(198 days)
Not Found
No
The document describes standard pulse oximetry technology and clinical studies for CCHD screening, with no mention of AI or ML.
No
The device is indicated for monitoring various physiological parameters (e.g., SpO2, pulse rate, SpCO, SpMet, SpHb, RRa) and for screening for critical congenital heart disease (CCHD), which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is described as "noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate" and the "indications for use" specify "continuous noninvasive monitoring" of various physiological parameters (SpO2, pulse rate, carboxyhemoglobin saturation, methemoglobin saturation, total hemoglobin concentration, and/or respiratory rate). The text also mentions its use for "screening newborn patients for critical congenital heart disease (CCHD)", all of which are diagnostic functions.
No
The device description explicitly mentions "Masimo SET® and Masimo rainbow SET® Pulse Oximeter instruments and sensors," indicating the device includes hardware components (instruments and sensors) in addition to any potential software.
Based on the provided text, the Masimo Rad 5 Pulse Oximeter and the other listed Masimo devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The text explicitly states that these devices provide noninvasive monitoring of physiological parameters like oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin, total hemoglobin, and respiratory rate. This means they measure these values directly from the patient's body without requiring a sample to be taken and analyzed outside the body.
- Intended Use: The intended use describes the devices as being used for continuous or non-continuous noninvasive monitoring of these parameters in various patient populations and settings. This aligns with non-invasive physiological monitoring, not in vitro testing.
Therefore, these devices fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Masimo Rad 5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad 5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5v Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo 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 Rainbow Rad 8 Pulse Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rad 57 Pulse CO-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) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rad 57 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive 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 and 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 non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter end accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The Masimo Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive 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 (RR). The Masimo Rad 87 Pulse CO- . Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitaltype facilities, mobile, and home environments.
The Masimo LNCS/M-LNCS Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo ReSposable SpO2 Series Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and 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
Device Description
Masimo SET® and Masimo rainbow SET® Pulse Oximeter instruments and sensors provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR). The Masimo rainbow SET technology also provides nonitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa).
This 510(k) is being submitted to support modifications to the device labeling to incorporate the results of clinical trials described in peer-reviewed publications regarding the use of Masimo pulse oximeters and sensors intended to screen newborn patients for critical congenital heart disease (CCHD). These modifications include the published newborn screening protocol for CCHD recommended by a work group selected by SACHDNC, AAP, ACCF and AHA (the "CCHD Workgroup"), and instructions regarding proper use of the subject Masimo devices to implement this protocol.
These labeling changes are being made in direct response to action taken by HHS in September 2011 adding pulse oximeter screening of newborns for CCHD to the Federal Recommended Uniform Screening Panel (RUSP) Guidelines. These guidelines recommend use of devices that a) are motion-tolerant, b) report functional oxygen saturation, c) have been validated in low perfusion conditions; and d) have been cleared by the FDA for use in newborns, criteria that are fully met by the subject Masimo devices.
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, newborn, infant
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, and home 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)
Clinical Summary:
In reaching their recommendations, the CCHD Workgroup relied upon two independent prospective clinical studies finding "... sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD in well-infant and intermediate care nurseries."
In both of these studies, the investigators selected the Masimo SET technology and the Masimo rainbow SET technology for newborn screening as follows:
- A prospective clinical study of 39,821 newborn subjects at 5 maternity centers in Sweden . using the Masimo Radical pulse oximeter.
- A prospective clinical study of 20,055 newborn subjects at 6 maternity centers in the UK ● using the Masimo Radical 7 pulse CO-Oximeter.
Non-Clinical Summary:
No non-clinical studies were required to support the proposed changes to the labeling regarding the use of the Masimo SET and Masimo rainbow SET technologies to perform screening of newborn subjects for CCHD. The Masimo pulse oximeter devices comply with the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K033296, K040214, K092838, K080238, K110280, K091241, K111888, K051212, K101896, K111888, K012992, K111621
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
510(k) Summary: K120657
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Patricia Milbank
Vice President, Regulatory Affairs |
| Date Summary Prepared | September 14, 2012 |
| Trade Name | Masimo SET® Rad 5 Pulse Oximeter
Masimo SET® Rad 5v Pulse Oximeter
Masimo SET® Rad-8 Pulse Oximeter
Masimo rainbow SET® Rad 57 Pulse CO-Oximeter
Masimo rainbow SET® Radical 7 Pulse CO-Oximeter
Masimo rainbow SET® Rad 87 Pulse CO-Oximeter
Masimo LNOP Oximetry Sensors
Masimo LNCS/M-LNCS Oximetry Sensors
Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors
Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors
Masimo ReSposable SpO2 Series Oximetry Sensors |
| Common Name | Pulse Oximeter and Oximeter Sensor |
| Regulation Number/Class | 21 CFR 870.2700 / Class II |
| Product Code | DQA |
| Substantially
Equivalent Devices: | Masimo SET Rad 5 Pulse Oximeter (K033296) |
| | Masimo SET Rad 5v Pulse Oximeter (K040214)
Masimo SET Rad 8 Pulse Oximeter (K092838)
Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238)
Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K110280
Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241)
Masimo LNOP Oximetry Sensors (K111888)
Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and
K101896)
Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors
(K111888)
Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012992)
Masimo ReSposable SpO2 Series Oximetry Sensors (K111621) |
SEP 19 2012
1
K120657 Pg 20f2
Description of the Device
Masimo SET® and Masimo rainbow SET® Pulse Oximeter instruments and sensors provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR). The Masimo rainbow SET technology also provides nonitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa).
