(165 days)
The MAC 5 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 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The device can capture 3, 6, or 12 lead electrocardiograms, provide interpretive analysis, and print reports.
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 cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.
The provided text is a 510(k) summary for the GE MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device (MAC 7 Resting ECG Analysis System) and a reference device (ELI 380 - 12 Lead Resting ECG). The documentation does not contain specific acceptance criteria and performance data for the device's diagnostic capabilities, nor does it detail a study proving the device meets particular acceptance criteria related to its interpretive analysis.
The document primarily focuses on explaining that the device is substantially equivalent to existing devices based on technical specifications, intended use, indications for use, and a comparison of features. It explicitly states, "The subject of this premarket submission, MAC 5 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I describe a study that proves the device meets those criteria, as such information related to diagnostic performance is not present.
However, I can extract information related to the device's characteristics and the comparison to predicate/reference devices:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy for disease detection) for the interpretive ECG analysis, nor does it report the device's performance against such criteria. The "performance" discussed is in terms of feature functionality and technical specifications being "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission states that clinical studies were not required to support substantial equivalence.
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)
This information is not provided. Since no clinical studies were deemed necessary, there is no mention of a test set with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 comparative effectiveness study was mentioned. The submission states that clinical studies were not required. The device provides "interpretation of the data for consideration by a physician" and "is not intended as a sole means of diagnosis," indicating it's an assistive tool, but no study validating its impact on human reader performance is presented here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone performance study of the interpretive algorithm (12SLTM analysis algorithm v24) is detailed in this document. The focus is on the substantial equivalence of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
The document does not provide information about the training set for the 12SLTM analysis algorithm. It only mentions that the proposed device uses "12SLTM analysis algorithm (v24)" (which is an updated version of the algorithm used in the predicate device, v23.1). It states "No changes to the interpretive statements of the 12SLTM analysis algorithm (v24) under K141963 and compared to the predicate device. The changes introduced with the 12SLTM (v24) do not impact the ECG analysis (measurement or accuracy) of the algorithm." This suggests the algorithm itself has been previously validated, but details are not in this document.
9. How the ground truth for the training set was established
This information is not provided in this document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2022
GE Medical Systems Information Technologies, Inc. Honghong Yang Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K221321
Trade/Device Name: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, DXH Dated: September 16, 2022 Received: September 20, 2022
Dear Honghong Yang:
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.
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K221321
Device Name
MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System
Indications for Use (Describe)
The MAC 5 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a slightly raised or embossed effect, giving it a three-dimensional appearance.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
I. SUBMITTER
GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226
Primary Contact Person:
Honghong Yang Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Telephone: +86 13915289019 Fax: +86 0510-85226688 E-mail: Honghong.yang@ge.com
Secondary Contact Person: Michael F. Petrini Executive, Regulatory Affairs - Life Care Solutions GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, Wisconsin 53226 Phone: +1-360-9283 Fax: +1-414-721-3864 E-mail: michael.petrini@ge.com
Date 510(k) Summary was Prepared: April 29, 2022
II. DEVICE
| Device Trade Name: | MAC 5 A4/MAC 5 A5/MAC 5 Lite 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 and Receiver |
| Regulatory Class: | II |
| Product Code: | DPS, DQK and DXH |
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GE Healthcare 510(k) Premarket Notification Submission
| Predicate Device(s): | MAC 7 Resting ECG Analysis System (K203786) |
|---|---|
| Reference Device: | ELI 380 12 lead Resting ECG (K142105) |
| Device Description: | The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECGAnalysis System is a mobile electrocardiograph designed toacquire, analyze, display, and record ECG signals from surfaceECG electrodes. |
| The device can capture 3, 6, or 12 lead electrocardiograms,provide interpretive analysis, and print reports. | |
| The device can connect to a network, either through a wiredLAN connection or via wireless WiFi access points. Once onthe network, the device can optionally interface withcardiology information systems such as the GEHC MUSE®system to participate in a complete electrocardiologyworkflow. | |
| The device provides state-of-the-art information technologysecurity features and a contemporary user interface. Mobility isprovided via an optional trolley. | |
| Indications for Use: | The MAC 5 Resting ECG Analysis System is a non-invasiveprescription device. |
| • The device is indicated for use to acquire, analyze, displayand print electrocardiograms.• The device is indicated for use to provide interpretation of thedata for consideration by a physician.• The device is indicated for use in a clinical setting, by aphysician or by trained personnel who are acting on the ordersof a licensed physician. It is not intended as a sole means ofdiagnosis.• The interpretations of ECG offered by the device are onlysignificant when used in conjunction with a physician overreadas well as consideration of all other relevant patient data.• The device is indicated for use on adult and pediatric (birththrough 21 years of age) populations |
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular shape. The logo is colored in a light blue hue, and the background is white.
