(389 days)
Not Found
No
The summary describes a sensor and monitoring system based on acoustic detection and signal processing, with no mention of AI or ML techniques. The performance studies focus on traditional accuracy metrics and clinical validation against manual counts.
No.
The device is indicated for continuous, noninvasive monitoring of respiratory rate. It does not treat or alleviate a medical condition.
No.
The device is used for continuous monitoring of respiratory rate, not for diagnosing a condition.
No
The device description explicitly states it is a "single-patient use device consisting of a piezoelectric sensor element and an adhesive strip" and is "intended to be attached via cable to a pulse oximeter monitor." This indicates the device includes physical hardware components (sensor, adhesive, cable) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Rainbow Acoustic Monitoring sensors and cables are used for continuous, noninvasive monitoring of respiratory rate (RRaTM) by being attached to the patient's neck. This is a direct measurement of a physiological parameter from the body, not a test performed on a sample taken from the body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA, BZQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neck
Indicated Patient Age Range
Adult and pediatric (> 10 kg)
Intended User / Care Setting
Hospital-type facilities, mobile and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
Two non-randomized clinical validation studies in healthy adult volunteers (n=26) and 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 .
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical validation studies (non-randomized)
Sample Size:
- RAS-125: 26 healthy adult volunteers, 26 hospitalized post-surgical adult subjects
- RAS-125c: 26 hospitalized post-surgical pediatric subjects
Key Results: - 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 for RAS-125 (Adult > 30 kg) for up to 30 breaths per minute.
- Clinical validation for RAS-125c (Adult, Pediatric > 10 kg) for up to 50 breaths per minute.
- Accuracy range for breaths per minute: 4 to 70 ± 1 breath per minute for both RAS-125 and RAS-125c.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K091241 – Masimo Rainbow SET® Rad-87 Pulse CO-Oximeter and Masimo Acoustic Monitoring Sensor (adult)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary: K120984
APR 2 6 2013
| Submitter: | Masimo Corporation
40 Parker
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|---------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Patricia Milbank
Vice President, Regulatory Affairs |
| Date Summary
Prepared: | 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-Oximeter
and Masimo Acoustic Monitoring Sensor (adult) |
Description of the Device
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.
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.
1
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 .
2
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.
3
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.
4
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
5
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