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 PERSONAL WHEEZOMETER™ ™ is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of wheczes. The device outputs a wheezerate score based on the amount of wheezing detected in a given time. The PERSONAL WHEEZOMETER™ (PW) is intended to be a home use version of the PulmoTrack® (K980878) and PulmoTrack model 2010 (WIM-PC) (K071955), providing wheeze-rate information for both home and clinical settings.

The PERSONAL WHEEZOMETER™ device consists of:

An acoustic contact sensor
An air-coupled electret microphone for ambient noise rejection module.
LCD screen to display measurement results
4 user buttons
Signal conditioning and digitization PCB
Dedicated DSP
SDRAM memory
Embedded software.

AI/ML Overview

This 510(k) summary does not contain sufficient information to comprehensively answer all aspects of your request. Specifically, it lacks detailed quantitative acceptance criteria and the results of the performance study against those criteria, as well as specific information about ground truth establishment and training set details.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific quantitative criteria for wheeze detection (e.g., sensitivity, specificity, accuracy, precision, F1-score) are not provided	"All testing results demonstrated satisfactory performance."
	"The PERSONAL WHEEZOMETER™ meets its labeled performance claims..."
Usability/Safety	"The results of this usability study clearly indicate that the Personal Wheezometer is safe and effective when operated by intended users. In addition, it is easy to learn and operate the Personal Wheezometer while using the User Manual."
Biocompatibility	"Materials of the PERSONAL WHEEZOMETER™ device are biocompatible in accordance with ISO 10993-1."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified for the clinical study.
Data Provenance: The document states that KarmelSonix is an Israeli company and the contact person is from Israel. The clinical study was likely conducted in Israel, but this is not explicitly stated. The study is prospective, as it's a "clinical usability study" performed with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (It's unclear if experts were even used to establish ground truth for wheezing, as the study primarily focused on usability.)

4. Adjudication method for the test set

Not specified. Given the focus on usability, a formal adjudication process for wheeze detection may not have been the primary objective.

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

A MRMC comparative effectiveness study was not conducted. The study described is a "clinical usability study" of the device itself, not a comparative study with human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device, PERSONAL WHEEZOMETER™, is essentially a standalone algorithm for quantifying wheezing, displaying a "wheezerate score." The "clinical usability study" would inherently assess its standalone performance in a real-world user context. However, specific metrics of algorithm-only performance (e.g., sensitivity/specificity against a gold standard) are not detailed.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for evaluating wheezing detection. Given the clinical usability study context, it's possible that clinical assessment by physicians (expert consensus) or correlation with other diagnostic tools might have been informally used, but this is not detailed.

8. The sample size for the training set

Not specified. The document does not mention details about a training set, implying a pre-trained algorithm or an algorithm developed without a distinct "training set" in the context of this submission. The device is a home-use version of previously cleared devices (PulmoTrack® and PulmoTrack model 2010), so its core algorithms might have been developed and validated previously.

9. How the ground truth for the training set was established

Not specified, as details about a training set are not provided.

Summary

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K0908023

SEP 2 1 2009

510(K) SUMMARY WIM-PCTMTM

Applicant's Name:

KarmelSonix 16 Palyam Avenue Haifa 33095 ISRAEL Tel: (972)4-861-5025 Fax: (972)4-866-7702

Contact Person:

Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@gsitemed.com

Trade Name:

PERSONAL WHEEZOMETER™

Classification:

Name: Diagnostic pulmonary-function interpretation calculator Product Code: BZM Regulation No: 868.1900 Class: II Panel: Anesthesiology

Device Description:

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. The PERSONAL WHEEZOMETER™ device consists of:

An acoustic contact sensor ●
An air-coupled electret microphone for ambient noise . rejection module.
LCD screen to display measurement results .
4 user buttons .
Signal conditioning and digitization PCB .
Dedicated DSP t
SDRAM memory ♥
Embedded software. .

Indications for Use Statement:

Predicate Device:

PulmoTrack model 2010 (WIM-PC), Diagnostic pulmonary-1. function interpretation calculator; KarmelSonix (K071955).
STG Monitor Multichannel Lung Sound Analysis System 2. (K012387)

Performance Data:

Performance Testing - bench tests

A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.

Performance Testing -clinical study

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KarmelSonix Ltd. | Personal Wheczometer ™ 510k Notification

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A clinical usability study was performed with the PERSONAL WHEEZOMETER™. The results of this usability study clearly indicate that the Personal Wheezometer is safe and effective when operated by intended users. In addition, it is easy to learn and operate the Personal Wheezometer while using the User Manual.

Tests conclusion:

We have demonstrated that the PERSONAL WHEEZOMETER™ meets its labeled performance claims, and that it is substantially equivalent to the predicate devices.

Materials:

Materials of the PERSONAL WHEEZOMETER™ device are biocompatible in accordance with ISO 10993-1.

Substantial Equivalence:

We have demonstrated that the PERSONAL WHEEZOMETER™ meets its labeled performance claims, and that it is substantially equivalent to its predicate devices.

2-4 KarmelSonix Ltd. | Personal Wheezometer ™ 510k Notification

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

SEP 2 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Karmelsonix C/O Mr. Yoram Levy Regulatory Consultant Osite 31 Haavoda Street Binyamina Israel 30500

Re: K090863

Trade/Device Name: Personal Wheezometer™ Regulation Number: 868.1900 Regulation Name: Diagnostic Pulmonary Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: August 28, 2009 Received: September 1, 2009

Dear Mr. Levy:

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.

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- Mr. Levy

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 (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 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 vours.

for

Susan Runner, D.D.S., M.A. Acting 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 STATEMENT

510(k) Number (if known):

Device Name:

PERSONAL WHEEZOMETER™

Indications for Use:

PERSONAL WHEEZOMETER™ The 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.

Prescription Use X (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)

(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number

L. Schultze

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090863

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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).