(59 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
No.
The device is used for monitoring and evaluation of cardiac activity, not for treating or preventing a disease or condition.
Yes
The device is described as an "ECG monitoring" device used for "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia" and other medical evaluations, which fall under the scope of diagnosis.
No
The description refers to an "NR Recorder" and mentions "Bluetooth communication" for ECG monitoring, implying a hardware component is involved in acquiring the ECG data. The summary does not explicitly state the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring the electrical activity of the heart (ECG) in patients. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The NR recorder is a device that records physiological signals from a living patient, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients · Evaluation of patients for ST segment changes · Evaluation of a patient's response after resuming occupational activities (for example, after myocardial infarction or cardiac surgery) · Clinical and epidemiological research studies · Evaluation of patients with pacemakers · Reporting of time and frequency domain heart rate variability · Reporting of QT interval
Product codes
MWJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician office setting by the medical professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2016
Norav Medical GmbH % Mr. Raymond Kelly Consultant Licensale Inc. 57 Lazy Brook Rd Monroe, Connecticut 06468
Re: K161062
Trade/Device Name: NR Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: April 12, 2016 Received: April 15, 2016
Dear Mr. Raymond Kelly,
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a bird or a wing, composed of three curved lines that suggest human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
1
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 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.
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.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161062
Indications for Use (Describe)
Device Name
NR Recorder
The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients · Evaluation of patients for ST segment changes · Evaluation of a patient's response after resuming occupational activities (for example, after myocardial infarction or cardiac surgery) · Clinical and epidemiological research studies · Evaluation of patients with pacemakers · Reporting of time and frequency domain heart rate variability · Reporting of QT interval Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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