(457 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 not to be used as a stand-alone diagnostic system.
It is intended for use with patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 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
• Quantification of diameter of the anatomical structure around the tip of the ETT
• 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. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
The monitor allows the user to manually adjust the sound of speed. This is to compensate for the changes in the sound of speed with high oxygen concentrations and the use of anesthesia gases. The monitor also has an auto-speed of sound mode. This mode automatically changes the speed of sound.
The monitor allows the user to manually enter the distance to the carina from the chest x-ray. This is an optional feature that the user can elect from the setting menu. Once selected the algorithm will calculate the distance to the carina based on the movement of the tip of the tube.
The provided text describes the SonarMed™ AirWave Airway Monitoring System (K143042) and its conformity with a predicate device through non-clinical testing. It focuses on demonstrating substantial equivalence to a previously cleared device (SonarMed Airway Management System K092611).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for clinical trials or performance goals. Instead, the performance is demonstrated through comparisons to the predicate device and verification of intended function in various tests. The key performance aspects evaluated are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ETT Tip Movement & Passageway Size Accuracy (Infant vs. Adult Size Sensor) | The new, infant sized sensors are at least as accurate as the predicate, adult sized sensors in detecting movement and passageway size. This was concluded from bench testing and a pre-clinical animal study. The pre-clinical study concluded that the tracking algorithm is accurate in determining ETT tip movement and passageway size. |
| ETT Obstruction Accuracy (Infant vs. Adult Size Sensor) | The new, infant sized sensors are at least as accurate as the predicate, adult sized sensors in detecting obstruction. This was concluded from bench testing. |
| Functionality during Prolonged Use (Heated, Humidified, Positive Pressure Ventilation) | The SonarMed AirWave Sensor functions as intended during prolonged use for over 30 days. This was demonstrated in a long-term bench study. |
| Biocompatibility | Testing for cytotoxicity, sensitization, and intracutaneous reactivity all passed. Exhaustive E&L (extractable and leachable) testing determined compounds were present at levels well below health consequences for the neonatal population with large safety margins. |
| Safety and Effectiveness Equivalence to Predicate | The conclusions drawn from the nonclinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device. This is the overall conclusion of the substantial equivalence determination for non-clinical aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The text mentions "Several bench tests were performed" and "A long-term bench study was conducted." It compares "movement and passageway accuracy of the infant sized sensor to the predicate, adult sized sensor" and "obstruction accuracy of the infant sized sensor to the predicate, adult sized sensor." However, specific sample sizes for the bench tests (e.g., number of ETTs, number of tests run) are not provided.
- Pre-clinical Animal Study: "The study utilized an animal model (rabbit)." The number of rabbits used in the study is not specified.
- Data Provenance: The studies were conducted by SonarMed, Inc. and are described as non-clinical bench and pre-clinical animal studies. The text does not refer to human data or data from a specific country of origin in terms of patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for the test sets. The ground truth in the bench and animal studies would have been established through controlled experimental setups (e.g., precisely measured ETT movements, intentionally created obstructions, known ETT tip positions).
4. Adjudication Method for the Test Set
Since human expert assessment for ground truth is not mentioned, an adjudication method for test set ground truth is not applicable or described in this context. The "adjudication" would be inherent in the controlled experimental design of the bench and animal studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The device is an airway monitoring system for direct measurement, not an AI-assisted diagnostic imaging interpretation tool that would involve "human readers" interpreting "cases."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described (accuracy in determining ETT tip movement, passageway size, and obstruction) is the standalone performance of the device's sensing and algorithm. The device is intended to provide information to a clinician, but the accuracy studies themselves evaluated the device's ability to measure these parameters directly. It is stated: "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." This statement regarding its clinical use as an adjunct does not negate that the performance evaluation of its measurements (as described in the non-clinical tests) is essentially its standalone accuracy.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench testing would be known, controlled, and precisely measured physical parameters (e.g., exact movement distances, known obstruction percentages, measured passageway sizes) created within the experimental setup.
- Pre-clinical Animal Study: For the animal study, the ground truth for ETT movement would be based on known physical manipulations of the ETT within the rabbit trachea, bronchus, and esophagus, likely verified by external measurement or direct observation during the procedure.
