(119 days)
The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by Health Care Professional. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency.
This electronic Stethoscope is used for the amplification of of heart, lung and other body sounds. This Stethoscope has 3 modes for selective frequency amplification & a 8-steps volume control.
The Tytan Model #600 series Electronic Stethoscope does not include a study proving device performance against acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Tytan Model #600 Series Electronic Stethoscope Performance |
|---|---|---|
| Performance Specification | Conforms to applicable standards: IEC 60601-1 and | "In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements." |
| Safety | Conforms to applicable standards: IEC 60601-1 and | "In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements." |
| EMC (Electromagnetic Compatibility) | Conforms to applicable standards: IEC 60601-1-2 | "In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements." |
| Intended Use | Same as predicate device (3M Littmann Model 2000 Electronic Stethoscope) | "The Tytan Model # 600 series Electronic Stethoscope have the same intended use... as the 3M Littmann Model 2000 Electronic Stethoscope (K#961848)..." |
| Technological Characteristics | Similar to predicate device; any differences do not raise new questions of safety or effectiveness. | "Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance:
Not applicable. The submission does not describe a clinical test set with human subjects or a dataset for evaluating an algorithm. The evidence presented focuses on bench testing and adherence to general safety and EMC standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable.
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:
Not applicable. This device is an electronic stethoscope; it is not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical instrument for sound amplification, not an algorithm.
7. The type of ground truth used:
Not applicable. Ground truth, in this context, would imply a reference standard for diagnostic accuracy, which is not evaluated. The "ground truth" for the performance claims appears to be adherence to recognized electrical and safety standards through bench testing.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.