(85 days)
Not Found
No
The summary describes standard ECG analysis techniques and does not mention AI or ML.
No.
The device is described as a monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG) to aid in diagnosis, not to provide therapy.
Yes
The device aids in disclosing patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value, and helps establish the diagnosis of ischemic heart disease by monitoring ECG changes during stress testing.
No
The device description explicitly states "The HyperQ™ AD-100 System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG)." This indicates the device includes hardware components (a monitor) for measurement, processing, storage, and display, in addition to the software for analysis.
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. The intended use and device description clearly state that the HyperQ™ AD-100 System measures, processes, stores, and displays information derived from an electrocardiogram (ECG). An ECG is a recording of the electrical activity of the heart, obtained by placing electrodes on the skin. It is a non-invasive measurement of a physiological process, not an analysis of a biological sample taken from the body (like blood, urine, tissue, etc.).
- The device analyzes electrical signals. The core function is to analyze the high frequency components of the QRS complex of standard ECG signals. This is an analysis of electrical data, not biological or chemical components of a sample.
Therefore, the HyperQ™ AD-100 System falls under the category of a medical device that performs physiological monitoring and analysis, but it does not meet the definition of an In Vitro Diagnostic device.
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 the following cases: Patients with suspected cardiac abnormalities Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.
Stress Testing
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of 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 thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bioycle, treadmill, or other means, while the ECG is monitored continuously. Exercise body of treading, on one may of The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, andreasonals phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. 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 is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
HyperQ™
The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The HyperQ™ AD-100 System is a compact monitor for measuring, processing, storing, and displaying information derived from an electrocardiogram (ECG). The device analyzes and records the high frequency components of the QRS complex of standard ECG.
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
§ 870.2300 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
K102579 pl/3
510(k) Summary of Safety & Effectiveness
.:'
DEC = 2 2011
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b)
Manufacturer
Address: | | Biological Signal Processing Ltd.
22a Raul Wallenberg Street
Tel-Aviv 69719, Israel |
| | Mfg. Phone: | Tel.: 972-3-647-4840 |
| | Contact Person: | Eran Toledo |
| | Date: | August 31, 2010 |
| 2. | Device &
Classification
Name: | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
device as a class II device (product code MWI, 21 CFR 870.2300)
HyperQ™ AD-100 System |
| 3. | Predicate Device: | HyperQ™ System K082564 |
| 4. | Description: | The HyperQ™ AD-100 System is a compact monitor for measuring,
processing, storing, and displaying information derived from an
electrocardiogram (ECG). The device analyzes and records the high
frequency components of the QRS complex of standard ECG. |
| 5. | Intended Use: | ECG |
| | | ECG is intended to disclose either normal condition or patterns of
arrhythmia, myocardial ischemia, rate abnormalities, or features of
prognostic value in the following cases:
Patients with suspected cardiac abnormalities
Populations of patients at an age or period in which a routine baseline
evaluation of ECG characteristics is desired. |
| | | Stress Testing |
| | | Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial
ischemia, indicative of 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 |
.
: ,
1
K102579
p2/3
pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG,records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root, meansquare (RMS) values, are compared to the resting values. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential.
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 is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
HyperQ TM
The HyperQ™ Software is intended to be used as an aid to stress ECG test by means of analysis of high frequency components present within the central portion of the QRS complex.
The significance of the HF-QRS changes must be determined by a physician.____________________________________________________________________________________________________________________________________________________________________ Carlos Concession Company Concession Company Concession Company Concession Company Controller Company Controller Company Controller Company Controller Company Controller Comp
Comparison of Technological Characteristics:
With respect to technology and intended use, the Modified HyperQ™ System (HyperQ™ AD-100 System) is substantially equivalent to its predicate device which is the HyperQ™ System. The primary difference is that the modified device has the ability to be an accessory (add-on) to a legally marketed ECG Stress System to provide HyperQ analysis from the acquired ECG. Based upon the validation results, BSP believes this change does not raise additional safety of efficacy concerns. In addition, the system has passed IEC Electrical Safety Testing as well as EMC.
The following predicate comparison table delinerates the specific similarities and differences:
2
K102579
P3/3
| Characteristic | Predicate Device (System) | Modified Device (System) |
|---|---|---|
| Number of | ||
| Electrodes | 10 | same |
| Number of Leads | 12 | same |
| ECG | ||
| Samples/second | 1000 | same |
| A/D Bits | 16 (0.15 µVLSB) | same |
| Defibrillation | ||
| Protection | Built In | same (utilizes a |
| defibrillation proof | ||
| patient cable) | ||
| Input Signal | ||
| dynamic range | 10 mV | same |
| Simultaneously | ||
| 12L | Yes, with | |
| sample/hold | ||
| circuitry to assure | ||
| zero delay | ||
| between leads | same | |
| CMMR | > 100 dB | same |
| Input Impedance | > 100M Ohm | same |
| DC max input | ±330 mV | same |
| Frequency Range | ||
| (-3db) | 0.05-300 Hz | same |
| Low pass filter | ||
| (software) | 35 Hz | same |
| Line pass filter | ||
| (software) | 50/60 Hz | same |
| Safety Standard | IEC 60601-1, EN | |
| 60601-2, IEC | ||
| 60601-2-25, IEC | ||
| 60601-2-27, EC11 | ||
| ST Segment | ||
| Analysis | ||
| EC 38-1999 | Same | |
| Operating | ||
| Temperature | 0°C to 50°C | same |
| Treadmill Control | yes | no |
| On Line ECG | yes | no |
| HyperQ calculated | ||
| from on line ECG | yes | yes |
| Power | 5 V | same |
| Current | 80 mA | 200 mA |
| Dimensions | 15 x 12 x 2 cm | 17 x 11 x 2.5 cm |
| Weight | 200 grams | same |
| Storing | ||
| Temperature | -20°C to 60°C | same |
| Humidity | 0.85% | same |
·
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3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biological Signal Processing, Ltd. c/o Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, MA 02726
DEC - 2 2010
Re: K102579
Trade/Device Name: Hyper-QTM AD-100 System Regulatory Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: October 26, 2010 Received: November 2, 2010
Dear Mr. Hattub:
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 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. George J. Hattub
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,
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
510(k) Number (if known):
DEC - 2 2010
Device Name: HyperQ™System
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 the following cases:
· Patients with suspected cardiac abnormalities
• Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.
Stress Testing
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of 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 thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bioycle, treadmill, or other means, while the ECG is monitored continuously. Exercise body of treading, on one may of The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, andreasonals phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQ™ stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values.
Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential.
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 is used as a tool for performance testing.
The significance of the ST segment changes must be determined by a physician.
HyperQ™
The HyperQ™ Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex.
The significance of the HF-QRS changes must be determined by a physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- J.M.
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Division of Cardiovascular Devices