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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies that support the device's performance, based on the provided 510(k) summary:

Masimo SET® and Masimo rainbow SET® Pulse Oximeters and Sensors (K120657)

This 510(k) pertains to labeling modifications for existing Masimo pulse oximeters and sensors to incorporate their use in screening newborns for Critical Congenital Heart Disease (CCHD), based on peer-reviewed clinical studies. It is not a de novo submission for a new device, nor does it present new performance data specific to the device itself within the 510(k) document. Instead, it leverages existing clinical evidence gathered on the predicate devices.

The acceptance criteria for this specific 510(k) submission are implicit: demonstrating that the existing Masimo devices meet the criteria established by the CCHD Workgroup and that there is sufficient clinical evidence (from published studies) to support the expanded labeling for CCHD screening.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for labeling modifications based on existing clinical evidence, the "acceptance criteria" are derived from the CCHD Workgroup's recommendations for suitable devices. The "reported device performance" refers to the capabilities of the Masimo devices as described in the submission and implicitly demonstrated in the cited clinical studies.

Acceptance Criteria (from CCHD Workgroup)	Reported Device Performance (by Masimo) / Implied in Studies
Device is motion-tolerant	Fully met by subject Masimo devices (per submission)
Reports functional oxygen saturation	Fully met by subject Masimo devices (per submission)
Has been validated in low perfusion conditions	Fully met by subject Masimo devices (per submission)
Cleared by the FDA for use in newborns	Masimo devices are already FDA-cleared for use in neonatal patients (per existing indications for use)
Effective for screening for low blood oxygen saturation to detect CCHD	Supported by two independent prospective clinical studies cited (see below)

2. Sample Size Used for the Test Set and Data Provenance

The "test set" here refers to the populations in the two clinical studies cited as evidence for CCHD screening.

Study 1 (Sweden):
- Sample Size: 39,821 newborn subjects
- Data Provenance: Prospective clinical study, conducted at 5 maternity centers in Sweden.
- Device Used: Masimo Radical pulse oximeter (Masimo Rad 5, Rad 5v, and Rad 8 systems incorporate the same Masimo SET technology).
Study 2 (UK):
- Sample Size: 20,055 newborn subjects
- Data Provenance: Prospective clinical study, conducted at 6 maternity centers in the UK.
- Device Used: Masimo Radical 7 pulse CO-Oximeter (Masimo Rad 57 and Rad 87 systems incorporate the same Masimo rainbow SET technology).

The submission does not specify a separate "test set" in the context of a typical algorithm validation for a new device. Instead, these are real-world prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The provided 510(k) summary does not detail the number or qualifications of experts used to establish ground truth for the two cited clinical studies. These studies were published in peer-reviewed literature, implying that their methodologies, including ground truth establishment, would have been subject to scientific vetting. For CCHD screening, ground truth typically involves a combination of echocardiography, clinical examination, and tracking of health outcomes.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify any adjudication method for establishing ground truth within the cited clinical studies. This information would typically be found within the full peer-reviewed publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, as this submission is for a medical device (pulse oximeter) that provides direct measurements, not an AI interpretation that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The clinical studies cited, while involving human operators for device application and data interpretation in a clinical setting, evaluate the performance of the device's measurement algorithm (Masimo SET and Masimo rainbow SET technology) in detecting low oxygen saturation in newborns, which is the direct output of the algorithm. The "standalone" performance here refers to the accuracy and reliability of the oximeter's readings in a real-world screening scenario, as published in the referenced studies.

7. The Type of Ground Truth Used

The specific type of ground truth used in the two cited clinical studies is not explicitly detailed in the 510(k) summary. However, for CCHD screening studies, the ground truth for "critical congenital heart disease" is typically established through:

Confirmed diagnosis by echocardiography: This is often considered the gold standard for diagnosing structural heart defects.
Clinical outcomes: This includes diagnosis during hospitalization, surgical intervention, or adverse events related to undiagnosed CCHD.
Expert clinical diagnosis: Based on a thorough medical evaluation by pediatric cardiologists or neonatologists.

The studies found "sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD," implying that the ground truth used allowed for this correlation to be made.

8. The Sample Size for the Training Set

This 510(k) is for existing devices, and the studies cited are validation studies for the application of CCHD screening, not studies used to develop or train the pulse oximetry algorithms themselves. The Masimo SET and Masimo rainbow SET technologies were developed prior to these studies. Therefore, no specific "training set" for the oximeter's core algorithm (which measures SpO2, PR, etc.) is discussed in the context of this 510(k) for labeling changes. The pulse oximetry technology itself would have gone through its own development and validation using various physiological models and human subject data.

9. How the Ground Truth for the Training Set was Established

As mentioned above, this 510(k) does not describe the specific training set or how ground truth was established for the development of the Masimo pulse oximetry algorithms. The technology was already developed and cleared prior to these CCHD screening studies. Typically, ground truth for pulse oximeter algorithm development involves:

Controlled desaturation studies: Where subjects' oxygen saturation is precisely controlled and measured directly via arterial blood gas analysis (co-oximetry) while simultaneous pulse oximeter readings are taken.
Physiological models: Use of simulators or animal models.

Summary

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510(k) Summary: K120657

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Contact	Patricia MilbankVice President, Regulatory Affairs
Date Summary Prepared	September 14, 2012
Trade Name	Masimo SET® Rad 5 Pulse OximeterMasimo SET® Rad 5v Pulse OximeterMasimo SET® Rad-8 Pulse OximeterMasimo rainbow SET® Rad 57 Pulse CO-OximeterMasimo rainbow SET® Radical 7 Pulse CO-OximeterMasimo rainbow SET® Rad 87 Pulse CO-OximeterMasimo LNOP Oximetry SensorsMasimo LNCS/M-LNCS Oximetry SensorsMasimo LNOP/M-LNCS/LNCS Multisite-L Oximetry SensorsMasimo LNOP/M-LNCS/LNCS Y-I Oximetry SensorsMasimo ReSposable SpO2 Series Oximetry Sensors
Common Name	Pulse Oximeter and Oximeter Sensor
Regulation Number/Class	21 CFR 870.2700 / Class II
Product Code	DQA
SubstantiallyEquivalent 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 (K110280Masimo rainbow SET® Rad 87 Pulse CO-Oximeter (K091241)Masimo LNOP Oximetry Sensors (K111888)Masimo LNCS/M-LNCS Oximetry Sensors (K051212 andK101896)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

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K120657 Pg 20f2

Description of the Device

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 (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

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510(k) Number: K120657

Device Name: Masimo SET® Rad 5 Pulse Oximeter

Indications for Use:

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)

(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:

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

(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:

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)

്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:

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:

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:

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:

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:

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 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:

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:

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

Regulation Number and Section

§ 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).