(413 days)
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds. The VR Lung Electrosonograph is a non-invasive device consisting 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 VR Lung Electrosonograph is intended to be used by trained healthcare practitioners, and has been designed to accommodate most clinic, treatment center, or hospital settings. While the VR Lung Electrosonograph may aid in diagnosis, the device is not intended to be used as a diagnostic instrument.
The provided text is a 510(k) summary for the Deep Breeze VR Lung Electrosonograph. This document is primarily focused on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or information typically found in clinical validation studies for AI/ML devices. Therefore, I cannot fully complete the requested table and answer many of the questions.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance metrics or acceptance criteria are provided in the document beyond a general statement of intended use. | No quantitative performance results are presented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing does not describe a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The filing does not describe a performance study with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The filing does not describe a performance study with an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was done, nor any mention of AI assistance. The device is described as an "Electrosonograph" for monitoring and recording lung sounds, not an AI-driven interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as a non-invasive tool to "aid in diagnosis," but "not intended to be used as a diagnostic instrument." It's an electronic stethoscope system designed for "trained healthcare practitioners" to collect, process, display, and store lung sound information. This suggests a human-in-the-loop scenario where the device provides data to the practitioner. There is no mention of standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document, as no specific performance study with ground truth is described.
8. The sample size for the training set
This information is not provided in the document. The 510(k) summary focuses on substantial equivalence, not on the development or training of an algorithm.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of the Study (Based on available information):
The provided document describes a 510(k) submission for the VR Lung Electrosonograph. The study is implicitly a substantial equivalence comparison to predicate devices rather than a direct performance study with acceptance criteria and a test set against ground truth.
- The device, a "VR Lung Electrosonograph," is intended for "monitoring and recording lung sounds."
- It is compared for substantial equivalence to the "Meditron Stethoscope System" (K991367) and the "STG Monitor Multichannel Lung Sound Analysis System" (K012387).
- The argument for substantial equivalence rests on similar intended use and technological characteristics (design, materials, energy source, function).
- The device is explicitly stated as being able to "aid in diagnosis" but "not intended to be used as a diagnostic instrument." This implies that the device provides data to a healthcare practitioner, who then uses their clinical judgment for diagnosis, rather than the device performing a diagnosis itself.
- The regulatory pathway chosen (510(k)) and the content provided focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative criteria.
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JUL 1 8 2007
510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR §807.92.
| Submission Date: | February 2, 2007 |
|---|---|
| ------------------ | ------------------ |
Submitter Information:
| Company Name: | Deep Breeze Ltd. |
|---|---|
| Company Address: | 2 Hailan Street, North Industrial ParkP.O. Box 140, Or-Akiva, 30600, Israel |
| Company Contact: | Alon KushnirVice President, Regulatory and Medical AffairsTel: 9-724-626-6650Fax: 9-724-626-6649alonk@deepbreeze.com |
| Official Correspondent: | Philip J. PhillipsDirector, Medical Device PracticeBecker & Associates Consulting, Inc.Tel: 202-822-1850Fax: 202-822-1859 |
| US Agent: | Becker & Associates Consulting, Inc.2001 Pennsylvania Avenue, NW, Suite 950Washington, DC 20006Tel: 202-822-1850Fax: 202-822-1859 |
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Device Information:
| Trade Name: | VR Lung Electrosonograph |
|---|---|
| Common Name: | Electronic stethoscope |
| Classification Name: | Electronic Stethoscope, 870.1875Diagnostic pulmonary-function interpretation calculator,868.1900 |
| Device Class: | Class II |
| Predicate Device: | Meditron Stethoscope System, Meditron AS (K991367)STG Monitor Multichannel Lung Sound Analysis System(K012387) |
| Device Description: | The VR Lung Electrosonograph is intended for use inmonitoring and recording lung sounds. The VR LungElectrosonograph is a non-invasive device consisting ofthree primary components: 1) Electronic stethoscopesdesigned to collect lung sounds via dermal contact with thehuman thorax; 2) a Digital Collection Module ("DCM") forthe conversion of analog data to digital data; and 3) amobile computer workstation to assist in processing,displaying, and/or storing recorded information. The VRLung Electrosonograph is intended to be used by trainedhealthcare practitioners, and has been designed toaccommodate most clinic, treatment center, or hospitalsettings. While the VR Lung Electrosonograph may aid indiagnosis, the device is not intended to be used as adiagnostic instrument. |
| Intended Use: | The VR Lung Electrosonograph is intended for use inmonitoring and recording lung sounds. |
Comparison to Predicate Device:
Deep Breeze's VR Lung Electrosonograph is substantially equivalent to the Meditron Stethoscope System, manufactured by Meditron AS. Furthermore, the VR Lung Electrosonograph is similar in its technological characteristics to the STG Monitor Multichannel Lung Sound Analyzer by Stethographics, Inc. The VR Lung Electrosonograph is a non-invasive device that has the same basic
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intended use and technological characteristics (i.e., design, materials, energy source) as the cited predicates.
Conclusion:
The VR Lung Electrosonograph falls within the same generic types of devices as defined by 21 CFR §870.1875 and 21 CFR § 868.1900. That is, the VR Lung Electrosonograph and the predicates do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness. The VR Lung Electrosonograph is also similar in technology, in the use of a visual display of sounds, as the STG Monitor Multichannel Lung Sound Analysis System. Furthermore, the regulatory controls applicable to the predicate devices are sufficient to provide reasonable assurance of the safety and effectiveness of the VR Lung Electrosonograph.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2007
Deep Breeze, Limited C/O Mr. Phillip J. Phillips Director, Medical Device Practice Becker & Associates Consulting, Incorporated 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006
Re: K061495
Trade/Device Name: VR Lung Electrosonograph Regulation Number: 870.1875 Regulation Name: Stethoscope Regulatory Class: II Product Code: OCR Dated: May 10, 2007 Received: May 10, 2007
Dear Mr. Phillips:
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
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Page 2 -Mr. Phillips
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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
510(k) Number:
Device Name:
VR Lung Electrosonograph
Indications for Use:
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ul J. Daal
Mision Sign-Or Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K061495
§ 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.