(196 days)
Not Found
No
The summary describes the device using acoustic reflection technology and signal processing to provide information to the clinician. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as a monitoring system used to assist in verifying ETT placement, detecting ETT movement/obstruction, and listening to breath sounds, acting as an adjunct to clinical practice rather than providing direct treatment.
No
The "Intended Use" section explicitly states that the device "is a not a stand-alone diagnostic system."
No
The device description explicitly states it is comprised of a "SonarMed Monitor" and a "single-patient use SonarMed Sensor," in addition to software. This indicates the device includes significant hardware components.
Based on the provided information, the SonarMed AirWave Airway Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SonarMed AirWave Function: The SonarMed AirWave system uses acoustic reflection technology to monitor the position, movement, and obstruction of an endotracheal tube within the patient's airway. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for assisting with artificial airway management and providing information about the ETT and the airway itself, not for analyzing bodily fluids or tissues.
Therefore, the SonarMed AirWave Airway Monitoring System falls under the category of a medical device used for monitoring and managing a patient's airway, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds.
The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport).
The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice and is a not a stand-alone diagnostic system.
It is intended for use with neonates, infants, children, adolescents, and adults (sizes 2.5 mm to 9.0 mm).
Product codes (comma separated list FDA assigned to the subject device)
OQU
Device Description
The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor) and software that operates the Monitor and Sensor. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator.
Using acoustic reflection technology, signals from the Sensor are displayed on the Monitor showing the clinician:
- The baseline location of the ETT tip as established by the clinician
- Estimation of passageway around the tipof the ETT, relative to the . ETT diameter
- ETT movement relative to the baseline location ●
- . ETT occlusion / obstruction information including percent obstructed and location of the obstruction
- The clinician can choose whether to view information about the . patient's airway in either a waveform or graphic on the Monitor's LCD. Additionally, the clinician can use the microphones to listen to breath sounds. The information provided by the device is to be used in conjunction with normal clinical practice to assist with management of the artificial airway of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
neonates, infants, children, adolescents, and adults
Intended User / Care Setting
qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing compared movement, obstruction and passageway accuracy of the subject device (Subject device patient populations: neonate, infant, child, adolescent and adult) to the predicate, K103042 (Predicate device: neonate, infant, younger child, older adolescent and adult). The Passageway Detection Study documented that the subject device accurately estimates the diameter of the passageway around the tip of the ETT for all patient populations. The Movement Study documented that the subject device accurately detects the distance and direction of the ETT tip movement both upward and downward for all patient populations. The Obstruction Detection Study documented that the subject device accurately detects the percentage of obstruction in the ETT for all patient populations. Additionally, the subject device was tested for: . Medical electrical equipment following IEC 60601-1:2015; Edition 3.1 Basic Safety and Essential Performance, following IEC 60601-1-2 General requirements tests and guidance for alarm system in medical environment, following IEC 60601-1-8, Edition 2.1 2012-11 . Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, following ISO 100993-5, Third edition 2009-06-01 Biological evaluation of medical devices-Part 10: Tests for irritation and . skin sensitization, following ISO 10993-10 Third Edited 2010-08-01 Biocompatibility evaluation of breathing gas pathways in healthcare applications, following ISO 18562 First Edited 2017-03 . Medical device software, following IEC 62304, Edited 1.1 2015-06 All testing passed.
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.
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
SonarMed, Inc. Laura Lyons VP Compliance & Respiratory Care 12220 N. Meridian St., Ste. 150 Carmel, Indiana 46032
Re: K193058
Trade/Device Name: SonarMed AirWave Airway Monitoring System Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: OQU Dated: April 10, 2020 Received: April 15, 2020
Dear Laura Lyons:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) 193058 Device Name: SonarMed™ AirWave® Airway Monitoring System
Indications for Use:
The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds.
The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport).
The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice and is a not a stand-alone diagnostic system.
It is intended for use with neonates, infants, children, adolescents, and adults (sizes 2.5 mm to 9.0 mm).
Prescription Use (Part 21 CFR 801 Subpart D) (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) Page 1 of 1
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510(k) Summary Traditional 510(k) Premarket Notification SonarMed™ AirWave Airway Monitoring System
K193058
| Submitter Information | SonarMed, Inc.
12220 N. Meridian St., Ste. 150, Carmel, IN 46032
317-489-3161
866-853-3684 |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person | Laura Lyons
Vice President Clinical, Quality & Regulatory
317-489-3161 ext. 208
866-853-3684 (fax) |
| Date | March 25,2020 |
| Trade Name | SonarMed AirWave Airway Monitoring System |
| Common Name | Endotracheal Tube Adapter |
| Classification Name | Airway Monitoring System |
| Classification Number | 21 CFR 868.5730 |
| Product Code | OQU |
| Predicate Device | SonarMed Airway
Management System K143042 OQU 868.5730 |
Image /page/3/Picture/5 description: The image shows the logo for SonarMED. The word "sonar" is in green, and the word "MED" is in blue. Above the word "sonar" are three curved lines that resemble sound waves.