Technology: The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite employs the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, and operating principles as the predicate device MAC 7 in acquiring, analyzing, recording, displaying and printing ECG data for both adult and pediatric populations. The basic system prints 3, 6 or 12 leads of ECG and provides optional transmission and reception of ECG data to and from a central ECG cardiovascular information system. The system can be upgraded with software options, such as communication options which is similar to the predicate device. The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is similar to the MAC 7 Resting ECG Analysis System, K203786, in the technology of downloading
cardiovascular information system (e.g. MUSE) as well as supporting ECG reports in PDF. Both are able to use WiFi communication.
orders and patient demographics from a central ECG
Determination of Substantial Equivalence:
The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is substantially equivalent to the predicate MAC 7 Resting ECG Analysis System (K203786) and the reference device ELI 380 - 12 Lead Resting ECG(K142105) as described in the following table:
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| Specification | Predicate Product:MAC 7 Resting ECG AnalysisSystem (K203786) | Proposed Product:MAC 5 A4/ MAC 5 A5/ MAC 5Lite Resting ECG Analysis System | Discussion of Differences |
|---|---|---|---|
| IntendedUse | The MAC 7 Resting ECGAnalysis System is intended toacquire, analyze, display, andrecord electrocardiographicinformation from adult orpediatric populations. Basicsystem delivers 3, 6, or 12 leadECG's and interpretive analysis.Transmission and reception ofECG data and other clinical datato and from a central clinicalinformation system is optional.The MAC 7 ECG AnalysisSystem is intended to be usedunder the direct supervision of alicensed healthcare practitioner,by trained operators in ahospital, medical professional'sfacility or wherever ECG testingis performed. | The MAC 5 Resting ECGAnalysis System is intended toacquire, analyze, display, andrecord electrocardiographicinformation from adult orpediatric populations. Basicsystem delivers 3, 6, or 12 leadECG's and interpretive analysis.Transmission and reception ofECG data and other clinical datato and from a central clinicalinformation system is optional.The MAC 5 ECG AnalysisSystem is intended to be usedunder the direct supervision of alicensed healthcare practitioner,by trained operators in a hospital,medical professional's facility orwherever ECG testing isperformed. | Identical |
| Indicationsfor Use | The MAC 7 Resting ECGAnalysis System is a non-invasive prescription device.• The device is indicated for useto acquire, analyze, display andprint electrocardiograms.• The device is indicated for useto provide interpretation of thedata for consideration by aphysician.• The device is indicated for usein a clinical setting, by aphysician or by trainedpersonnel who are acting on theorders of a licensed physician. Itis not intended as a sole meansof diagnosis.• The interpretations of ECGoffered by the device are onlysignificant when used inconjunction with a physicianover-read as well asconsideration of all otherrelevant patient data.• The device is indicated for useon adult and pediatric (birththrough 21 years of age)populations. | The MAC 5 Resting ECGAnalysis System is a non-invasiveprescription device.• The device is indicated for useto acquire, analyze, display andprintelectrocardiograms.• The device is indicated for useto provide interpretation of thedata for consideration by aphysician.• The device is indicated for usein a clinical setting, by aphysician or by trained personnelwho are acting on the orders of alicensed physician. It is notintended as a sole means ofdiagnosis.• The interpretations of ECGoffered by the device are onlysignificant when used inconjunction with a physicianover-read as well as considerationof all other relevant patient data.• The device is indicated for useon adult and pediatric (birththrough 21 years of age)populations. | Identical |
| Specification | Predicate Product:MAC 7 Resting ECG AnalysisSystem (K203786) | Proposed Product:MAC 5 A4/ MAC 5 A5/ MAC 5Lite Resting ECG Analysis System | Discussion of Differences |
