The Masimo Acoustic Monitoring Sensor is a single-patient use device consisting of a piezoelectric sensor element and an adhesive strip that is attached to the patient's neck for the purpose of noninvasive respiratory rate monitoring in adult and pediatric patients (> 10 kg). As with the predicate Masimo Acoustic Monitoring Sensor (model RAS-125 for adults only), the RAS-125c for pediatric patients is intended to be attached via cable to a pulse oximeter monitor incorporating the Masimo Rainbow® Acoustic Monitoring™ technology to provide a continuous display of the patient's acoustic respiratory rate. Suitable pulse oximeter monitors include the previously cleared Radical 7 and Rad 87 devices.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Masimo Acoustic Monitoring Sensors, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Stated as "Accuracy Range")	Reported Device Performance (Clinical Validation)
Breaths per Minute (bpm) (RAS-125)	4 to 70 ± 1 breath per minute	Up to 30 bpm in adult subjects >30 kg
Breaths per Minute (bpm) (RAS-125c)	4 to 70 ± 1 breath per minute	Up to 30 bpm in adult patients >10 kg; Up to 50 bpm in hospitalized pediatric subjects (age ≥ 2 years, >10kg)
Body Weight (RAS-125)	Adult > 30 kg	Adult > 30 kg
Body Weight (RAS-125c)	Adult, Pediatric > 10 kg	Adult, Pediatric > 10 kg
Application Site	Neck	Neck

Note: The document states "Accuracy Range 4 to 70 ± 1 breath per minute" in the table under "Breaths per Minute" for both models, implying this is the overall target accuracy. However, the subsequent text specifies the clinical validation ranges achieved within that overall range.*

2. Sample Size and Data Provenance

Test Set Sample Size:
- Healthy adult volunteers: n=26
- Hospitalized post-surgical adult subjects: n=26
- Hospitalized post-surgical pediatric subjects: n=26
Data Provenance: The study in hospitalized post-surgical pediatric subjects was conducted at "3 hospital centers in the United States." The provenance for the adult studies is not explicitly stated, but it can be inferred to be from clinical settings given the description of "healthy adult volunteers" and "hospitalized post-surgical adult subjects." All studies are retrospective in nature given that they describe completed studies where data was obtained rather than ongoing collection.

3. Number of Experts and Qualifications for Ground Truth

The document states "a comparison of a manual count of respiratory rate." This implies that human observers (experts) were used to manually count respirations.
Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified. The document only mentions "a comparison of a manual count of respiratory rate," without detailing how discrepancies between multiple manual counts (if any were performed) would be resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly mentioned. The study described focuses on the accuracy of the device against a manual count, not on how human readers' performance might improve with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Accuracy data was obtained from a comparison of a manual count of respiratory rate in healthy adult subjects and in hospitalized pediatric subjects" directly describes the device's performance (algorithm only, as it's a sensor taking measurements) against a ground truth.

7. Type of Ground Truth Used

Expert Consensus (Manual Count): The ground truth was established by "a manual count of respiratory rate."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The clinical studies mentioned (n=26 for each group) appear to be for validation/testing.

9. How Ground Truth for the Training Set Was Established

The document does not provide information about a separate training set or how its ground truth might have been established. The clinical validation studies describe the process for establishing ground truth for the test/validation data.

Summary

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510(k) Summary: K120984

APR 2 6 2013

Submitter:	Masimo Corporation40 ParkerIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Contact:	Patricia MilbankVice President, Regulatory Affairs
Date SummaryPrepared:	April 23, 2013
Trade Name:	Masimo Acoustic Monitoring Sensors (adult/pediatric)
Common Name:	Pulse Oximeter
Classification Name:	DQA - Oximeter (870.2700)BZQ - Breathing frequency monitor (868.2375)
Predicate Device:	K091241 – Masimo Rainbow SET® Rad-87 Pulse CO-Oximeterand Masimo Acoustic Monitoring Sensor (adult)

Description of the Device

Indications for Use

The Rainbow Acoustic Monitoring™ sensors and cables are indicated for continuous, noninvasive monitoring of respiratory rate (RRaTM).

