TR-USB TELEPHONIC STETHOSCOPE

K081032 · Rnk Products, Inc. · DQD · Jun 6, 2008 · Cardiovascular

Device Facts

• Record ID: K081032
• Device Name: TR-USB TELEPHONIC STETHOSCOPE
• Applicant: Rnk Products, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

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.

Device Story

Device consists of chest piece assembly, audio headset, and electronics module containing amplifiers, filters, CODEC, UART, and USB interface. Operates as transmitting unit (digitizing auscultation signals from chest piece) or receiving unit (converting digitized signals to analog audio for headset). Used for remote auscultation; clinician at one location listens to patient at another. Data transmitted via USB interface to PC over data communication channel. Facilitates remote patient monitoring; enables clinician to perform auscultation without physical proximity to patient.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Electronic stethoscope with chest piece, headset, and electronics module. Features amplifiers, filters, CODEC, and UART. Connectivity via standard USB data interface to PC. Operates as a transmitting/receiving unit for digitized auscultation signals.

Indications for Use

Indicated for use as a remote monitoring device to transmit patient auscultation sounds to a clinician at a different location via a data communication channel. Prescription use only.

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

• RNK Products TR-1 Telephonic Stethoscope

Submission Summary (Full Text)

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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:

K081032

## Submitter Information

| Submitter: | RNK Products<br>12700 Diamond Drive<br>Burnsville, MN 55337<br>Telephone: [phone]<br>Facsimile: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles R. Abbruscato<br>RNK Products<br>Telephone: [phone]<br>Facsimile: [phone] |
| 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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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.

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#### 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 [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/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

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# 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 _________________________________________________________________________________________________________________________________________________________

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