SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901

K092611 · Sonarmed, Inc. · OQU · Apr 28, 2010 · Anesthesiology

Device Facts

• Record ID: K092611
• Device Name: SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
• Applicant: Sonarmed, Inc.
• Product Code: OQU · Anesthesiology
• Decision Date: Apr 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Intended Use

The SonarMed AMS is intended to be used to assist in verifying placement of the 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 weighing >35 kilograms.

Device Story

SonarMed AMS monitors endotracheal tube (ETT) status using sonic reflection technology. System includes a sterile, single-use plastic adapter placed in-line between the ventilator circuit and the ETT, and a portable digital monitor. The adapter contains a speaker and two microphones that acoustically communicate with the tube lumen. The monitor processes acoustic signals to determine ETT tip location relative to a clinician-established baseline, quantifies passageway diameter, detects ETT movement, and identifies obstructions (percent obstructed). Output is displayed on a color LCD as waveforms or graphics. Used by clinicians in hospital settings (ICU, OR, ED) to manage artificial airways. Provides real-time adjunctive data to assist clinical decision-making regarding tube position and patency, potentially reducing complications from ETT displacement or occlusion.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical (lab) performance testing.

Technological Characteristics

System consists of a plastic disposable ETT adapter and a portable digital monitor. Adapter includes a speaker, two microphones, and a cable. Monitor features an embedded processor, graphical display, user input interface, and serial communications interface. Operates via sonic reflection technology. Powered by external supply with battery backup. Connectivity via serial interface.

Indications for Use

Indicated for patients >35 kg requiring endotracheal tubes (ETT) sizes 6.5-9.0 mm. Used by qualified personnel in hospital settings (ICU, OR, ED, transport) to assist in verifying ETT placement, detecting ETT tip movement, and detecting ETT obstruction. Adjunctive use only.

Regulatory Classification

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.

Predicate Devices

• Eccovision Acoustic Diagnostic Imaging Pharyngometer (K011329)
• ETView Tracheoscopic Ventilation Tube (K082420)
• PosiTube Esophageal Intubation Detection (K000045)
• RhinoScan Acoustic Rhinometry (K000406)
• Tidal Wave SP Model 710/715 (K032971)

Submission Summary (Full Text)

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K092611

## SonarMed™ Airway Monitoring System

## 510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness

| Submitter<br>Information | SonarMed, Inc.<br>5513 West 74th St, Indianapolis, IN 46268<br>317-489-3161<br>866-853-3684 | | | APR 29 2010 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----|-------------|
| Contact<br>Person | Laura Lyons<br>Vice President Clinical, Quality & Regulatory Affairs<br>317-489-3161 ext. 208<br>866-853-3684 (fax) | | | |
| Date | August 24, 2009 | | | |
| Trade Name | SonarMedTM Airway Monitoring System | | | |
| Common<br>Name | Airway Monitoring System | | | |
| Product Code | OQU | | | |
| Classification<br>Number | 21 CFR 868.5730 | | | |
| Predicate<br>Devices | Eccovision Acoustic<br>Diagnostic Imaging<br>Pharyngometer | K011329 | BXQ | 868.1800 |
| | ETView Tracheoscopic<br>Ventilation Tube | K082420 | BTR | 868.5730 |
| | PosiTube Esophageal<br>Intubation Detection | K000045 | BTR | 868.5730 |
| | RhinoScan Acoustic<br>Rhinometry | K000406 | BXQ | 868.1800 |
| | Tidal Wave SP<br>Model 710/715 | K032971 | DQA | 870.2700 |
| Device<br>Description | The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is used<br>in conjunction with a sterile, single-use SonarMed Adapter (Adapter) and<br>software that operates the Monitor and Adapter. The Monitor is powered from<br>an external power supply and has a battery backup. When in use, the<br>SonarMed 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 airway<br>in either a waveform or graphic on the Monitor's color LCD. This information<br>should only be used in an adjunctive manner to assist with management of the<br>artificial airway of the patient. | |
| Intended Use | The SonarMed AMS is intended to be used to assist in verifying placement of<br>the ETT, to assist in detecting movement of the ETT tip, and to assist in<br>detecting obstruction of the ETT. |
| | The SonarMed AMS is intended for use by qualified personnel to assist with<br>artificial airway management for patients in an in-hospital setting (intensive care,<br>operating room, and emergency department settings, as well as intra-hospital<br>transport). |
| | The SonarMed AMS is to be used as an adjunct to normal clinical practice, and<br>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<br>mm weighing >35 kilograms. |
| Comparison to<br>Predicate<br>Devices | The SonarMed Airway Monitoring System is similar or identical in technology,<br>intended use, performance and environments of use. |
| Technological<br>Characteristics | The SonarMed AMS consists of two components: a plastic disposable ET tube<br>Adapter and a portable digital Monitor. The SonarMed AMS Adapter contains a<br>speaker, two microphones, and a cable. The speaker and microphones, which<br>acoustically communicate with the tube lumen via ports, have electrical<br>connections running to the cable exiting the Adapter. The cable connects the<br>speaker and microphones to a portable digital Monitor. The Monitor contains an<br>embedded processor, a graphical display, a user input interface, and a serial<br>communications interface. Both the Eccovision Acoustic Diagnostic Imaging<br>Pharyngometer and the RhinoScan Acoustic Rhinometry use the same<br>technology. |
| | The Tidal Wave SP, ETView Tracheoscopic Ventilation Tube and the PosiTube<br>Esophageal Intubation Detection verify placement within the airway. The Tidal<br>Wave SP and the ETView Tracheoscopic Ventilation Tube detect movement of<br>the endotracheal tube. The Acoustic Diagnostic Imaging Pharyngometer and<br>the 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.

1. The state of the state

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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 [phone] or [phone] 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