RNK TELEPHONIC STETHOSCOPE, MODEL TR-1

K034046 · Rnk Products · DQD · Mar 10, 2004 · Cardiovascular

Device Facts

• Record ID: K034046
• Device Name: RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
• Applicant: Rnk Products
• Product Code: DQD · Cardiovascular
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The RNK Telephonic Stethoscope Model TR-1 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.

Device Story

Device consists of chest piece, audio headset, and electronics module; module contains amplifiers, filters, CODEC, UART, and RS232 interface. Operates as transmitting unit (digitizing auscultation signals from chest piece) or receiving unit (converting digitized signals to analog audio for headset). Used by clinicians to facilitate remote auscultation; enables remote patient monitoring; improves access to diagnostic cardiac/pulmonary sounds.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electronic stethoscope comprising chest piece, headset, and electronics module. Features amplifiers, filters, CODEC, UART, and RS232 interface. Connectivity via data communications channel. Power provided by wall-mount adapter. Components are detachable.

Indications for Use

Indicated for use by clinicians to remotely listen to patient auscultation sounds transmitted over a data communications channel.

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

• American TeleCare CareTone II (K963678)
• American TeleCare CareTone II/LBR (CareTone Ultra) (K973873)

Submission Summary (Full Text)

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K034046

RNK Products

3/10/04

## 510(k) SUMMARY RNK Products Telephonic Stethoscope TR-1

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: K034046

## Submitter Information

| Submitter: | RNK Products<br>12700 Diamond Drive<br>Burnsville, MN 55337<br>Telephone: [phone]<br>Facsimile: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles Richard Abbruscato<br>RNK Products<br>Telephone: [phone]<br>Facsimile: [phone] |
| Date Prepared: | December 19, 2003 |
| Device Information | |
| Name of Device | RNK Telephonic Stethoscope Model TR-1 |
| Common or Usual Name | Electronic Stethoscope |
| Classification Name | Electronic Stethoscope |
| Predicate Devices | American TeleCare's CareTone II and CareTone II/LBR<br>(Marketed as CareTone Ultra) Digital Telephonic<br>Stethoscopes |

## Device Description

The RNK Telephonic Stethoscope Model TR-1 consists of a Chest Piece Assembly, a standard audio Headset, a wall-mount power adapter and an electronics Module containing amplifiers, filters, CODEC, UART and RS232 interface. The power adapter, Chest Piece Assembly and Headset are detachable and can plug into the electonics 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.

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The RNK Telephonic Stethoscope TR-1 is substantially equivalent to American TeleCare's CareTone II Digital TelePhonic Stethoscope (K963678) and American TeleCare's CareTone Il/LBR TelePhonic Stethoscope (marketed as the CareTone Ultra) which was included with the Digital PTM (K973873).

The RNK Telephonic Stethoscope TR-1 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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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring an abstract representation of a human figure embracing a three-barred emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

RNK Products c/o Mr. Charles Richard Abbruscato President 12700 Diamond Drive Burnsville, MN 55337

K034046 Re: Trade Name: RNK Telephonic Stethoscope, Model TR-1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: II (two) Product Codc: DQD Dated: December 19, 2003 Received: December 29, 2003

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.

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Page 2 - Mr. Charles Richard Abbruscato

Please be advised that FDA's issuance of a substantial equivalence determination does 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 set 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna R Vachner

் Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: JIR-1 Telephonic Stethoscope

Indications For Use:

The RNK Telephonic Stethoscope Model TR-1 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna P. Vochner

1 11 - 65 -Division and Govascular Devices

510(K) Number K 634

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