This 510(k) is being submitted to support modifications to the device labeling to incorporate the results of clinical trials described in peer-reviewed publications regarding the use of Masimo pulse oximeters and sensors intended to screen newborn patients for critical congenital heart disease (CCHD). These modifications include the published newborn screening protocol for CCHD recommended by a work group selected by SACHDNC, AAP, ACCF and AHA (the "CCHD Workgroup"), and instructions regarding proper use of the subject Masimo devices to implement this protocol.
These labeling changes are being made in direct response to action taken by HHS in September 2011 adding pulse oximeter screening of newborns for CCHD to the Federal Recommended Uniform Screening Panel (RUSP) Guidelines. These guidelines recommend use of devices that a) are motion-tolerant, b) report functional oxygen saturation, c) have been validated in low perfusion conditions; and d) have been cleared by the FDA for use in newborns, criteria that are fully met by the subject Masimo devices.
Clinical Summary
In reaching their recommendations, the CCHD Workgroup relied upon two independent prospective clinical studies finding "... sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD in well-infant and intermediate care nurseries."1
In both of these studies, the investigators selected the Masimo SET technology and the Masimo rainbow SET technology for newborn screening as follows:
- A prospective clinical study of 39,821 newborn subjects at 5 maternity centers in Sweden . using the Masimo Radical pulse oximeter.3 The Masimo Rad 5, Rad 5v and Rad 8 systems incorporate the same Masimo SET technology used in this study.
- A prospective clinical study of 20,055 newborn subjects at 6 maternity centers in the UK ● using the Masimo Radical 7 pulse CO-Oximeter.4 The Masimo Rad 57 and Rad 87 systems incorporate the same Masimo rainbow SET technology used in this study.
Non-Clinical Summary
No non-clinical studies were required to support the proposed changes to the labeling regarding the use of the Masimo SET and Masimo rainbow SET technologies to perform screening of newborn subjects for CCHD. The Masimo pulse oximeter devices comply with the requirements
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 19 2012
Masimo Corporation c/o Patricia Milbank, JD Vice President, Regulatory Affairs 40 Parker Irvine, CA 92618
Re: K120657
Trade/Device Name: Masimo SET and Masimo rainbow SET Pulse Oximeters and Sensors Regulation Number: 21 CFR 8870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 14, 2012 Received: September 17, 2012
Dear Ms. Milbank:
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.
3
Page 2 - Ms. Patricia Milbank, JD
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 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 yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K120657
Device Name: Masimo SET® Rad 5 Pulse Oximeter
Indications for Use:
The Masimo Rad 5 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices 51 C(k) Number K12065
5
510(k) Number: K120657
Device Name: Masimo SET® Rad 5v Pulse Oximeter
Indications for Use:
The Masimo Rad 5v Pulse Oximcter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo Rad 5v Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e
(Division Sign-C Division of C 510(k) Number
6
510(k) Number: K120657
Device Name: Masimo SET® Rad 8 Pulse Oximeter
Indications for Use:
The Masimo 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 Rainbow Rad 8 Pulse Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Indications for Use
WE
(Division Slan-Off) 510(k) Number
7
510(k) Number: K120657
Device Name: Masimo Rainbow SET® Rad 57 Pulse CO-Oximeter
Indications for Use:
The Masimo Rad 57 Pulse CO-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) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rad 57 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
he
്ഷം Sign-Off) : Asion of Cardiovascular Devices 510(k) Number K12045
8
510(k) Number: K120657
Device Name: Masimo rainbow SET® Radical 7 Pulse CO-Oximeter
Indications for Use:
The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive 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 and 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 non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter end accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign Sign-Off) sion of Cardiovascular Devlaes 510{k} Number
9
510(k) Number: K120657
Device Name: Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter
Indications for Use:
The Masimo Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive 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 (RR). The Masimo Rad 87 Pulse CO- . Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
10
510(k) Number: K120657
Device Name: Masimo LNOP Oximetry Sensors
Indications for Use:
The Masimo LNOP Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitaltype facilities, mobile, and home environments.
Prescription Usc X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 510(k) Number
11
510(k) Number: K120657
Device Name: Masimo LNCS/M-LNCS Oximetry Sensors
Indications for Use:
The Masimo LNCS/M-LNCS Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
:
Sign-Off)
on of Cardiovascular Devices
510(k) Number K120657
12
510(k) Number: K120657
Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors Device Name:
Indications for Use:
The Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
We
(Division Sigh-Off) Division of Cardiovascular Devices 510(k) Number
13
510(k) Number: K120657
Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors Device Name:
Indications for Use:
The Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
... . on Sidn-Off Division of C SIO(k) Numb
14
510(k) Number: K120657
Device Name: Masimo ReSposable SpO2 Series Oximetry Sensors
Indications for Use:
The Masimo ReSposable SpO2 Series Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of Cardiovascular Devices 47065 510(k) Number