(60 days)
The MI-1000 system is used to measure Wavelet Surface Residuum indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 system is also used for the measurement of SAECG indices. The MI-1000 system should be used only as an adjunct to clinical history and the results of other noninvasive and /or invasive tests.
The device consists of an IBM compatible PC, nine skin surface electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data.
The provided text describes a 510(k) premarket notification for the Micro-Induction 1000 system (MI-1000 System). It focuses on the device's substantial equivalence to a previously cleared version and the performance data for the modified system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "A complete software validation and verification was completed to verify that the acquired data was able to be correctly analyzed and the Wedensky indices were correctly calculated and displayed. All testing successfully met the required criteria."
However, specific numerical acceptance criteria (e.g., accuracy, precision thresholds) and the exact reported performance metrics (e.g., specific error rates, percentages of correct calculations) are not detailed in the provided text. The statement above is a general affirmation of successful testing without quantitative measures.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) is provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
No information regarding the number of experts used to establish ground truth or their qualifications is provided.
4. Adjudication Method for the Test Set:
No information regarding the adjudication method is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The text states:
- "No clinical testing was required."
- "All of the displayed information is subject to physician interpretation." (This implies a human-in-the-loop scenario, but no study comparing human readers with and without AI assistance is described.)
6. Standalone (Algorithm Only) Performance Study:
The document suggests that the performance evaluation was focused on the "signal post-processing and display" and that "the acquired data was able to be correctly analyzed and the Wedensky indices were correctly calculated and displayed." This implies a standalone performance evaluation of the algorithmic components related to data analysis and calculation.
However, specific metrics for this standalone performance (e.g., accuracy of calculations, error rates in post-processing) are not provided. The statement "All testing successfully met the required criteria" is a general summary.
7. Type of Ground Truth Used:
The ground truth used to verify the software performance would primarily be known reference values or expected outcomes for the "acquired data" and "Wedensky indices" calculations. Since it's a software validation for calculation and display, it would involve comparing the system's output against a defined correct output for specific inputs. This is a form of "truth by design" or "truth by calculation correctness" rather than expert consensus on medical findings or pathology.
8. Sample Size for the Training Set:
No information regarding the sample size for the training set is provided. The document focuses on modifications to an existing system's post-processing and display, implying less emphasis on a de novo machine learning model's training.
9. How Ground Truth for the Training Set Was Established:
No information regarding the establishment of ground truth for a training set is provided. Given the nature of the device (signal processing and display modifications to an existing technology), it's unlikely that a traditional "training set" with medical ground truth labels was used in the way it would be for a diagnostic AI algorithm. Instead, the validation appears to be focused on the correctness of the mathematical transformations and presentation of data.
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APR - 3 2009
510(k) Summary
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| Submitter: | Harbinger Medical, Inc.10125 Crosstown Circle, Suite 105Eden Prairie, Minnesota 55344 |
|---|---|
| Contact: | Harold HoiumTelephone: (952) 943-1686Fax: (952) 943-1686 |
| Date Prepared: | January 30, 2009 |
| Trade Name: | Micro-Induction 1000 system (MI-1000 System) |
| Classification Name | 21 CFR 870.2340 (Electrocardiograph) and |
| And Regulation Number | 21CFR 870.2360 (Electrode Electrocardiography) |
| Class: | Class II |
| Product Code: | DPS and DPX |
| Predicate Devices: | Micro-Induction 1000 System (MI-1000) (K013615) |
| Device Description: | The device consists of an IBM compatible PC, nine skin surface electrodes, one electronics board, a patient interface module and software. Seven of the electrodes are used for sensing cardiac electrical activity. The remaining two electrodes are used to apply low level current pulses (maximum 40 milliamps) to the patient. This technology uses noninvasive, externally applied, subthreshold (low amplitude) far-field stimulus while acquiring electrocardiogram data. |
| Intended Use: | The MI-1000 system is used to measure Wavelet SurfaceResiduum indices at rest and during low level electricalstimulation during the cardiac refractory period. This datais presented in a graphical format for interpretation by atrained physician. The MI-1000 system is also used for themeasurement of SAECG indices. The MI-1000 systemshould be used only as an adjunct to clinical history andthe results of other noninvasive and /or invasive tests. |
The MI-1000 system is a tool used to identify heart cells that are significantly less stable than normal or conduct
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K090249
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slower than normal and, thus, are an indication of cardiac electrical problems.
The modified MI-1000 system is substantially equivalent to Technological Characteristics: the original MI-1000 system and utilizes all of the same fundamental technology to capture the ECG signal from the patient. The only change for the current model is in the signal post-processing and display. All of the displayed information is subject to physician interpretation.
A complete software validation and verification was Performance Data-non-clinical: completed to verify that the acquired data was able to be correctly analyzed and the Wedensky indices were correctly calculated and displayed. All testing successfully met the required criteria. No clinical testing was required. Performance Data - clinical:
The modified Micro-Induction 1000 system is substantially Conclusion: equivalent to the previously cleared version of the Micro-Induction 1000 system.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2009
Harbinger Medical, Inc. C/O Harold Hoium 10125 Crosstown Circle, Suite 105 Eden Prairie, Minnesota 55344
Re: K090249
Trade/Device Name: Micro-Induction 1000 System Regulation Number: 21 CFR 870.2340 (Electrocardiograph) Regulatory Class: Class II Product Code: DPS and DPX Dated: March 18, 2009 Received: March 20, 2009
Dear Mr. Hoium:
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.
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.
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Page 2 - Mr. Harold Hoium
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
[signature]
0 / 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): K090249
Device Name: _ Micro-Induction (MI) 1000 System
Indications For Use:
The MI-1000 is used to measure Wavelet Surface Residuum indices at rest and during low level electrical stimulation during the cardiac refractory period. This data is presented in a graphical format for interpretation by a trained physician. The MI-1000 is also used for the measurement of SAECG indices. The MI-1000 should be used only as an adjunct to clinical history and the results of other noninvasive and/or invasive tests.
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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for B Zuckerman
| (Division Sign-Off) | 4/3/09 |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K090249 |
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§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).