(90 days)
Not Found
No
The summary describes a system for amplifying, recording, and storing sounds, with "computer-aided recordings" provided by software. There is no mention of AI, ML, or any form of automated analysis or interpretation of the sounds beyond simple recording and storage.
No.
The device is clearly stated as "intended for use as a diagnostic aid." It amplifies sounds and stores recordings, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring." The "Device Description" also reiterates that it is "intended for use as a diagnostic aid."
No
The device description clearly states it consists of four major components, including an electronic stethoscope, distributor, and connector, which are hardware components. While it includes software, it is not solely software.
Based on the provided information, the Meditron Stethoscope System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Meditron Stethoscope System is used to amplify and record sounds from within the body (heart, respiratory, and circulatory organs). It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state its function is to amplify and record internal body sounds for diagnostic aid. This is a function of a medical device used for physical examination and auscultation, not in vitro analysis.
- The performance studies described focus on biocompatibility, environmental testing, and electromagnetic compatibility. These are typical tests for medical devices that interact with the body or its environment, not for IVD devices which would require analytical and clinical performance studies related to specimen analysis.
- The predicate devices listed are all electronic stethoscopes and auscultation systems. These are also medical devices used for physical examination, not IVD devices.
Therefore, the Meditron Stethoscope System falls under the category of a medical device used for physical examination and diagnostic aid through auscultation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Meditron stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It consists of four major components: electronic stethoscope (thestethoscope), distributor (thedistributor), connector (thecomnector), and CD software (theanalyzer). Thestethoscope amplifies sounds from the body's internal organs, mainly the heart and respiratory and circulatory organs, without introducing signals or energy into the body. Thedistributor is a co-listening device that has been specially developed for teaching purposes as it permits up to six persons to listen to the patient at the same time. Thedistributor can also be used during maternity check-ups to permit the physician and expectant mother to simultaneously listen to the sounds. Theconnector (connection box and cables) links thedistributor to the sound card of a personal computer (PC). Theanalyzer is a Microsoft Windows-based CD software application supplied with theconnector and is designed to provide computeraided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
The Meditron stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It consists of four major components: electronic stethoscope (thestethoscope), distributor (thedistributor), connector (thecomnector), and CD software (theanalyzer). Thestethoscope amplifies sounds from the body's internal organs, mainly the heart and respiratory and circulatory organs, without introducing signals or energy into the body. Thedistributor is a co-listening device that has been specially developed for teaching purposes as it permits up to six persons to listen to the patient at the same time. Thedistributor can also be used during maternity check-ups to permit the physician and expectant mother to simultaneously listen to the sounds. Theconnector (connection box and cables) links thedistributor to the sound card of a personal computer (PC). Theanalyzer is a Microsoft Windows-based CD software application supplied with theconnector and is designed to provide computeraided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body's internal organs, mainly the heart and respiratory and circulatory organs
Indicated Patient Age Range
Not Found
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)
Brief Description of Nonclinical Testing: Thestethoscope is the only component of the Meditron stethoscope system that routinely comes into contact with the health practitioner and patient. Biocompatability information for the materials in thestethoscope was provided in accordance with the CDRH Office of Device Evaluation General Program Memorandum #95-1 dated May 1, 1995, re the use of International Standard ISO-10993 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). Meditron AS product specifications for the environmental and electromagnetic compatibility (EMC) testing of the Meditron thestethoscope reference appropriate international standards (IEC, CISPR and EN). Environmental testing included climatic and mechanical tests and a determination of the protection provided by the enclosure against solid foreign objects and water ingress. EMC tests measured radiated emission, radiated electromagnetic field immunity, and electrostatic discharge. All product specifications were met.
Brief Description of Clinical Testing: Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
E-scope Electronic Stethoscope Model 718-7120 (K961301), DELWA-STAR® STETHOSTM (K963621), SimulScope® Ausculation System (K961937), Labtron Electromax Electronic Stethoscope Model N (K961837)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 19 1999
510(k) Summary
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- Name and Address of Submitter: Meditron AS Leangbukta 40 N-1392 Vettre Norway
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- Contact Person: Charles H. Kyper, RAC Kyper & Associates (301) 776-3546
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- Date of Summary Preparation: April 12, 1999
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- Name of Device: Meditron stethoscope system (electronic-amplified stethoscope)
6. Device Description and Intended Use:
The Meditron stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It consists of four major components: electronic stethoscope (thestethoscope), distributor (thedistributor), connector (thecomnector), and CD software (theanalyzer). Thestethoscope amplifies sounds from the body's internal organs, mainly the heart and respiratory and circulatory organs, without introducing signals or energy into the body. Thedistributor is a co-listening device that has been specially developed for teaching purposes as it permits up to six persons to listen to the patient at the same time. Thedistributor can also be used during maternity check-ups to permit the physician and expectant mother to simultaneously listen to the sounds. Theconnector (connection box and cables) links thedistributor to the sound card of a personal computer (PC). Theanalyzer is a Microsoft Windows-based CD software application supplied with theconnector and is designed to provide computeraided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information.
7. Brief Description of Nonclinical Testing:
Thestethoscope is the only component of the Meditron stethoscope system that routinely comes into contact with the health practitioner and patient. Biocompatability information for the materials in thestethoscope was provided in accordance with the CDRH Office of Device Evaluation General Program Memorandum #95-1 dated May 1, 1995, re the use of International Standard ISO-10993 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing).
1
Meditron AS product specifications for the environmental and electromagnetic compatibility (EMC) testing of the Meditron thestethoscope reference appropriate international standards (IEC, CISPR and EN). Environmental testing included climatic and mechanical tests and a determination of the protection provided by the enclosure against solid foreign objects and water ingress. EMC tests measured radiated emission, radiated electromagnetic field immunity, and electrostatic discharge. All product specifications were met.
8. Brief Description of Clinical Testing:
Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes.
9. Conclusions Drawn:
The indication for use of the Meditron stethoscope system is consistent with that in the labeling for electronic stethoscopes legally marketed in the United States as well as that in the FDA classification regulation under 21 CFR 870.1875(b) for this generic type of device. Differences in technological characteristics between this device and the cited predicate devices do not raise new issues of safety or effective ness and are addressed in the 510(k) submission. Based upon the criteria in section 513(i) of the Federal Food, Drug, and Cosmetic Act, the Meditron stethoscope system is substantially equivalent to electronic stethoscopes legally marketed in the United States.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 19 1999
Meditron AS C/O Kyper & Associates Mr. Charles A. Kyper 11902 Simpson Road Clarksville, MD 21029
Re: K991367 Meditron Stethoscope System Regulatory Class: II (two) Product Code: DQD Dated: April 12, 1999 Received: April 20, 1999
Dear Mr. Kyper:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
3
concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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|--|--|--|
| 510(k) Number (if known): | K991367 |
|---|---|
| Device Name: | Meditron Electronic Stethoscope System |
Indications For Use:
The Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies sounds from the bodys internal organs, mainly the heart and respitatory and circulatory organs. It provides computer-aided recordings of these sounds and stores these recordings along with other appropriate patient information.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascula and Neurological Devic 510(k) Number
Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)