VRIICU SYSTEM

K073582 · Deep Breeze , Ltd. · OCR · Oct 15, 2008 · Cardiovascular

Device Facts

• Record ID: K073582
• Device Name: VRIICU SYSTEM
• Applicant: Deep Breeze , Ltd.
• Product Code: OCR · Cardiovascular
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Indications for Use

The VRIxy is intended for use in monitoring and recording lung sounds.

Device Story

VRIxv system monitors/records lung sounds via electronic stethoscopes placed on thorax. System comprises electronic stethoscopes, Digital Collection Module (DCM) for analog-to-digital conversion, and mobile computer workstation. Device visualizes regionally distributed vibration energy; displays as grayscale/color images or vibration energy graphs. In mechanically ventilated patients, system synchronizes lung images/graphs with ventilator pressure and flow waveforms. Data stored on system; allows side-by-side comparison of current/previous recordings. Used by trained healthcare practitioners in hospitals/clinics to facilitate bedside monitoring. Output viewed on workstation or exported/printed for offline review. Assists clinicians in monitoring lung sound changes over time; not intended as diagnostic instrument.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Electronic stethoscope system; non-invasive dermal contact sensors. Includes DCM for signal conversion and mobile workstation for processing/display. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, AAMI/ISO 14971-1, and AAMI ANSI ISO 10993-1:2003. Software-based processing for visualization of vibration energy.

Indications for Use

Indicated for monitoring and recording lung sounds in spontaneously breathing and mechanically ventilated patients. Intended for use by trained healthcare practitioners in clinical, treatment center, or hospital settings. Not for diagnostic use.

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

• VR Lung Electrosonograph (K061495)

Submission Summary (Full Text)

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K073582

# 510(k) Summary

# Deep Breeze, Ltd

# VRIxv System

| Applicant's Name: | Deep Breeze Ltd.<br>2 Ha'llan Street PO Box 75<br>Or Akiva 30600, Israel<br>Tel: [phone]<br>Fax: [phone] | OCT 15 2008 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Alon Kushnir<br>Vice President, Regulatory and Medical Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| US Correspondent: | Becker & Associates Consulting, Inc.<br>Attn: Jeffrey A. Baetz<br>2001 Pennsylvania Ave. NW, #950<br>Washington, DC 20006 | |
| Date Prepared: | December 20, 2007 | |
| Trade Name: | VRIXV System | |
| Classification Name: | Electronic Stethoscope (21 CFR 870.1875) | |
| Classification: | Class II; Product Code OCR | |
| Predicate Devices: | The VRIXV System is substantially equivalent to the<br>previous version of the device, the VR Lung<br>Electrosonograph (K061495). | |

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#### Device Description:

The modified VR Lung Electrosonograph, the VRIxy is intended for use in monitoring and recording lung sounds. The VRIxy is a non-invasive device designed to facilitate visualization and monitoring of regionally distributed vibration energy. The VRIxy is comprised of three primary components: 1) Electronic stethoscopes designed to collect lung sounds via dermal contact with the human thorax; 2) A Digital Collection Module ("DCM") for the conversion of analog data to digital data; and, 3) A mobile computer workstation to assist in processing, displaying, and/or storing recorded information.

The VRIxy represents a natural progression in the company's desire to improve bedside monitoring capabilities, and is designed to provide lung imaging capability in spontaneously breathing patients, as well as mechanically ventilated patients. In the latter, monitoring capabilities are enhanced by the synchronization of the VRIxy image and vibration energy graph, with the pressure and flow waveform sampled from a ventilator. All dynamic images can be viewed as video file or frame-by-frame. The vibration energy of the lungs can be depicted in grayscale or color. Patient recording and all associated data are stored in the VRIxy system. Current and/or previous recordings can be viewed side-by-side in order to compare patients' lung sound images during hospitalization. These recordings and associated reports can be viewed or exported for offline viewing or printed on a conventional PC computer.

The VRIxv is intended to be used by trained healthcare practitioners and has been designed to accommodate most clinic, treatment center, or hospital settings. The VRIxy is not intended to be used as a diagnostic instrument.

#### Intended Use:

The VRIxy is intended for use in monitoring and recording lung sounds.

#### Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the VRIxy System complies with the voluntary standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, AAMI / ISO 14971-1 and AAMI ANSI ISO 10993-1:2003.

#### Performance Data & Substantial Equivalence

The VRIxv System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the VR Lung Electrosonograph cleared under K061495.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 5 2008

Deep Breeze Limited C/O Mr. Jeffrey A. Baetz Project Manager Becker & Associates Consulting, Incorporated 2001 Pennsylvania Avenue, N.W. #950 Washington, DC 20006

Re: K073582

Trade/Device Name: VRIxv System Regulation Number: 21 CFR 870.1875(b) Regulation Name: Electronic Stethoscope Regulatory Class: II Product Code: OCR Dated: September 16, 2008 Received: September 16, 2008

Dear Mr. Baetz:

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. Baetz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Qre

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 STATEMENT

510(k) Number (if known):____

Device Name: YRIxv System

Indications for Use:

The VRIxy is intended for use in monitoring and recording lung sounds.

L. Almid

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

510(k) Number: k073582

Prescription Use V (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)