(245 days)
Not Found
No
The description focuses on "sonic reflection technology" and displaying quantitative data (passageway diameter, ETT movement, obstruction) based on these signals. There is no mention of AI, ML, or any learning algorithms used for interpretation or analysis.
Yes
The device assists in verifying placement, detecting movement, and detecting obstruction of an endotracheal tube, which are actions that directly assist in the management and treatment of a patient's artificial airway.
No.
The device's intended use explicitly states, "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."
No
The device description explicitly states it is comprised of a Monitor and an Adapter, in addition to software. These are hardware components.
Based on the provided text, the SonarMed™ AMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SonarMed AMS Function: The SonarMed AMS uses sonic reflection technology to assess the position, movement, and obstruction of an endotracheal tube within the patient's airway. It does not analyze biological specimens taken from the patient.
- Intended Use: The intended use clearly states it's for assisting with artificial airway management in vivo (within the living body).
Therefore, the SonarMed AMS falls under the category of a medical device used for monitoring and assisting with a procedure performed directly on the patient, not for analyzing samples in vitro.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OQU
Device Description
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.
The SonarMed AMS consists of two components: a plastic disposable ET tube Adapter and a portable digital Monitor. The SonarMed AMS Adapter contains a speaker, two microphones, and a cable. The speaker and microphones, which acoustically communicate with the tube lumen via ports, have electrical connections running to the cable exiting the Adapter. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
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)
The results of non-clinical (lab) performance testing demonstrate that the device is safe and effective. Clinical data and conclusions were not needed for this device.
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.
K011329, K082420, K000045, K000406, K032971
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
SonarMed™ Airway Monitoring System
510(k) Summary Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
| Submitter
Information | SonarMed, Inc.
5513 West 74th St, Indianapolis, IN 46268
317-489-3161
866-853-3684 | | | APR 29 2010 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----|-------------|
| Contact
Person | Laura Lyons
Vice President Clinical, Quality & Regulatory Affairs
317-489-3161 ext. 208
866-853-3684 (fax) | | | |
| Date | August 24, 2009 | | | |
| Trade Name | SonarMedTM Airway Monitoring System | | | |
| Common
Name | Airway Monitoring System | | | |
| Product Code | OQU | | | |
| Classification
Number | 21 CFR 868.5730 | | | |
| Predicate
Devices | Eccovision Acoustic
Diagnostic Imaging
Pharyngometer | K011329 | BXQ | 868.1800 |
| | ETView Tracheoscopic
Ventilation Tube | K082420 | BTR | 868.5730 |
| | PosiTube Esophageal
Intubation Detection | K000045 | BTR | 868.5730 |
| | RhinoScan Acoustic
Rhinometry | K000406 | BXQ | 868.1800 |
| | Tidal Wave SP
Model 710/715 | K032971 | DQA | 870.2700 |
| Device
Description | 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 | | | |
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.
Page 1 of 3
1
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 | |
| 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. | |
| 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. | |
| Comparison to | |
| Predicate | |
| Devices | The SonarMed Airway Monitoring System is similar or identical in technology, |
| intended use, performance and environments of use. | |
| Technological | |
| Characteristics | The SonarMed AMS consists of two components: a plastic disposable ET tube |
| Adapter and a portable digital Monitor. The SonarMed AMS Adapter contains a | |
| speaker, two microphones, and a cable. The speaker and microphones, which | |
| acoustically communicate with the tube lumen via ports, have electrical | |
| connections running to the cable exiting the Adapter. 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. Both the Eccovision Acoustic Diagnostic Imaging | |
| Pharyngometer and the RhinoScan Acoustic Rhinometry use the same | |
| technology. | |
| The Tidal Wave SP, ETView Tracheoscopic Ventilation Tube and the PosiTube | |
| Esophageal Intubation Detection verify placement within the airway. The Tidal | |
| Wave SP and the ETView Tracheoscopic Ventilation Tube detect movement of | |
| the endotracheal tube. The Acoustic Diagnostic Imaging Pharyngometer and | |
| 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.
- 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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3
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.
4
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
5
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