NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

K012712 · Norav Medical , Ltd. · MLO · May 8, 2002 · Cardiovascular

Device Facts

• Record ID: K012712
• Device Name: NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
• Applicant: Norav Medical , Ltd.
• Product Code: MLO · Cardiovascular
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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: 1) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3) Evaluation of patients for ST segment changes. 4) Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.) 5) Clinical and epidemiological Research Studies 6) 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. 7) Evaluation of patients with pacemakers.

Device Story

System performs ambulatory ECG analysis; inputs include recorded Holter ECG data (1-48 hours). Device processes signals to detect arrhythmias, ST segment changes, and Heart Rate Variability (HRV). Operated by clinicians in clinical settings; output provided as diagnostic reports for physician review. Assists in clinical decision-making regarding cardiac therapeutic interventions and patient recovery monitoring. HRV software provides measurements within 4 ms tolerance.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Ambulatory Holter analysis system; software-based ECG signal processing; HRV analysis capability with 4 ms tolerance; intended for 1-48 hour monitoring durations.

Indications for Use

Indicated for patients requiring ambulatory (Holter) ECG monitoring (1-48 hours) for evaluation of arrhythmia, myocardial ischemia, ST segment changes, pacemaker function, post-cardiac event recovery, and research.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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:

1) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3) Evaluation of patients for ST segment changes.

4) Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.)

5) Clinical and epidemiological Research Studies

6) 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.

7) 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