| Contraindications | This MAC 7 Resting ECGAnalysis System is not intendedin the following manner:• During patient transport• With high-frequency surgicalunits• As an intra-cardiac application• As a sole means of diagnosis• As a vital signs physiologicalmonitor | This MAC 5 Resting ECGAnalysis System is not intendedin the following manner:• During patient transport• With high-frequency surgicalunits• As an intra-cardiac application• As a sole means of diagnosis• As a vital signs physiologicalmonitor | Identical |
| PatientPopulation | Adult and pediatric (birththrough 21 years of age)populations | Adult and pediatric (birth through21 years of age) populations | Identical |
| Environmentof Use | Intended to be used under thedirect supervision of a licensedhealthcare practitioner in ahospital or medicalprofessional's facility by trainedoperators | Intended to be used under thedirect supervision of a licensedhealthcare practitioner in ahospital or medical professional'sfacility by trained operators | Identical |
| PatientAcquisitionCircuitry | Acquisition module integrated inthe device and digitalizingfunctions provided by the deviceitself. | Acquisition module integrated inthe device and digitalizingfunctions provided by the deviceitself. | Identical |
| InterpretiveECGAnalysis | Yes | Yes | Identical |
| CriticalValues | Critical Test Values identifiedand indicated:- Dialog Box- Printed ReportUser acknowledgement requiredto clear notification | Critical Test Values identifiedand indicated:- Dialog Box- Printed ReportUser acknowledgement requiredto clear notification | Identical |
| ECGPacemakerDetection | Pacemaker pulses are detecteddigitally and maintained in aseparate printable and viewablechannel from the ECGwaveform. All recorded leadsare examined for pace pulsepresence.For the acquisition moduleintegrated in the device,software instructs 12SL todisable digitaldetection/reconstruction andaccept all pace detections fromacquisition module. | Pacemaker pulses are detecteddigitally and maintained in aseparate printable and viewablechannel from the ECG waveform.All recorded leads are examinedfor pace pulse presence. Theseparate pacemaker pulseschannel is configurable for enableand disable. It is enabled bydefault.For the acquisition moduleintegrated in the device, softwareinstructs 12SL to disable digitaldetection/reconstruction andaccept all pace detections fromacquisition module. | SubstantiallyEquivalentThe pacemaker pulseschannel can be turnedoff by the user,according to preference.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| Specification | Predicate Product:MAC 7 Resting ECG AnalysisSystem (K203786) | Proposed Product:MAC 5 A4/ MAC 5 A5/ MAC 5Lite Resting ECG Analysis System | Discussion of Differences |
| Displaytype, size,resolution,andinformation | 10 inch diagonal LCD, 1280 x800 text and waveforms. | 8.9 inch diagonal LCD, 892 x 558text and waveforms. | SubstantiallyEquivalentA more compact displayis offered; there is nochange to displayedinformation.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| BatteryOperation | Yes. Battery is rechargeable anduser replaceable. | Yes. Battery is rechargeable anduser replaceable,a more compact battery isprovided for the proposedcompact design. | SubstantiallyEquivalent.A compact battery forthe proposed device.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| RecorderMethod | Thermal dot array | - Thermal dot array- MAC 5 Lite: Offered withoutan integrated printer | - Identical for MAC 5 A4and MAC 5 A5 whichsupport thermal printing.MAC 5 Lite offeredwithout an integratedprinter.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| ThermalPaper size | A4 or Letter format, thermalpaper Z-fold | - models with printers, A4,A5, Letter format, orthermal paper Z-fold | SubstantiallyEquivalentOnly different thermalpaper from predicatedevice.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| Specification | Predicate Product:MAC 7 Resting ECG AnalysisSystem (K203786) | Proposed Product:MAC 5 A4/ MAC 5 A5/ MAC 5Lite Resting ECG Analysis System | Discussion of Differences |
