MEDITRON II THESTERTHOSCOPE SYSTEM

K013725 · Meditron AS · DQD · Jan 30, 2002 · Cardiovascular

Device Facts

• Record ID: K013725
• Device Name: MEDITRON II THESTERTHOSCOPE SYSTEM
• Applicant: Meditron AS
• Product Code: DQD · Cardiovascular
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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 arteries, and includes 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 includes computer-aided recordings and storage of these sounds along with other patient information.

Device Story

Meditron II thestethoscope system; electronic stethoscope; amplifies, records, and plays back internal body sounds (heart, arteries, veins). System integrates 5-lead ECG; displays ECG on PC monitor; synchronizes phonocardiogram with heart cycle. Used by healthcare practitioners in clinical settings. Output allows visualization and storage of acoustic data alongside ECG for diagnostic aid. Benefits include improved correlation of heart sounds with cardiac cycle timing.

Clinical Evidence

Bench testing only. Specifications for biocompatibility, electrical safety, and electromagnetic compatibility (21 CFR) were met. No clinical study data provided.

Technological Characteristics

Electronic stethoscope; 5-lead ECG integration; PC-based display/storage; connectivity via PC interface. Biocompatibility and electrical safety standards met.

Indications for Use

Indicated for use as a diagnostic aid for healthcare practitioners to amplify, record, and play back internal body sounds (heart, arteries, veins) and synchronize phonocardiograms with ECG signals for patient diagnosis, treatment, and monitoring.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809)
• Meditron thestethoscope system (K991367)
• Mendall-LTP Disposable ECG Electrode (K953649)

Submission Summary (Full Text)

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JAN 3 0 2002

# 510(k) Summary

- 1. Name/Address of Submitter: Meditron AS Leangbukta 40 N-1392 Ventre Norway
- 2. Contact Person: Charles H. Kyper, RAC Kyper & Associates [phone]

3. Date Summary Prepared: November 7, 2001

- 4. Device Name: Meditron II thestethoscope system
- 5. Predicate Devices: CADItec AG CADIscope Electronic Stethoscope with Integrated ECG (K990809) Meditron thestethoscope system (K991367) Mendall-LTP Disposable ECG Electrode (K953649)
- 6. 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.

- 7. 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.

- 8. 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.

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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.

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## 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 [phone]. Additionally, for questions on the promotion and adv Compliance at [phone]. 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 [phone] 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

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# 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 _