PULMOTRACK 5050 WHOLTER, MODEL 5050

K101022 · Karmelsonix · DSH · Jul 9, 2010 · Cardiovascular

Device Facts

• Record ID: K101022
• Device Name: PULMOTRACK 5050 WHOLTER, MODEL 5050
• Applicant: Karmelsonix
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended 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.

Device Story

PulmoTrack 5050 Wholter is an ambulatory respiratory data recorder. Inputs include acoustic signals from 4 sensors (including ambient noise sensor) and tension-sensitive respiration belt data. Device filters, performs A/D conversion, and stores data on internal flash memory. Used in clinical or home settings; operated by healthcare professionals. Data is downloaded via USB to a PC for analysis using PulmoTrack Series software. Output consists of recorded respiratory signals for playback, review, editing, and printing. Device does not perform automated diagnosis; output assists clinicians in evaluating respiratory symptoms like wheeze and cough.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy were established through validation testing against device specifications and comparison to predicate devices.

Technological Characteristics

Components: acoustic sensors, tension-sensitive respiration belt, ambient microphone, A/D converter, flash memory, USB interface. Biocompatible materials per ISO 10993-1. Connectivity: USB download to PC. Power: battery-operated (implied by ambulatory use). Software: firmware for data acquisition and storage.

Indications for Use

Indicated for patients requiring ambulatory recording of respiratory activity, including signals reflecting symptoms such as wheeze and cough, for up to 24 hours.

Regulatory Classification

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.

Predicate Devices

• WIM-PC (PulmoTrack 2010), Diagnostic pulmonary-function interpretation calculator; KarmelSonix (K071955)
• Vasomedical Biox 1305; Medical Magnetic Tape Recorder, Vasomedical, Inc (K083820)

Submission Summary (Full Text)

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Klolozz

JUL - 9 2010

510(K) SUMMARY PulmoTrack 5050 Wholter™

#### Applicant's Name:

KarmelSonix Palyam 16 Street Haifa 33095 ISRAEL Tel: [phone] Fax: [phone]

Contact Person:

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

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

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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:

- 1. WIM-PC (PulmoTrack 2010), Diagnostic pulmonary-function interpretation calculator; KarmelSonix (K071955).
- 2. 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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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.

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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.

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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 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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Image /page/5/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 design, possibly representing sound waves or a related concept.

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: