(267 days)
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.
Not Found
This FDA 510(k) clearance letter for the Norav Holter Analysis System, Model NH-300, V1.07, does not contain the detailed acceptance criteria or a study description as requested.
The document is a regulatory approval letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide specific performance metrics, study designs, or data provenance.
Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a separate clinical study report for the Norav Holter Analysis System.
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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.
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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
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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
§ 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).