CARETONE II

K963678 · American Telecare, Inc. · DQD · Feb 24, 1997 · Cardiovascular

Device Facts

• Record ID: K963678
• Device Name: CARETONE II
• Applicant: American Telecare, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Feb 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The intended use of American Telecare, Inc.'s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.

Device Story

CareTone II is an electronic amplifying stethoscope for remote auscultation. System consists of a sending unit (patient side) and a receiving unit (clinician side). Patient places chest piece on body; microphone captures acoustic signals. Sending unit processes signal, converts to digital format, and transmits over standard telephone lines. Receiving unit receives digital signal, converts back to audio, and outputs to headphones for clinician. Used in clinical settings or remote locations to facilitate physical exams by physicians or nurses. Enables remote diagnostic assessment of heart/lung sounds; improves access to specialist care.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing (EMC/EMI) and a physician assessment of the quality of the digital signal received compared to the predicate device.

Technological Characteristics

Electronic amplifying stethoscope; digital signal transmission; utilizes commanding circuitry and data communication cables; connects via standard telephone lines; output via headphones.

Indications for Use

Indicated for patients requiring remote auscultation examinations conducted by a nurse or physician.

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

• CareTone Telephonic Stethoscope

Submission Summary (Full Text)

{0}

K963678

510(k) Summary

FEB 24 1997

American Telecare, Inc.'s

## CareTone II Telephonic Stethoscope

## Submitter's Name, Address, and Telephone Number

American Telecare, Inc.
7680 Golden Triangle Drive
Eden Prairie, MN 55344-3732
Telephone: [phone]
Facsimile: [phone]

## Contact Persons

C. Richard Abbruscato
or
Gerard J. Prud'homme, Esq.
American Telecare, Inc.
7680 Golden Triangle Drive
Eden Prairie, MN 55344-2247
Telephone: [phone]
Facsimile: [phone]

Hogan & Hartson L.L.P.
555 Thirteenth Street, N.W.
Washington, D.C. 20004-1109
Telephone: [phone]
Facsimile: [phone]
(as Regulatory Counsel to American Telecare, Inc.)

## Date Prepared

September 6, 1996

## Name of Device

CareTone II Telephonic Stethoscope

## Classification Name

Stethoscope (Electronic)

## Common Name

Electronic Amplifying Stethoscope

## Product Code

DQD

\DOC - 65798/1 - 0335863.01

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# Predicate Device

## CareTone Telephonic Stethoscope

### Intended Use

The intended use of American Telecare, Inc.'s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.

### Substantial Equivalence

To use the CareTone, a patient plugs the sending unit's telephone cable into a telephone wall outlet and the examiner plugs the receiving unit's telephone cable into a telephone wall outlet. The examiner dials the patient's telephone number to connect the receiving unit and sending unit over the telephone line. When the connection is made, the patient places the stethoscope chest piece on his/her chest. The sounds captured by the chest piece are transmitted to the patient end unit of the sending unit by a microphone located within the chest piece. The signal is processed within the circuitry of the patient end unit and transmitted over the telephone line to the receiving unit and through headphones to the examiner.

American Telecare is principally modifying the CareTone to permit the transmission and receipt of a digital signal. The safety and effectiveness of the modified device, the CareTone II, has been demonstrated by EMC/EMI testing and a physician assessment of the quality of the signal received. The CareTone II has the same intended use as the CareTone: to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line. It also has very similar principles of operation and technological characteristics as they both transmit an auscultatory signal to a receiver. The minor technological differences between the CareTone II and the CareTone, primarily, use of commanding circuitry and the use of data communication cables, do not raise new questions of safety or effectiveness. Thus, the CareTone II is substantially equivalent to the CareTone.

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