Carnation Ambulatory Monitor

K143067 · Bardy Diagnostics, Inc. · DSH · Dec 22, 2014 · Cardiovascular

Device Facts

• Record ID: K143067
• Device Name: Carnation Ambulatory Monitor
• Applicant: Bardy Diagnostics, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Dec 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

Device Story

Carnation Ambulatory Monitor provides extended duration cardiac monitoring for patients suspected of arrhythmias. Device records cardiac signals for later analysis. Used in clinical or home settings; operated by patients or healthcare providers. Output consists of recorded cardiac data used by clinicians to diagnose arrhythmias and inform clinical decision-making. Benefits include improved detection of intermittent cardiac events compared to short-term monitoring.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

Ambulatory cardiac monitor; Class II; Product Codes DSH, MWJ; 21 CFR 870.2800. Device functions as a medical magnetic tape recorder for cardiac signal acquisition.

Indications for Use

Indicated for individuals suspected of having cardiac arrhythmias requiring extended duration cardiac monitoring.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

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

December 22, 2014

Bardy Diagnostics, Inc. Dr. Jon Hunt President and Chief Executive Officer 17141 Vashon Highway, SW Vashon Island, Washington 98070

Re: K143067

> Trade/Device Name: Carnation Ambulatory Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, MWJ Dated: October 23, 2014 Received: October 24, 2014

Dear Dr. Hunt,

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

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Page 2 - Jon Hunt, Ph.D.

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 yours,

Melissa A. Torres -S

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 Statement Section I.

510(k) Number (if known):

K143067 ______________________________________________________________________________________________________________________________________________________________________

Device Name:

Carnation Ambulatory Monitor

Indications for Use:

The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

× Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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