VR LUNG ELECTROSONOGRAPH

K061495 · Deep Breeze , Ltd. · OCR · Jul 18, 2007 · Cardiovascular

Device Facts

• Record ID: K061495
• Device Name: VR LUNG ELECTROSONOGRAPH
• Applicant: Deep Breeze , Ltd.
• Product Code: OCR · Cardiovascular
• Decision Date: Jul 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Indications for Use

The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.

Device Story

VR Lung Electrosonograph is a non-invasive electronic stethoscope system for monitoring and recording lung sounds. System components: electronic stethoscopes for dermal contact with human thorax; Digital Collection Module (DCM) for analog-to-digital conversion; mobile computer workstation for processing, display, and storage. Operated by trained healthcare practitioners in clinics, treatment centers, or hospitals. Device aids in clinical assessment but is not a diagnostic instrument. Output allows providers to visualize and review recorded lung sounds to assist in clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive electronic stethoscope system. Components: electronic stethoscopes, Digital Collection Module (DCM), and mobile computer workstation. Energy source: electrical. Connectivity: workstation-based processing and storage. Intended for clinical/hospital use.

Indications for Use

Indicated for monitoring and recording lung sounds in patients. Intended for use by trained healthcare practitioners in clinical, treatment center, or hospital settings. Prescription use only.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Meditron Stethoscope System (K991367)
• STG Monitor Multichannel Lung Sound Analysis System (K012387)

Submission Summary (Full Text)

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K061495

JUL 1 8 2007

# 510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR §807.92.

| Submission Date: | February 2, 2007 |
|------------------|------------------|
|------------------|------------------|

### Submitter Information:

| Company Name: | Deep Breeze Ltd. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 2 Hailan Street, North Industrial Park<br>P.O. Box 140, Or-Akiva, 30600, Israel |
| Company Contact: | Alon Kushnir<br>Vice President, Regulatory and Medical Affairs<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Official Correspondent: | Philip J. Phillips<br>Director, Medical Device Practice<br>Becker & Associates Consulting, Inc.<br>Tel: [phone]<br>Fax: [phone] |
| US Agent: | Becker & Associates Consulting, Inc.<br>2001 Pennsylvania Avenue, NW, Suite 950<br>Washington, DC 20006<br>Tel: [phone]<br>Fax: [phone] |

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Device Information:

| Trade Name: | VR Lung Electrosonograph |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electronic stethoscope |
| Classification Name: | Electronic Stethoscope, 870.1875<br>Diagnostic pulmonary-function interpretation calculator,<br>868.1900 |
| Device Class: | Class II |
| Predicate Device: | Meditron Stethoscope System, Meditron AS (k991367)<br>STG Monitor Multichannel Lung Sound Analysis System<br>(k012387) |
| Device Description: | The VR Lung Electrosonograph is intended for use in<br>monitoring and recording lung sounds. The VR Lung<br>Electrosonograph is a non-invasive device consisting of<br>three primary components: 1) Electronic stethoscopes<br>designed to collect lung sounds via dermal contact with the<br>human thorax; 2) a Digital Collection Module ("DCM") for<br>the conversion of analog data to digital data; and 3) a<br>mobile computer workstation to assist in processing,<br>displaying, and/or storing recorded information. The VR<br>Lung Electrosonograph is intended to be used by trained<br>healthcare practitioners, and has been designed to<br>accommodate most clinic, treatment center, or hospital<br>settings. While the VR Lung Electrosonograph may aid in<br>diagnosis, the device is not intended to be used as a<br>diagnostic instrument. |
| Intended Use: | The VR Lung Electrosonograph is intended for use in<br>monitoring and recording lung sounds. |

# Comparison to Predicate Device:

Deep Breeze's VR Lung Electrosonograph is substantially equivalent to the Meditron Stethoscope System, manufactured by Meditron AS. Furthermore, the VR Lung Electrosonograph is similar in its technological characteristics to the STG Monitor Multichannel Lung Sound Analyzer by Stethographics, Inc. The VR Lung Electrosonograph is a non-invasive device that has the same basic

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intended use and technological characteristics (i.e., design, materials, energy source) as the cited predicates.

#### Conclusion:

The VR Lung Electrosonograph falls within the same generic types of devices as defined by 21 CFR §870.1875 and 21 CFR § 868.1900. That is, the VR Lung Electrosonograph and the predicates do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness. The VR Lung Electrosonograph is also similar in technology, in the use of a visual display of sounds, as the STG Monitor Multichannel Lung Sound Analysis System. Furthermore, the regulatory controls applicable to the predicate devices are sufficient to provide reasonable assurance of the safety and effectiveness of the VR Lung Electrosonograph.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 8 2007

Deep Breeze, Limited C/O Mr. Phillip J. Phillips Director, Medical Device Practice Becker & Associates Consulting, Incorporated 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006

Re: K061495

Trade/Device Name: VR Lung Electrosonograph Regulation Number: 870.1875 Regulation Name: Stethoscope Regulatory Class: II Product Code: OCR Dated: May 10, 2007 Received: May 10, 2007

Dear Mr. Phillips:

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

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Page 2 -Mr. Phillips

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 vours.

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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# INDICATIONS FOR USE

510(k) Number:

K061495

Device Name:

VR Lung Electrosonograph

Indications for Use:

The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ul J. Daal

Mision Sign-Or Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K061495