VRLXP, MODEL XP

K091732 · Deep Breeze , Ltd. · OCR · Mar 4, 2010 · Cardiovascular

Device Facts

• Record ID: K091732
• Device Name: VRLXP, MODEL XP
• Applicant: Deep Breeze , Ltd.
• Product Code: OCR · Cardiovascular
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VRIxp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management. The VRIxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.

Device Story

VRIxp is a non-invasive electronic stethoscope system for lung sound monitoring. Inputs: acoustic energy collected via dermal sound sensors. Processing: Digital Collection Module (DCM) converts analog signals to digital; mobile computer workstation processes, displays, and stores data. Output: visual grayscale lung sound map and audible playback per sensor; automated detection of crackles and wheezes. Usage: healthcare facilities; operated by physicians. Clinical utility: aids diagnosis and patient management by providing visual/audible lung data for physician interpretation, allowing validation against conventional auscultation. Benefits: objective recording and automated detection of adventitious lung sounds to support clinical decision-making.

Clinical Evidence

Bench testing only. Biocompatibility testing and software verification/validation were performed. Accuracy of automated crackle and wheeze detection was compared to the STG Monitor Multichannel Lung Sound Analysis System, demonstrating similar performance.

Technological Characteristics

Electronic stethoscope system; non-energy emitting. Components: dermal sound sensors, Digital Collection Module (DCM), mobile computer workstation. Connectivity: PC-based display/storage. Software: automated detection of crackles and wheezes. Biocompatible materials used.

Indications for Use

Indicated for monitoring/recording lung sounds and automatic detection of crackles and wheezes in adults, adolescents, and children over 2 feet 9 inches tall in healthcare facilities. Aids physicians in diagnosis and patient management.

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

• VRIxv (K073582)
• VR Lung Electrosonograph (K061495)
• Meditron Stethoscope System (K991367)
• STG Monitor Multichannel Lung Sound Analysis System (K012387)

Submission Summary (Full Text)

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K091732
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# 510(K) SUMMARY

| Submission Date: | June 11, 2009 |
|------------------|---------------|
|------------------|---------------|

February 26, 2010 Preparation Date:

MAR - 4 2010

# Submitter Information:

| Company Name: | | | Deep Breeze Ltd. |
|---------------|--|--|------------------|
|---------------|--|--|------------------|

Applicant Address: Deep Breeze, Ltd. Attn: Alon Kushnir 2 Hailan Street, North Industrial Park PO Box 140, Or-Akiva, 30600, Israel Telephone: [phone] Fax: [phone]

| Contact Person: | Jack A. Kent |
|-----------------|----------------------------------------|
| | Project Manager, Strategic Consulting |
| | Becker & Associates Consulting, Inc. |
| | 2001 Pennsylvania Avenue NW, Suite 950 |
| | Washington, DC 20006 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | |

# Device Information:

| Trade Name: | VRIXP |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electronic Stethoscope |
| Classification Name: | Electronic Stethoscope |
| Device Class: | Class II, 21 CFR 870.1875(b)<br>Product Code OCR |
| Predicate Devices: | VRIxv (K073582)<br>Deep Breeze, Ltd.<br>Class II<br><br>VR Lung Electrosonograph (K06 1495)<br>Deep Breeze, Ltd.<br>Class II |

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Meditron Stethoscope System (K991367) Meditron AS Class II

STG Monitor Multichannel Lung Sound Analysis System (K012387) Stethographics, Inc. Class II

#### Device Description:

The VRIxp is a non-invasive, non-energy emitting device indicated for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxP aids in diagnosis, monitoring, and patient management.

The VRIxp consists of same fundamental components as its predecessors the VRLE and the VRIxy, which are I) sound sensors designed to collect lung sounds via dermal contact with human skin; 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 recording information.

During the breathing process, the VRIxp detects lung sounds (i.e., acoustic energy) and converts them into a visual display, which can be viewed via a personal computer (PC) monitor and stored for future review. The device is designed to record breath sounds based on sensor location. Additionally, the VRIxp has an automated feature for detecting sounds consistent with crackles and wheezes for further clinical evaluation. Lung sounds can be viewed collectively as a grayscale image, as well as audibly by sensor. This latter feature provides greater flexibility for physicians to validate visual lung data by applying his or her previous clinical experience with conventional auscultation (gold standard).

### Indications for Use:

The VRIxp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management. The VRIxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.

#### Comparison to Predicate Device:

The VRIxp is substantially equivalent to the VRLE (manufactured by Deep Breeze; K061495), the VRIxy (manufactured by Deep Breeze; K073582), and the Meditron stethoscope system (manufactured by Meditron AS; K991367). The VRIxp and these three predicate devices share the same intended use and fundamental technological

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characteristics; the VRLE and VRIxy are indicated for monitoring and recording lung sounds, while the Meditron stethoscope system is indicated for use as an aid in diagnosis, treatment, and monitoring.

Additionally, the VRIxr has the same fundamental technological characteristics as the VRLE, VRIxy, and Meditron stethoscope system. Like the VRIxp, the VRLE and VRIxy use sound sensors to collect lung sounds via dermal contact, which is then converted to a visual display. The Meditron stethoscope system amplifies sound from the body's internal organs without introducing signals or energy into the body, and in fact, represents the electronic sensors contained within the VRLE and VRIxp. Additionally, the Meditron stethoscope system contains a software application that is designed to provide computer-aided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information, same as the VRIxp.

The STG Monitor Multichannel Lung Sounds Analysis System (STG) is a predicate device for the clearance of the VRIxp. It has the same intended use, namely: "automatic detection of crackles and wheezes." The VRIxp testing has demonstrated similar accuracy in crackles and wheezes detection as the reported accuracy of the predicate device.

Non-clinical testing has been conducted to demonstrate the performance of VRIxp and that it meets its intended use. The VRLxphas been evaluated for biocompatabiliuty, and appropriate software verification and validation testing was conducted. Pre-determined product specifications were met.

## Conclusion:

The VRIxp falls within the generic type of device as defined by 21 CFR 870.1875(b), Electronic Stethoscope. The VRIxp does not differ from the intended use or fundamental technological characteristics of the cited predicates, the VRLE, VRIxy, or the Meditron stethoscope system, and therefore is substantially equivalent to them.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

MAR - 4 2010

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

Deep Breeze, Limited C/O Mr. Jack Kent Project Manager, Strategic Consulting Becker & Associates Consulting, Incorporated 2001 Pennsylvania Avenue Northwest, Suite 950 Washington, DC 20006

Re: K091732

Trade Name: VRIxP Regulation Number: 21 CFR 870.1875(b) Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: OCR Dated: March 4, 2010 Received: March 4, 2010

Dear Mr. Kent:

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 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. Kent

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

flin 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

Enclosure

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### INDICATIONS FOR USE

K091732 510(k) Number (if known):

VRIxP Device Name:

Indications for Use:

The VRIxp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management. The VRIxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.

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)

L. Schullitin

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

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510(k) Number: k091732