(470 days)
Not Found
No
The description mentions a "Dedicated DSP" and "Embedded software" for signal conditioning and analysis, but does not explicitly mention AI or ML algorithms being used for the detection or calculation of WheezeRate™. The analysis is described as based on "acoustic contact sensor" data and calculating a percentage of "abnormal breath sound detected," which could be achieved through traditional signal processing techniques.
No
The device is intended to detect and record abnormal breath sounds, providing diagnostic information (WheezeRate™) rather than providing a therapeutic effect.
Yes
The device detects and records abnormal breath sounds and outputs a WheezeRate, which is a measurement used to understand a patient's condition related to breath sounds. The description also mentions that a licensed healthcare professional's advice is required to understand the meaning and importance of the readings, indicating its role in informed medical decision-making.
No
The device description explicitly lists multiple hardware components, including an acoustic contact sensor, microphone, LCD screen, buttons, PCB, DSP, and memory, in addition to embedded software.
Based on the provided information, the SonoSentry™ WheezeRate™ Detector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SonoSentry™ Function: The SonoSentry™ WheezeRate™ Detector works by acquiring, amplifying, filtering, recording, and analyzing breath sounds directly from the patient's trachea using an acoustic sensor. It does not involve the collection or analysis of biological specimens from the body.
- Method of Operation: The device relies on the physical detection and analysis of sound waves generated by breathing, not on biochemical or cellular analysis of a sample.
Therefore, the SonoSentry™ WheezeRate™ Detector falls under the category of a medical device that performs a physical measurement on the body, rather than an in vitro analysis of a specimen.
N/A
Intended Use / Indications for Use
The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
Product codes
PHZ
Device Description
The SonoSentry™ WheezeRate™ Detector is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze breath sounds at the trachea for the presence of continuous adventitious breath sounds/CABS. The device calculates and outputs a WheezeRate™ based on the amount of abnormal breath sounds detected in a given time. The device is designed for use in adults and children (ages 2 years and older).
The SonoSentry™ WheezeRate™ Detector consists of:
- . An acoustic contact sensor
- . An air-coupled electret microphone for ambient noise reiection module
- LCD screen to display measurement results .
- . 4 user buttons
- . Signal conditioning and digitization PCB
- Dedicated DSP .
- . SDRAM memory
- . Embedded software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
windpipe (trachea)
Indicated Patient Age Range
adults and children (2 years and older)
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
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
A clinical study was conducted to ensure that the SonoSentry™ WheezeRate™ Detector can detect and record continuous adventitious breath sounds (CABS), including wheeze, compared to physician assessment of those same breath sounds. Sound files of pediatric and adult study subjects with a previous diagnosis of moderate to severe asthma were analyzed by the SonoSentry and an Expert Panel consisting of Board Certified Pulmonologists. The Multiple Reader/Multiple Case Study demonstrated an acceptable agreement between the output of the SonoSentry and physician detection of CABS.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).
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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 a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2014
iSonea, Limited C/O Korina A. Akhondzadeh Regulatory Consultant to iSonea 6965 El Camino Real, Suite 105-428 Carlsbad, California 92009
Re: K131285
Trade/Device Name: SonoSentry™ WheezeRate™ Detector Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary- Function Interpretation Calculator Regulatory Class: II Product Code: PHZ Dated: July 29, 2014 Received: July 30, 2014
Dear Ms. Akhondzadeh:
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. 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 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,
Erin I. Keith -S
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 Radiological Health
Enclosure
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K131285 510(k) Number:
Device Name:
SonoSentry™ WheezeRate™ Detector
Indications For Use:
The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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)
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Image /page/3/Picture/0 description: The image shows the logo for iSonea. The logo features two curved lines in light green and teal, resembling sound waves. To the right of the sound waves is the company name, "iSonea," in a dark, sans-serif font. The "i" in "iSonea" is stylized with a small dot above it, connecting to the sound wave graphic.
The 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information conforms to the requirements of 21 CFR § 807.92.
