(163 days)
The BM-520 Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs. It can be used on any person undergoing a physical assessment.
The Sharp Electronic Stethoscope Model BM-520 is an electronic stethoscope to auscultate sounds from heart, lung, blood vessels, and other internal organs. It can be used on adults undergoing a physical assessment. The sounds can also be transmitted to an appropriately configured receiving device via Bluetooth® wireless communication.
The provided text describes the Sharp Electronic Stethoscope Model BM-520. However, it does not contain details about specific acceptance criteria or an analytical study that proves the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting specific conditions).
Instead, the submission document focuses on establishing substantial equivalence to predicate devices based on:
- Intended Use: "medical diagnostic purposes only... detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs... on any person undergoing a physical assessment."
- Principles of Operation: "operates continuously to provide sounds from heart, lungs, and blood vessels. The sounds detected by the chest piece are output through the ear tips after being amplified and digitally filtered. At the same time, the sounds can be transmitted to an appropriately configured receiving device via Bluetooth® wireless communication. The BM-520 offers two selectable modes, Bell and Diaphragm. Volume is adjustable between 0 and 48 dB."
- Functional Design: Not explicitly detailed but implied through the description of the device's operation.
- Technological Characteristics: Similar to principles of operation, emphasizing the features like digital filtering, amplification, adjustable volume, and wireless communication.
The "Summary of Test Data" section states: "The Sharp BM-520 was developed and is produced under consideration of all applicable technical standards and internal specifications. The performance of the BM-520 has been verified in the course of bench testing and software validation testing."
This indicates that internal testing was conducted to ensure the device met its design specifications and general safety/performance standards, rather than a clinical study evaluating its diagnostic accuracy against a specific ground truth or clinical outcome.
Therefore, many of the requested details related to clinical performance studies cannot be extracted from this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Submission) | Reported Device Performance |
|---|---|
| Compliance with "applicable technical standards and internal specifications" | Verified by "bench testing and software validation testing" |
| Substantial equivalence to predicate devices (K050159, K041934, K083903 3M Littmann Stethoscope models). | "BM-520 to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use." |
| Functionality as an electronic stethoscope (amplification, digital filtering, selectable modes, adjustable volume) | Device description outlines these functionalities. |
| Bluetooth® wireless communication capability | Device description confirms this capability. |
Note: The document does not provide specific numerical acceptance criteria (e.g., minimum amplification, frequency response ranges, signal-to-noise ratio) or corresponding numerical performance results from the bench testing.
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes bench testing and software validation, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set or ground truth establishment by experts is described.
4. Adjudication method for the test set:
- Not Applicable. No clinical test set or adjudication process is described.
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:
- No. This is not an AI/CAD device. It's an electronic stethoscope. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a medical device for sound amplification, not an algorithm. Bench testing for device functionality was performed, which is a form of standalone performance verification, but not in the context of diagnostic accuracy.
7. The type of ground truth used:
- Not Applicable. The submission focuses on substantial equivalence based on technical specifications and functionality, not clinical ground truth for diagnostic performance validation.
8. The sample size for the training set:
- Not Applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable.
In summary: The 510(k) submission for the Sharp Electronic Stethoscope Model BM-520 relies on demonstrating substantial equivalence to previously cleared predicate devices through similarities in intended use, principles of operation, and functional design. It references internal bench testing and software validation to confirm the device meets "applicable technical standards and internal specifications," but it does not detail a clinical study with specific acceptance criteria related to diagnostic performance or efficacy for a particular condition.
§ 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.