(57 days)
The RNK PCP-USB 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.
The PCP-USB Stethoscope consists of a hardware element, the PCP-Chest Piece, and software elements consisting of some audio signal processing in the Streaming Stethoscope Over IP (sSOIP) Anywhere software on the end station PCs, communications software on the end station PCs (sSOIP Anywhere), and communications networking software on the Telemedicine Communications Server (TMCS), Relay Server and Stethoscope User Data (SUD) Server. It provides remote auscultation between a patient at one location and a clinician at another location.
The PCP-USB Chest Piece contains an embedded piezo sensor, audio amplifier Analog to Digital Converter (ADC) and Encoder to create a digitized stream, plus a USB interface to send that data to the PC. The PCP-USB Chest Piece derives its operating voltage from the 5v lead of the USB interface to the PC.
Under direction of the sSOIP Anywhere program in the PC, the digitized signal is formatted in the PC into IP packets for transmit end station (i.e. patient end) and the receive end station (i.e. clinician end) log into the TMCS, which indicates their availability for a connection.
In the sSOIP Anywhere program, the clinician at the receive end, selects a patient from a list of available patients and initiates a connection request to the TMCS, which passes on the request to the patient station. When the patient accepts the incoming connection request in the sSOIP Anywhere program, the TMCS facilitates a direct (peer-to-peer) connection between the two parties. If a direct connection is not possible, the TMCS facilitates a relay connection between the two parties through a Relay Server. No patient stethoscope data passes through the TMCS.
At the receive end PC, the sSOIP Anywhere program directs the acceptance of the IP packets, conversion of the digitized signal back to analog and presentation of the analog signal to the Headset port of the PC.
The TMCS receives information on users that are permitted to use the TMCS services from a SUD Server. That information would be entered into the SUD Server by the health care provider responsible for those users.
The provided text is a 510(k) summary for the RNK PCP-USB Stethoscope, focusing on its substantial equivalence to a predicate device. It details the device's function, technical characteristics, and the testing conducted to support its claims. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that allows for a direct population of the requested table and comprehensive answers to all questions.
The device is an electronic stethoscope intended for remote auscultation. The submission asserts substantial equivalence to a previous device (RNK Products PCP/PC Stethoscope, K102893) based on similar intended use, principles of operation, and technological characteristics.
Here's a breakdown of what can be extracted and what is missing, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and a detailed table of reported device performance are NOT available. The document states:
- "The PCP-USB Stethoscope passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians."
- "Both the PCP-USB Stethoscope and the predicate device successfully demonstrated conformance to IEC60601-1:2005 3rd Edition Medical Electrical Equipment Part 1: General Requirement for Safety and to EN60601-1-2, 2007/03, EMC Immunity Requirements for Medical Electrical Equipment Part 1: General Requirements for Safety, 2."
This indicates that the acceptance criteria were likely based on successful demonstration of conformance to these standards and equivalence in performance to the predicate device, but the specific metrics are not quantified in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to IEC60601-1:2005 3rd Edition (Medical Electrical Equipment Safety) | Successfully demonstrated conformance |
| Conformance to EN60601-1-2, 2007/03 (EMC Immunity Requirements) | Successfully demonstrated conformance |
| Auscultation Performance equivalent to predicate device (PCP/PC Stethoscope) | Passed the same auscultation performance tests as the predicate device in bench testing and by clinicians. |
2. Sample size used for the test set and the data provenance
The text mentions "bench testing and clinical testing" were performed. However, it does not specify the sample size for the test set (number of subjects, number of recordings, etc.) or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text mentions "clinicians" were involved in testing: "The PCP-USB Stethoscope passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians." However, it does not specify the number of clinicians/experts or their qualifications used to establish ground truth or evaluate performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The text does not describe any adjudication method used for the test set.
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
This device is an electronic stethoscope for transmitting auscultation sounds. There is no indication of a MRMC comparative effectiveness study involving AI assistance in the provided text. The device itself is a tool for remote auscultation, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device is a hardware and software system for transmitting sound; it's inherently a human-in-the-loop device (a clinician listens to the transmitted sounds). There is no standalone "algorithm only" performance reported, as the primary function is to enable remote listening by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The text implies "auscultation performance tests" conducted by "clinicians." This suggests a form of expert evaluation or comparison to the predicate device's performance as the basis for "ground truth" (or, more accurately, basis for equivalence), but the specific method (e.g., expert consensus on specific sound characteristics, comparison of diagnoses made using the device vs. predicate) is not detailed.
8. The sample size for the training set
The concept of a "training set" typically applies to machine learning algorithms. While the device involves "audio signal processing" in its software, the document presents it as an enhancement of an existing system (sSOIP software) for connection purposes, not as an AI-powered diagnostic tool requiring a distinct training phase in the context of typical AI/ML development. Thus, a "training set" in this context is not explicitly mentioned or applicable based on the provided information.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set in the context of AI/ML, there is no information on how its "ground truth" was established.
