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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the VRIXP device, broken down by your requested criteria:

1. Table of Acceptance Criteria & Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., "sensitivity must be > X%, specificity must be > Y%"). Instead, the performance is described in relation to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate for intended use and technology.	Stated as "substantially equivalent" to VRLE, VRIxy, and Meditron stethoscope system.
Similar accuracy in crackle and wheeze detection to predicate.	"The VRIxp testing has demonstrated similar accuracy in crackles and wheezes detection as the reported accuracy of the predicate device [STG Monitor Multichannel Lung Sound Analysis System]."
Biocompatibility requirements met.	"The VRIxp has been evaluated for biocompatibility."
Software verification and validation conducted.	"appropriate software verification and validation testing was conducted."
Predetermined product specifications met.	"Pre-determined product specifications were met."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). It simply states "Non-clinical testing has been conducted to demonstrate the performance of VRIxp and that it meets its intended use."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It discusses "interpretation by physicians with general medical training and experience" but doesn't quantify improvement with or without AI assistance.

6. Standalone Performance

The device does perform standalone detection of crackles and wheezes, as stated: "Additionally, the VRIxp has an automated feature for detecting sounds consistent with crackles and wheezes for further clinical evaluation." The "similar accuracy" claim implies this standalone performance was evaluated against the predicate's reported accuracy.

7. Type of Ground Truth Used

The ground truth for the "automatic detection of crackles and wheezes" functionality appears to be expert consensus or traditional auscultation. The text states:

"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)." This suggests that conventional auscultation by an expert is considered the 'gold standard' against which the device's visual and automated detection is compared.
The indications for use state, "When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management," further emphasizing the human role in validating the device's output.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. Given the nature of the device and the comparison to "conventional auscultation (gold standard)," it is highly probable that expert auscultation alongside other clinical assessments would have been used.

Summary

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K091732
page 1 of 3

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: +972 (4) 626-6650 Fax: +972 (4) 626-6649

Contact Person:	Jack A. Kent
	Project Manager, Strategic Consulting
	Becker & Associates Consulting, Inc.
	2001 Pennsylvania Avenue NW, Suite 950
	Washington, DC 20006
	Telephone: (202) 822-1850
	Fax: (202) 822-1859
	Email: jack.kent@becker-consult.com

Device Information:

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

Indications for Use:

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 (800) 638-2041 or (240) 276-3150 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:

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

Page 1 of 1

510(k) Number: K091732

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.