The RAS-125 is indicated for adult patients in hospital-type facilities, mobile and home environments.

The RAS-125c is indicated for adult and pediatric patients in hospital-type facilities, mobile and home environments.

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Contraindications

The RAS-125 and RAS-125c sensors are contraindicated in patients who exhibit allergic reactions to foam rubber products and/or adhesive tape.

Results from Clinical Studies

Accuracy data was obtained from a comparison of a manual count of respiratory rate in healthy adult subjects and in hospitalized pediatric subjects for whom post-operative monitoring of respiratory rate was indicated.

Respiration rate accuracy for the Rainbow Acoustic Monitoring sensor and instrument has been validated for the range of 4 to 70 breaths per minute in bench top testing. Clinical validation was performed with the RAS-125 and RAS-125c sensors and instrument for up to 30 breaths per minute in adult subjects >30 kg, and up to 50 breaths per minute in hospitalized pediatric subjects, age 2 years or older and >10kg.

	RAS-125	RAS-125c
Body Weight	Adult > 30 kg	Adult, Pediatric > 10 kg
Application Site	Neck	Neck
Breaths per Minute,Accuracy Range*	4 to 70 ± 1 breath per minute	4 to 70 ± 1 breath per minute

The accuracy of this device has not been validated for monitoring of respiratory rate in patients with specific medical conditions, e.g., asthma, COPD or cystic fibrosis. Accuracy of the sensor has not been validated in infants or neonates.

Test Summary

The RAS-125 and RAS-125c sensors comply with the voluntary standards as detailed in Section 9 of this submission and the following quality assurance, verification and validation measures were included in the development process:

Design control activities per 21 CFR 820 .
Risk analysis and risk management activities per ISO 14971 .
Software verification and validation testing per 21 CFR 820 and the applicable FDA . guidance documents (General Principles of Software Validation, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, and Off-The-Shelf Software Use in Medical Devices)
Biocompatibility testing per EN ISO 10993 for patient skin contacting, prolonged . duration materials, including cytotoxicity, skin irritation and sensitization
Environmental testing (operating temperature, humidity, fluid ingress), safety and . mechanical testing per ISO 9919
Electromagnetic compatibility per IEC 60601-1-2 .
Electrical safety testing per IEC 60601-1 �
Two non-randomized clinical validation studies in healthy adult volunteers (n=26) and .

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hospitalized post-surgical adult subjects (n=26)

A non-randomized clinical validation study in hospitalized post-surgical pediatric . subjects (n=26), conducted at 3 hospital centers in the United States .

Conclusion

The information in this 510(k) submission demonstrates that the Masimo RAs-125 and RAS-125c Acoustic Respiration Sensors are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance, when used in adult and pediatric patients.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2013

Ms. Patricia Milbank Vice President, Regulatory Affairs Masimo Corporation 40. Parker_ IRVINE CA 92618

Re: K120984

Trade/Device Name: Masimo Acoustic Respiration Sensor (Adult/Pediatric) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZA Dated: March 13, 2013 Received: March 14, 2013

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. Milbank

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Digitally signed by Mary 5. Runner -5
ON: c=US, o=U.S. Government,
ou-HHS, ou=FDA, ou=People,
Susan Runner, DOSMA cn=Mary 5. Runner -S,
0.9.2342.19200300.100.1.1=13000879
50
Date: 2013.04.26 07:26:55 -04'00'

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number: K120984

Masimo Acoustic Respiration Sensor (Adult/Pediatric) Device Name: ________

Indications for Use:

The Rainbow Acoustic Monitoring™ sensors and cables are indicated for continuous, noninvasive monitoring of respiratory rate (RRaTM).

The RAS-125 is indicated for adult patients in hospital-type facilities, mobile and home environments.

The RAS-125c is indicated for adult and pediatric patients 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)

Chan O. Lee -S
2013.04.25 14:13:49
-04'00' For LS

thesiology, General Hospital on Control, Dental Devices

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).