Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies sounds from the body's internal organs, mainly the heart and lungs. Included with the system is a manual 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 includes computer-aided recordings and storage of these sounds along with other patient information.

Device Description

The Meditron electronic stethoscope system is 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 modification involves the addition of a 5-lead electrocardiograph to produce an ECG on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle.

AI/ML Overview

This 510(k) summary for the Meditron II Thestethoscope System (K013725) unfortunately lacks detailed information regarding specific acceptance criteria and the comprehensive study results that would typically prove the device meets these criteria. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance validation report.

However, based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	(Not specified)	"specifications and testing for biocompatibility... were met"
Electrical Safety	(Not specified)	"specifications and testing for... electrical safety... were met"
Electromagnetic Compatibility (EMC)	(Not specified)	"specifications and testing for... electromagnetic compatibility (21.20)... were met"
Product Specifications	(Not specified)	"specifications and testing for... product specifications were met"
Software Verification/Validation	(Not specified)	"software verification/validation reference applicable FDA Consensus started [standards]... were met"
Clinical Equivalence	Comparable performance to legally marketed electronic stethoscopes with an integrated ECG.	"Clinical study information was gathered for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes with an integrated ECG."

Missing Information:

Specific quantitative or qualitative acceptance criteria for each category (e.g., specific thresholds for biocompatibility tests, electrical leakage limits, EMC emission/immunity levels, software robustness metrics).
Detailed results or metrics showing how these criteria were met for each category.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical study information was gathered for the purpose of demonstrating substantial equivalence," but it does not specify the number of patients or cases included in this study.
Data Provenance: Not explicitly stated. It's unclear if the data was retrospective or prospective, or from which country.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not noted as being performed. The clinical information gathered was for the purpose of demonstrating substantial equivalence to predicate devices, not for comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not explicitly reported. The device is described as a "diagnostic aid" for a healthcare practitioner, implying a human-in-the-loop context. The summary does not provide any isolated algorithm performance metrics.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated in detail for the clinical study. Given the objective of demonstrating substantial equivalence to other electronic stethoscopes with integrated ECGs, the "ground truth" would likely be derived from a comparison to clinical judgment and/or established diagnostic methods, but specifics are absent.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not mentioned. This device does not appear to employ a machine learning algorithm that requires a "training set" in the conventional sense. Its function is to amplify, record, play back, and transmit sounds, and to produce an ECG for synchronization. It's an electronic measurement and display device, not an AI-driven diagnostic system.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable/Not mentioned, as there is no apparent training set for an AI algorithm.

Summary of what the document does convey regarding acceptance and studies:

The primary "study" mentioned is the gathering of "clinical study information" to demonstrate substantial equivalence to existing legally marketed electronic stethoscopes with integrated ECG. The acceptance criteria, while not quantified, seem to be met if:

The device adheres to established standards for biocompatibility, electrical safety, electromagnetic compatibility, and product specifications.
The software is verified and validated.
Its indications for use and technological characteristics are "minor" and do not raise new safety or effectiveness issues compared to predicate devices.

The 510(k) pathway relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove efficacy against a specific "gold standard" or to quantify AI performance improvements. The provided text strongly aligns with this approach.

Summary

{0}------------------------------------------------

JAN 3 0 2002

510(k) Summary

1. Name/Address of Submitter: Meditron AS Leangbukta 40 N-1392 Ventre Norway
1. Contact Person: Charles H. Kyper, RAC Kyper & Associates (919) 960-0049

Date Summary Prepared: November 7, 2001

1. Device Name: Meditron II thestethoscope system
1. Predicate Devices: CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809) Meditron thestethoscope system (K991367) Mendall-LTP Disposable ECG Electrode (K953649)
1. 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.

1. 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.
1. 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.

{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,

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)

Over-the-counter Use

Division of Cardiovascular & Respiratory Devices KO 1 510(k) Number _

Regulation Number and Section

§ 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.