PERSONAL WHEEZOMETER

K090863 · Karmelsonix · BZM · Sep 21, 2009 · Anesthesiology

Device Facts

• Record ID: K090863
• Device Name: PERSONAL WHEEZOMETER
• Applicant: Karmelsonix
• Product Code: BZM · Anesthesiology
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1900
• Device Class: Class 2

Intended 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 Story

Hand-held electronic device; utilizes acoustic contact sensor to acquire pulmonary sounds from trachea; includes air-coupled electret microphone for ambient noise rejection. Dedicated DSP processes signals; embedded software analyzes sounds for wheezing; outputs wheezerate score to LCD screen. Used in home or clinical settings; operated by patient or healthcare professional. Provides objective wheeze-rate information to assist clinicians in monitoring pulmonary function and clinical decision-making.

Clinical Evidence

Clinical usability study performed; results indicated the device is safe, effective, and easy to learn/operate by intended users. Bench testing confirmed performance claims.

Technological Characteristics

Hand-held device; acoustic contact sensor; air-coupled electret microphone for noise rejection; signal conditioning/digitization PCB; dedicated DSP; SDRAM memory; embedded software. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients requiring monitoring of acoustic pulmonary functions to quantify wheezing; intended for use under the direction of a physician or licensed healthcare professional in home or clinical settings.

Regulatory Classification

Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

Predicate Devices

• PulmoTrack model 2010 (WIM-PC) (K071955)
• STG Monitor Multichannel Lung Sound Analysis System (K012387)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Contact Person:

Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel [phone] Fax [phone] [e-mail]

Trade Name:

## PERSONAL WHEEZOMETER™

Classification:

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

#### 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.

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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:

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.

#### 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 [phone] or [phone] 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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