NR Recorder by Norav Medical GmbH

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

Device Description

NR Recorder

AI/ML Overview

This FDA 510(k) clearance letter (K161062) for the Norav Medical GmbH NR Recorder does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

Approval of the 510(k) submission: Stating that the device is substantially equivalent to legally marketed predicate devices.
Regulatory compliance: Reminding the company of general controls provisions and other applicable regulations (e.g., registration, listing, labeling, adverse event reporting, good manufacturing practice).
Indications for Use: Describing the intended clinical applications for the NR Recorder.

Therefore, based on the provided text, I cannot provide the requested information.

To fulfill your request, I would need a more detailed technical document, such as the full 510(k) summary or an associated clinical/performance study report submitted by Norav Medical GmbH to the FDA. These documents typically contain the specific performance metrics, study designs, sample sizes, and ground truth methodologies used to validate the device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K161062

Indications for Use (Describe)

Device Name

NR Recorder

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 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).