatrics, Neonates: 0% - 69% unspecified
Adults, Pediatrics, Neonates: 70% - 100% ± 2%
Pulse Rate, No Motion Conditions:
Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm
Pulse Rate, Motion Conditions:
Adults, Pediatrics, Neonates: 25 - 300 ± 5 bpm
Pulse Rate, Low Perfusion:
Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm
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
OCT 1 5 2009
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
(949) 297-7000
FAX (949) 297-7001 |
|----------------------------------|---------------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | September 14, 2009 |
| Trade Name | Masimo SET® Rad-8 Pulse Oximeter and Accessories, Model Rad-8 |
| Common Name | Pulse Oximeter |
| Classification Name | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices | Masimo SET® Rad 8 Pulse Oximeter
510(k) Number – K053269 |
Device Description
The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have the following features and benefits:
- Clinically proven Masimo SET 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 perfusion index displays .
- Signal IQ™ for signal identification and quality indication .
- · Lightweight, convenient handheld design
- · Audible alarm for sensor-off and low battery
- Alarms for Hi/Low saturation and pulse rate .
- Trauma and FastSat™ .
- Three sensitivity levels Max, Normal and APOD™ .
- · Adjustable alarm volume
- · Adjustable averaging 2 to 16 seconds
- · Trend data storage and output
- · Two models: Horizontal or Vertical position
The Rad 8 in this filing is substantially equivalent to the predicate device (K053269). The reason for this filing is to revise the upper limit of the pulse rate accuracy range.
Predicate Device
The predicate device used in this filing is the Masimo SET® Rad 8 Pulse Oximeter, 510(k) No. K053269.
1
Indications For Use/ Intended Use
The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO- sensor). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Technology Comparison
The Rad 8 in this filing is substantially equivalent in design, principles of operation, materials, and performance to predicate device (K053269). The only difference is the change of the upper limit of the pulse rate range from 240 to 300 beats per minute.
Similar to the predicate, the Rad 8 in this filing is designed, and manufactured for full compatibility with Masimo sensors.
Specifications
The following are the device specifications for the Rad 8:
| FEATURES | SPECIFICATIONS |
|---|---|
| Display Range | Saturation (SpO2): 1% - 100% |
| Pulse Rate (bpm): 25 - 480 bpm | |
| Perfusion Index: 0.02% - 20% | |
| Accuracy | See footnotes 1, 2, 3, 4 and 5 |
| SpO2, No Motion Conditions | Pediatrics, Infants, Neonates: 60 - 80% + 4% |
| Adults, Pediatrics: 70% - 100% ± 2% | |
| Neonates: 70% - 100% ± 3% | |
| SpO2, Motion Conditions | Adults, Pediatrics, Neonates: 0% - 69% unspecified |
| Adults, Pediatrics, Neonates: 70% - 100% ± 3% | |
| SpO2, Low Perfusion | Adults, Pediatrics, Neonates: 0% - 69% unspecified |
| Adults, Pediatrics, Neonates: 70% - 100% ± 2% | |
| Pulse Rate, No Motion Conditions | Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm |
| Pulse Rate, Motion Conditions | Adults, Pediatrics, Neonates: 25 - 300 ± 5 bpm |
| Pulse Rate, Low Perfusion | Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm |
| General | |
| Resolution | SpO2: 1% |
| Pulse Rate: 1 bpm | |
| Measurements | Low Signal IQ |
| Perfusion Index (PI) | |
| Interfering Substances | • Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2 measurements |
| • Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements. | |
| • Severe anemia may cause erroneous SpO2 readings. | |
| • Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings. | |
| • Elevated levels of total bilirubin may lead to inaccurate SpO2 readings | |
| FEATURES | SPECIFICATIONS |
| Electrical | |
| Power (AC) | Voltage Input Range: 100-240 Vac, 47-63 Hz |
| Max. AC Power Consumption: 20 VA | |
| Power (battery) | One rechargeable sealed lead acid battery |
| Operating time: up to 7 hours | |
| Charging time: approximately 8 hours | |
| Circuitry | Microprocessor controlled |
| Firmware | Masimo SET technology, MS-2000 Series Technology Board |
| Mechanical | |
| Material | Polycarbonate/ABS Blend |
| 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 | Operating Altitude: 500 mbar to 1,060 mbar pressure; -1,000 ft |
| to 18,000 ft (-304 m to 5,486m) | |
| Mode & Sensitivity | |
| Averaging Mode | General: 2, 4, 6, 8, 10, 12 and 16 seconds |
| FastSat | |
| Sensitivity | APOD, Normal, Maximum |
| Alarms | |
| Out of Limits | High and low alarms for SpO2 and Pulse Rate |
| Sensor Condition | No Sensor, Sensor Off |
| Battery | Low battery |
| System | System failure |
| Display and Indicators | |
| Data Display | %SpO2 |
| Pulse rate | |
| Alarm status | |
| Status messages | |
| Signal IQ | |
| Perfusion index | |
| FastSat | |
| Trauma | |
| Battery status | |
| Sensor status | |
| Display Type | LED |
| Output Interface | |
| Serial Output Port | RS-232 Connector |
| Open/Close Switch | Nurse Call |
| Compliance | |
| EMC Compliance | EN 60601-1-2, Class B |
| Electrical Safety | IEC 60601-1, |
| UL 60601-1 | |
| Type of Protection (AC power) | Class 1 |
| Type of Protection (battery power) | Internally Powered |
| Degree of Protection-Patient Cable | Type BF Defib Proof-Applied Part |
| Enclosed Degree of Ingress Protection | |
| from Solids/ Liquids | IPX1 |
| Mode of Operation | Continuous |
2
3
Footnotes:
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 co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
- 2 The Masimo SET Technology with LNOP Blue sensors has been validated for no motion accuracy in human blood studies in the range of 60 - 100% on neonates, infants and pediatric patients with congenital cyanotic cardiac lesions.
- 3 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% SpO2against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
- 4 The Masimo SET Technology with LNOP-Neo and Neo Pt sensors for neonatal motion accuracy is based on human blood studies for adults (see Notes 1 and 2 above), with added 1% to adult accuracy specifications.
- 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. Plus or minus one standard deviation encompasses approximately 68% of the population.
Test Summary
The Rad 8 complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the Rad 8:
- Risk Analysis .
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing .
- Safety Testing .
- Environmental Testing .
- Clinical Testing .
Conclusions
The information in this 510(k) submission demonstrates that the Masimo SET® Rad 8 Pulse Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like emblem with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
OCT 1 5 2009
Re: K092838
Trade/Device Name: Masimo SET® Rad-8 Pulse Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: September 14, 2009 Received: September 15, 2009
Dear Ms. Thomlinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2- Ms. Thomlinson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket hotification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
h for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known):
Masimo SET® Rad-8 Pulse Oximeter and Accessories Device Name:
Indications For Use:
The Masimo SET® Rad-8 Pulse 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). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use × (Per 21 CFR 801.109 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number: K092838
Masimo Special 510(k) Rad8 w/ 300 bpm, 9/14/09 Page 98 of 249