(94 days)
Not Found
No
The device description focuses on amplification and filtering of audio signals, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is used for detecting and amplifying body sounds for diagnostic or monitoring purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes". The word "diagnostic" within this statement directly indicates its intended use as a diagnostic device.
No
The device description explicitly details hardware components including a Chest Piece assembly, Amplifier module, and Headset, powered by batteries. It is not solely software.
Based on the provided information, the RNK Electronic Stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- RNK Electronic Stethoscope Function: The RNK Electronic Stethoscope is used to detect and amplify sounds within the human body (heart, lungs, etc.) for diagnostic or monitoring purposes. It does not involve the analysis of specimens taken from the body.
The device description and intended use clearly indicate that it's an external listening and amplification device for physical assessment, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.
Product codes
DOD
Device Description
The RNK Electronic Stethoscope is comprised of a Chest Piece assembly, an Amplifier module containing an amplifier, and a standard audio Headset. The Chest Piece assembly and Headset are detachable and can plug into the Amplifier module. The Amplifier module amplifies and filters the signal from the Chest Piece and presents it to the attached Headset.
A standard 3.5 mm audio cable is used to connect the RNK Chest Piece Assembly to the RNK Amplifier. A standard, off-the-shelf Headset with a 3.5 mm plug can plug into the RNK Amplifier to enable a listener to hear the sounds from the RNK Chest Piece.
The RNK Amplifier is powered by x2 AAA batteries, which can be easily accessed for replacement. Unplugging the RNK Chest Piece puts the Amplifier into low power mode.
The RNK Electronic Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK Electronic Stethoscope is 20 Hz - 1,500 Hz.
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
any patient
Intended User / Care Setting
Not Found
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)
The effectiveness of the RNK Electronic Stethoscope has been demonstrated in user testing with clinicians.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for RNK Products, Inc. The logo consists of the letters "RNK" in a stylized font, followed by the words "Products, Inc." in a simpler font. The logo is black and white and appears to be a vector graphic.
007 26 2007
510(k) SUMMARY RNK Products, Inc. Electronic 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: K
Submitter Information
| Submitter: | RNK Products, Inc. |
|---|---|
| 12700 Diamond Drive | |
| Burnsville, MN 55337 | |
| Telephone: (612) 414-0289 | |
| Facsimile: (952) 894-2623 | |
| Contact Person: | Charles R. Abbruscato |
| Date Prepared: | July 16, 2007 |
Device Information
| Name of Device | RNK Electronic Stethoscope |
|---|---|
| Common or Usual Name | Electronic Stethoscope |
| Classification Name | Electronic Stethoscope |
| Predicate Devices | RNK Products TR-1 (K030446) and |
| Meditron Stethoscope (K991367) |
Device Description
The RNK Electronic Stethoscope is comprised of a Chest Piece assembly, an Amplifier module containing an amplifier, and a standard audio Headset. The Chest Piece assembly and Headset are detachable and can plug into the Amplifier module. The Amplifier module amplifies and filters the signal from the Chest Piece and presents it to the attached Headset.
A standard 3.5 mm audio cable is used to connect the RNK Chest Piece Assembly to the RNK Amplifier. A standard, off-the-shelf Headset with a 3.5 mm plug can plug into the RNK Amplifier to enable a listener to hear the sounds from the RNK Chest Piece.
The RNK Amplifier is powered by x2 AAA batteries, which can be easily accessed for replacement. Unplugging the RNK Chest Piece puts the Amplifier into low power mode.
The RNK Electronic Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK Electronic Stethoscope is 20 Hz - 1,500 Hz.
Intended Use
The RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.
Page 1 OF 2
1
Substantial Equivalence
The RNK Electronic Stethoscope is substantially equivalent to the RNK Products TR-1 (K030446) and the Meditron Stethoscope (K991367). The effectiveness of the RNK Electronic Stethoscope has been demonstrated in user testing with clinicians.
The RNK Electronic Stethoscope has the same intended use, principles of operation and technological characteristics as the auscultation function of 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 and Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 2007
RNK Products, Inc. c/o Mr. Charles R. Abbruscato CEO 12700 Diamond Drive Burnsville, MN 55337
Re: K072026
Trade Name: RNK Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DOD Dated: October 15, 2007 Received: October 16, 2007
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,
Bhumimator for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1072026 510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.
(Please Do Not Write Below This Line – Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummon
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
X Prescription Use: (Per CRF 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)