(203 days)
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No
The summary describes a system for amplifying and transmitting sounds, with no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as amplifying and transmitting sounds for multiple listeners, which serves a diagnostic or observational purpose rather than directly treating a medical condition.
No
The description states the device "allows the user to amplify heart, lung and bowel sounds and transmit them" for listening, but does not indicate any function for analyzing these sounds to diagnose a condition.
No
The device description explicitly mentions hardware components such as an electronic stethoscope, transmitter unit, and receiving unit(s).
Based on the provided information, the SimulScope® Bedside Auscultation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SimulScope Function: The SimulScope system amplifies and transmits sounds from within the body (heart, lung, bowel). It does not analyze biological samples.
- Intended Use: The intended use is to facilitate the listening and sharing of these sounds, not to perform diagnostic tests on bodily fluids or tissues.
The device is a diagnostic tool in the sense that it aids in the process of diagnosis by allowing healthcare professionals to better hear internal sounds, but it does not fit the regulatory definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
Product codes
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Device Description
The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Graphic Auscultation System from Blood Line Technology, DSP-200 Digital Stethoscope from International Acoustics Incorporated
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
510(к) submission, SimulScope® Bedside Auscultation System Delphi Consulting Group, Stafford, Texas 77477
DEC વે વિવેત્કર
Section 2 510(k) Summary & Certification
961937
The following is a Summary & Certification of the SimulScope® Bedside Auscultation System
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the safety and/or effectiveness for an SimulScope® Bedside Auscultation System.
Printed Name J. Harvey Knauss
Signature J. Harry Knauss
Title Owner
Title
Date
May 16, 1996
Delphi Consulting Group, P. O. Box 932, Stafford, Texas 77477, 713-723-8169 Fax 713-723-4080
| CLASSIFICATION NAME: | STETHOSCOPE, ELECTRONIC |
|---|---|
| COMMON/USUAL NAME: | STETHOSCOPE, ELECTRONIC |
| PROPRIETARY NAME: | SimulScope® Bedside Auscultation System |
| CLASSIFICATION: | 21 CFR Part 882.1835, Amplifier, Physiological Signal, Class II |
| PERFORMANCE STANDARDS: | None established |
| INDICATIONS | The SimulScope® Bedside Auscultation System allows the user to amplify heart, lung and bowel sounds and transmit them via infrared energy to wireless headphone worn by more then one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener. |
| CONTRAINDICATIONS | None known. Accepted clinical practices must always be observed. |
1
SUBSTANTIAL EQUIVALENCE
The SimulScope® Bedside Auscultation System material and design is substantial equivalent to the Graphic Auscultation System from Blood Line Technology, Incline Village, Nevada 89450-3937 and the DSP-200 Digital Stethoscope from International Acoustics Incorporated, Palatine, Illinois 60067
SUBSTANTIAL EQUIVALENCE
Comparison of features and principles of operation between the SimulScope® Bedside Auscultation System and other devices in the market via Section 510(k) of the Act.
| Parameter | SimulScope® | Graphic Auscultation | DSP-200 |
|---|---|---|---|
| Acoustic | |||
| Operation | No | Yes | No |
| Electronic | |||
| Operation | Yes | Yes | Yes |
| Battery | |||
| Operation | Yes | Yes | Yes |
| AC Powered | |||
| Operation | Yes | No | Yes |
| Frequency | |||
| Range | 30 Hz to 4 KHz | 50 Hz - 2 KHz | 50 Hz - 4 KHz |
| Equalizer | Yes (8 band) | Switchable filters | No |
| Infrared Sound | |||
| Transmission | Yes | No | No |
| Unit Weight | 4 Lbs | 10.8 Oz | Unknown |
| Electronics in | |||
| chest piece | No | Yes | No |
| Speaker in | |||
| tubing | Yes | Yes | No |
| Accessory jack | |||
| output | Yes | Yes | Yes |
| Output for a | |||
| number of | |||
| listeners | Yes | Yes | Yes |
| Micro Processor | No | Unknown | Yes |