ZOLL ECG Analysis Software

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January 28, 2019 ZOLL Manufacturing Corporation Zachary Nelson Sr. Regulatory Affairs Manager 2000 Ringwood Avenue San Jose, California 95131 Re: K182093 Trade/Device Name: ZOLL ECG Analysis Software Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 20, 2018 Received: December 26, 2018 # Dear Zachary Nelson: 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). 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Zuckerman, M.D. Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182093 Device Name ZOLL ECG Analysis Software #### Indications for Use (Describe) The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <div> <span> <b> \[x] Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> <b> \[ ] Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are a bright blue color. A small registered trademark symbol is located to the right of the second "L". # 7. 510(k) Summary | 510(k) Owner: | ZOLL Manufacturing Corporation<br>121 Gamma Drive<br>Pittsburgh, PA 51238<br>U. S. A. | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Zachary Nelson<br>Sr. Regulatory Affairs Engineer<br>Phone: 412-968-3333 x14814<br>Fax: 412-592-0953<br>Email: znelson@zoll.com | | Date Summary Prepared: | January 24, 2019 | | Trade Name: | ZOLL ECG Analysis Software | | Common Name: | ECG Analysis Software | | Device Classification Name: | Electrocardiograph | | Product Code: | DPS | | Classification Regulation: | 870.2340 | | Device Classification: | II | | Classification Panel: | Cardiovascular (74) | | Predicate Device: | Monebo Automated ECG Analysis and Interpretation Software Library<br>(K062282)<br>The predicate device has not been subjected to recall. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. The letters are stylized and connected, with a registered trademark symbol next to the second "L". Above the word "ZOLL" is the text "K182093" in a smaller, black font. The background is plain white. # Device Description The ZOLL ECG Analysis Software is a SaMD (Software as a Medical Device) which is of Moderate Level of Concern. It is a software library consists of callable functions that are accessible through an Application Programming Interface (API). The ZOLL ECG Analysis Software provides ECG signal processing, QRS detection, classification of normal/VEB/SVEB, heart rate measurement, and the following rhythm interpretation for up to 3 leads (any combination of the standard 12 leads) of captured ECG data: - Bradycardia - . Tachycardia - Atrial Fibrillation - . Pause - Ventricular Runs - Ventricular Bigeminy / Ventricular Trigeminy - . Ventricular Tachycardia - Supraventricular Tachycardia - 2nd Degree Atrioventricular (AV) Block ● - . 3rd Degree Atrioventricular (AV) Block The ZOLL ECG Analysis Software is made up of: - An ECG analysis engine that is responsible for ECG analysis and interpretation ● - An API to access the ECG analysis engine The functions of the ZOLL ECG Analysis Software are intended to be called by a Windows application program written in C++, C# or MATLAB using the Microsoft .NET architecture. Furthermore, the ZOLL ECG Analysis Software requires the installation of MATLAB Runtime R2015B for execution. The ZOLL ECG Analysis Software has only been tested and validated to be used with MATLAB R2015B." ### Indications for Use Statement The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not intended for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. #### Level of Concern Statement The ZOLL ECG Analysis Software is a Moderate Level of Concern Software Device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the text "K182093" in the upper left corner. To the right of this text is the word "ZOLL" in large, bold, blue letters. The letters are stylized and connected, with a registered trademark symbol to the right of the second "L". The library is intended for use only with devices authorized for commercialization by FDA for acquiring an ECG signal. