(267 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related terms in the intended use or other sections.
No
The device is used for monitoring and evaluation of cardiac activity, which falls under diagnostic purposes, not therapeutic intervention.
Yes
The system is used for monitoring and evaluating various cardiac conditions and responses to interventions, which are diagnostic purposes. The indications include "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia" and "Evaluation of patients for ST segment changes."
Unknown
The provided text only describes the intended use of the Norav Holter Analysis System. It does not contain a device description, which is necessary to determine if the device is software-only or includes hardware components.
Based on the provided information, the Norav Holter Analysis System is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Norav Holter System Function: The description clearly states the system is for "ambulatory (Holter) monitoring" and "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia," "Evaluation of ECG," etc. This involves recording and analyzing electrical activity of the heart directly from the patient's body via electrodes, not from a sample taken from the body.
The Norav Holter Analysis System is a medical device used for in vivo monitoring and analysis of physiological signals (ECG).
N/A
Intended Use / Indications for Use
The Norav Holter Analysis System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
-
Evaluation of patients for ST segment changes.
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Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.)
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Clinical and epidemiological Research Studies
-
Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor 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.
Product codes
MLO
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Norav Medical Ltd. c/o Mr. Steve Springrose Springrose Partners, LLP 12505 58™ Avenue N Plymouth, MN 55442
Re: K012712
Trade Name: Norav Holter Analysis System, Model NH-300, V1.07 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: February 6, 2002 Received: February 7, 2002
Dear Mr. Springrose:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
Page 2 .- Mr. Steve Springrose
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Teast of advised that I Dr I iboadies or our device complies with other requirements of the Act that I Dr Has matures and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K rat 607); adocime (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins lotter will and will and with the of substantial equivalence of your device to a legally premaince notification " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, Traison on your responsibilities under the Act may be obtained from the Other goneral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Daht Telle
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510K Number: K012712 Device Name: Norav Holter Analysis System Indications for Use:
The Norav Holter Analysis System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:
- Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2 ) 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 or recreational activities (e.g. after M.I. or cardiac surgery.)
-
Clinical and epidemiological Research Studies
-
Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor 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.
(Per 21 CFR 801.109)
(PLEASE DO NOT WIRTE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR
Over-the-Counter Use (Optional Format)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012742