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Device Description
The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor) and software that operates the Monitor and Sensor. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator.
Using acoustic reflection technology, signals from the Sensor are displayed on the Monitor showing the clinician:
- The baseline location of the ETT tip as established by the clinician
- Estimation of passageway around the tipof the ETT, relative to the . ETT diameter
- ETT movement relative to the baseline location ●
- . ETT occlusion / obstruction information including percent obstructed and location of the obstruction
- The clinician can choose whether to view information about the . patient's airway in either a waveform or graphic on the Monitor's LCD. Additionally, the clinician can use the microphones to listen to breath sounds. The information provided by the device is to be used in conjunction with normal clinical practice to assist with management of the artificial airway of the patient.
Image /page/4/Picture/10 description: The image shows the logo for SonarMED. The logo features a series of curved lines above the word "sonarMED". The word "sonar" is in green, while "MED" is in blue. The curved lines above the word "sonarMED" are also in green and appear to represent sound waves.
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The SonarMed AirWave Airway Monitoring System is used to assist inverifying Intended Use placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds.
The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport).
The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice and is not to be used as a stand-alone diagnostic system.
It is intended for use with neonates, infants, children, adolescents and adults (sizes 2.5 mm - 9.0 mm).
Comparison to The SonarMed Airway Monitoring System is similar or identical to the Predicate predicate in intended use and technology.
Acoustic reflectometry is used to estimate airway characteristics. The Technology Monitor contains an embedded processor, a graphical display, a user input interface, and a serial communications interface.
Additional sensor sizes have been added to the subject submission. The predicate K143042 included sensor sizes for neonates, infants, younger children, older adolescents and adults. The subject device adds sensor sizes for older children and younger adolescents. These additional sizes are bracketed by the predicate device clearance (K143042).
The sensor has slightly different materials for the speaker gasket and membrane. The new materials are similar in nature as they are medical grade. The predicate device has a silicone elastomer membrane that is attached with a polyurethane medical tape. The subject device has an EVA membrane and uses a polyolefin foam medical tape. Additionally, a silicone sealant is used on the inside and outside. Biocompatibility testing was repeated as a result of the new materials. This testing included gas pathway testing for both polar and non-polar leachables and extractables. Biocompatibility test results demonstrate there are no new safety concerns with the new materials.
Acoustic reflectometry is used to estimate airway characteristics. The Monitor contains an embedded processor, a graphical display, a user input interface, and a serial communications interface.
Additional sensor sizes have been added to the subject submission. The predicate K143042 included sensor sizes for neonates, infants, younger children, older adolescents and adults. The subject device adds sensor sizes for older children and younger adolescents. These additional sizes
Image /page/5/Picture/12 description: The image contains the logo for SonarMED. The logo features the word "sonar" in green and "MED" in blue. Above the word "sonar" are three curved lines in light green, resembling sound waves or a signal. The overall design is clean and modern, suggesting a company in the medical technology or healthcare sector.
Device
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are bracketed by the predicate device clearance (K143042).
Modifications were made to the menu options for sound speed correction. The predicate device had two oxygen concentration ranges (21-60 and 61-100), where the subject device has four oxygen concentrations (21-40, 41-60, 61-80, 81-100). Additionally, the auto OR and ICU feature was eliminated, and functionality was added to the waveform screen providing the user with the ability to make changes from that screen. All changes were validated, and the testing confirmed there are no changes to efficacy or safety.