8. The Sample Size for the Training Set
The document does not mention a concept of a "training set" as would be relevant for machine learning or AI algorithm development in the traditional sense. The device appears to be based on more traditional acoustic reflection technology and algorithms, which likely don't involve a distinct "training set" in the way a deep learning model would. If an algorithm was "trained," the details are not provided.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this question is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
SonarMed, Inc. Laura Lyons VP Compliance & Respiratory Care 12220 N. Meridian St., Ste. 150 Carmel, IN 46032
Re: K143042 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: January 13, 2016 Received: January 19, 2016
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiologic Health
Enclosure
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Indications for Use
510(k) Number: K143042
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 not to be used as a stand-alone diagnostic system.
It is intended for use with patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.
Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/3/Picture/0 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 that resemble sound waves. The logo is simple and modern.
510(k) Summary Traditional 510(k) Premarket Notification Summary SonarMed™ AirWave Airway Monitoring System
| SubmitterInformation | SonarMed, Inc.12220 N. Meridian St., Ste. 150, Carmel, IN 46032317-489-3161866-853-3684 | |||
|---|---|---|---|---|
| ContactPerson | Laura LyonsVice President Compliance & Respiratory Care317-489-3161 ext. 208866-853-3684 (fax) | |||
| Date | October 16, 2014 | |||
| Trade Name | SonarMed AirWave Airway Monitoring System | |||
| CommonName | Endotracheal Tube Adapter | |||
| Product Code | OQU | |||
| ClassificationName | Tracheal Tube | |||
| ClassificationNumber | 21 CFR 868.5730 | |||
| PredicateDevice | SonarMed AirwayManagement System SonarMed AirwayManagement System | K092611 | OQU | 868.5730 |
| DeviceDescription | The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that isused in conjunction with a single-patient use SonarMed Sensor (Sensor) andsoftware that operates the Monitor and Sensor. The Monitor is powered from anexternal power supply and has a battery backup. When in use, the SonarMedSensor is placed in-line between the ventilator circuit and the proximal end ofthe endotracheal tube (ETT) of a patient who is connected to a ventilator.Using acoustic reflection technology, signals from the Sensor are displayed onthe Monitor showing the clinician:• The baseline location of the ETT tip as established by the clinician• Quantification of diameter of the anatomical structure around the tip ofthe ETT• ETT movement relative to the baseline location |
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Image /page/4/Picture/0 description: The image shows the logo for SonarMED. The logo consists of the word "sonarMED" in a sans-serif font. 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, also in green.
- 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. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
The monitor allows the user to manually adjust the sound of speed. This is to compensate for the changes in the sound of speed with high oxygen concentrations and the use of anesthesia gases. The monitor also has an auto-speed of sound mode. This mode automatically changes the speed of sound.
The monitor allows the user to manually enter the distance to the carina from the chest x-ray. This is an optional feature that the user can elect from the setting menu. Once selected the algorithm will calculate the distance to the carina based on the movement of the tip of the tube.
- The SonarMed AirWave Airway Monitoring System is used to assist in verifying 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 patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.
- Comparison to The SonarMed Airway Monitoring System is similar or identical to the predicate Predicate in indications for use and technology. The differences to the predicate is the addition of two new features in the subject device; the user can input the Devices distance from the tip of the tube to the carina as determined by the chest x-ray, and sound of speed mode, which allows for both manual and automatic corrections to the sound of speed in high levels of oxygen and anesthesia gases. Also the subject device has a biocompatible silicone tube over the microphones.
- The SonarMed AirWave uses the exact same technology as the predicate Technological Characteristics device. The SonarMed AirWave consists of two components: a plastic disposable ET tube Sensor and a portable digital Monitor. The SonarMed Sensor contains a speaker, two microphones, and a cable.
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Image /page/5/Picture/0 description: The image shows the logo for SonarMED. The logo consists of the word "sonar" in green and "MED" in blue. Above the word "sonar" are three curved lines that resemble sound waves. The logo is simple and modern, and the colors are bright and eye-catching.
The SonarMed AirWave Sensor is manufactured with the same plastics as the predicate. The outer body is Polycarbonate; the nozzle is Polypropylene. The internal lumen is also Polycarbonate, and also contains Silicone (which is a new material added to make the sensor more mucus resistant).
The speaker and microphones acoustically communicate with the tube lumen. The cable connects the speaker and microphones to a portable digital Monitor. The Monitor contains an embedded processor, a graphical display, a user input interface, and a serial communications interface.