| Manufacturer | iSonea, Ltd. |
|---|---|
| Address | 16 Palyam Avenue |
| Haifa 33095 | |
| Israel | |
| Telephone | 972-4-861-5025 |
| Fax number | 972-4-866-7702 |
| Contact at iSonea | Stephen Tunnell |
| Managing Director | |
| Address | 125 South Tremont |
| Oceanside, CA 92054 | |
| Telephone | 760-547-1613 |
| Fax | 760-547-5706 |
| stunnell@isoneamed.com | |
| Official Correspondent | Korina A. Akhondzadeh |
| KARA & Associates - Regulatory Consultant to iSonea | |
| Address | 6965 El Camino Real, Suite 105-428 |
| Carlsbad, CA 92009 | |
| Telephone | 760-798-9642 |
| Fax | 760-798-9643 |
| korina@karaandassociates.com | |
| Device Name and Classification |
| Trade name/Product Name | SonoSentry™ WheezeRate™ Detector |
|---|---|
| Common/Usual Name | Abnormal Breath Sound Device |
| Classification Name | Diagnostic pulmonary-function interpretation calculator |
| Classification Panel | Anesthesiology Devices |
| Product Code | PHZ |
| Regulation Number | 21 CFR § 868.1900 |
| Device Class | II |
CONFIDENTIAL
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Predicate Device
| Manufacturer | KarmelSonix (now known as iSonea Ltd.) |
|---|---|
| Device Name | Personal Wheezometer™ |
| 510(k) Number | K090863 |
| Clearance Date | September 21, 2009 |
| Indications for Use | The Personal Wheezometer™ is intended for quantifying the presence of |
| wheezing. This device should be used under the direction of a physician or | |
| licensed healthcare professional for monitoring acoustic pulmonary | |
| functions. |
Device Description
The SonoSentry™ WheezeRate™ Detector is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze breath sounds at the trachea for the presence of continuous adventitious breath sounds/CABS. The device calculates and outputs a WheezeRate™ based on the amount of abnormal breath sounds detected in a given time. The device is designed for use in adults and children (ages 2 years and older).
The SonoSentry™ WheezeRate™ Detector consists of:
- . An acoustic contact sensor
- . An air-coupled electret microphone for ambient noise reiection module
- LCD screen to display measurement results .
- . 4 user buttons
- . Signal conditioning and digitization PCB
- Dedicated DSP .
- . SDRAM memory
- . Embedded software
Indications for Use
The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.
Substantial Equivalence
The SonoSentry™ WheezeRate™ Detector and the legally marketed predicate device, the Personal Wheezometer™ (K090863) have the same technological characteristics. The Personal Wheezometer™ is a prescription (Rx) device intended for quantifying the presence of wheezing. Wheezometer™ device is intended for use in the home and clinical settings by lay users under the direction of a physician or licensed healthcare professional for acoustically monitoring pulmonary
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functions. The SonoSentry™ is available over-the-counter (OTC) as a tool to detect and record continuous adventitious breath sounds/CABS and report them as a WheezeRate ™. While the SonoSentry™ is an OTC device, a licensed healthcare professional's advice is required to understand the meaning and importance of the SonoSentry™ WheezeRate™ readings.
The technological characteristics for the SonoSentry WheezeRate™ Detector are identical to those of the predicate device. The SonoSentry™ is identical to the Personal Wheezometer™ in design, physical size, materials and function. The SonoSentry™ software is a revision of the Personal Wheezometer™ software. The revised software does not add any additional functionality for the user, and has been documented and validated in the same manner as the predicate device. There have been no other technological changes since the 510(k) clearance of the Personal Wheezometer™. The SonoSentry™ WheezeRate™ Detector is substantially equivalent to the Personal Wheezometer™.
Performance Testing - Electromagnetic Compatibility and Electrical Safety
The SonoSentry™ WheezeRate™ Detector has been tested to the following standards:
-
- IEC 60601-1:1988, A1:1991, A2:1995 Medical electrical Equipment Part 1: General requirements for safety
-
- IEC 60601-1-2:2001, A1:2004 Medical electrical equipment Part 1: General requirements for safety -2. Collateral standard: Electromagnetic compatibility -Requirements and tests
Performance Testing - Bench Testing
Bench testing was conducted to ensure the performance and functionality of the SonoSentry™ WheezeRate™ Detector. Testing included the following:
-
- Ambient Microphone Validation Testing
-
- Pressure Switch Validation Testing
-
- Algorithm Validation Testing
-
- Accuracy Testing
-
- Sensitivity Testing
-
- Embedded Performance Testing
Performance Testing - Clinical Study
A clinical study was conducted to ensure that the SonoSentry™ WheezeRate™ Detector can detect and record continuous adventitious breath sounds (CABS), including wheeze, compared to physician assessment of those same breath sounds. Sound files of pediatric and adult study subjects with a previous diagnosis of moderate to severe asthma were analyzed by the SonoSentry and an Expert Panel consisting of Board Certified Pulmonologists. The Multiple Reader/Multiple Case Study demonstrated an acceptable agreement between the output of the SonoSentry and physician detection of CABS.
CONFIDENTIAL
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Summary of Performance Testing – Conclusion
The SonoSentry™ WheezeRate™ Detector and the legally marketed predicate device have the same intended use and technological characteristics. SonoSentry™ was demonstrated to meet the requirements for electrical safety and electromagnetic compatibility as specified in the FDA recognized IEC 60601-1 and IEC 60601-1-2 standards. Bench testing involving the ambient microphone, pressure switch, algorithm, device accuracy, device sensitivity and embedded system demonstrate the performance and functionality of the device and a clinical study demonstrate that the device fulfills its intended use. The SonoSentry™ WheezeRate™ Detector is substantially equivalent to the Personal Wheezometer™, that is, SonoSentry™ is as safe and effective as the legally marketed predicate and does not raise any new types of safety or effectiveness.
CONFIDENTIAL