Carnation Ambulatory Monitor

K192556 · Bardy Diagnostics, Inc. · DSH · Oct 17, 2019 · Cardiovascular

Device Facts

• Record ID: K192556
• Device Name: Carnation Ambulatory Monitor
• Applicant: Bardy Diagnostics, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Oct 17, 2019
• Decision: SESE
• Submission Type: Special
• 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 (CAM) provides extended duration cardiac monitoring for patients suspected of cardiac arrhythmias. Device records ECG signals; data processed to identify arrhythmias. Used in clinical settings; operated by healthcare professionals. Output assists clinicians in diagnosing cardiac rhythm abnormalities; facilitates clinical decision-making regarding patient management.

Indications for Use

Indicated for patients 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

October 17, 2019

Bardy Diagnostics, Inc Brit Baird Senior Director, Regulatory Affairs and Quality Assurance 316 Occidental Avenue South, Suite B310 Seattle, Washington 98104

Re: K192556

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 Dated: September 16, 2019 Received: September 17, 2019

## Dear Brit Baird:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Nicole Goodsell Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192556

Device Name Carnation Ambulatory Monitor

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

| ☑ Commercial and/or Industrial Use | ☐ Private Residence Use |
|------------------------------------|-------------------------|
|------------------------------------|-------------------------|

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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