(112 days)
034046, K072026
Not Found
No
The description focuses on the transmission and amplification of auscultation sounds over an IP network. There is no mention of algorithms that learn from data or perform complex analysis of the sounds, which are characteristic of AI/ML.
No
The device is described as a remote monitoring device that transmits auscultation sounds for diagnostic purposes, not for treating or rehabilitating a patient.
No
Explanation: The device is described as a "remote monitoring device" and is intended to "transmit auscultation sound data" for a clinician to listen to. It does not state that the device itself performs any diagnostic analysis or provides diagnostic output. It merely facilitates the transmission of sounds for a clinician to interpret.
No
The device description explicitly states it is comprised of a "PCP/PC Chest Piece" which is a hardware component containing a piezo sensor and embedded amplifier. The software component (sSOIP) runs on a generic PC, but the system requires the dedicated hardware chest piece to function as intended.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The RNK PCP/PC Stethoscope is a device used for remote auscultation. It transmits and receives sound from the patient's body (heart, lungs, etc.) to a clinician. This is a form of in vivo (within the living body) examination, not an in vitro test on a sample.
- Intended Use: The intended use clearly states it's for a clinician to "listen to the auscultation sounds of a patient." This involves directly interacting with the patient's body to gather information, not analyzing a sample taken from the patient.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician at one location on an IP network
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and clinical testing was performed to verify specification and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RNK Products TR-1 Telephonic Stethoscope (034046), RNK Products Precordial Stethoscope (K072026)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the text "RNK Products" in a stylized font. The letters "RNK" are connected and have a unique, almost hand-drawn appearance. The word "Products" is written in a more standard, sans-serif font and is slightly smaller than the "RNK" portion.
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
4195 US Hwy 1
Suite 101
Rockledge, FL 32955
Telephone: (321) 626-7717
Facsimile: (321) 305-5983 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles R. Abbruscato
RNK Products
Telephone: (321) 626-7717
Facsimile: (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
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.
1
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.
2
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.
3
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
4
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)