(82 days)
No
The summary describes a standard electronic stethoscope with an integrated ECG for synchronization, focusing on amplification, recording, and storage of sounds. There is no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a "diagnostic aid" for amplifying, recording, playing back, and transmitting sounds from internal organs, and providing a visual display of the ECG for synchronization. Its intended use focuses on diagnosis, not treatment of a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring." This is further reinforced in the "Device Description."
No
The device description explicitly states it is an "electronic stethoscope system" and mentions hardware components like a 5-lead electrocardiograph and PC monitor, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Meditron electronic stethoscope system amplifies and records sounds from within the body (heart, lungs, etc.). It also displays an ECG, which is a measurement of electrical activity within the body.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and measures physiological signals from the patient.
Therefore, while it is a diagnostic aid, it falls under the category of a medical device that interacts directly with the patient, rather than an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
"Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies, records, plays back, and transmits sounds associated with the heart, arteries, and veins and other internal organs. The Meditron II thestethoscope system is equipped with an integrated 5-lead electrocardiograph to produce a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The system also enables computer-aided recordings and storage of these sounds along with other patient information."
Product codes
DQD
Device Description
"The Meditron electronic stethoscope system is intended for use as a diagnostic atom aid in patient diagnosis, treatment and monitoring. It amplifies, records, and weine ald in patient diagnosis, treatmen associated with the heart, arteries, and veins plays back, and transmits sounds assess modification involves the addition of a and other internal organs. The produce an ECG on the PC monitor to enable the 5-lead electrocardiograph to produce the phonocardiogram with the beginning of the heart cycle."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, arteries, veins, and other internal 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)
"The specifications and testing for biocompatibility, electrical safety, electro-I he specifications and testing to: broostware verification/validation reference Magnetic compatibility (21.20), and product specifications were met. applicable IDA Consensus started for the purpose of demonstrating Chilical study information washered electronic stethoscopes with an integrated ECG."
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
JAN 3 0 2002
510(k) Summary
-
- Name/Address of Submitter: Meditron AS Leangbukta 40 N-1392 Ventre Norway
-
- Contact Person: Charles H. Kyper, RAC Kyper & Associates (919) 960-0049
- Date Summary Prepared: November 7, 2001
-
- Device Name: Meditron II thestethoscope system
-
- Device Description and Intended Use:
The Meditron electronic stethoscope system is intended for use as a diagnostic atom aid in patient diagnosis, treatment and monitoring. It amplifies, records, and weine ald in patient diagnosis, treatmen associated with the heart, arteries, and veins plays back, and transmits sounds assess modification involves the addition of a and other internal organs. The produce an ECG on the PC monitor to enable the 5-lead electrocardiograph to produce the phonocardiogram with the beginning of the heart cycle.
-
- Brief Description of Nonclinical and Clinical Testing:
The specifications and testing for biocompatibility, electrical safety, electro-I he specifications and testing to: broostware verification/validation reference Magnetic compatibility (21.20), and product specifications were met. applicable IDA Consensus started for the purpose of demonstrating Chilical study information washered electronic stethoscopes with an integrated ECG.
- Brief Description of Nonclinical and Clinical Testing:
-
- Conclusions Drawn:
The indications for use are consistent with those for legally marketed electronic I he moreations for about and ECG. Differences in technological characterissice are minor and do not raise new issues of safety or effectiveness.
- Conclusions Drawn:
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Meditron AS c/o Mr. Charles H. Kyper, RAC President and Founder Kyper & Associates LLC 103 Nolen Lane Chapel Hill, NC 27516
Re: K013725
Trade Name: Meditron II Thestethoscope System Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: November 7, 2001 Received: November 9, 2001
Dear Mr. Kyper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren or the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreate) to tegains actment date of the Medical Device Amendments, or to eoniner of they 2011-12-11 accordance with the provisions of the Federal Food. Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, morelore, market are 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 If your device 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.
2
Page 2 - Mr. Charles H. Kyper, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Act Please be advised that FDA's issuance of a substance oquies with other requirements of the Act
that FDA has made a determination that your device and other actes. You must that FDA has made a determination inal your devices other Federal agencies. You must
or any Federal statutes and regulations administered by other for and listing or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not his provinents as set comply with all the Act s requirements, mename, owners on the requirements as set
CFR Part 807); labeling (21 CFR Part 801); god if applicable, the electronic CFR Part 807); labeling (21 CFR Part of ); good manufactoring production the electronic
forth in the quality systems (QS) regulation (21 CFR Part 201); and if applicable, 105 forth in the quality systems (QS) regulation (21 OFF Public)
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)
I had begally and the may be between the bestical assisseless of your device to This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalend this premarket notification. The FDA inding of substantal equivalies 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 and If you desire specific advice for your device on on stice devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vited on the commention and advertisin additionally 21 CFR Part 809.10 ID III Vitto unserious on the promotion and advertising of
Compliance at (301) 594-4646. Additionally, for questions on the promotion and adv Compliance at (301) 594-4646. Additionally, for question of S944-4639. Also, please note the your device, please contact the Office of Collighton's (C1CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not the obtained from the regulation entitled, "Misbranding by recrence to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Dillaor (301) 443-6597 or at its Internet address (600) 030 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Sincerely yours,
Sincerely yours,
Qarth Tell
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number (if known): K013725
Device Name: Meditron II thestethoscope system
Indication for Use: Intended for use as a diagnostic aid in patient diagnosis, thoucation for Use. Intended for ulifies sounds from the body's internal organs, treatinent, and montoring. It ampidited with the system is includes a manily the ficart and encamat y wisual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the (ECO) on the I C montor to enabing of the heart cycle. The ECG is not intended phoulocardiogram with the sognialism computer-aided recordings and storage of these sounds along with other patient information.
Concurrence of CDRH Office of Device Evaluation
Prescription Use (per 21 CFR 801.109)
OR
Over-the-counter Use
Division of Cardiovascular & Respiratory Devices KO 1 510(k) Number _