← Product Code [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD) · K963678 # CARETONE II (K963678) _American Telecare, Inc. · DQD · Feb 24, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K963678 ## Device Facts - **Applicant:** American Telecare, Inc. - **Product Code:** [DQD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1875 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: (612) 897-0000 Facsimile: (612) 944-2247 ## Contact Persons C. Richard Abbruscato or Gerard J. Prud'homme, Esq. American Telecare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-2247 Telephone: (612) 897-0000 Facsimile: (612) 944-2247 Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5735 Facsimile: (202) 637-5910 (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 {1} # 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. \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ Page 2 \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K963678](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQD/K963678) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com