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. A latent design flaw, failure or malfunction of the software, which were not revealed during the validation, verification and testing process, is possible over the life of the product. The results could result in a delayed response of appropriate medical care that would lead to injury or further diagnostic evaluations. The intended end users of the ECG analysis information are trained medical professional who are responsible for reviewing the device output and rendering the final diagnostic treatment decision. ### Technological Characteristics and Substantial Equivalence Discussion The ZOLL ECG Analysis Software and the predicate device Monebo have the same intended use. Both of them are intended for ECG signal analysis and interpretation, intended for use with ECG management software, and not intended for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The ZOLL ECG Analysis Software and Monebo have the same technological characteristics. Both of them are software libraries consist of callable functions that are accessible through an API. Both are provided to the users in compiled file (Dynamic Link Library) and for installation in the user's hardware. Both provide ECG signal processing, QRS detection, beat classification, heart rate measurement, and rhythm interpretation. Table 7-1 provides further comparison between the ZOLL ECG Analysis Software and Monebo. | | ZOLL ECG Analysis<br>Software<br>(Subject Device) | Monebo<br>(Predicate Device) | Comparison | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DPS | DPS | Same | | Device<br>Classification | Electrocardiograph | Electrocardiograph | Same | | Regulation<br>Number | 870.2340 | 870.2340 | Same | | Device Class | II | II | Same | | Intended Use | ECG signal analysis and<br>interpretation | ECG signal analysis<br>and interpretation | Same | | Patient Population | Adult | Adult | Same | | Level of Concern | Moderate | Moderate | Same | | | ZOLL ECG Analysis | Monebo | | | | Software | (Predicate Device) | Comparison | | | (Subject Device) | | | | Beat Classification | Classifies and label all<br>beats as "N" (Normal),<br>("V") Ventricular Ectopic<br>Beat, or ("A")<br>Supraventricular Ectopic<br>Beat. | Classifies and labels all<br>beats as Normal (N) or<br>Ventricular (V).<br>V is a Ventricular<br>Ectopic Beat. | Similar.<br>Both the ZOLL ECG Analysis<br>Software and Monebo classify and<br>label Normal, VEB and SVEB.<br>Monebo uses the term APC (Atrial<br>Premature Contraction under their<br>rhythm interpretation section),<br>which is equivalent to SVEB. ZOLL<br>ECG Analysis Software adopts the<br>term SVEB following AAMI/ANSI EC<br>57:2012. | | Measurement | Heart Rate | - Heart Rate<br>- PR interval<br>- QRS duration<br>- QT interval | Similar.<br>Both the ZOLL ECG Analysis<br>Software and Monebo measure<br>Heart Rate. Monebo additionally<br>provides PR interval, QRS duration<br>and QT interval, lacking of which<br>does not affect the safety and<br>effectiveness of the ZOLL ECG<br>Analysis Software. Both the ZOLL<br>ECG Analysis Software and Monebo<br>are subjected to EC57 testing to<br>verify the accuracy of Heart Rate<br>measurement. Test results<br>demonstrate that the ZOLL ECG<br>Analysis Software is at least as safe<br>and effective as Monebo. | | Arrhythmia<br>Detection | - Bradycardia<br>- Tachycardia<br>- Atrial Fibrillation<br>- Pause<br>- Ventricular Runs<br>- Ventricular Bigeminy /<br>- Ventricular Trigeminy<br>- Ventricular<br>- Tachycardia<br>- Supraventricular<br>- Tachycardia<br>- 2nd degree<br>- Atrioventricular (AV)<br>- Block<br>- 3rd degree<br>- Atrioventricular (AV)<br>- Block | - Normal Sinus Rhythm<br>(NSR)<br>- Bradycardia<br>- Tachycardia<br>- Nodal Rhythm<br>- Pause<br>- Premature<br>- Ventricular<br>Complexes (PVC)<br>- Atrial Premature<br>Contraction (APC)<br>- Atrial Fibrillation or<br>Flutter<br>- Ventricular<br>- Tachycardia<br>- Supraventricular<br>- Tachycardia<br>- Ventricular Flutter<br>- AV Blocks | Similar.<br>Arrhythmia detected by the ZOLL<br>ECG Analysis Software is a subset of<br>Monebo. Those arrhythmia<br>detected by Monebo but not by the<br>ZOLL ECG Analysis Software are<br>underlined, lacking of which does<br>not affect the safety and<br>effectiveness of the ZOLL ECG<br>Analysis Software.<br>Note that the ZOLL ECG Analysis<br>Software does not explicitly label<br>NSR, and that VEB and SVEB are<br>equivalent to PVC and APC. ZOLL<br>ECG Analysis Software adopts the<br>term VEB and SVEB following<br>AAMI/ANSI EC 57:2012. | | ZOLL ECG Analysis<br>Software<br>(Subject Device) | Monebo<br>(Predicate Device) | Comparison | | | | - Bundle Branch Block<br>- Ventricular Trigeminy<br>- Ventricular Bigeminy<br>- Accelerated<br>Idioventricular<br>Rhythm | Both the ZOLL ECG Analysis<br>Software and Monebo are<br>subjected to EC57 testing to<br>validate their arrhythmia detection<br>capability. Test results<br>demonstrate that the ZOLL ECG<br>Analysis Software is at least as safe<br>and effective as Monebo. | | #### Table 7-1: Comparison Chart between the ZOLL ECG Analysis Software and Monebo {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. The letters are stylized and appear to be part of a logo. Above the word "ZOLL" is the text "K182093" in a smaller, black font. The registered trademark symbol is to the right of the second L. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. Above the word "ZOLL" is the text "K182093" in a smaller, black font. The letters of the word "ZOLL" are connected to each other. There is a registered trademark symbol to the right of the second "L" in "ZOLL". #### Verification and Validation Activities Data Since the ZOLL ECG Analysis Software is a SaMD, safety and effectiveness for the software is demonstrated through verification and validation activities (V&V) at the unit, integration and system level. Validation includes performance testing following AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms. Table 7-2 below provides a summary of the V&V activities for the ZOLL ECG Analysis Software. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "ZOLL" in blue, with the registration mark on the bottom right. The letters are large and bold. Above the word "ZOLL" is the text "K182093" in black. | Table 7-2:<br>Verification and<br>Validation<br>ActivitiesTitle | Description | |-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Unit Tests | In this verification activity, the smallest testable parts of the ZOLL<br>ECG Analysis Software are individually and independently<br>scrutinized for proper operation. The test cases simulate various<br>operation conditions and error conditions of the ZOLL ECG<br>Analysis Software. Each test case has an input test vector and an<br>expected output. The actual output of each test case is<br>compared to the expected output. All unit tests pass. | | Functional Tests | Also a part of the verification activities, functional tests are<br>conducted at the integration level. This testing verifies that each<br>function of the ZOLL ECG Analysis Software operates in<br>conformance with the requirement specification when program<br>units are combined. Similar to the unit tests, each functional test<br>case simulates the operation conditions and boundary conditions<br>of the ZOLL ECG Analysis Software. Each test case has an input<br>test vector and an expected output. The actual output of each<br>test case is compared to the expected output. All functional tests<br>pass. | | API Test | As the sole function of the API is to correctly transfer the input<br>and output parameters into and out of the ZOLL ECG Analysis<br>Software, the API Test therefore is a simple atomic test to verify<br>that the API transfers the input and output parameters correctly.<br>Test result demonstrates that the API correctly transfer the input<br>and output parameters. | | Performance Test | Performance test is the validation activity conducted for the ZOLL<br>ECG Analysis Software. It is a system level testing that<br>demonstrates the detection capability of the software. Following<br>AAMI/ANSI EC 57:2012 Testing and Reporting Performance<br>Results of Cardiac Rhythm and ST Segment Measurement<br>Algorithms, the ZOLL ECG Analysis Software is applied to the ECG<br>databases required by the standard. The ZOLL ECG Analysis<br>Software is required to generate an attribute file with the analysis<br>results. The test results from the ZOLL ECG Analysis Software are<br>compared to the reference results (which are available as part of<br>the databases) using the comparison applications. Results from<br>the EC 57 testing demonstrates that the performance of the ZOLL<br>ECG Analysis Software meets the clinical requirements for<br>arrhythmia detection and heart rate estimation. | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Zoll Medical Corporation logo in blue. The logo is a stylized version of the company name, with the letters "ZOLL" in a bold, sans-serif font. The registration mark is on the bottom right of the logo. The number K182093 is on the top left of the logo. # Conclusion As demonstrated in this 510(k), the ZOLL ECG Analysis Software has the same intended use and technological characteristics as the predicate device Monebo. Both devices have the same questions of safety and effectiveness. Verification and validation activities demonstrate that the ZOLL ECG Analysis Software is at least as safe and effective as Monebo. Therefore, the ZOLL ECG Analysis Software is substantially equivalent to Monebo.