Masimo Acoustic Respiration Sensors, infant and neonate

K173976 · Masimo Corporation · BZQ · Sep 5, 2018 · Anesthesiology

Device Facts

• Record ID: K173976
• Device Name: Masimo Acoustic Respiration Sensors, infant and neonate
• Applicant: Masimo Corporation
• Product Code: BZQ · Anesthesiology
• Decision Date: Sep 5, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

Device Story

Device is a disposable, single-use piezoelectric sensor applied to infant/neonatal chest to capture acoustic respiratory signals (vibrations). Sensor connects via dual cable to compatible pulse oximeter monitor. Monitor digitizes signals, evaluates frequency of signal envelope, and calculates real-time respiratory rate. Used in hospitals, home environments, and transport by clinicians or caregivers. Output displayed on oximeter screen; assists clinicians in continuous respiratory monitoring. Benefits include noninvasive, continuous tracking of respiratory rate in small patients.

Clinical Evidence

Clinical study on convenience sample of infant/neonatal patients. Raw acoustic data collected via production-equivalent sensors and processed through RAS-45 Inf/Neo algorithm. Compared against manual/auditory annotation (ground truth) and capnography. Results: Accuracy Root Mean Square (Arms) of 1.1 breaths per minute vs. manual reference; 1.1 Arms vs. 2.1 Arms for capnography.

Technological Characteristics

Piezoelectric sensor element; adhesive strip; M6 rainbow® connector. Patient-contacting materials ISO 10993 compliant. Dimensions 2.18" x 1.7" x 0.12". Powered by host oximeter. Non-sterile. Connectivity via dual cable to Masimo rainbow® Acoustic Monitoring-enabled pulse oximeter.

Indications for Use

Indicated for continuous, noninvasive respiratory rate monitoring in infant and neonatal patients weighing < 10 kg. Not indicated for apnea monitoring.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Masimo Acoustic Respiration Sensor (K120984)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2018

Masimo Corporation Sindura Penubarthi Regulatory Affairs Specialist 52 Discovery Irvine, California 92618

Re: K173976

Trade/Device Name: Masimo Acoustic Respiration Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, BZQ Dated: August 3, 2018 Received: August 6, 2018

Dear Ms. Penubarthi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K173976

Device Name Masimo Acoustic Respiration Sensors

#### Indications for Use (Describe)

The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red symbol to the left of the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the company's address, which is "52 Discovery, Irvine CA 92618".

#### 510(k) Summary Section 5:

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 27, 2017 |
| Contact: | Sindura Penubarthi<br>Regulatory Affairs Manager |
| Trade Name: | Masimo Acoustic Respiration Sensors |
| Common Name: | Pulse Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/DQA - oximeter |
| Secondary Classification/<br>Product Code: | Class II/BZQ - breathing frequency monitor |
| Establishment Registration<br>Number: | 2031172 |
| Reason for Premarket<br>Notification: | New Device |
| Predicate Device: | K120984 - Masimo Acoustic Respiration Sensor (adult/pediatric) |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514 of the Food and Drug<br>Administration Modernization Act of 1997 (FDAMA) |

### 5.1 Device Description

The subject device, the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo, is a noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest for the purpose of noninvasive respiration/respiratory rate monitoring in infant and neonatal patients (< 10 kg). Like the predicate (K120984), the RAS-45 Inf/Neo sensor is a rainbow Acoustic Monitoring® sensor intended to be used with, and attached via dual cable to, pulse oximeter monitors incorporating the Masimo rainbow® Acoustic Monitoring technology to provide a continuous calculation and display of the patient's acoustic respiration/respiratory rate (RRa®).

## 5.2 Intended Use/Indications for Use

The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa"). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospital-type facilities, home

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red circle with a white checkmark inside, followed by the company name in bold, black letters. To the right of the logo is the company's address, which is 52 Discovery, Irvine CA 92618.

#### Section 5: 510(k) Summary

environments, and transport within healthcare facilities.

The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

### 5.3 Device Specifications

Specifications of the RAS-45 Inf/Neo are provided in Table 5.1 below.

| Table 5.1 Specifications of RAS-45 Inf/Neo | | |
|--------------------------------------------|-----------------------------------------------|--|
| Feature | Specification | |
| Application Site | Chest | |
| Body Weight | Infant, Neonate < 10 kg | |
| Type of Use | Single-use | |
| Sterility | Supplied non-sterile | |
| Performance | | |
| Respiration Rate Measurement | 4-120 breaths per minute | |
| Range | | |
| Respiration Rate Measurement | ± 1 breaths per minute, over the entire range | |
| Accuracy | | |
| Physical | | |
| General Overall Dimensions | 2.18" x 1.7" x 0.12" | |
| Weight | 13 grams | |
| Shelf Life | 2 years | |
| Patient-Contacting Materials | ISO 10993 compliant | |
| Electrical | | |
| Interface | M6 rainbow® connector | |
| Type of Power | Oximeter dependent | |
| Environmental | | |
| Operating Temperature | +5°C to +40°C, ambient humidity | |
| Storage/Transport Temperature | -40°C to +60°C, ambient humidity | |
| Storage/Transport Humidity | 10% to 95%, non-condensing | |

### 5.4 Technological Characteristics

### 5.4.1 Principle of Operation

Rainbow® Acoustic Monitoring involves capture of the acoustic signals (vibrations) associated with respiration via a piezoelectric sensor attached to the measurement site (i.e., patient's chest). The captured signals are transmitted via the sensor cable and the dual cable to a compatible pulse oximeter monitor where they are digitized and the frequency of the resultant signal envelope (outline) is evaluated to provide and display a real-time, continuous respiratory rate.

