(245 days)
The SonarMed™ AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT.
The SonarMed AMS 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 AMS 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 from 6.5 mm to 9.0 mm, with a body weight of >35 kg.
The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a sterile, single-use SonarMed Adapter (Adapter) and software that operates the Monitor and Adapter. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Adapter 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 sonic reflection technology, signals from the Adapter allow the color LCD on the Monitor to display to a clinician:
The baseline location of the ETT tip as established by the clinician
Quantification of passageway diameter relative to the ETT diameter (for example a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus)
ETT movement relative to the baseline location
ETT occlusion / obstruction information including percent obstructed
The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's color LCD. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.
SonarMed™ Airway Monitoring System: Acceptance Criteria and Study Details
The provided 510(k) summary for the SonarMed™ Airway Monitoring System indicates that "The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective." It explicitly states "Clinical data and conclusions were not needed for this device."
Based on this information, the device relies on non-clinical (lab) performance testing to demonstrate its safety and effectiveness, and no clinical study was conducted or deemed necessary for this submission. Therefore, some of the requested information regarding clinical studies (like sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, or specific ground truth based on patient outcomes/pathology) is not applicable or provided in this document.
1. Table of Acceptance Criteria and Reported Device Performance
Since the provided document only mentions "non-clinical (lab) performance testing" without detailing specific acceptance criteria or quantitative performance metrics, this table cannot be fully completed. The document broadly states the device's capabilities.
| Acceptance Criteria Category | Specific Acceptance Criteria (from Study) | Reported Device Performance (from Study) |
|---|---|---|
| ETT Tip Placement Verification | Not specified in the document. | Ability to display the baseline location of the ETT tip as established by the clinician. |
| Passageway Diameter Quantification | Not specified in the document. | Quantification of passageway diameter relative to the ETT diameter (e.g., a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus). |
| ETT Movement Detection | Not specified in the document. | Ability to display ETT movement relative to the baseline location. |
| ETT Occlusion/Obstruction Detection | Not specified in the document. | Ability to display ETT occlusion/obstruction information, including percent obstructed. |
| General Safety & Effectiveness | Not specified in the document. | "The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable as no clinical test set was used/described. The document refers to "non-clinical (lab) performance testing."
- Data Provenance: Not applicable as no clinical data or country of origin is mentioned for the non-clinical lab testing. The testing was reported as "non-clinical (lab) performance testing," implying an engineered or simulated environment rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth establishment was used/described. The performance was assessed through non-clinical lab testing.
4. Adjudication method for the test set
Not applicable, as no clinical test set involving human interpretation and needing adjudication was used/described.
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
No MRMC comparative effectiveness study was indicated or performed. The device is an "adjunct to normal clinical practice" and is "not to be used as a stand-alone diagnostic system," implying it does not replace human interpretation but provides additional information.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "non-clinical (lab) performance testing" which would represent a standalone evaluation of the device's ability to measure and display the stated parameters. However, the device's intended use is adjunctive, meaning it is designed to be used with human clinicians, not as a standalone diagnostic. The lab tests would have validated the technical performance of the algorithm in a controlled environment.
7. The type of ground truth used
For the "non-clinical (lab) performance testing," the ground truth would have been established through calibrated physical models or simulations where the true values of ETT tip location, movement, diameter, and obstruction were precisely known and controlled. This is characteristic of laboratory-based engineering validation.
8. The sample size for the training set
Not applicable, as no clinical training set was used/described. For non-clinical lab testing, the "training" equivalent would involve iterative testing and calibration during the device's development using controlled physical setups.
9. How the ground truth for the training set was established
Not applicable, as no clinical training set was used/described. For non-clinical lab testing, ground truth for development and calibration would have been established by precisely creating known conditions (e.g., ETT at a specific depth, tubes of known diameter, controlled obstructions) within a laboratory setup and using highly accurate measurement tools to verify these conditions.
