(175 days)
No
The description mentions a "Dedicated DSP" and "Embedded software" for signal conditioning, digitization, and analysis, but does not mention AI or ML algorithms. The analysis is described as outputting a "wheezerate score based on the amount of wheezing detected," which suggests a rule-based or traditional signal processing approach rather than AI/ML.
No
The device is intended for quantifying the presence of wheezing and monitoring acoustic pulmonary functions, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device is described as quantifying the presence of wheezing, outputting a "wheezerate score," and is intended for use under the direction of a physician for monitoring acoustic pulmonary functions. This indicates its use in assessing a physiological condition to aid in diagnosis or monitoring of disease. The predicate device, "Diagnostic pulmonary-function interpretation calculator," further reinforces its diagnostic nature.
No
The device description explicitly lists multiple hardware components including an acoustic contact sensor, microphone, LCD screen, PCB, DSP, and memory, in addition to embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PERSONAL WHEEZOMETER™ analyzes acoustic pulmonary sounds from the trachea. This is a non-invasive method of collecting data directly from the body, not from a sample taken from the body.
- Input Modality: The input modality is "Acoustic pulmonary sounds," which are physical sounds, not biological samples.
The device is a diagnostic tool, but it falls under the category of in vivo diagnostic devices, as it analyzes data directly from within the living body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions. Intended for both home and clinical settings.
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)
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: 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.
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.
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.
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
§ 868.1900 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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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:
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.
1
. 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
2-3
KarmelSonix Ltd. | Personal Wheczometer ™ 510k Notification
2
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.
4
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
5
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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