(71 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard physiological monitoring parameters and signal processing technology (Rainbow SET).
No
The device is described as a "Pulse CO-Oximeter" intended for "continuous non-invasive monitoring" of various physiological parameters. Its primary function is to measure and display these parameters, and it is not described as delivering any form of treatment or therapy.
Yes
The provided text states that the device is "indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa)." These parameters are clinical measures used to assess a patient's physiological state, which directly contributes to diagnosis.
No
The device description explicitly states that the Radical 7 Pulse CO-Oximeter and accessories include hardware components such as a touchscreen, output interfaces (SatShare, Nurse Call, RS-232), and a wireless radio. It is not solely software.
Based on the provided information, the Masimo Radical 7 Pulse CO-Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "continuous non-invasive monitoring" of various physiological parameters (SpO2, pulse rate, SpCO, SpMet, SpHb, RRa). This involves measuring these parameters directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description reinforces the non-invasive nature of the device, mentioning parameters like Perfusion Index, Pleth Variability Index, and the pleth waveform, which are all derived from non-invasive measurements.
- Lack of IVD Characteristics: There is no mention of analyzing samples of blood, urine, tissue, or other bodily fluids. The device measures parameters directly from the patient's body using sensors.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Masimo Radical 7 does not fit this definition. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masino Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO₂2) and pulse rate to multi-parameter devices for the display of those devices.
Product codes
DQA, BZQ, DPZ, JKS
Device Description
The Radical 7 Pulse CO-Oximeter and accessories (Radical 7) include the Masimo Rainbow SET technology. The Radical 7 Pulse CO-Oximeter provides monitoring of arterial oxygen saturation (SpO3), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa). Other information displayed by the Radical 7 Pulse CO-Oximeter includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Hematocrit (SpHct), Signal Identification Quality (SIQa), Respiration Indicator (R), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 Pulse CO-Oximeter also has a touchscreen and output interfaces, which include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output, and wireless radio.
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
Not Found
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
Clinical Studies: SpO2, SpCO and SpMet accuracy was determined by testing healthy adult volunteers in the range of 60-100% SpO2, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter. SpHb accuracy has been validated on healthy adult volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. The variation in these studies equals one standard deviation which encompasses 68% of the population. SpO₂ and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100% SaO2 and 0.5-2.5% MetHb with a resultant accuracy of 2 9% SpO2 and 0.9% SpMet.
Clinical Results: No device-related adverse events. The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7 specifications.
Key Metrics
Accuracy:
SpO2:
No Motion (adults/pediatrics/infants): 60-80 ± 3%; 70-100 ± 2%, ± 3%(neonates)
Motion (adults/pediatrics/infants/neonates): 70-100 ± 3%
Low Perfusion (adults/pediatrics/infants/neonates): 70-100 ± 2%
PR:
No Motion/ Low Perfusion(adults/pediatrics/ infants/neonates): 25-240 ± 3 bpm
Motion (adults/pediatrics/infants/neonates): 25-240 ± 5 bpm
SpCO: 1-40 + 3%, adults/pediatrics/infants
SpMet: 1-15 ± 1%, adults/pediatrics/infants/neonates
SpHb: 8-17 +1 g/dl (arterial or venous), adults/pediatrics
RRa: 4-70 + 1 breath per minute, adults
Predicate Device(s)
Reference Device(s)
Not Found
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
510(k) Summarv
MAR 1 7 2011
| Submitted by: | Masimo Corporation
40 Parker, Irvine, CA 92618
Phone: (949) 297-7000; FAX: (949) 297-7592 |
|---------------------------------|-------------------------------------------------------------------------------------------------|
| Contact | Shelly Harris, Manager of Regulatory Affairs |
| Date Summary Prepared | January 3, 2010. |
| Establishment Registration No. | 2031172 |
| Trade Name | Masimo Radical 7 Pulse CO-Oximeter and Accessories |
| Common Name | Pulse Oximeter and Sensor |
| Regulation Number/Name/ Class | 21 CFR 870.2700/ Oximeter/ Class II |
| Product Code | DQA, BZQ, DPZ, JKS |
| Substantially Equivalent Device | Masimo Rainbow SET® Radical 7R Pulse CO-Oximeters and Accessories
510(k) Number - K100428 |
Description of the Device
The Radical 7 Pulse CO-Oximeter and accessories (Radical 7) include the Masimo Rainbow SET technology. The Radical 7 Pulse CO-Oximeter provides nonitoring of arterial oxygen saturation (SpO3), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa). Other information displayed by the Radical 7 Pulse CO-Oximeter includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Hematocrit (SpHct), Signal Identification Quality (SIQa), Respiration Indicator (R), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 Pulse CO-Oximeter also has a touchscreen and output interfaces, which include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output, and wireless radio.
Intended Use/Indications for Use
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masino Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
Principles of Operation
SpO2 and Pulse Rate: Pulse oximetry is governed by the principles that blood contents differ in their absorption of red and infrared light and blood pulsation.
SpCO, SpMet, and SpHb: The Radical 7 includes the Masimo Rainbow SET technology board, which calculates functional oxygen saturation (SpO₂), fractional concentration of carboxyhemoglobin (SpCO), fractional concentration of methemoglobin (SpMet), total hemoglobin concentration (SpHb) and pulse rate.
