(122 days)
The MobileECG System is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.
The MobileECG System is intended for use in adults and children of any age from birth upwards.
The MobileECG System's interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
The MobileECG System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu interpretation software.
The Model 950-12LR HHC module is a small, light weight, single battery, wireless module designed to transmit 12Lead electrical heart activity of a patient to a computer. This module will transmit a patient's ECG wirelessly to a laptop, netbook, tablet, or desktop computer containing the CardioVu interpretation software from up to 100 feet away.
Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings. Wireless dedicated and secure communication links the Model 950-12LR HHC module to CardioVu interpretation software.
The CardioVu software receives, displays, and stores the patients ECG data wirelessly on a laptop, netbook, tablet, or desktop computer in "real time". The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only in conjunction with the physician's knowledge of ECG. The wireless feature allows the patient not to be tethered to the computer or a bulky box thus reducing motion artifacts caused by movement of the connecting cables and providing comfort to the patient.
The provided 510(k) summary for the Memtec Corporation's MobileECG System (K103427) does not describe an extensive study (clinical or analytical) with specific acceptance criteria and performance metrics for the device's diagnostic capabilities. Instead, it focuses on non-clinical testing for substantial equivalence to predicate devices based on applicable standards.
Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment cannot be extracted from this document as such a study is not presented.
Here's a breakdown of what can be inferred from the document regarding comparative effectiveness and analytical performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity) for its ECG interpretation software. The assessment is based on demonstrating equivalence to predicate devices through compliance with technical standards.
| Metric | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Diagnostic Accuracy of ECG Interpretation | Implicitly, the MobileECG System's interpretation software should perform comparably to the interpretation software of the predicate devices in identifying common ECG abnormalities. | The document broadly states the software has data using ECG algorithms for review. No specific performance metrics like sensitivity, specificity, or agreement with a reference standard are provided in this summary. |
| Wireless Communication Range | Implied to be sufficient for clinical use, up to 100 feet. | Transmits ECG wirelessly to a computer from up to 100 feet away. |
| Artifact Reduction | Improved over cabled systems. | "Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings." |
| Compliance with Standards | Adherence to various specified AAMI, IEC, FCC, and CFR standards. | "Non-clinical tests were performed to compare the MobileECG System to the predicated devices. The following applicable standards were used... [listed standards]." |
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set is described. The "non-clinical tests" focused on standards compliance, not diagnostic performance on a patient dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set with expert-established ground truth is described. The software's interpretation is "an advisory basis only in conjunction with the physician's knowledge of ECG."
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set for diagnostic performance is described.
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:
No MRMC study is mentioned. The device's software is described as providing "interpretation software... on an advisory basis only," suggesting it's an aid, but no study on human performance improvement with this aid is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states, "The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only." While algorithms are present, a formal standalone performance study (e.g., sensitivity/specificity of the algorithm alone against a gold standard) is not described or quantified in this 510(k) summary.
7. The Type of Ground Truth Used:
Not applicable, as a study requiring ground truth for diagnostic performance is not described.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set for the ECG interpretation algorithms.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set or its ground truth establishment is described.
Summary of what the 510(k) does convey:
The document primarily demonstrates substantial equivalence to predicate devices through non-clinical testing against relevant industry standards (e.g., electrical safety, electromagnetic compatibility, ECG performance requirements like filtering and lead accuracy). It asserts that the device's technical specifications and intended use are similar to those of previously cleared devices, making it equally safe and effective from a manufacturing and functional standpoint, rather than providing a detailed clinical validation of its diagnostic algorithm's accuracy.
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2011
510(k) K103427
SUMMARY OF SAFETY AND EFFECTIVENE
510(k) SUMMARY of Safety and Effectiveness
1. General Information
| Submitter's Name:Address: | Memtec Corporation68 Stiles Road Unit DSalem, NH 03079 |
|---|---|
| Telephone: | 603 893-8080 Ext. 204 |
| Contact Person: | Dennis Garboski |
| Trade Name: | MobileECG System |
| Common Name: | Electrocardiograph (per 21 CFR 870.2340) |
| Class: | II |
2. Predicated Devices
The legally marketed predicated devices to which equivalence is being claimed is:
| Micromedical, Inc. | Biolog 3000 | K974351 |
|---|---|---|
| Datrix, Inc. | Cardio WiFi and | K053083 |
| Datrix, Inc. | CardioServer | K052883 |
| QRS Diagnostic | EKGCARD SYSTEM | K030535 |
| QRS Diagnostic | Cardioview 32 | K083749 |
3. Description of Device
·
The MobileECG System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu interpretation software.
The Model 950-12LR HHC module is a small, light weight, single battery, wireless module designed to transmit 12Lead electrical heart activity of a patient to a computer. This module will transmit a patient's ECG wirelessly to a laptop, netbook, tablet, or desktop computer containing the CardioVu interpretation software from up to 100 feet away.
Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings. Wireless dedicated and secure communication links the Model 950-12LR HHC module to CardioVu interpretation software.
The CardioVu software receives, displays, and stores the patients ECG data wirelessly on a laptop, netbook, tablet, or desktop computer in "real time". The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only in conjunction with the physician's knowledge of ECG. The wireless feature allows the patient not to be tethered to the computer or a bulky box thus reducing motion artifacts caused by movement of the connecting cables and providing comfort to the patient.
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4. Indications For Use
The MobileEG System is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.
The MobileECG System is intended for use in adults and children of any age from birth upwards.
The MobileECG System's interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
5. Non-clinical Tests Used in Determination of Substantial Equivalence
Non-clinical tests were performed to compare the MobileECG System to the predicated devices.
The following applicable standards were used to compare the MobileECG System to the predicated devices: ANS/AAMI EC11, IEC 60601-1-2, IEC 60601-1-1, IEC 60601-1-4, 21 CFR 898, ANSI/AAMI EC53, AND FCC Part 15.247.
6. Conclusions From Non-clinical Testing
After comparing predicated devices to Memtec's MobileECG System, results show that with the intended use, the Model 950-12LR HHC module with CardioVu interpretation software is equivalent in safety and effectiveness. Therefore Memtec supports a claim of substantial equivalence for the MobileECG System.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Memtec Corporation c/o Mr. Dennis Garboski President 68 Stiles Road Unit D Salem, NH 03079
MAR 2 4 2511
K103427 Re:
Trade/Device Name: MobileECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 14, 2011 Received: March 16, 2011
Dear Mr. Garboski:
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.
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Page 2 –Mr. Dennis Garboski
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,
17 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 STATEMENT
Indications for Use
510(k) Number(if known) KIO 3427
Device Name: MobileECG System
Indications for Use
The MobileECG System is intended to provide an analysis of rhythm and of detailed morphology of complex cardiac complexes for the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is adjunct to the diagnosis of all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.
The MobileECG System is intended for use in adults and children of any age from birth upwards.
Prescription Use
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(Please Do Not Write Below This Line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.D.O. for B.Zuckerman
(Division Sign-Off) ular Device 510(k) Number
§ 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).