PCP/PC STETHOSCOPE

K102893 · Rnk Products, Inc. · DQD · Jan 20, 2011 · Cardiovascular

Device Facts

• Record ID: K102893
• Device Name: PCP/PC STETHOSCOPE
• Applicant: Rnk Products, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Jan 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The RNK PCP/PC Stethoscope is intended for use as a remote monitoring device, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.

Device Story

Device consists of PCP/PC chest piece and sSOIP software; chest piece uses piezo sensor to capture auscultation sounds; embedded amplifier boosts signal; analog signal transmitted to PC microphone port; sSOIP software digitizes signal, converts to IP packets for network transport; receiving PC software converts packets back to analog for headset output; enables remote monitoring between patient and clinician; facilitates clinical decision-making via remote sound transmission.

Clinical Evidence

Bench and clinical testing performed to verify specification and performance. No specific quantitative metrics (e.g., sensitivity, specificity) provided in summary.

Technological Characteristics

PCP/PC chest piece with piezo sensor and embedded amplifier; derives power from PC microphone port bias voltage; connects to PC via analog input; software-based signal digitization and IP packet conversion; operates over IP networks.

Indications for Use

Indicated for remote auscultation of patients by clinicians via IP network connection. 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 (034046)
• RNK Products Precordial Stethoscope (K072026)

Submission Summary (Full Text)

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K102893

# 510(k) SUMMARY RNK Products PCP/PC Stethoscope

JAN. 2 0 2011

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<br>4195 US Hwy 1<br>Suite 101<br>Rockledge, FL 32955<br>Telephone: [phone]<br>Facsimile: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles R. Abbruscato<br>RNK Products<br>Telephone: [phone]<br>Facsimile: [phone] |
| Date Prepared: | Sept. 3, 2010 |
| Device Information | |
| Name of Device | RNK PCP/PC Stethoscope |
| Common or Usual Name | Electronic Stethoscope |
| Classification Name | Electronic Stethoscope |
| Predicate Devices | RNK Products TR-1 Telephonic Stethoscope (034046)<br>RNK Products Precordial Stethoscope (K072026) |

### Device Description

The PCP/PC Stethoscope is comprised of a PCP/PC Chest Piece that plugs into a generic PC on an IP network (e.g. the Internet) and the streaming Stethoscope Over IP (sSOIP) software application running on the PC. It provides remote auscultation between a patient at one location and a clinician at another location.

The PCP/PC Chest Piece derives operating voltage from the bias voltage on the Microphone port of the PC. PCP/PC Chest Piece contains an embedded amplifier which amplifies the auscultation signal from the piezo sensor and presents it as an analog signal to the Microphone input of the PC.

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Under direction of the sSOIP program, the analog signal is digitized in the PC, formatted and converted to IP packets for transport. At the receive end PC, the sSOIP program directs the acceptance of the IP packets, conversion of the signal back to analog and presentation of the analog signal to the Headset port of the PC.

#### Intended Use

The RNK PCP/PC Stethoscope is intended for use as a remote monitoring device, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.

## Substantial Equivalence

The RNK PCP/PC Stethoscope uses a similar amplifier and chest piece sensor technology as the predicates. The RNK PCP/PC Stethoscope is substantially equivalent to the RNK Products, Inc. Telephonic Stethoscope Model TR-1 and Precordial Stethoscope. Bench testing and clinical testing was performed to verify specification and performance.

The RNK PCP/PC Stethoscope 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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# JAN 2 0 2011

RNK Products, Inc. c/o Mr. Charles R. Abbruscato CEO 12700 Diamond Drive Burnsville, MN 55337

Re: K102893

Trade Name: RNK PCP/PC Telephonic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: January 12, 2011 Received: January 14, 2011

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 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/industry/support/index.html.

Sincerely yours.

VMD
Bram D. Zuckerman, M.D.

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): K102893

Device Name: _PCP/PC Stethoscope

Indications for Use:

The RNK PCP/PC Stethoscope is intended to transmit auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.

Prescription Use:_ X (Part 21 CRF 801 Subpart D) OR

Over-the-Counter Use (Part 21 CRF 801 Subpart C)

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K02283

(Optional Format 1-2-96)