(198 days)
The 3M™ Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.
The 3M™ Littmann® Electronic Stethoscope. Model 3200 is a healthcare device that picks up sounds of the heart, arteries, veins, lungs and other internal organs with the use of selective frequency ranges. After amplification and filtering, the sounds are transferred to the user's ears via an active speaker and passive sound tubes. The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link. The user interface includes a 5-button keypad and an LCD display. Sound processing is carried out with the aid of a digital signal processor. The Model 3200 does not incorporate any off-the-shelf (OTS) software. The Model 3200 operates on one (1) AA alkaline, lithium, or NiMH battery.
The provided text describes the 3M™ Littmann® Electronic Stethoscope, Model 3200, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/ML-driven devices.
The submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than establishing novel performance metrics or conducting clinical trials for performance acceptance as might be seen for entirely new technologies or AI models.
Therefore, many of the requested sections below cannot be filled with the provided information.
Description of Device and Comparison
The 3M™ Littmann® Electronic Stethoscope, Model 3200, is a healthcare device designed to pick up, amplify, and filter sounds from internal organs (heart, arteries, veins, lungs, etc.) using selective frequency ranges. It transfers these sounds to the user's ears via an active speaker and passive sound tubes. A key technological characteristic noted is its ability to exchange audio data wirelessly with a personal computing device via Bluetooth. The device uses a 5-button keypad and an LCD display for its user interface and carries out sound processing with a digital signal processor. It does not incorporate off-the-shelf (OTS) software.
The submission demonstrates "substantial equivalence" to two predicate devices: the 3M™ Littmann® Electronic Stethoscope, Model 3000 (cleared under K050159), and the 3M™ Littmann® Electronic Stethoscope, Model 4100 (cleared under K051790). This equivalence is based on "intended use, indications for use, composition, physical properties and technological characteristics." The document explicitly states that "There are no new questions of safety or effectiveness."
Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence to predicate devices, specific, quantifiable performance acceptance criteria and a detailed report of the device's performance against these criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) are not provided in the given text. The substantial equivalence argument implies that the new device performs at least as well as the predicate devices for its intended use.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified in the provided text. However, the submission argues "Substantial Equivalence" to predicate devices. | The device is deemed "substantially equivalent" to predicate devices (3M™ Littmann® Electronic Stethoscope, Model 3000 and Model 4100) in terms of intended use, indications for use, composition, physical properties, and technological characteristics. This implies its performance is comparable and acceptable for its intended diagnostic purpose. |
Study Details (Based on the provided text, many fields cannot be filled)
Given that this is a 510(k) for an electronic stethoscope and not a diagnostic AI/ML device, the typical "study" involves demonstrating functional equivalence and safety rather than diagnostic performance metrics like those for an AI algorithm. Therefore, the following information is largely not applicable or not present in the provided text.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / not provided. The submission does not detail a "test set" in the context of an AI/ML algorithm's diagnostic performance study. The evaluation likely involved engineering verification and validation testing to ensure functional requirements were met and that the device performed similarly to its predicates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / not provided. Ground truth, in the context of diagnostic accuracy for an AI/ML model, is not relevant here. The device amplifies sounds for human interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / not provided.
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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:
- Not applicable / not provided. This device is a tool for human clinicians; it does not intrinsically involve AI assistance for "human readers" in a comparative effectiveness study as would be done for an AI diagnostic model.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / not provided. This is an electronic stethoscope, designed for human-in-the-loop use. It does not operate as a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / not provided. The device's "ground truth" performance would be about its ability to accurately capture and amplify physiological sounds, which is a functional test, not a diagnostic accuracy test against a clinical outcome.
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The sample size for the training set:
- Not applicable / not provided. This device does not use an AI/ML training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable / not provided.
§ 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.