(196 days)
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).
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.
The provided text describes the SonarMed AirWave Airway Monitoring System and its substantial equivalence determination by the FDA. However, it does not explicitly detail the acceptance criteria and a study proving the device meets these criteria in the typical quantitative manner (e.g., sensitivity, specificity, AUC values) usually associated with AI/ML device performance.
The document focuses on demonstrating substantial equivalence to a predicate device (K143042) through various bench tests and by addressing modifications. The "acceptance criteria" appear to be implicit in the comparative performance against the predicate device, aiming for "as accurate or more accurate."
Based on the provided text, here's an attempt to answer your questions to the extent possible, acknowledging the limitations of the information provided for a typical AI/ML device performance study:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide explicit quantitative acceptance criteria or corresponding reported performance metrics (like percentage accuracy thresholds) in a tabular format. Instead, it describes the conclusion of the bench testing:
| Performance Aspect | Implied Acceptance Criterion / Comparison | Reported Device Performance |
|---|---|---|
| Passageway Detection Accuracy | Accurately estimates diameter of passageway around ETT tip (compared to predicate) | "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." |
| ETT Movement Detection | Accurately detects distance and direction of ETT tip movement (compared to predicate) | "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." |
| Obstruction Detection | Accurately detects percentage of obstruction in ETT (compared to predicate) | "The Obstruction Detection Study documented that the subject device accurately detects the percentage of obstruction in the ETT for all patient populations." |
| Overall Performance | As accurate or more accurate than the predicate. | Stated under the "Performance" section of the comparison table: "As accurate or more accurate than predicate." |
2. Sample size used for the test set and the data provenance
The document refers to "bench testing" and "studies" (Passageway Detection Study, Movement Study, Obstruction Detection Study) but does not specify the sample sizes used for these tests.
The data provenance is not mentioned. It is implied these are pre-clinical/bench test data, not clinical patient data, given the description of testing on the device itself. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" as applied to patient cohorts are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. Given that the testing is described as "bench testing" on the device's accuracy for physical measurements (ETT movement, obstruction, passageway diameter), it's more likely that the "ground truth" was established by calibrated instruments or known physical alterations to the test setup, rather than human expert interpretation of images/data.
4. Adjudication method for the test set
The document does not mention any adjudication method, as it does not describe a study involving multiple human readers or interpretations. The "studies" appear to be objective measurements from the device against a known physical ground truth during bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study involving human readers is not mentioned in the provided text. The evaluation focuses on the device's intrinsic measurement capabilities in a bench test setting, not on how human readers' performance with or without the device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "bench testing" described appears to be a standalone performance evaluation of the device's sensors and algorithms, given that it aims to demonstrate the device "accurately detects" or "accurately estimates" various parameters.
7. The type of ground truth used
The ground truth used appears to be objective, known physical parameters established by the bench test setup for ETT tip location, obstruction percentage, and airway diameter. This is inferred from the description of "Passageway Detection Study," "Movement Study," and "Obstruction Detection Study." It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
The document does not mention a training set size. This device relies on acoustic reflection technology and embedded processing, which are described as being similar to the predicate device. It's not explicitly stated as an AI/ML device that requires a large, dedicated "training set" in the common sense of deep learning. Updates were made to software (e.g., O2 ranges, waveform screen functionality), but the underlying "technology" (acoustic reflectometry) remains the same as the predicate.
9. How the ground truth for the training set was established
As no training set is explicitly mentioned for a machine learning model, the method for establishing ground truth for such a set is not described.
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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
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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 46032317-489-3161866-853-3684 |
|---|---|
| Contact Person | Laura LyonsVice President Clinical, Quality & Regulatory317-489-3161 ext. 208866-853-3684 (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 AirwayManagement 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 MonitoringSystem | SonarMed Airway MonitoringSystem | Differences |
|---|---|---|
| K193058 | K143042 | |
| OQU | OQU | No Differences |
| 868.5730 | 868.5730 | |
| Technology | Technology | |
| Uses acoustic signals (acousticreflectometry) | Uses acoustic signals (acousticreflectometry | No Differences |
| Has 2 microphones and 1 speaker | Has 2 microphones and 1 speaker | No Differences |
| Uses acoustic reflections to estimateairway characteristics | Uses acoustic reflections to estimateairway characteristics | No Differences |
| Uses analysis software to present datain graphical manner | Uses analysis software to present datain graphical manner | No Differences |
| Indications for Use | Indications for Use | |
| Verifies ETT placement | Verifies ETT placement | No Differences |
| Detects movement of the endotrachealtube and displays on monitor | Detects movement of theendotracheal tube and displays onmonitor | No Differences |
| Provides real-time continuousmonitoring of the airway | Provides real-time continuousmonitoring of the airway | No Differences |
| Detects obstructions/occlusions in theairway | Detects obstructions/occlusions inthe airway | No Differences |
| Estimates the diameter of theanatomical structure around the tip ofthe ETT | Estimates the diameter of theanatomical structure around the tipof 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 Sizes4.0 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 TapeIn 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.
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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.
§ 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).