(59 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses solely on the intended use of cardiac monitoring.
No
The device is intended for monitoring cardiac arrhythmias, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis rather than directly treating a condition.
Yes
The device is designed for "extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias," which implies it is used to identify or characterize a medical condition, fitting the definition of a diagnostic device.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the Carnation Ambulatory Monitor is software-only or includes hardware components.
Based on the provided information, the Carnation Ambulatory Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias." This describes a device that monitors physiological signals (electrical activity of the heart) directly from the patient's body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The description of the Carnation Ambulatory Monitor does not mention the analysis of any such specimens.
Therefore, the Carnation Ambulatory Monitor falls under the category of a medical device that monitors physiological parameters, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
Product codes
DSH, MWJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
್ಷಗ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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