### 5.4.2 Mechanism of Action

The pulse oximeter is turned on for its operation. The RAS-45 Inf/Neo sensor is applied to the patient's chest. The RAS 45 Inf/Neo sensor and an SpO2 sensor are connected to a dual channel cable.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red circle with a white checkmark inside, followed by the company name in black, bold letters. To the right of the logo is the company's address, which is 52 Discovery, Irvine CA 92618.

#### Section 5: 510(k) Summary

The dual channel cable is connected to a pulse oximeter that has the Masimo rainbow" Acoustic Monitoring technology. The pulse oximeter displays acoustic respiration/respiratory rate (RRa) measurements. Once use is complete, the user turns the pulse oximeter power "off" and removes the sensor from the patient.

### 5.5 Summary of Similarities and Difference between the Subject and Predicate Devices

The subject device, RAS-45 Inf/Neo, and the predicate device, RAS-125c (K120984), have the following key similarities:

- . both have the same intended use,
- both have the same technological characteristics, including principle of operation (except that the subject device intended to be applied to the patient's chest, rather than the neck) and mechanism of action,
- . both have the same intended environment (e.g., hospital-type facilities, mobile and home environments), and
- both have the same acoustic respiration/respiratory rate (RRa) measurement accuracy (± 1 ● breaths per minute).

The subject device, RAS-45 Inf/Neo, and the predicate device, RAS-125c, have the following key differences:

- the subject device is designated for use with infant and neonatal patients (< 10 kg) whereas the predicate device is designated for use with adult and pediatric patients (> 10 kg),
- . the subject device has a respiration/respiratory rate (RRa) measurement range of 4 to 120 breaths per minute whereas the predicate device has a measurement range of 4 to 70 breaths per minute,
- the subject device is intended to be applied to the patient's chest whereas the predicate device ● is intended to be applied to the patient's neck, and
- . the subject device has a circular shape and a smaller footprint than the predicate device.

Table 5.2 compares specification differences between the RAS-45 Inf/Neo and the RAS-125c.

| Table 5.2 RAS-45 Inf/Neo and RAS-125c Comparison | | |
|--------------------------------------------------|----------------------------------|---------------------------------|
| Feature | Specifications | |
| | RAS-45 Inf/Neo | RAS-125c |
| Application Site | Chest | Neck |
| Body Weight | Infant, Neonate < 10 kg | Adult, Pediatric > 10 kg |
| Range and Accuracy,<br>(breaths per minute) | 4-120 ± 1, over the entire range | 4-70 ± 1, over the entire range |
| Sensor Shape | Circular | Rectangular |

### 5.6 Non-Clinical Testing

Bench testing was performed on the subject device to validate measurement accuracy (of ± 1 breaths

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red circle with a white checkmark inside, followed by the company name in black, bold letters. To the right of the logo is the company's address, which is 52 Discovery, Irvine CA 92618.

# Section 5: 510(k) Summarv

per minute) for the entire measurement range of 4 to 120 breaths per minute. Additionally, the following non-clinical testing, as applicable, was performed in accordance with Masimo design control requirements and quality system to demonstrate substantial equivalence of the subject device with its predicate:

- Electromagnetic Compatibility and Electrical Safety testing per IEC 60601-1 .
- EMC testing per: ●
- o IEC-60601-1-2
- ISO 80601-2-61 Clause 202.6.2.3 o
- IEC 60601-2-49 Section 202.6.2.101 O
- AIM 7351731 O
- . Usability testing per FDA Human Factors and Usability Guidance
- . Testing per IEC 60601-1-11
- . Biocompatibility testing per ISO-10993
- Mechanical testing per ISTA-2A and MIL-STD 810E ●
- Environmental testing per IEC-60601-1 ●

### 5.7 Clinical Testing

Clinical testing was completed to assess clinical performance of the subject device in the infant and neonate population. Production equivalent sensors, connected to pulse oximeters with Masimo rainbow® Acoustic Monitoring technology, were applied to a convenience sample of infant and neonatal patients to gather raw acoustic data. The production equivalent sensors were physically and functionally identical to the RAS-45 Inf/Neo, and only differed in that the sensors did not identify themselves as RAS-45 Inf/Neo sensors to the pulse oximeters. The raw acoustic data was processed through the RAS-45 Inf/Neo algorithm and, as with the predicate K120984, compared against clinicians manually annotating the raw acoustic data. The results showed that the Ams (Accuracy Root Mean Square) of the subject device was 1.1 breaths per minute when compared to the manual/auditory reference method. Clinical performance of the subject device was further assessed by comparison to the performance of a capnography device in a similar infant and neonatal patient population, and the results showed comparable performance (See Table 5.3).

| Table 5.3 – Comparison of Clinical Performance of RAS-45 Inf/Neo vs. Capnograph | |
|---------------------------------------------------------------------------------|----------------------------|
| Device | Arms (breaths per minute)* |
| RAS-45 Inf/Neo* | 1.1 |
| Capnograph* | 2.1 |

* Assessment of clinical performance was based on convenience sampling on two similar cohorts of patients.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo consists of a red symbol on the left and the company name "Masimo" in black text to the right of the symbol. Below the company name is the address "52 Discovery Irvine CA 92618".

# Section 5: 510(k) Summary

## 5.8 Conclusion

The information in this 510(k) submission demonstrates that the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is substantially equivalent to the predicate device.