| NetworkPrinterOption | Not supported. | Support to print the report via thenetwork printer. | The contents of thenetwork printer reportsare the same as thermalprinter reports.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| PharmacyOption | Not supported. | New data entry featureconvenience to enter clinical trialdata along with the patient datawhich could be included in thereport. | The new data entryfeature is forconvenience ofadditional data appendedto the record; it isavailable on similardevices as a userpreference.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| Interpretation Statements | Provides interpretive statementsfrom the 12SLTM analysisalgorithm (v23.1) for 10 secondsECG. | Provides interpretive statementsfrom the 12SLTM analysisalgorithm (v24) for 10 secondsECG. | SubstantiallyEquivalentNo changes to theinterpretive statementsof the 12SLTM analysisalgorithm (v24) underK141963 and comparedto the predicate device.The changes introducedwith the 12SLTM (v24)do not impact the ECGanalysis (measurementor accuracy) of thealgorithm.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
| Specification | Predicate Product:MAC 7 Resting ECG AnalysisSystem (K203786) | Proposed Product:MAC 5 A4/ MAC 5 A5/ MAC 5Lite Resting ECG Analysis System | Discussion of Differences |
| Dimensionsand Weight | 40 x 32 x 21 cm,5.2 Kg | - MAC 5 A4: 31.5 x 36.0 x11.4 cm,3.6 Kg- MAC 5 A5: 31.5 x 26.0 x10.8 cm,3.0 Kg- MAC 5 Lite: 30.9 x 26.0 x8.4 cm,2.0 Kg | SubstantiallyEquivalentThe proposed producthas a more compactdesign from predicatedevice.GE Healthcare considersthe MAC 5 tobe substantiallyequivalent to thepredicate device |
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| Specification | Reference device:ELI 380K142105 | ProposedMAC 5 A4/ MAC 5A5/ MAC 5 LiteResting ECGAnalysis System | Discussion of Differences |
|---|---|---|---|
| FrequencyResponse | 0.05-300Hz | 0.04-300Hz | Substantially equivalentThe 300Hz filter is being added to the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG. The 300Hz frequency response feature is substantially equivalent to the reference device, ELI 380. The technology for the delivery of 300Hz low pass filter, is not novel or new to the Resting ECG. The 300Hz filter feature is available for pediatric patients. The addition of 300Hz low-pass filter will present waveforms with high frequency elements. Verification evidence demonstrates that the performance and specifications of the 300Hz filter feature on the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System are equivalent to those on the ELI 380. The 300 Hz filter feature on the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System does not differ in its technological characteristics, function, or performance and therefore, it is substantially equivalent.The lower limit of 0.04Hz frequency bandwidth is identical to the predicate device, MAC 7 therefore, it is substantial equivalentThe 300Hz bandwidth feature for MAC 5 shall include the MAC 7 (K203786) and MAC VU 360 (K173830) as a bundle as they all developed on the same software platform. Verification evidence demonstrates that the performance and specifications of the 300Hz filter feature on the MAC 7 and MAC VU 360 are equivalent to the MAC 5. |
Substantial Equivalence to the reference device, ELI 380 (K142105)
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| Performance Standards: | The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECGAnalysis System complies with thevoluntary consensus standard ANSI/AAMI ES60601-1:2005/(R)2012 and its relevant collateral and particularstandards. |
|---|---|
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECGAnalysis System and its applicationscomply with voluntary standards. The following qualityassurance measures were applied to the development of thesystem:- Risk Analysis- Required Reviews- Design Reviews- Software Development Lifecycle- Testing on unit level- Integration testing (System verification)- Performance testing (Verification)- Safety testing (Verification) |
| Summary of Clinical Tests: | The subject of this premarket submission, MAC 5 RestingECG Analysis System, did not require clinical studies tosupport substantial equivalence. |
| Conclusion: | GE Healthcare considers the MAC 5 A4/ MAC 5 A5/ MACLite Resting ECG Analysis System to be as safe, as effective,and perform as well as the legally marketed predicate deviceMAC 7 Resting ECG Analysis System. |
§ 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).