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.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SonoSentry™ WheezeRate™ Detector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a specific performance metric table with pass/fail thresholds. However, it does state the device's intended use and the outcome of the clinical study.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to detect and record continuous adventitious breath sounds (CABS), including wheeze.	Demonstrated an acceptable agreement with physician detection of CABS in a a clinical study

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact number of participants (pediatric and adult) in the clinical study that formed the test set. It mentions "pediatric and adult study subjects."
Data Provenance: Not explicitly stated (e.g., country of origin). The study subjects had "a previous diagnosis of moderate to severe asthma." The study appears to be prospective since it describes "Sound files... were analyzed by the SonoSentry and an Expert Panel."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: An "Expert Panel" was used, but the exact number of experts is not specified.
Qualifications of Experts: The Expert Panel consisted of "Board Certified Pulmonologists."

4. Adjudication Method for the Test Set

The document states that an "Expert Panel consisting of Board Certified Pulmonologists" analyzed the sound files. It doesn't explicitly detail a specific adjudication method like "2+1" or "3+1." It implies a consensus or agreement by the panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? Yes, the document explicitly states, "The Multiple Reader/Multiple Case Study demonstrated an acceptable agreement between the output of the SonoSentry and physician detection of CABS."
Effect size of human readers improve with AI vs without AI assistance: The document does not provide any specific effect size or quantitative measure of how much human readers improved with AI assistance compared to without it. It only states that there was "acceptable agreement" between the device and physician detection. The study seemed to compare the device's performance against physician assessment, rather than human performance with the device versus without it.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The clinical study describes the SonoSentry analyzing sound files and its output being compared to physician assessment. This indicates a standalone evaluation of the algorithm's performance without direct human-in-the-loop assistance for the physicians in the comparison.

7. Type of Ground Truth Used

The ground truth used was expert consensus / physician assessment. Specifically, it was established by an "Expert Panel consisting of Board Certified Pulmonologists" who analyzed the same breath sounds.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the SonoSentry™ WheezeRate™ Detector or its underlying algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. It only discusses the clinical study used for performance evaluation (test set).

Summary

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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

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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:

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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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 AvenueHaifa 33095Israel
Telephone	972-4-861-5025
Fax number	972-4-866-7702
Contact at iSonea	Stephen TunnellManaging Director
Address	125 South TremontOceanside, CA 92054
Telephone	760-547-1613
Fax	760-547-5706
E-mail	stunnell@isoneamed.com
Official Correspondent	Korina A. AkhondzadehKARA & Associates - Regulatory Consultant to iSonea
Address	6965 El Camino Real, Suite 105-428Carlsbad, CA 92009
Telephone	760-798-9642
Fax	760-798-9643
Email	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 ofwheezing. This device should be used under the direction of a physician orlicensed healthcare professional for monitoring acoustic pulmonaryfunctions.

Device Description

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

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:

1. IEC 60601-1:1988, A1:1991, A2:1995 Medical electrical Equipment Part 1: General requirements for safety
1. 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:

1. Ambient Microphone Validation Testing
1. Pressure Switch Validation Testing
1. Algorithm Validation Testing
1. Accuracy Testing
1. Sensitivity Testing
1. 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

Regulation Number and Section

§ 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).