(250 days)
No
The summary describes a sensor that uses a piezoelectric element to capture acoustic data and an algorithm to process it. There is no mention of AI, ML, or related concepts like training sets or complex models. The performance evaluation compares the device's algorithm to manual annotation and another device, not to an AI/ML model.
No.
The device is indicated for monitoring respiratory rate, not for treating any condition.
Yes
The device is indicated for "continuous, noninvasive monitoring of respiratory rate (RRa®)," which is a form of monitoring used to assess a patient's physiological state, thus serving a diagnostic purpose for identifying respiratory issues.
No
The device description explicitly states that the device comprises a piezoelectric sensor element and an adhesive strip, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., to provide information about a physiological state, health, or disease.
- The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is a noninvasive sensor. It is attached to the patient's chest to monitor respiratory rate by detecting acoustic signals. It does not analyze any biological specimens.
The description clearly states it's a "noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest". This aligns with a non-IVD medical device used for physiological monitoring.
N/A
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 hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.
Product codes
DQA, BZQ
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 (
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 27, 2017 |
| Contact: | Sindura Penubarthi
Regulatory Affairs Manager |
| Trade Name: | Masimo Acoustic Respiration Sensors |
| Common Name: | Pulse Oximeter |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/DQA - oximeter |
| Secondary Classification/
Product Code: | Class II/BZQ - breathing frequency monitor |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | New Device |
| Predicate Device: | K120984 - Masimo Acoustic Respiration Sensor (adult/pediatric) |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514 of the Food and Drug
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),
- . 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 | |
| Range and Accuracy, | ||
| (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
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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.
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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.