Respiratory or Respiration Rate (RRa) General Description: The Masimo Rainbow SET technology also provides respiratory or respiration rate measurements, based on vibratory signals from respiratory sounds.
1
510(k) Summary
Comparison to Predicate Device
The Radical 7 in this filing is the same as the predicate in the K100428 filing, with the addition of wireless radio for remote monitoring, a Bluetooth radio module, and update to the user interface controls. Below are the specifications for the Radical 7.
| FEATURES | SPECIFICATIONS |
|---|---|
| Display Range | SpO2: 0-100%; PR: 25-240 bpm; SpCO: 0-99%; SpMet: 0-99.9%; SpHb: 0-25 g/dL; |
| RRa: 0-70 breaths per minute; SpOC: 0-35 ml/dl, SpHct: 0-75%; PI: 0.02-20%; PVI: 0-100% | |
| Accuracy: SpO2 | No Motion (adults/pediatrics/infants): 60-80 ± 3%; 70-100 ± 2%, ± 3%(neonates) |
| Motion (adults/pediatrics/infants/neonates): 70-100 ± 3% | |
| Low Perfusion (adults/pediatrics/infants/neonates): 70-100 ± 2% | |
| Accuracy: PR | No Motion/ Low Perfusion(adults/pediatrics/ infants/neonates): 25-240 ± 3 bpm |
| Motion (adults/pediatrics/infants/neonates): 25-240 ± 5 bpm | |
| Accuracy: SpCO | 1-40 + 3%, adults/pediatrics/infants |
| Accuracy: SpMet | 1-15 ± 1%, adults/pediatrics/infants/neonates |
| Accuracy: SpHb | 8-17 +1 g/dl (arterial or venous), adults/pediatrics |
| Accuracy: RRa | 4-70 + 1 breath per minute, adults |
| Resolution | SpO2: 1%; PR: 1 bpm; SpCO: 1%; SpMet: 0.1%; SpHb: 0.1 g/dl; RRa: 1 breath per minute |
| Measurements | Low Signal IQ, PI, SpOC, SpHct, PVI, SIQa, RI |
| Power | AC Input Range: 100-240 VAC, 47-63 Hz; Rechargeable batteries |
| Environmental | Op temp: 32 to 122°F; Storage temp: -40 to 158°F; RH: 10-95% non-condensing |
| SpO2 Averaging | Averaging: 2, 4, 6, 8, 10, 12 and 16 seconds; FastSat |
| Mode/ Sensitivity | Sensitivity: APOD, Normal, Maximum |
| Alarm | Volume (pulse/tone), out of limit (high/low), sensor condition, system failure, low battery |
| Display/ | |
| Indicators | SpO2, PR, SPCO, SpMet, SpHb, SpHbv, RRa, SpOC, SpHct, PI, PVI, Pleth waveform, SIQ |
| SIQa, RI, sensitivity, sensor status/time/messages, alarm status, battery status | |
| Output Interface | Trends, Satshare to Multiparameter monitors (SpO2 only), RS-232 (PC/printer), Vuelink, |
| Spacelabs Flexport, RadNet, PSN, wireless radio | |
| Compliance | EMC: EN 60601-1-2, Class B; Electrical Safety: IEC 60601-1/UL 60601-1, Class 1 (AC |
| Power), internally powered, patient cable-Type BF applied part, Satshare cable-type CF | |
| applied part; 802.11 a/b/g | |
| Operation Mode | Continuous |
Clinical Summary
Clinical Studies: SpO2, SpCO and SpMet accuracy was determined by testing healthy adult volunteers in the range of 60-100% SpO2, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter. SpHb accuracy has been validated on healthy adult volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. The variation in these studies equals one standard deviation which encompasses 68% of the population. SpO₂ and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100% SaO2 and 0.5-2.5% MetHb with a resultant accuracy of 2 9% SpO2 and 0.9% SpMet.
Clinical Results: No device-related adverse events. The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7 specifications.
Non-Clinical Summary
The Radical 7 complies with the voluntary standards as detailed in this submission. Laboratory testing for rne radical 7 compleo with the voluntary overify that the Radical 7 met all design specifications and was circularitially equivalent to the predicate device. This device was not tested for biocompatibility because like the predicate device, it does not contain any patient contacting materials.
2
510(k) Summary
Conclusions
·
·
. .
!
The information in this 510(k) submission demonstrates that the Masimo Radical 7 Pulse CO-Oximeter is substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
Ms. Shelly Harris Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
MAR 1 7 2011
Re: K110028
Trade/Device Name: Radical 7 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZQ, DPZ, JKS Dated: February 14, 2011 Received: February 15, 2011
Dear Ms. Harris:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2- Ms. Harris
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 (OS) 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/CDRHQffices/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 notification" (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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Radical 7 Pulse CO-Oximeter and Accessories Device Name:
Indications For Use:
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpQ₂) and pulse rate to multiparameter devices for the display of those devices.
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
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesional Devices Division of Anostrios of Antson of Antection Controllers
510(k) Number: K1100281
Special 510(k), Radical 7 01/03/2011, Page 4-1