CADence System

K170928 · Aum Cardiovascular, Inc. · DQD · Aug 3, 2017 · Cardiovascular

Device Facts

• Record ID: K170928
• Device Name: CADence System
• Applicant: Aum Cardiovascular, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Aug 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application. CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/ physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG. The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.

Device Story

CADence System is a digital stethoscope with integrated ECG sensors; records cardiac sounds and electrical activity. Used in clinical settings by trained personnel. Software application performs automated analysis of heart sounds to assist clinicians in identifying physiological vs. pathological murmurs. Output provided to clinician as decision support; not a stand-alone diagnostic tool. Clinician integrates output with patient history and physical exam to inform diagnostic decisions. Benefits include enhanced detection of murmurs through objective analysis of acoustic and electrical data.

Technological Characteristics

Digital stethoscope with integrated ECG sensors; includes single-use Patient Booklet and software application. Operates as a clinical decision support tool for cardiac sound analysis.

Indications for Use

Indicated for use by trained personnel in clinical settings to aid clinicians in the analysis of normal/physiological and pathological heart murmurs in patients via simultaneous recording of cardiac sounds and ECG.

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.

Submission Summary (Full Text)

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

August 3, 2017

AUM Cardiovascular, Inc. Marie Johnson CEO 1405 Heritage Dr., Suite 100 Northfield, Minnesota 55057

Re: K170928

Trade/Device Name: CADence System Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD, DOC Dated: June 30, 2017 Received: Julv 6, 2017

Dear Marie Johnson:

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 device

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related 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.

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.

M.A. Willemen

for

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)

K170928

Device Name CADence System

## Indications for Use (Describe)

The CADence System is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensors used to record electrical activity of the heart (ECG), a single-use Patient Booklet, and the CADence Software application.

CADence Software is a clinical decision support tool intended to aid a qualified clinician's analysis of normal/ physiological and pathological heart murmurs after simultaneous recording of cardiac sounds and ECG.

The device must be used in a clinical setting by trained personnel. The automated analysis of cardiac sounds by the CADence System are only significant when used in conjunction with physician oversight as well as consideration of all other relevant patient information. All relevant patient information must be taken into consideration before making a diagnosis. The CADence System is not intended to be a stand-alone diagnostic device. It does not supersede the judgment of the clinician.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10pt">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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