SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM

K961937 · Delphi Consulting Group · DQD · Dec 9, 1996 · Cardiovascular

Device Facts

• Record ID: K961937
• Device Name: SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
• Applicant: Delphi Consulting Group
• Product Code: DQD · Cardiovascular
• Decision Date: Dec 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended 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 than one listener. The system uses an electronic stethoscope connected to a transmitter unit and a receiving unit(s) for each listener.

Device Story

System captures heart, lung, and bowel sounds via electronic stethoscope; transmits audio signals via infrared energy to wireless headphones. Enables simultaneous auscultation by multiple listeners. Used in clinical settings by healthcare providers. Device includes 8-band equalizer for sound adjustment. Output allows clinicians to listen to physiological sounds for diagnostic assessment; facilitates teaching or collaborative consultation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic stethoscope system; 30 Hz to 4 KHz frequency range; 8-band equalizer; infrared wireless transmission; AC/battery powered; 4 lbs weight. No microprocessor.

Indications for Use

Indicated for clinicians requiring amplification and multi-listener transmission of heart, lung, and bowel sounds. No specific patient population or contraindications identified.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• Graphic Auscultation System (Blood Line Technology)
• DSP-200 Digital Stethoscope (International Acoustics Incorporated)

Submission Summary (Full Text)

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510(k) SUBMISSION, SimulScope® Bedside Auscultation System
Delphi Consulting Group, Stafford, Texas 77477

DEC 9 1996

K961937

Section 2

510(k) Summary & Certification

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. Harvey Knauss

Title Owner

Date
May 16, 1996

Delphi Consulting Group, P. O. Box 932, Stafford, Texas 77477, 713-723-8169
Fax [phone]

| 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 than 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. |

Section 2, Page 1

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510(k) SUBMISSION, SimulScope® Bedside Auscultation System
Delphi Consulting Group, Stafford, Texas 77477

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 |

Section 2, Page 2