(87 days)
Not Found
No
The summary describes a data acquisition and storage device. The analysis is performed by separate software, and the summary explicitly states the device itself does not perform diagnosis. There are no mentions of AI, ML, or related concepts.
No
The device is described as a recording device for acquiring, storing, and reviewing ambulatory respiratory data, and it explicitly states that it "does not perform diagnosis." It works in concert with other systems for analysis and playback, but its function is solely data acquisition, not treatment or therapy.
No
The device description explicitly states, "The PulmoTrack 5050 Wholter™ itself does not perform diagnosis." It is a recording device that collects data for later analysis by a separate diagnostic software package.
No
The device description explicitly lists multiple hardware components, including acoustic sensors, a respiration belt, an ambient microphone, an A/D data acquisition device, and a USB cable. While it includes firmware and software for data storage and later analysis, it is not solely software.
Based on the provided information, the PulmoTrack 5050 Wholter™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- PulmoTrack 5050 Wholter™ Function: The description clearly states that the device is "non-invasive" and acquires, records, and stores "ambulatory respiratory activity" and "pulmonary sounds" directly from the patient's body using external sensors and a belt. It does not analyze biological specimens.
- Intended Use: The intended use is to record respiratory activity and signals reflecting symptoms like wheeze and cough, which are physiological measurements, not analyses of biological samples.
- Device Description: The components listed are all related to acquiring and storing physical signals (acoustic sensors, respiration belt, microphone, A/D converter, memory), not handling or analyzing biological specimens.
Therefore, the PulmoTrack 5050 Wholter™ is a non-invasive physiological monitoring and recording device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.
The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
Product codes (comma separated list FDA assigned to the subject device)
DSH
Device Description
The PulmoTrack 5050 Wholter™ is a recording device of pulmonary sounds. The device collects the pulmonary data from 4 sensors including a sensor for ambient sounds to reduce background noise. The acquired data is filtered, undergoes A/D conversion and is stored on a flash disk. The digital data is later downloaded to a PC for analyzing using a diagnosis software package.
The PulmoTrack 5050 Wholter™ device consists of:
- Acoustic sensors (attached to the patient using adhesive pads)
- Tension-sensitive respiration belt
- Ambient microphone
- A/D data acquisition device
- Firmware and Flash memory
- USB cable
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: The PulmoTrack 5050 Wholter underwent validation testing to ensure performance according to its specifications and that it is as good as the predicate devices. All tests demonstrated satisfactory results.
Performance Testing - clinical study: The PulmoTrack 5050 Wholter™ device is used in conjunction with an analysis software package that is used by the PulmoTrack 2010 (WIM-PC) (K071955), which has been validated by performance tests for performing diagnosis of the recording. The PulmoTrack 5050 Wholter™ itself does not perform diagnosis and therefore does not require clinical testing. The safety and efficacy of the PulmoTrack 5050 Wholter™ was proven by bench performance tests.
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.
Not Found
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for KarmelSonix. The logo features a stylized graphic to the left of the company name. The graphic appears to be an abstract representation of a brain or neural network.
Klolozz
JUL - 9 2010
510(K) SUMMARY PulmoTrack 5050 Wholter™
Applicant's Name:
KarmelSonix Palyam 16 Street Haifa 33095 ISRAEL Tel: (972)4-861-5025 Fax: (972)4-866-7702
Contact Person:
Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@qsitemed.com
Trade Name:
PulmoTrack 5050 Wholter™
Submission Date: March 21, 2010
Classification:
Name: Medical magnetic tape recorder Product Code: DSH Regulation No: 21 CFR 870.2800 Class: II Panel: Anesthesiology
Device Description:
The PulmoTrack 5050 Wholter™ is a recording device of pulmonary sounds. The device collects the pulmonary data from 4 sensors including a sensor for ambient sounds to reduce background noise. The acquired data is filtered, undergoes A/D conversion and is stored on a flash disk. The digital data is later downloaded to a PC for analyzing using a diagnosis software package.
KarmelSonix Ltd. | PulmoTrack 5050 Wholter ™ 510k Notification
1
The PulmoTrack 5050 Wholter™ device consists of:
- . Acoustic sensors (attached to the patient using adhesive pads)
- . Tension-sensitive respiration belt
- . Ambient microphone
- A/D data acquisition device .
- . Firmware and Flash memory
- . USB cable
Indications for Use Statement:
The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.
The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
Predicate Device:
-
- WIM-PC (PulmoTrack 2010), Diagnostic pulmonary-function interpretation calculator; KarmelSonix (K071955).
-
- Vasomedical Biox 1305; Medical Magnetic Tape Recorder, Vasomedical, Inc (K083820).
Performance Data:
Performance Testing - bench tests
The PulmoTrack 5050 Wholter underwent validation testing to ensure performance according to its specifications and that it is as good as the predicate devices. All tests demonstrated satisfactory results.
Performance Testing -clinical study
The PulmoTrack 5050 Wholter™ device is used in conjunction with an analysis software package that is used by the PulmoTrack 2010 (WIM-PC) (K071955), which has been validated by performance tests for performing diagnosis of the recording.
KarmelSonix Ltd. | PulmoTrack 5050 Wholter TM 510k Notification
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Image /page/2/Picture/0 description: The image shows a logo for "KarmelSonix". The logo features a stylized graphic to the left of the text. The graphic appears to be an abstract design, possibly representing sound waves or a stylized letter. The text "KarmelSonix" is written in a simple, sans-serif font, with the first letter "K" capitalized and the rest of the letters in lowercase.
The PulmoTrack 5050 Wholter™ itself does not perform diagnosis and therefore does not require clinical testing. The safety and efficacy of the PulmoTrack 5050 Wholter™ was proven by bench performance tests.
Materials:
Materials of the PulmoTrack 5050 Wholter™ device that are in contact with the human body are biocompatible in accordance with ISO 10993-1.
Substantial Equivalence:
We have demonstrated that the PulmoTrack 5050 Wholter™ meets its labeled performance claims, and that it is substantially equivalent to the predicate devices.
2-4
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
JUL - 9 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Yoram Levy Quality Assurance/Regulatory Affairs Consultant KarmelSonix 31 Haavoda Street Binyamina, Israel 30500
Re: K101022
Trade/Device Name: PulmoTrack 5050 WhoIter™ Regulation Number: 21CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II Product Code: DSH Dated: March 24, 2010 Received: April 13, 2010
Dear Ms. 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. 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.
4
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 yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices . Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PulmoTrack 5050 Wholter™
Indications for Use:
The PulmoTrack 5050 Wholter™ is a non-invasive device intended to acquire, record and store ambulatory respiratory activity from patients for up to 24 hours. It works in concert with the PulmoTrack® Series for playback, review, analysis, editing and printing of respiratory data.
The PulmoTrack 5050 Wholter™ is indicated for but not limited to recording of signals that reflect symptoms such as wheeze and cough.
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 OF NEEDED)
L. Schulthe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
11/01/22 510(k) Number: