(147 days)
The ViScope Electronic Stethoscope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
The ViScope Electronic Stethoscope (ViScope) is an audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Gram (VPCG) with visual display on which the heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dia/wide) for hearing heart, lung, blood vessel, enteral and other body sounds with different frequency ranges. In addition, the ViScope has an incorporated 'memory' feature that provides the user with the ability to review the saved 4 waveforms. The user also has the option to delete each waveform individually.
The ViScope comes in two models. the ViScope 100S and the ViScope 100P. The models are the same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that the ViScope 100P has the ability to download data to a PC or printer, the ViScope 100S does not offer this download feature. The ViScope 100P is supported by software that can be installed in a PC. The user can see the real-time waveforms on the PC monitor (as live data) and record in 10 second intervals. The software allows the user with an option of selecting the entire 10 second signal or select any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.
The ViScope Electronic Stethoscope's acceptance criteria and the study proving it meets these criteria are described below. The device is intended to be a diagnostic aid as part of a physical assessment, using an integrated graphics display to show amplified heart sounds as phonocardiograms. It can amplify heart, lung, blood vessel, enteral, and other body sounds.
The device's performance was evaluated against predicate devices, specifically the CADI Tech AG CADIscope electronic ECG Stethoscope (K990809) and the 3M Healthcare Littman Electronic Stethoscope, Model 3200 with Zargis Sethassist Software (K083903 and K090493). The primary metric for acceptance was substantial equivalence to these predicate devices in terms of technological characteristics and performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in technological characteristics to predicate devices | The ViScope meets specified requirements and is substantially equivalent to the predicate devices in technological characteristics. |
| Substantial equivalence in performance requirements to predicate devices | The ViScope meets specified requirements and is substantially equivalent to the predicate devices in performance requirements. |
| Functionality as an audio-visual auscultation tool | The ViScope is an audio-visual auscultation tool. |
| Ability to represent heart sounds as waveforms (phonocardiograms) | The ViScope displays heart sounds as waveforms. |
| Switchable modes (Bell/Dia/wide) for different frequency ranges | The ViScope has switchable modes for hearing various body sounds. |
| Memory feature to review saved waveforms | The ViScope incorporates a 'memory' feature for reviewing saved 4 waveforms. |
| Ability to download data to PC/printer (for 100P model) | The ViScope 100P has the ability to download data to a PC or printer. |
| Software for real-time waveform display and recording on PC (for 100P model) | The ViScope 100P is supported by software for real-time waveform display and recording. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a numerical sample size for a test set in the context of clinical or performance data collection. Instead, it states that "PERFORMANCE DATA and CONCLUSION: The performance data indicate that the Viscope meets specified requirements, and is substantially equivalent to the predicate devices." This suggests that the evaluation was likely based on engineering testing, functional verification, and a comparative analysis of specifications against the predicate devices, rather than a clinical study involving a specific patient cohort for performance assessment.
Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided within this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The substantial equivalence argument relies on a comparison of technological characteristics and performance requirements to existing legally marketed devices, rather than a clinical study requiring expert-established ground truth on patient cases.
4. Adjudication Method for the Test Set
Since a specific clinical test set and ground truth establishment by experts are not described, an adjudication method is not applicable or provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission focuses on substantial equivalence based on technological and performance specifications rather than a comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The ViScope is described as an "audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional," implying it is always used with a human in the loop. The device displays waveforms for medical practitioners to recognize and understand, and the software allows for further analysis by the user.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/medical imaging studies (e.g., pathology, outcomes data) is not directly applicable or specified in this 510(k) summary. The submission argues for substantial equivalence primarily based on design specifications, technological characteristics, and demonstrated performance (e.g., sound amplification, waveform display, memory function) that match or are comparable to predicate devices. The "ground truth" implicitly used for comparison would be the established performance and characteristics of the legally marketed predicate devices.
8. Sample Size for the Training Set
This information is not applicable or provided. The ViScope is an electronic stethoscope that visualizes heart sounds; it is not presented as an AI/machine learning device that requires a training set in the conventional sense for algorithmic development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided for the same reason as above (not an AI/ML device requiring a training set).
§ 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.