(300 days)
Not Found
No
The description focuses on data collection, conversion, processing, display, and storage of lung sounds and vibration energy. There is no mention of algorithms that learn from data or perform tasks typically associated with AI/ML, such as automated analysis, pattern recognition beyond simple visualization, or diagnostic assistance. The device is explicitly stated as "not intended to be used as a diagnostic instrument."
No
The device is described as "monitoring and recording lung sounds" and "is not intended to be used as a diagnostic instrument," indicating it is an observation tool rather than an intervention or treatment device.
No
The device description explicitly states, "The VRIxy is not intended to be used as a diagnostic instrument."
No
The device description explicitly lists three primary hardware components: electronic stethoscopes, a Digital Collection Module (DCM), and a mobile computer workstation. This indicates it is not a software-only device.
Based on the provided information, the VRIxy is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "monitoring and recording lung sounds." This involves collecting physiological data directly from the patient's body (via electronic stethoscopes on the thorax).
- Device Description: The device collects lung sounds via dermal contact and processes this data for visualization and monitoring. It does not analyze biological samples (like blood, urine, tissue, etc.) in vitro (outside the body).
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VRIxy does not fit this definition.
- Explicit Statement: The description explicitly states, "The VRIxy is not intended to be used as a diagnostic instrument." While this doesn't definitively rule out all IVD uses, it strongly suggests it's not intended for the primary purpose of an IVD.
Therefore, the VRIxy is a non-invasive device for monitoring and recording physiological signals (lung sounds) from the human body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VRIxy is intended for use in monitoring and recording lung sounds.
Product codes (comma separated list FDA assigned to the subject device)
OCR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs (implied from "lung sounds")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare practitioners; most clinic, treatment center, or hospital settings.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary
Deep Breeze, Ltd
VRIxv System
| Applicant's Name: | Deep Breeze Ltd.
2 Ha'llan Street PO Box 75
Or Akiva 30600, Israel
Tel: +972 (4) 6266650
Fax: +972 (4) 6266653 | OCT 15 2008 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Alon Kushnir
Vice President, Regulatory and Medical Affairs
Tel: +972 (4) 6266650
Fax: +972 (4) 6266653
Email: Alon.Kushnir@deepbreeze.com | |
| US Correspondent: | Becker & Associates Consulting, Inc.
Attn: Jeffrey A. Baetz
2001 Pennsylvania Ave. NW, #950
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
previous version of the device, the VR Lung
Electrosonograph (K061495). | |
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the left and its wings outstretched. The eagle is composed of thick, black lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)