(163 days)
Not Found
No
The description mentions analysis via an "algorithm" but provides no indication of AI/ML techniques being used. The focus is on traditional signal processing and display.
No.
The device is for analysis and display of ECG data to aid in the evaluation of conditions, not to provide treatment or therapy.
Yes
Explanation: The device is described as "Ambulatory ECG Analysis Software" intended for "evaluation of symptoms," "evaluation of ECG documenting therapeutic interventions," "evaluation of patients for ST segment changes," "evaluation of patient's response," "evaluation of patients with pacemakers." It is designed to "disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value." These are all activities related to diagnosing or assessing medical conditions.
Yes
The device description explicitly states that the instrument is delivered as "software and interface assembly to be used with an off the shelf computer system," and that it does not design a computer inside a medical instrument. This indicates that the core medical device functionality resides solely in the software.
Based on the provided information, the NH-301 Ambulatory ECG Analysis Software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The NH-301 analyzes ECG data, which is a measurement of electrical activity of the heart, not a sample taken from the body (like blood, urine, or tissue).
- The intended use and device description focus on analyzing physiological signals. The software processes and displays ECG waveforms and related parameters to help diagnose and evaluate cardiac conditions. This is characteristic of a medical device that analyzes physiological data, not an IVD.
Therefore, the NH-301 falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Holter) monitoring from 1 to 168 hours. Such monitoring is most frequently used for the following indications:
-
- Evaluation of symptoms suggesting arthythmia or myocardial ischemia.
-
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes. 3.
- Evaluation of patient's response after resuming occupational or recreational activities, (e.g., 4. after M.1. or cardiac surgery.)
-
- Clinical and epidemiological research studies.
-
- Norav Hotter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
- 7 Evaluation of patients with pacemakers
Product codes (comma separated list FDA assigned to the subject device)
MLO
Device Description
The NH-301 Ambulatory ECG Analysis Software is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
The Software uploads long term ECG data from compatible ambulatory ECG recorders, analyzes via an algorithm and then displays it on the color monitor, in a manner that allows the analyses to be edited and reported. Several parameters are adjustable in the set-up of the analysis system.
The Software has an open architecture designed to operate on various IBM PC or compatible. It uses r his convalion printer. Instead of designing a computer inside a medical instrument, the instrument is delivered as a software and interface assembly to be used with an off the shelf computer system. This technique enhances the system cost effectiveness and reliability.
Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
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
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 (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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the word "NORAV" in a stylized font, with a heart shape incorporated into the letter "O". A line resembling an electrocardiogram (ECG) runs beneath the letters. Below the word "NORAV", the word "medical" is written in a smaller font.
510(k) Summary
Summary of Safety and Effectiveness
edica
21 CFR 807 92(c)
| Submitter 21 CFR 807.92(a)(1) | Manufacturer |
|---|---|
| Arazy Group - Medical device Consultatnts | Norav Medical Ltd. |
| Telephone (972) 4-994-7880 | 2 Hamada Street, PO Box 81 |
| Fax number (972) 4-994-4224 | Yokneam 20692 Israel |
| Industrial Park 13, M.P. Misgav | Telephone (972) 4-9893001 |
| Mitzpe Aviv 20187 Israel | Fax number (972) 4-9893004 |
| Benny Arazy - CEO and President | Contact: David Seal - QA Manager |
| benny.a@arazygroup.com | david@norav.com |
Device Name:
NH-301 Ambulatory ECG Analysis Software Trade Name: NH-301 Ambulatory ECG Analysis Software
The classification name 1
Regulation Number 1
Classification code 1
The classification name 2
21 CFR 807.92(a)(2)
electrocardiograph, ambulatory, with analysis algorithm
870.2800
MLO
transmitters and receivers, electrocardiograph, telephone
Substantial Equivalence 21 CFR 807.92(a)(3)
Norav's NH-300 Holter Analysis System \012712 for complete structural and functional identity of both software applications as well as their intended use and indications for use.
The only difference between the applications is that NH-300 is designed for monitoring 1 to 48 hours of Holter records, while NH-301 is capable of monitoring up to 168 hours.
Device Definition 21 CFR 807.92(a)(4)
The NH-301 Ambulatory ECG Analysis Software is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
Indications for Use and Intended Use 21 CFR 807.92(a)(5)
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Holter) monitoring from 1 to 168 hours. Such monitoring is most frequently used for the following indications:
-
- Evaluation of symptoms suggesting arthythmia or myocardial ischemia.
-
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
- Evaluation of patients for ST segment changes. 3.
- Evaluation of patient's response after resuming occupational or recreational activities, (e.g., 4. after M.1. or cardiac surgery.)
-
- Clinical and epidemiological research studies.
1
Image /page/1/Picture/1 description: The image shows the word "NORAV" in a stylized font. The "O" in "NORAV" is shaped like a heart. There is a line running underneath the word that resembles an EKG. The word "medical" is written below "NORAV".
Summary of Safety and Effectiveness
-
- Norav Hotter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
- 7 Evaluation of patients with pacemakers
Technological characteristics 21 CFR 807.92(a)(6)
The Software uploads long term ECG data from compatible ambulatory ECG recorders, analyzes via an algorithm and then displays it on the color monitor, in a manner that allows the analyses to be edited and reported. Several parameters are adjustable in the set-up of the analysis system.
The Software has an open architecture designed to operate on various IBM PC or compatible. It uses r his convalion printer. Instead of designing a computer inside a medical instrument, the instrument is delivered as a software and interface assembly to be used with an off the shelf computer system. This technique enhances the system cost effectiveness and reliability.
Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
Recognized Consensus Standards
AAM / ANSI EC38:2007, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (Cardiovascular)
IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 -Collateral standard: Programmable electrical medical systems
ISO 14971:2007, Medical devices - Application of risk management to medical devices
Summary 21 CFR 807.92(b)(3)
The NH-301 Ambulatory ECG Analysis Software constitutes a safe and reliable medical device. Similarly to the predicate device, its operation presents no adverse health effect or safety risks to patients when used as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Norav Medical Ltd. c/o Mr. Benny Arazy Arazy Group - Medical Device Consultants Industrial Park 13, M.P. Misgav Mitzpe Aviv Israel 20197
Re: K111487
Trade/Device Name: NH-301 Ambulatory ECG Analysis Software Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: September 18, 2011 Received: October 11, 2011
Dear Mr. Arazy:
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
3
Page 2 - Mr. Benny Arazy
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fo- Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
5 10(k) Number (if known):
Device Name:
Indications for Use:
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Holter) monitoring from 1 to 168 hours. Such monitoring is most frequently used for the following indications:
- Evaluation of symptoms suggesting armythmia or myocardial ischemia. 1.
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of 2. patients.
-
- Evaluation of patients for ST segment changes.
- Evaluation of patient's response after resuming occupational or recreational activities, (e.g., 4. after M.I. or cardiac surgery.)
-
- Clinical and epidemiological research studies.
- Norav Holter Systems containing Heart Rate Variability (HRV) software have been tested to റ്. measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
-
- Evaluation of patients with pacemakers
Prescription Use [X] (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Division Sign-Off
on of Cardiovascular Devices
510(k) Number K111487