(56 days)
RNK Products TR-1 Telephonic Stethoscope
Not Found
No
The description focuses on the transmission of audio signals and standard electronic components (amplifiers, filters, CODEC, UART). There is no mention of AI, ML, or any algorithms that would process or interpret the audio data using such techniques.
No
The device is a telephonic stethoscope used for remote monitoring of auscultation sounds, not for treating any medical condition.
No
This device is described as a "Telephonic Stethoscope" intended for "transmitting auscultation sounds" for a clinician to "listen to the auscultation sounds of a patient." It facilitates remote monitoring but does not itself provide a diagnosis or diagnostic information in the sense of analyzing or interpreting data for pathological conditions. It simply transmits sounds.
No
The device description explicitly states it consists of hardware components including a Chest Piece Assembly, Headset, and an electronics Module.
Based on the provided information, the RNK Telephonic Stethoscope Model TR-USB is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Device Function: The RNK Telephonic Stethoscope Model TR-USB is described as a device that transmits and receives auscultation sounds (sounds from within the body, like heart or lung sounds). It works by picking up these sounds from the patient's body surface using a chest piece and transmitting them electronically.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from the patient. It directly interacts with the patient's body to capture sounds.
Therefore, the function and intended use of the RNK Telephonic Stethoscope Model TR-USB fall outside the scope of In Vitro Diagnostics. It is a medical device used for remote auscultation.
N/A
Intended Use / Indications for Use
The RNK Telephonic Stethoscope Model TR-USB is intended for use to transmit auscultation sounds, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communications channel between the two locations.
The RNK Telephonic Stethoscope Model TR-USB is intended for use as remote monitoring device, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communication channel between the two locations.
Product codes
DQD
Device Description
The RNK Telephonic Stethoscope Model TR-USB consists of a Chest Piece Assembly, a standard audio Headset and an electronics Module containing amplifiers, filters, CODEC, UART and communication interface. The Chest Piece Assembly and Headset are detachable and can plug into the electronics Module. The electronics Module is capable of operating as a transmitting unit sending digitized auscultation signals from the attached Chest Piece, or as a receiving unit accepting the digitized auscultation signals, converting them to analog audio and presenting them to the attached Headset.
The communication interface to the RNK Telephonic Stethoscope is a standard USB data interface to a PC with a data communication channel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RNK Products TR-1 Telephonic Stethoscope
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo for "RNK Products". The letters "RNK" are connected and stylized. The word "Products" is written to the right of the letters "RNK" in a simple, sans-serif font.
JUN - 6 2008
510(k) SUMMARY RNK Products Telephonic Stethoscope Model TR-USB
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter Information
| Submitter: | RNK Products
12700 Diamond Drive
Burnsville, MN 55337
Telephone: (612) 414-0289
Facsimile: (952) 894-2623 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles R. Abbruscato
RNK Products
Telephone: (612) 414-0289
Facsimile: (952) 894-2623 |
| Date Prepared: | April 3, 2008 |
| Device Information | |
| Name of Device | RNK Telephonic Stethoscope Model TR-USB |
| Common or Usual Name | Electronic Stethoscope |
| Classification Name | Electronic Stethoscope |
| Predicate Devices | RNK Products TR-1 Telephonic Stethoscope |
Device Description
The RNK Telephonic Stethoscope Model TR-USB consists of a Chest Piece Assembly, a standard audio Headset and an electronics Module containing amplifiers, filters, CODEC, UART and communication interface. The Chest Piece Assembly and Headset are detachable and can plug into the electronics Module. The electronics Module is capable of operating as a transmitting unit sending digitized auscultation signals from the attached Chest Piece, or as a receiving unit accepting the digitized auscultation signals, converting them to analog audio and presenting them to the attached Headset.
The communication interface to the RNK Telephonic Stethoscope is a standard USB data interface to a PC with a data communication channel.
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Intended Use
The RNK Telephonic Stethoscope Model TR-USB is intended for use to transmit auscultation sounds, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communications channel between the two locations.
Substantial Equivalence
The RNK Telephonic Stethoscope Model TR-USB is substantially equivalent to the RNK Products, Telephonic Stethoscope Model TR-1.
The RNK Telephonic Stethoscope TR-USB has the same intended use, principles of operation and technological characteristics as the predicate devices. There are no new questions of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
RNK Products c/o Mr. Charles R. Abbruscato CEO 12700 Diamond Drive Burnsville, MN 55337
Re: K081032
RNK Telephonic Stethoscope, Model TR-USB Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: April 3, 2008 Received: April 11, 2008
Dear Mr. Abbruscato:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Charles R. Abbruscato
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bzimnimor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: TR-USB Telephonic Stethoscope
Indications for Use:
The RNK Telephonic Stethoscope Model TR-USB is intended for use as remote monitoring device, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communication channel between the two locations.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
B.Bummetta
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
X Prescription Use: (Per CRF 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)