(266 days)
Not Found
Unknown
The summary mentions "automatic detection of crackles and wheezes" but does not specify the technology used for this detection. It could be rule-based algorithms or AI/ML, but the document doesn't provide enough detail to confirm.
No.
The device is intended for diagnosis and patient management by recording lung sounds and detecting crackles and wheezes, not for directly treating a medical condition.
Yes
The device "aids in diagnosis" and "automatic detection of crackles and wheezes", which are diagnostic functions.
No
The device description explicitly states that the VRIxp consists of sound sensors and a Digital Collection Module (DCM) for converting analog data to digital data, in addition to a mobile computer workstation. These are hardware components, not solely software.
Based on the provided information, the VRIxp is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- VRIxp Function: The VRIxp directly interacts with the patient's body (via dermal contact) to collect lung sounds. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for monitoring and recording lung sounds and detecting crackles and wheezes, which is a form of physiological monitoring and diagnostic aid based on physical signals, not laboratory analysis of specimens.
Therefore, the VRIxp falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OCR
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung
Indicated Patient Age Range
adults, adolescents, and/or children over the height of 2 feet 9 inches.
Intended User / Care Setting
physicians with general medical training and experience, in healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073582, K061495, K991367, K012387
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 II |
VR Lung Electrosonograph (K06 1495)
Deep Breeze, Ltd.
Class II |
1
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
2
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.
4
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
5
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