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SonarMed™ Airway Monitoring System
510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
| SubmitterInformation | SonarMed, Inc.5513 West 74th St, Indianapolis, IN 46268317-489-3161866-853-3684 | APR 29 2010 | ||
|---|---|---|---|---|
| ContactPerson | Laura LyonsVice President Clinical, Quality & Regulatory Affairs317-489-3161 ext. 208866-853-3684 (fax) | |||
| Date | August 24, 2009 | |||
| Trade Name | SonarMedTM Airway Monitoring System | |||
| CommonName | Airway Monitoring System | |||
| Product Code | OQU | |||
| ClassificationNumber | 21 CFR 868.5730 | |||
| PredicateDevices | Eccovision AcousticDiagnostic ImagingPharyngometer | K011329 | BXQ | 868.1800 |
| ETView TracheoscopicVentilation Tube | K082420 | BTR | 868.5730 | |
| PosiTube EsophagealIntubation Detection | K000045 | BTR | 868.5730 | |
| RhinoScan AcousticRhinometry | K000406 | BXQ | 868.1800 | |
| Tidal Wave SPModel 710/715 | K032971 | DQA | 870.2700 | |
| DeviceDescription | The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is usedin conjunction with a sterile, single-use SonarMed Adapter (Adapter) andsoftware that operates the Monitor and Adapter. The Monitor is powered froman external power supply and has a battery backup. When in use, theSonarMed Adapter is placed in-line between the ventilator circuit and the |
Image /page/0/Picture/4 description: The image shows the word "SONARMED" in a stylized font. To the right of the word, there is a graphic of curved lines emanating from a central point, resembling sonar waves. The text and graphic are in black and white.
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proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator.
Using sonic reflection technology, signals from the Adapter allow the color LCD on the Monitor to display to a clinician:
| on the Monitor to display to a clinician. | |
|---|---|
| The baseline location of the ETT tip as established by the clinician Quantification of passageway diameter relative to the ETT diameter (for example a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus) ETT movement relative to the baseline location ETT occlusion / obstruction information including percent obstructed | |
| The clinician can choose whether to view information about the patient's airwayin either a waveform or graphic on the Monitor's color LCD. This informationshould only be used in an adjunctive manner to assist with management of theartificial airway of the patient. | |
| Intended Use | The SonarMed AMS is intended to be used to assist in verifying placement ofthe ETT, to assist in detecting movement of the ETT tip, and to assist indetecting obstruction of the ETT. |
| The SonarMed AMS is intended for use by qualified personnel to assist withartificial airway management for patients in an in-hospital setting (intensive care,operating room, and emergency department settings, as well as intra-hospitaltransport). | |
| The SonarMed AMS is to be used as an adjunct to normal clinical practice, andis not to be used as a stand-alone diagnostic system. | |
| It is intended for use with patients who use ET tube sizes from 6.5 mm to 9.0mm weighing >35 kilograms. | |
| Comparison toPredicateDevices | The SonarMed Airway Monitoring System is similar or identical in technology,intended use, performance and environments of use. |
| TechnologicalCharacteristics | The SonarMed AMS consists of two components: a plastic disposable ET tubeAdapter and a portable digital Monitor. The SonarMed AMS Adapter contains aspeaker, two microphones, and a cable. The speaker and microphones, whichacoustically communicate with the tube lumen via ports, have electricalconnections running to the cable exiting the Adapter. The cable connects thespeaker and microphones to a portable digital Monitor. The Monitor contains anembedded processor, a graphical display, a user input interface, and a serialcommunications interface. Both the Eccovision Acoustic Diagnostic ImagingPharyngometer and the RhinoScan Acoustic Rhinometry use the sametechnology. |
| The Tidal Wave SP, ETView Tracheoscopic Ventilation Tube and the PosiTubeEsophageal Intubation Detection verify placement within the airway. The TidalWave SP and the ETView Tracheoscopic Ventilation Tube detect movement ofthe endotracheal tube. The Acoustic Diagnostic Imaging Pharyngometer andthe Tidal Wave SP detect obstruction in the airway. | |
| Performance | The results of non-clinical (lab) performance testing demonstrate that the device |
Performance
Image /page/1/Picture/4 description: The image shows the word "SONARMED" in a bold, sans-serif font. The letters are evenly spaced and appear to be in all caps. To the right of the word, there is a graphic that resembles a radar or sonar signal, with curved lines emanating from a central point. The overall design is simple and modern.
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is safe and effective. of Non-Clinical
:
Clinical data and conclusions were not needed for this device.
End of document.
- The state of the state
Image /page/2/Picture/3 description: The image shows the word "SONARMED" in a stylized font. To the right of the word is a graphic that resembles sound waves emanating from a point. The graphic is composed of several curved lines that get progressively larger as they move away from the point of origin.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
APR 2 9 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Laura Lyons Vice President, Clinical, Quality & Regulatory Affairs SonarMed, Incorporated 5513 West 74th Street Indianapolis, Indiana 46268
Re: K092611
Trade/Device Name: SonarMed™ Airway Monitoring System Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: OQU Dated: April 27, 2010 Received: April 28, 2010
Dear Ms. 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.
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Page 2- Ms. Lyons
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Th for
Anthony Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: SonarMed TM Airway Monitoring System
Indications For Use:
The SonarMed™ AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT.
The SonarMed AMS 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 AMS 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 from 6.5 mm to 9.0 mm, with a body weight of >35 kg.
L. Schullton
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092611
AND/OR Over-The-Counter Use 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of
§ 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).