WIM-PC, MODEL 1010

K071955 · Karmelsonix · BZM · Nov 1, 2007 · Anesthesiology

Device Facts

• Record ID: K071955
• Device Name: WIM-PC, MODEL 1010
• Applicant: Karmelsonix
• Product Code: BZM · Anesthesiology
• Decision Date: Nov 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1900
• Device Class: Class 2

Intended Use

The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ 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.

Device Story

WIM-PC™ is a computer-based electronic stethoscope system; utilizes dual contact sensors to acquire, amplify, filter, and record pulmonary sounds from trachea and thorax. System includes acoustic sensors, sensor pod with dielectric microphone for ambient noise, tension-sensitive respiration belt, A/D data acquisition unit, and laptop PC with analysis software. Used in clinical pulmonary function testing environments by physicians or under their supervision. Software processes acoustic signals and respiration data to detect/quantify wheezing and respiratory patterns. Provides high-fidelity audio, visual displays, and printed reports. Output assists clinicians in evaluating lung function, assessing response to bronchodilators, and documenting pulmonary status, potentially improving diagnostic accuracy and patient management.

Clinical Evidence

No clinical data. Performance validation consisted of bench testing: tension-sensitive respiration belt (electrical response, activity detection), acoustic sensors (frequency response, sensitivity), front-end electronics performance, and software validation (wheeze detection, breath detection). Packaging integrity was also verified.

Technological Characteristics

System includes acoustic sensors, dielectric microphone, tension-sensitive respiration belt, A/D converter, and laptop PC. Biocompatible materials per ISO 10993-1. Software utilizes algorithm-based rules for interpreting acoustic pulmonary function and chest impedance. Connectivity via USB. Sterilization not specified.

Indications for Use

Indicated for patients requiring acoustic pulmonary function measurement to quantify wheezing or listen to amplified/filtered breath sounds during provocation tests, bronchodilator administration, or physical examinations in pulmonary function testing environments. Use by or under physician supervision.

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 1010 (K980878)

Reference Devices

• SleepSense (K042253)

Submission Summary (Full Text)

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K071955
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KarmelSonix Israel Ltd

# ATTACHMENT NO. 7: 510(K) SUMMARY WIM-PCTM

# 510(K) SUMMARY WIM-PCTM

NOV - 1 2007

- Applicant's Name: KarmelSonix 5 Palyam Street Haifa 33095 ISRAEL Tel: [phone] Fax: [phone]
- Contact Person: Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel [phone] Fax [phone] [e-mail]
- WIM-PCTM Trade Name:
- Classification: Name: Diagnostic pulmonary-function interpretation calculator Product Code: BZM Regulation No: 868.1900 Class: II Panel: Anesthesiology

# Device Description:

The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.

The WIM-PCTM system consists of:

- Acoustic sensors (attached to the patient using adhesive pads). .
- Sensor pod with a built-in dielectric microphone for ambient noise pick-up. �
- Tension-sensitive respiration belt. .
- A/D data acquisition device ●
- USB cable and signal cable .

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KarmelSonix Israel Ltd

K071955
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- Laptop PC unit with Data Analysis software. .
## Predicate Device:

PulmoTrack™ model 1010 (k980878).

## Technological Characteristics

Both the WIM-PC™ device and its predicate device (PulmoTrack™; k980878) implement an algorithm-based set of rules to interpret acoustic pulmonary function and chest impedance measurements with respect to wheeze and respiratory pattern.

### Technological Modifications from Predicate Device

The modifications between the WIM-PCTM and its predicate device PulmoTrack™ 1010 (K980878) are:

- . Improved Acoustic sensors.
- Respiration belt (SleepSense k042253) instead of Impedance electrode .
- Laptop PC instead of desk-top PC .
- New version of software (Validated) .
- Improved Front End Electronics ●

.

### Indications for Use Statement:

The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds.

The WIM-PCTM 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.

### Performance Validation:

The following tests were performed on the WIM-PCTM hardware components:

- · Tension-sensitive Respiration Belt:
- · Electrical response to tension.
- · Respiratory activity detection
- · Acoustic sensors: sensors frequency response and sensitivity.
- · Front End performance.

The following validation tests were performed on the WIM-PCTM software:

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Image /page/2/Picture/0 description: The image shows the logo for KarmelSonix Israel Ltd. The logo includes the word "Karmel" in a decorative font, surrounded by a circular wreath. Below the logo is the text "KarmelSonix Israel Ltd" in a simpler font. The image is in black and white.

KC71955
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Karmelsonix Israel Ltd

- · Wheeze detection validation test.
- · Breath detection validation test.

The WIM-PCTM packaging was tested for its durability to shipment conditions.

The following test was performed on the WIM-PC™ packaging:

- WIM-PC™ packaging system integrity .
## Materials:

Materials of the WIM-PC™ system that are in contact with the human body are biocompatible in accordance with ISO 10993-1.

# Substantial Equivalence:

The WIM-PC™ and the PulmoTrack™ model 1010 predicate device, have the same intended use and indication for use, and they are implement the same technology.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KarmelSonix Israel Limited C/O Mr. Yoram Levy General Manager Osite 31 Haavoda Street Binyamina 33095 ISRAEL

NOV -- 1 2007

Re: K071955

Trade/Device Name: WIM-PC™ Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: October 15, 2007 Received: October 18, 2007

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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. 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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510(k) Number (if known): K071955

for

Device Name:

WIM-PCTM

. Indications Use:

The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ 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.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

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 (OI

(Division Sign-off)

Device Evaluation (ODE)

(Division Sign-off)

510(k) Number

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

510(k) Number: K071955

1-5 KarmelSonix, 5 Palyam St. Haifa 33095 ISRAEL Tel: [phone]; Fax: [phone]