Adscope 658 Electronic Stethoscope

K162589 · American Diagnostic Corp. · DQD · Mar 10, 2017 · Cardiovascular

Device Facts

• Record ID: K162589
• Device Name: Adscope 658 Electronic Stethoscope
• Applicant: American Diagnostic Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control. The 658 can be used on patients of any age undergoing a physical assessment. This device is designed for use in a professional setting by a healthcare practitioner.

Device Story

Adscope 658 Electronic Stethoscope; amplifies heart, lung, and body sounds for diagnostic purposes. Input: acoustic body sounds captured via chest piece. Transformation: electronic amplification and frequency filtering controlled by operator via buttons. Output: amplified audio signals for clinician auscultation. Used in professional clinical settings by healthcare practitioners. Benefits: enhanced sound detection for physical assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electronic stethoscope; frequency selection and volume control buttons; battery-powered; handheld form factor; professional use.

Indications for Use

Indicated for patients of any age undergoing physical assessment for amplification of heart, lung, and other body sounds. For use by healthcare practitioners in professional settings.

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

• Littmann Electronic Stethoscope Model 3200 (K082635)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2017

American Diagnostic Corp. Michael Falco Quality Manager 55 Commerce Dr. Hauppauge. New York 11788

Re: K162589

Trade/Device Name: Adscope 658 Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: January 27, 2017 Received: January 30, 2017

Dear Michael Falco:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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## Indications for Use

510(k) Number (if known) K162589

Device Name Adscope® 658 Electronic Stethoscope

## Indications for Use (Describe)

The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control. The 658 can be used on patients of any age undergoing a physical assessment. This device is designed for use in a professional setting by a healthcare practitioner.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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