(274 days)
The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device.
-The device is indicated for use to acquire, analyze, display and print electrocardiograms.
-The device is indicated for use to provide interpretation of the data for consideration by a physician.
-The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
-The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
-The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
The MAC VU360 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The MAC VU360 can capture 3, 6, 12, or 15 lead electrocardiograms, provide interpretive analysis, and print reports. The MAC VU360 is indicated for use on adult and pediatric (birth through 21 years of age) populations. The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with the cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow. The device can also optionally display data from external systems which provide web or Citrix content. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via a wheeled trolley. The MAC VU360 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the MAC VU360 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. The MAC VU360 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
The provided text does not contain detailed information about a study proving the device meets specific acceptance criteria with a table of performance metrics, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document is a 510(k) summary for the MAC VU360 Resting ECG Analysis System. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELI 380 Resting Electrocardiograph), rather than presenting a performance study with detailed acceptance criteria and results.
Here's what can be extracted and what is not available based on the provided text:
Acceptance Criteria and Device Performance:
The document states "The subject of this premarket submission, MAC VU360 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This implies that the acceptance criteria for this submission were primarily based on technological similarity to the predicate device and compliance with voluntary standards, rather than a clinical performance study with defined quantitative metrics.
Therefore, a table of acceptance criteria and reported device performance, as requested, cannot be generated from the provided text because such a study was not deemed necessary for substantial equivalence in this context.
Other Information:
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Sample sizes used for the test set and the data provenance: Not applicable, as no dedicated clinical performance test set is described. The device's performance is asserted through its use of the 12SL Algorithm, which is referenced as being used by a reference device (MAC 5500 HD), implying its prior validation. Data provenance is not specified beyond "adult and pediatric (birth through 21 years of age) populations" for intended use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a specific test set is described for performance evaluation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. The device provides "interpretation of the data for consideration by a physician" and states that "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." This suggests a human-in-the-loop use case, but no MRMC study is detailed to quantify improvements.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." and "It is not intended as a sole means of diagnosis." This indicates it's designed for human-in-the-loop, and a standalone performance study is not described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth is detailed. The device relies on the established 12SL Algorithm.
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The sample size for the training set: Not applicable. The document states the device "utilizes the 12SL Algorithm," implying that the algorithm's training (if any was needed) was done previously and is not part of this submission's new data.
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How the ground truth for the training set was established: Not applicable, as no specific training set or its ground truth establishment is described for this submission. The 12SL Algorithm is a pre-existing component/technology.
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September 18, 2018
GE Medical Systems Information Technologies, Inc. Marcella Entwisle Regulatory Affairs Leader 9900 West Innovation Drive Wauwatosa. Wisconsin 53226
Re: K173830
Trade/Device Name: MAC VU360 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, DXH Dated: August 17, 2018 Received: August 20, 2018
Dear Marcella Entwisle:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
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) K173830
Device Name
MAC VU360 Resting ECG Analysis System
Indications for Use (Describe)
The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device.
-The device is indicated for use to acquire, analyze, display and print electrocardiograms.
-The device is indicated for use to provide interpretation of the data for consideration by a physician.
-The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
-The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
-The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Section 5: 510(k) Summary
In accordance with 21 CFR Part 807.92(a)(1) the following summary of information is provided:
| Date: | September 17, 2018 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies, Inc.9900 Innovation DriveWauwatosa, WI 53226 |
| Primary Contact: | Marcella EntwisleSenior Regulatory Affairs LeaderPhone: (414) 721-3809Fax: (414) 721-3863email: marcella.entwisle@ge.com |
| Secondary Contact: | Joel KentSenior Regulatory Affairs ManagerGE Medical Systems Information Technologies, Inc.Phone: (617) 851-0943email: joel.kent@ge.com |
| PRODUCT IDENTIFICATION | |
| Device Trade Name: | MAC VU360 Resting ECG Analysis System |
| Common / Usual Name: | Electrocardiograph |
| Classification Names | 21 CFR 870.2340 – Electrocardiograph21 CFR 870.1425 – Programmable Diagnostic Computer21 CFR 870.2920 – Telephone electrocardiograph Transmitter andReceiver |
| Product Codes: | DPS, DQK, and DXH |
| Predicate Device(s): | ELITM 380 Resting Electrocardiograph (K142105) |
| Reference Device(s): | MAC™ 5500 HD Resting ECG Analysis System (K073625)12SLTM (v23) ECG Analysis Program (K141963) |
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo, which is a stylized monogram of the letters 'G' and 'E' in a circular shape. The logo is colored in blue, and the letters are interconnected in a flowing, cursive style. The circular border around the letters has small, stylized water droplet shapes evenly spaced around it.
Device Description: The MAC VU360 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The MAC VU360 can capture 3, 6, 12, or 15 lead electrocardiograms, provide interpretive analysis, and print reports. The MAC VU360 is indicated for use on adult and pediatric (birth through 21 years of age) populations. The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with the cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow. The device can also optionally display data from external systems which provide web or Citrix content. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via a wheeled trolley. The MAC VU360 is intended to be a high-performance, Intended Use / multichannel resting electrocardiograph. As a resting electrocardiograph, the MAC VU360 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. The MAC VU360 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility. Indications for Use / The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device. -The device is indicated for use to acquire, analyze, display and print electrocardiograms. -The device is indicated for use to provide interpretation of the data for consideration by a physician. -The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data. -The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
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| Contraindications: | The MAC VU360 Resting ECG Analysis System is not intended foruse in the following manner:-During patient transport-With high-frequency surgical units-As an intra-cardiac application-As a sole means of diagnosis-As a vital signs physiological monitor |
|---|---|
| Technology: | The MAC VU360 employs the same fundamental scientifictechnology, basic design, construction, materials, energy source,control mechanism, operating principles as the predicate device ELI380 and the MAC 550 HD in acquiring, analyzing, recording,displaying and printing ECG data for both adult and pediatricpopulations. The MAC VU360 utilizes the 12SL Algorithm as doesthe MAC 5500 HD.The basic system prints 6 or 12 leads of ECG and provides optionaltransmission and reception of ECG data to and from a central ECGcardiovascular information system.The MAC VU360 is similar to the ELI 380 Resting ECG AnalysisSystem, K142105, in the technology of downloading orders andpatient demographics from a central ECG cardiovascular informationsystem (e.g. MUSE) as well as supporting ECG reports in PDF. Bothare able to use WiFi communication.For more on the predicate device comparison refer to Section 12 ofthis submission. |
| Performance Standards: | The MAC VU360 Resting ECG Analysis System complies with thevoluntary standards as detailed in Section 9 of this submission. |
| Sterilization: | The MAC VU360 Resting ECG Analysis System does not requiresterilization. |
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| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: |
|---|---|
| The MAC VU360 Resting ECG Analysis System and its applicationscomply with voluntary standards. The following quality assurancemeasures were applied to the development of the system: | |
| ● Risk Analysis● Required Reviews● Design Reviews● Software Development Lifecycle● Testing on unit level (Module verification)● Integration testing (System verification)● Performance testing (Verification)● Safety testing (Verification) | |
| Summary of ClinicalTests: | The subject of this premarket submission, MAC VU360 RestingECG Analysis System, did not require clinical studies to supportsubstantial equivalence. |
| Conclusion: | GE Healthcare considers the MAC VU360 Resting ECG AnalysisSystem to be as safe, and as effective, and performance issubstantially equivalent to the predicate device, ELI 380 RestingElectrocardiograph. |
§ 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).