PULMOTRACK 2020 SYSTEM

K102229 · Karmelsonix · BZM · Mar 4, 2011 · Anesthesiology

Device Facts

• Record ID: K102229
• Device Name: PULMOTRACK 2020 SYSTEM
• Applicant: Karmelsonix
• Product Code: BZM · Anesthesiology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PulmoTrack™ 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack™ 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack™ 2020 is indicated for patient population above two years old

Device Story

Computer-based electronic stethoscope; utilizes acoustic contact sensor to acquire, amplify, filter, record, and analyze tracheal and thoracic lung sounds. Data transmitted via Bluetooth wireless communication to PC. Provides high-fidelity audio, visual displays, printed reports, and automated identification of lung sounds. Used in pulmonary function testing environments by or under physician supervision. Assists clinicians in quantifying wheezing and assessing breath sounds during provocation tests or bronchodilator administration; aids clinical decision-making by providing objective acoustic data.

Clinical Evidence

Bench testing only. Validation testing confirmed performance specifications are equivalent to the predicate device. Biocompatibility of patient-contact materials verified per ISO 10993-1.

Technological Characteristics

Electronic stethoscope with acoustic contact sensor. Connectivity: Bluetooth wireless. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ISO 14971 (risk management).

Indications for Use

Indicated for patients >2 years old requiring acoustic pulmonary function measurement to quantify wheezing or to listen to amplified/filtered breath sounds during provocation tests, bronchodilator administration, or physical exams in pulmonary function testing environments.

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™ 2010 (WIM-PC™) (K071955)

Reference Devices

• HOSPIRA Vital Signs Wireless Monitoring System (K090610)

Submission Summary (Full Text)

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# K102229

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510(K) SUMMARY

MAR - 4 2011

PulmoTrack™ 2020

510(k) Number K

| Preparation Date: | August 3, 2010 | | | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Applicant's Name: | Karmel Sonix Ltd<br>16 Palyam St.<br>Haifa 33095<br>Tel: [phone]<br>Fax: [phone] | | | |
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda St.<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] | | | |
| Trade Name: | PulmoTrackTM 2020 | | | |
| Classification: | Name: Diagnostic pulmonary-function interpretation calculator<br>Product Code: BZM<br>Regulation No: 21 CFR 868.1900<br>Class: II<br>Panel: Anesthesiology | | | |

### Device Description:

The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.

#### Intended Use Statement:

The PulmoTrackTM 2020 is intended for the analysis,

interpretation and documentation of lung sounds.

The PulmoTrack™ 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when

1-3 PulmoTrack™ 2020 - Special 510k Notification

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there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The PulmoTrack™ 2020 is indicated for patient population above two vears old

#### Predicate Devices:

Substantial equivalence to the following predicate device is claimed:

| Device Name | 510k No | Clearance Date |
|--------------------------------|---------|----------------|
| PulmoTrack™ 2010 (WIM-<br>PC™) | K071955 | Nov 01, 2007 |

#### Performance Standards:

PulmoTrack"151 2020 complies with U.S. Federal Performance Requirements and Standards 21 CFR 801, 21 CFR 820 and FD&C act sections 501, 502, 516, 518, 519, 520.

In addition, the system complies with the following standards:

- . IEC 60601-1:1998 Medical electrical Equipment Part 1: "General requirements for safety" Second addition, 1990 including amendments No.1 (1993) No.2 (1995).
- . IEC 60601-1-2:2001 and IEC 60601:2005 Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests.
- EN ISO 10993-1:2003 Biological Evaluation of Medical . Devices.
- ISO 14971:2007 Risk management for medical devices . ●

## Technical Modifications from Predicate Device:

The PulmoTrack™ 2020 is identical to the PulmoTrack™ 2010 (WIM-PC"1) predicate except for the data transfer from the A/D to the PC which is done via Bluetooth wireless channel, thus contains generic software driver that handles the Bluetooth channel.

#### Substantial Equivalence:

The PulmoTrack™ 2020:

- Incorporates the same intended use and the same . technology as the PulmoTrackTM 2010 (WIM-PC™), cleared in K071955

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- The Bluetooth is substantial equivalence to HOSPIRA . Vital Signs Wireless Monitoring System, cleared in K090610
## Performance Validation:

The PulmoTrack™ 2020 underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance.

- Materials of the PulmoTrack"]1 2020 that are in contact with the Materials: human body are biocompatible in accordance with ISO 10993-1.
- KarmelSonix Ltd. believes that, based on the information provided Conclusion: in this submission, the PulmoTrack™ 2020 is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Karmelsonix C/O Mr. Yoram Levy Osite 31 Haavoda St. Binyamina, Israel 30500

MAR - 4 2011

Re: K102229

Trade/Device Name: Pulmo Track"" 2020 Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: January 28, 2011 Received: February 3, 2011

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. 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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# 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 (OS) 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,

Anthony V. Rao

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K102229

Device Name:

PulmoTrack™ 2020

| Indications for Use: | The <i>PulmoTrack</i> ^TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The <i>PulmoTrack</i> ^TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The <i>PulmoTrack</i> ^TM 2020 is indicated for patient population above two years old |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 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 Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number

L. Schultheis

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

K 102229 510(k) Number: _

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