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.

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 an IP network with the signal carried on an IP connection between the two locations.

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the RNK PCP/PC Stethoscope. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance data from a specific study against such criteria. The document explicitly states: "Bench testing and clinical testing was performed to verify specification and performance." However, it does not provide the details of these tests, including specific acceptance criteria or the reported performance metrics.

Therefore, many of the requested details cannot be extracted from the given document.

Here's an analysis of what information can be extracted and what information cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states "Bench testing and clinical testing was performed to verify specification and performance," but does not list any specific acceptance criteria or the reported device performance against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "clinical testing" but does not specify the sample size used, the country of origin, or if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. The document does not describe the establishment of a "ground truth" using experts for the clinical testing mentioned. This type of detail is usually associated with studies evaluating diagnostic accuracy, which is not implicitly described here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No information on adjudication methods for a test set is present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. The device is an electronic stethoscope for remote auscultation; there's no mention or implication of "AI assistance" or "human readers" in the context of a diagnostic interpretation task that would typically necessitate an MRMC study. The study described seems to be a performance verification against predicate devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Cannot be fully determined. The device is a stethoscope, which fundamentally involves a human clinician for interpretation. While it transmits an analog signal to a PC for digitization and transport, the "standalone" performance of an "algorithm" in the typical sense (e.g., for automated diagnosis) is not described or implied by this document. The "device performance" would refer to the clarity and fidelity of the transmitted sound.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. The document does not describe the use of any specific "ground truth" type as would be relevant for diagnostic accuracy studies. For a stethoscope, "ground truth" might refer to the actual body sounds, which are then compared to the transmitted sounds. However, no such comparison methodology is detailed.

8. The sample size for the training set

Not Applicable/Cannot be provided. This document does not describe a machine learning or AI algorithm that would require a "training set." The device is a hardware and software system for sound transmission.

9. How the ground truth for the training set was established

Not Applicable/Cannot be provided. As there's no training set mentioned, there's no information on how its ground truth was established.

Summary of available information:

The document focuses on establishing substantial equivalence to predicate devices (RNK Products TR-1 Telephonic Stethoscope K034046 and RNK Products Precordial Stethoscope K072026). It states:

The RNK PCP/PC Stethoscope uses similar amplifier and chest piece sensor technology as the predicates.
It has the same intended use, principles of operation, and technological characteristics as the predicate devices.
"Bench testing and clinical testing was performed to verify specification and performance."

However, the specific acceptance criteria and the detailed results of these tests are not included in this summary. The 510(k) summary format often emphasizes the comparison to predicates and a high-level statement of testing, rather than detailed study results. The purpose is to confirm the device is as safe and effective as legally marketed predicate devices, not always to prove absolute performance against strict numerical criteria in the public summary.

Summary

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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 Products4195 US Hwy 1Suite 101Rockledge, FL 32955Telephone: (321) 626-7717Facsimile: (321) 305-5983
Contact Person:	Charles R. AbbruscatoRNK ProductsTelephone: (321) 626-7717Facsimile: (321) 305-5983
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)RNK Products Precordial Stethoscope (K072026)

Device Description

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Intended Use

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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 (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.

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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Page 101

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)

Regulation Number and Section

§ 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.