MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS

K120657 · Masimo Corporation · DQA · Sep 19, 2012 · Cardiovascular

Device Facts

• Record ID: K120657
• Device Name: MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Masimo SET and rainbow SET pulse oximeters/CO-oximeters use noninvasive optical sensors to measure arterial oxygen saturation, pulse rate, and (in rainbow models) carboxyhemoglobin, methemoglobin, total hemoglobin, and respiration rate. Devices utilize motion-tolerant signal processing to provide data in clinical settings (hospitals, nurseries, home). This submission updates labeling to include newborn screening protocols for critical congenital heart disease (CCHD) based on clinical studies. Clinicians use output to screen newborns for low blood oxygen saturation, facilitating early detection of CCHD. Devices are intended for use by healthcare professionals in well-infant and intermediate care nurseries.

Clinical Evidence

No new clinical trials were conducted for this submission. Evidence relies on two cited prospective clinical studies: one involving 39,821 newborns using Masimo SET technology and another involving 20,055 newborns using Masimo rainbow SET technology. These studies demonstrated the efficacy of pulse oximetry screening for detecting critical congenital heart disease (CCHD) in well-infant and intermediate care nurseries.

Technological Characteristics

Devices utilize Masimo SET (Signal Extraction Technology) and rainbow SET technology for noninvasive optical monitoring. Features include motion-tolerant signal processing and validation for low perfusion conditions. Form factors include handheld and bedside monitors with compatible optical sensors. Connectivity includes data output to multi-parameter displays. No changes to hardware or materials were made in this submission.

Indications for Use

Indicated for continuous or non-continuous noninvasive monitoring of functional SpO2, pulse rate, and (for rainbow SET models) SpCO, SpMet, SpHb, and RRa. Applicable to adult, pediatric, infant, and neonatal patients, including those with motion or poor perfusion, in hospital, mobile, and home settings.

Regulatory Classification

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.

Predicate 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)

Submission Summary (Full Text)

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# 510(k) Summary: K120657

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Patricia Milbank<br>Vice President, Regulatory Affairs |
| Date Summary Prepared | September 14, 2012 |
| Trade Name | Masimo SET® Rad 5 Pulse Oximeter<br>Masimo SET® Rad 5v Pulse Oximeter<br>Masimo SET® Rad-8 Pulse Oximeter<br>Masimo rainbow SET® Rad 57 Pulse CO-Oximeter<br>Masimo rainbow SET® Radical 7 Pulse CO-Oximeter<br>Masimo rainbow SET® Rad 87 Pulse CO-Oximeter<br>Masimo LNOP Oximetry Sensors<br>Masimo LNCS/M-LNCS Oximetry Sensors<br>Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors<br>Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors<br>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<br>Equivalent Devices: | Masimo SET Rad 5 Pulse Oximeter (K033296) |
| | Masimo SET Rad 5v Pulse Oximeter (K040214)<br>Masimo SET Rad 8 Pulse Oximeter (K092838)<br>Masimo rainbow SET® Rad 57 Pulse CO-Oximeter (K080238)<br>Masimo rainbow SET® Radical 7 Pulse CO-Oximeter (K110280<br>Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241)<br>Masimo LNOP Oximetry Sensors (K111888)<br>Masimo LNCS/M-LNCS Oximetry Sensors (K051212 and<br>K101896)<br>Masimo LNOP/M-LNCS/LNCS Multisite-L Oximetry Sensors<br>(K111888)<br>Masimo LNOP/M-LNCS/LNCS Y-I Oximetry Sensors (K012992)<br>Masimo ReSposable SpO2 Series Oximetry Sensors (K111621) |

SEP 19 2012

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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

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## 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.

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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 [phone] or [phone] 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

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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

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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

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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

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#### 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

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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

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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)

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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

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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

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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

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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

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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