| SonarMed Airway Monitoring
System | SonarMed Airway Monitoring
System | Differences |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------|
| K193058 | K143042 | |
| OQU | OQU | No Differences |
| 868.5730 | 868.5730 | |
| Technology | Technology | |
| Uses acoustic signals (acoustic
reflectometry) | Uses acoustic signals (acoustic
reflectometry | No Differences |
| Has 2 microphones and 1 speaker | Has 2 microphones and 1 speaker | No Differences |
| Uses acoustic reflections to estimate
airway characteristics | Uses acoustic reflections to estimate
airway characteristics | No Differences |
| Uses analysis software to present data
in graphical manner | Uses analysis software to present data
in graphical manner | No Differences |
| Indications for Use | Indications for Use | |
| Verifies ETT placement | Verifies ETT placement | No Differences |
| Detects movement of the endotracheal
tube and displays on monitor | Detects movement of the
endotracheal tube and displays on
monitor | No Differences |
| Provides real-time continuous
monitoring of the airway | Provides real-time continuous
monitoring of the airway | No Differences |
| Detects obstructions/occlusions in the
airway | Detects obstructions/occlusions in
the airway | No Differences |
| Estimates the diameter of the
anatomical structure around the tip of
the ETT | Estimates the diameter of the
anatomical structure around the tip
of the ETT | No Differences |
| Population & Sensor Sizes | Population & Sensor Sizes | |
|---|---|---|
| • Sizes 2.5 mm - 9.0 mm | • Sizes 2.5, 3.0, 3.5 and 6.5-9.0 mm | Additional Sensor Sizes |
| 4.0 to 6.0 mm | ||
| • Neonates, infants, children, adolescents, and adults | • Neonates, infants, younger children, older adolescents, and adults | Added sizes for older children and younger adolescents |
| • Sensor weight 0.5 oz (14g) (neonates, infants, children) | • Sensor weight 0.5 oz (14g) (neonates, infants) | No Differences |
| • Weight 0.9 oz (28g) (adolescents and adults) | • Weight 0.9 oz (28g) (adolescents and adults) | No Differences |
| Performance | Performance | |
| • Bench testing for verifying placement, detecting movement, detecting obstructions | • Bench testing for verifying placement, detecting movement, detecting obstructions | As accurate or more accurate than predicate |
| Materials | Materials | |
| • Monitor | • Monitor | No Differences |
| • Sensor: Polypropylene, Silicone Elastomer, Polycarbonate, Polyurethane Medical Tape | • Sensor: Polypropylene, Silicone Elastomer, Polycarbonate, EVA Membrane, Polyethylene Tape, Polyolefin Foam Medical Tape | New Materials in Subject Device are: EVA Membrane, Polyethylene Tape, Polyolefin Foam Medical Tape |
In predicate but not contained in subject device: Polyurethane Medical Tape |
| Electronic Components | Electronic Components | |
| • Printed Circuit Boards (populated components) | • Printed Circuit (populated components) | Populated components on the Subject device were updated to address obsolescence, however all functionality remained the same. |
| Software | Software | |
| • Alarms | • Alarms | Updated to meet IEC 60601-1-8 (Alarm Standard) |
| • O2 Ranges 21-60% and 61-100% | • O2 Ranges 21-40%, 41-60%, 61-80%, 81-100% | Four ranges are now provided across all patient populations |
| • Auto OR and Auto ICU in Menu | • Functionality on Waveform Screen | Functionality added to Waveform Screen |
Image /page/6/Picture/6 description: The image shows the logo for SonarMED. The word "sonar" is in green, and the word "MED" is in blue. Above the word "sonar" are three curved lines in a lighter shade of green.
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Image /page/7/Picture/3 description: The image shows the logo for SonarMED. The logo consists of a green sound wave icon above the word "sonar" in green and the word "MED" in blue. The logo is simple and modern, and it is likely used to represent a company that provides medical imaging or diagnostic services.
8
Several different bench tests were completed to demonstrate substantial Discussion equivalence. The bench testing compared movement, obstruction and and Conclusion of passageway accuracy of the subject device. (Subject device patient Non-Clinical populations: neonate, infant, child, adolescent and adult) to the predicate, K103042 (Predicate device: neonate, infant, younger child, older adolescent Testing and adult). The Passageway Detection Study documented that the subject device accurately estimates the diameter of the passageway around the tip of the ETT for all patient populations. The Movement Study documented that the subject device accurately detects the distance and direction of the ETT tip movement both upward and downward for all patient populations. The Obstruction Detection Study documented that the subject device accurately detects the percentage of obstruction in the ETT for all patient populations. Additionally, the subject device was tested for: . Medical electrical equipment following IEC 60601-1:2015; Edition 3.1 Basic Safety and Essential Performance, following IEC 60601-1-2 ● ● General requirements tests and guidance for alarm system in medical environment, following IEC 60601-1-8, Edition 2.1 2012-11 . Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, following ISO 100993-5, Third edition 2009-06-01 Biological evaluation of medical devices-Part 10: Tests for irritation and . skin sensitization, following ISO 10993-10 Third Edited 2010-08-01 ● Biocompatibility evaluation of breathing gas pathways in healthcare applications, following ISO 18562 First Edited 2017-03 . Medical device software, following IEC 62304, Edited 1.1 2015-06 All testing passed. SonarMed performed an exhaustive extraction at 50°C for 72 hours on the final finished device using polar and non-polar solvents per ISO 10993-12. A toxicological risk assessment was conducted on the compounds that were identified in the extractable and leachable testing. The risk assessment did not identify any additional question of safety, including that the identified compounds raised no genotoxicity or carcinogenicity concerns. Conclusion: Based on the comparison of technological characteristics and non-clinical testing summarized in this 510(k) submission, the results demonstrate that the subject device is substantially equivalent to the predicate. The differences do not raise different questions of safety or
effectiveness when compared to the predicate.
Image /page/8/Picture/3 description: The image shows the logo for SonarMED. The word "sonar" is written in green, and the word "MED" is written in blue. Above the word "sonar" are three curved lines, also in green, that resemble sound waves.