(94 days)
Not Found
No
The document describes standard ECG analysis and stress testing algorithms, focusing on specific measurements and tolerances. There is no mention of AI, ML, or related concepts.
No
The device is intended for diagnosis and monitoring, and does not provide therapy.
Yes
The device is intended to "disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value," and its use in stress testing aims to "establish the diagnosis of ischemic heart disease" and aid in "the evaluation of myocardial ischemia." These clearly indicate a diagnostic purpose.
No
The device description explicitly lists hardware components: "PCECG 1200W data acquisition unit", "PCECG 1200WR RF transceiver", and "USB communications cable".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes electrical signals from the human body (ECG).
- The intended use and device description clearly indicate that it is an electrocardiograph (ECG) system. ECGs are used to measure and record the electrical activity of the heart, which is a physiological measurement taken directly from the patient.
- There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a medical device that performs physiological measurements, not an IVD.
N/A
Intended Use / Indications for Use
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients: l ) suspected of cardiac abnormalities, or 2) in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired. 3) OT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therary. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The clinical significance of Heart Rate Variability measures should be determined by a physician. 5) The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician. Stress testing intended use: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXH
Device Description
The PC ECG 1200W System is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises: - PCECG 1200W data acquisition unit - PCECG 1200WR RF transceiver - USB communications cable - Software application - Software security lock (dongle) for access to stress testing functions (optional)
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
Not Found
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)
The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for NORAV medical. The logo is black and white and features the word "NORAV" in large, bold letters. The "O" in NORAV is replaced with a heart symbol. Below the word "NORAV" is the word "medical" in smaller letters.
Summarv of Safetv and Effectiveness
510(k) Summary
Submitter
Arazy Group - Medical device Consultatnts Telephone (972) 4-994-7880 Fax number (972) 4-994-4224 Industrial Park 13, M.P. Misgav Mitzpe Aviv 20187 Israel Benny Arazy - CEO and President benny a(a)arazygroup.com
21 CFR 807.92(c) 21 CFR 807.92(a)(1)
APR 2 5 2008
Manufacturer
Norav Medical Ltd. 2 Hamada Street, PQ Box 81 Yokneam 20692 Israel Telephone (972) 4-9893001 Fax number (972) 4-9893004 Contact: David Seal - QA Manager david(@norav.com
Device Name: PC ECG 1200W
Trade Name: PC ECG 1200W System
The classification name 1
Regulation Number 1
Classification code 1
The classification name 2
Requlation Number 2
Classification code 2
monitor, physiological, patient (without arrhythmia detection or alarms)
870.2300
MWI
transmitters and receivers. electrocardiograph, telephone
21 CFR 807.92(a)(2)
870.2920
DXH
Substantial Equivalence 21 CFR 807.92(a)(3)
The clearance for the PC ECG 1200W System is sought on the grounds of its claimed substantial equivalence (SE) to Norav's PC ECG 1200 K000404 for complete physical and functional identity except the capability of wireless data communication.
Device Definition 21 CFR 807.92(a)(4)
The PC ECG 1200W System is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises:
- · PCECG 1200W data acquisition unit
- · PCECG 1200WR RF transceiver
- · USB communications cable
- · Software application
- · Software security lock (dongle) for access to stress testing functions (optional)
1
Image /page/1/Picture/1 description: The image shows the word "NORAV" in bold, black letters. The "O" in NORAV is shaped like a heart. Underneath the word "NORAV" is a thin line that resembles an EKG readout. Below the word "NORAV" is the word "medical" in smaller, black letters.
Intended Use 21 CFR 807.92(a)(5)
ECG intended use:
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:
-
suspected of cardiac abnormalities, or
-
in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired.
-
QT Analysis is useful in the assessment of long QT syndrome (LQTS), a genetic risk factor associated with sudden cardiac death. In some instances, LQTS can be corrected by pharmacologic therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization.
-
Heart Rate Variability Analysis may be useful in the assessment of risk after acute myocardial infarction, assessment of diabetic neuropathy, and has developing utility in the assessment of patients after recent transplantation, in heart failure, in certain cases of tetraplegia, and to assess modifications of baseline heart rate variability after certain medical interventions. (Eur Heart J (1996) 17, 354-381.
-
Late Potential Analysis is useful in the evaluation of vulnerability to sustained ventricular tachycardia, in unexplained syncope, and to assess modifications of baseline late potential levels after surgical intervention. Late Potential analysis may also be helpful in assessment of rejection of cardiac transplants and in prompt recognition of myocardial reperfusion. (JACC 1991 17:5 999-1006).
Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol.
ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
Technological characteristics 21 CFR 807.92(a)(6)
The system acquires ECG data and displays it on the color monitor, calculates and controls some parameters of ECG display such as sweep speed, filters line interference and muscle noises introduced during monitoring, makes necessary outputs, handles the user interface, and controls the flow of operations.
Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of / loquilou and state of stille. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
2
Image /page/2/Picture/1 description: The image shows the word "NORAV" in bold, black letters. The "O" in NORAV has a heart symbol inside of it. Underneath the word "NORAV" is a thin line that resembles an EKG. Underneath the word "NORAV" and the EKG line is the word "medical" in smaller, black letters.
Summary of Safety and Effectiveness
PC ECG 1200W is identical to the predicate device in all features, functions and specifications except its capability of wireless data communication.
Referenced Standard
- 1.1 Recognized Consensus Standards
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-2-25 Amendment 1 (1999), Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardiographs
- IEC 60601-2-27 (1994) Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
- ISO 14971:2007, Medical devices Application of risk management to medical devices
Other Standards 1.2
- IEC 60601-2-51; Medical electrical equipment -Part 2-51: Particular requirements for safety, including essential performance, of recording and analyzing single channel and multichannel electrocardiographs
- EN301 489-1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
- EN301 489-3; Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 40 GHz
- EN300 440 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range;
Summary 21 CFR 807.92(b)(3)
PC ECG 1200W System constitutes a safe and reliable medical device. Similarly to the predicate devices, the System operation presents no adverse health effect or safety risks to patients when used as intended.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
Norav Medical Ltd. c/o Mr. Benny Arazy CEO & President Arazy Group - Medical Device Consultants Industrial Park 13, M.P. Misgav Mitzpe Aviv 200187 ISRAEL
Re: K080141 PC ECG 1200W System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: April 17, 2008 Received: April 17, 2008
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.
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.
4
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. S. Hilleheme
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 408014
510(k) Number (if known):
Device Name: PC FCG 1200W System
Indications for Use:
ECG intended use:
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:
l ) suspected of cardiac abnormalities, or
-
in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired.
-
OT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therary. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
-
The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician.
Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol.
ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
Prescription Use 1× (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)
Q9M02
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
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