(25 days)
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 bicvcle, 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-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 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.
The HyperQ™ 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.
The provided document, K072389, is a 510(k) summary for the HyperQ™ System. It outlines the device's intended use and a comparison to a predicate device, but it does not contain information regarding detailed acceptance criteria, specific study designs (like sample sizes, data provenance, ground truth establishment, or expert qualifications), or performance metrics (sensitivity, specificity, accuracy, etc.) typically found in a clinical study report.
The document focuses on demonstrating substantial equivalence to a predicate device (HyperQ™ System K070624) based on technological characteristics and intended use. It states: "The primary difference is that the modified device provides a reformatted graphic interface unit (GIU) with additional enhancements, features, and user selectable options. Based upon the validation results, BSP believes these differences do not raise additional safety of efficacy concerns."
The only mention of performance testing is related to the ST segment algorithm: "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." However, no details about this testing (e.g., acceptance criteria, results, study design, sample size, or ground truth) are provided.
Therefore, many of the requested details cannot be extracted from this specific 510(k) summary.
Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document only states that "differences do not raise additional safety of efficacy concerns" based on "validation results." Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not present. | Not specified in the document. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the HyperQ™ System in this 510(k) summary. The document mentions the ST segment algorithm "has been tested for accuracy," but no results are given. It also mentions "changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values" for the HyperQ™ stress test, but no performance outcomes are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. It mentions "a database is used as a tool for performance testing" for the ST segment algorithm, but no details about this database are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified in the document.
- Qualifications of Experts: Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No evidence of an MRMC study is mentioned. The document primarily focuses on technological equivalence to a predicate device, not on human-AI comparative effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: The document indirectly suggests some form of standalone testing for the ST segment algorithm, stating it "has been tested for accuracy of the ST segment data," and for the HyperQ™ stress test where it analyzes HF-QRS changes. However, no specific results or a clear "standalone performance study" section with metrics are provided. The device itself is described as a "compact monitor for measuring, processing, storing, and displaying information." The "HyperQ™ Software is intended to be used as an aid to stress ECG test," implying it complements rather than replaces physician interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified in the document for any testing.
8. The sample size for the training set
- Sample Size for Training Set: Not specified in the document.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not specified in the document.
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510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | Biological Signal Processing Ltd.2a Habarzel StreetTel-Aviv 69710, Israel |
| Mfg. Phone: | Tel.: 972-3-647 4840 | |
| Contact Person: | Eran Toledo | |
| Date: | August 20, 2007 | |
| 2. | Device &ClassificationName: | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)device as a class II device (product code MWI).HyperQ |
| 3. | Predicate Device: | HyperQ™ System K070624 |
| 4. | Description: | The HyperQ™ 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 ofthe QRS complex of standard ECG. |
| 5. | Intended Use: | ECGECG is intended to disclose either normal condition or patterns ofarrhythmia, myocardial ischemia, rate abnormalities, or features ofprognostic value in the following cases:Patients with suspected cardiac abnormalitiesPopulations of patients at an age or period in which a routine baselineevaluation of ECG characteristics is desired. |
| Stress Testing | ||
| Angina pectoris (chest pain) is a clinical syndrome resulting from myocardialischemia, indicative of reduced blood supply to the cardiac muscle. Theelectrocardiogram may establish the diagnosis of ischemic heart disease ifcharacteristic changes are present.Stress testing is the most widely used method to decide whether this chest |
Page 1 of 2
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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 bicvcle, 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™
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.
-
- Comparison of Technological Characteristics:
With respect to technology and intended use, the Modified HyperQ™ System is substantially equivalent to its predicate device which is the HyperQ™ System. The primary difference is that the modified device provides a reformatted graphic interface unit (GIU) with additional enhancements, features, and user selectable options. Based upon the validation results, BSP believes these differences do not raise additional safety of efficacy concerns.
- Comparison of Technological Characteristics:
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2007
MedicSense, USA c/o Mr. George J. Hattub, RAC and CQE Senior Staff Consultant 291 Hillside Avenue Somerset, MA 02726
Re: K072389
HyperQTM 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: August 21, 2007 Received: August 24, 2007
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 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. 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); 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 vours.
Ashley B. Boan
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
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 Testina
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 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, exercy seasing on 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.
HyperQTM
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)
Unlulu Doane for BDZ
(Division Sign Off)
rdiovascular Devices
Page 1 of 1
510(k) Number K072389
§ 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).