(94 days)
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.
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.
The provided text is a 510(k) summary for the RNK Electronic Stethoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.
However, I can extract information related to the device description, intended use, and the nature of the evaluation for substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a table format. The primary demonstration of effectiveness is through user testing to show substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative performance metrics. | - Up to about 20 times greater amplitude signal than a typical acoustic stethoscope. - Overall auscultation frequency response of 20 Hz - 1,500 Hz. - Demonstrated effectiveness in user testing with clinicians. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "user testing with clinicians" but does not specify the sample size of this test set, the data provenance (country of origin), or whether it 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)
This information is not provided. The user testing is described generally as being with "clinicians," without specifying their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the user testing.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described. The device is an electronic stethoscope intended to amplify and filter body sounds for human clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an electronic stethoscope, designed to be used by a human listener. It's not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implies that the ground truth for "effectiveness" in the user testing was based on clinicians' assessment during the user testing, likely comparing the device's performance to predicate devices in identifying and hearing body sounds. No explicit "ground truth" method (like pathology or outcomes data) is described.
8. The sample size for the training set
This is not applicable. The device is a hardware electronic stethoscope and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is a hardware electronic stethoscope and not an AI/ML algorithm that requires a training set and established ground truth for it.
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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) andMeditron 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.
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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.
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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.
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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,
Bhumimator for
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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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)
§ 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.