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RNK Products
K132560 P 1/3
OCT 1 1 2013
510(k) SUMMARY RNK Products PCP-USB Stethoscope
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: K132560
Submitter Information
Submitter:
RNK Products 8247 Devereux Drive Suite 101 . Viera, FL 32940 Telephone: (321) 610-3980 Facsimile: (321) 610-3979
Contact Person:
Charles R. Abbruscato RNK Products Telephone: (321) 610-3980 Facsimile: (321) 610-3979 October 9, 2013
Device Information
Date Prepared:
| Name of Device | RNK PCP-USB Stethoscope |
|---|---|
| Common or Usual Name | Electronic Stethoscope |
| Classification Name | Electronic Stethoscope |
| Predicate Devices | RNK Products PCP/PC Stethoscope (K102893) |
Device Description
The PCP-USB Stethoscope consists of a hardware element, the PCP-Chest Piece, and software elements consisting of some audio signal processing in the Streaming Stethoscope Over IP (sSOIP) Anywhere software on the end station PCs, communications software on the end station PCs (sSOIP Anywhere), and communications networking software on the Telemedicine Communications Server (TMCS), Relay Server and Stethoscope User Data (SUD) Server. It provides remote auscultation between a patient at one location and a clinician at another location.
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K132560 P 2/3
The PCP-USB Chest Piece contains an embedded piezo sensor, audio amplifier Analog to Digital Converter (ADC) and Encoder to create a digitized stream, plus a USB interface to send that data to the PC. The PCP-USB Chest Piece derives its operating voltage from the 5v lead of the USB interface to the PC.
Under direction of the sSOIP Anywhere program in the PC, the digitized signal is formatted in the PC into IP packets for transmit end station (i.e. patient end) and the receive end station (i.e. clinician end) log into the TMCS, which indicates their availability for a connection.
In the sSOIP Anywhere program, the clinician at the receive end, selects a patient from a list of available patients and initiates a connection request to the TMCS, which passes on the request to the patient station. When the patient accepts the incoming connection request in the sSOIP Anywhere program, the TMCS facilitates a direct (peer-to-peer) connection between the two parties. If a direct connection is not possible, the TMCS facilitates a relay connection between the two parties through a Relay Server. No patient stethoscope data passes through the TMCS.
At the receive end PC, the sSOIP Anywhere program directs the acceptance of the IP packets, conversion of the digitized signal back to analog and presentation of the analog signal to the Headset port of the PC.
The TMCS receives information on users that are permitted to use the TMCS services from a SUD Server. That information would be entered into the SUD Server by the health care provider responsible for those users.
Intended Use
The PCP-USB 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.
Substantial Equivalence
The PCP-USB Chest Piece includes the same piezo sensor and the same audio amplifier as the predicate PCP/PC Chest Piece. But whereas the PCP/PC Stethoscope uses the Analog to Digital Converter (ADC) and Encoder of the PC's audio circuitry, the PCP-USB Chest Piece embeds those circuit elements within the chest piece head itself. Whereas the PCP/PC Chest Piece derives its operating voltage from the phantom voltage on the Microphone port of the PC, the PCP-USB derives its operation voltage from the 5v lead of the USB interface to the PC. The PCP-USB Stethoscope is substantially equivalent to the RNK Products. Inc. PCP/PC Stethoscope. Bench testing and clinical testing were performed to verify specifications and performance.
The sSOIP Anywhere software is an enhancement of the predicate sSOIP software such that working with the TMCS. SUD Server and Relay Server. IP connections can be accomplished
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K132560 P 3/3
3
across Network Address Translation (NAT) boundaries, whereas sSOIP could only make IP connections between static IP addresses.
Both the PCP-USB Stethoscope and the predicate device successfully demonstrated conformance to IEC60601-1:2005 3rd Edition Medical Electrical Equipment Part 1: General Requirement for Safety and to EN60601-1-2, 2007/03, EMC Immunity Requirements for Medical Electrical Equipment Part 1: General Requirements for Safety, 2. Collateral Standard - Electromagnetic Compatibility Requirements and Tests. Since both devices use the same materials that a patient or clinician might touch, the biocompatibility analysis is the same. The PCP-USB Stethoscope passed the same auscultation performance tests as the predicate device both in bench testing and by clinicians.
The RNK PCP-USB 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 Center - WO66-G609 Silver Spring, MD 20993-002
October 11, 2013
Rnk Products, Inc. c/o Mr. Charles Abbruscato C.E.O. 8247 Devereux Dr Ste 101 Melbourne, FL 32940 US
Re: K132560
Trade/Device Name: PCP-USB Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 4, 2013 Received: August 15, 2013
Dear Mr. Charles 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97), For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132560
Indications for Use
510(k) Number (if known): K
Device Name: PCP-USB Stethoscope
Indications for Use:
The RNK PCP-USB 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)
Over-the-Counter Use (Part 21 CRF 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Optional Format 1-2-96)
§ 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.