(164 days)
Not Applicable
Not Found
No
The description focuses on the transmission and processing of audio signals over a telephone line, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used to conduct a stethoscope examination remotely, which is a diagnostic procedure, not a therapeutic one.
No
The CareTone II is described as a telephonic stethoscope used for remote examinations, transmitting sounds but not interpreting them or providing diagnostic information.
No
The device description clearly outlines hardware components (sending unit, receiving unit, telephone cables, stethoscope chest piece with microphone, headphones) and their physical interaction for signal transmission and processing. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CareTone II Function: The CareTone II is a telephonic stethoscope system. It transmits sounds from a patient's chest to a remote examiner. It does not analyze biological samples.
- Intended Use: The intended use is to conduct a stethoscope examination, which is a physical examination technique, not an in vitro diagnostic test.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / 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. 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.
Product codes
DOD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nurse or physician at another location
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CareTone Telephonic Stethoscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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(k) Summary
FEB 2 4 1997
American Telecare, Inc.'s
CareTone II Telephonic Stethoscope
Submitter's Name, Address, and Telephone Number
or
American Telecare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-3732 Telephone: (612) 897-0000 (612) 944-2247 Facsimile:
Contact Persons
C. Richard Abbruscato American Telecare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-2247 Telephone: (612) 897-0000 · (612) 944-2247 Facsimile:
Gerard J. Prud'homme, Esq. 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
DOD DOD
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 companding 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.