The predicate device, the SonarMed Airway Monitoring System, uses the exact same technology. There is no difference in the technological characteristics from the predicate to the new device. There are new features in the subject device (Distance to Carina and Speed of Sound Modes).
| SonarMed AirWave (K143042) Newdevice | SonarMed Airway Monitoring System (K092611) Predicate |
|---|---|
| Uses speaker and two microphones | Uses speaker and two microphones |
| Reusable monitor | Reusable monitor |
| Embedded processor, a graphical display, a user input interface, and a serial communications interface | Embedded processor, a graphical display, a user input interface, and a serial communications interface |
| Plastic single patient use sensor | Plastic single patient use sensor |
| Cable attaches sensor to monitor | Cable attaches sensor to monitor |
| Sensor Materials: Polycarbonate, Polypropylene, Silicone | Sensor materials: Polycarbonate, Polypropylene |
| Optional Distance to Carina feature | Not included |
| Speed of Sound Modes | Not included |
| For use with ETT sizes 2.5, 3.0, 3.5 and 6.5-9.0 mm | For use with ETT sizes 6.5-9.0 mm |
| Size (for 2.5, 3.0 and 3.5 mm ETTs)1.375" x 0.688" x 1" / 3.5 x 1.7 x 2.5 cmSize (for 6.5-9.0 mm ETTs ) 2.125" x1.125" x 1.125" / 5.4 x 2.9 x 2.9 cm | Size 2.125" x 1.125" x 1.125" / 5.4 x 2.9 x 2.9 cm |
| Weight 14 g (for 2.5, 3.0 and 3.5 mm ETTs)Weight 28 g (for 6.5-9.0 mm ETTs ) | Weight 28 g |
| Dead space 0.5 ml (for 2.5, 3.0 and 3.5 mm ETTs)Dead space 3.0 ml (for 6.5-9.0 mm ETTs) | Dead space 3.0 ml |
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Image /page/6/Picture/0 description: The image shows the logo for SonarMED. The logo consists of a green graphic of curved lines above the word "sonar" in green, followed by the word "MED" in blue. The curved lines are meant to represent sound waves.
Discussion and Conclusion of Non-Clinical Testing
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. The site of exposure is the humidified gas pathway of the patient. SonarMed performed testing for cytotoxicity, sensitization and intracutaneous reactivity, which all passed. Also an exhaustive E&L testing was performed. All of the reported extractable and leachable compounds have been determined to be present at levels well below that which would have any health consequences to the intended neonatal population and large safety marqins (very large in many cases) have been determined from the risk characterizations process.
Both bench testing and animal testing was completed for the non-clinical testing for determination of substantial equivalence.
Several bench tests were performed. One test compared movement and passageway accuracy of the infant sized sensor to the predicate, adult sized sensor. Another test compared the obstruction accuracy of the infant sized sensor to the predicate, adult sized sensor. All testing passed.
A long-term bench study was conducted to document that the subject device performs as intended during prolonged use with heated, humidified, positive pressure ventilation. The conclusion of the bench study was that the SonarMed AirWave Sensor functions as intended during prolonged use for over 30 days.
The pre-clinical study was designed to verify the acoustics in the smaller airways would allow for very precise tracking of tube movement and tube location. The study utilized an animal model (rabbit) that was known to be close to the human neonatal airways. During the study, the endotracheal tube was moved up and down in the trachea, into the bronchus and also into the esophagus. These movements were made in small increments and tracked with the SonarMed monitor.
The pre-clinical study concluded that the tracking alqorithm is accurate in determining ETT tip movement and passageway size.
The conclusions drawn from the non-clinical testing are that the new, infant sized sensors are at least as accurate as the predicate, adult size sensors in detecting movement, obstruction and passageway size and that they function as intended during prolonged use.
Clinical data and conclusions were not needed for this device.
Conclusion The SonarMed AirWave was modified to be small enough for the neonatal/pediatric endotracheal tubes. The sensor was designed to be as small as possible with minimal dead space. The new, infant sized sensors are at least as accurate as the predicate, adult size sensors in detecting movement, obstruction and passageway size, and they function as
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Image /page/7/Picture/0 description: The image shows the logo for SonarMED. The logo consists of the word "sonarMED" in a sans-serif font. 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, also in green.
intended during prolonged use.
The conclusions drawn from the nonclinical testing demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
§ 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).