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.

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.

AI/ML Overview

The provided document describes the ZOLL ECG Analysis Software and its successful 510(k) submission primarily based on substantial equivalence to a predicate device (Monebo Automated ECG Analysis and Interpretation Software Library, K062282). While it mentions "Performance Test" following AAMI/ANSI EC 57:2012, it does not provide specific acceptance criteria values or detailed performance results. The document states that the performance "meets the clinical requirements for arrhythmia detection and heart rate estimation," but does not list those requirements or the exact results.

Therefore, many of the requested details, particularly quantitative acceptance criteria and performance data, cannot be extracted directly from this document.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a quantitative table of acceptance criteria or specific reported performance values. It only states that the performance "meets the clinical requirements" set forth by AAMI/ANSI EC 57:2012.

2. Sample size used for the test set and the data provenance

Test Set Description: The document states: "Following AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms, the ZOLL ECG Analysis Software is applied to the ECG databases required by the standard."
Sample Size: The exact sample size is not explicitly stated, but it refers to "the ECG databases required by the standard" (AAMI/ANSI EC 57:2012). This standard typically specifies the use of well-known, publicly available ECG databases for performance testing (e.g., MIT-BIH Arrhythmia Database, AHA Database, European ST-T Database). The size of these databases varies, but they typically contain thousands of hours of ECG recordings.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given the reference to AAMI/ANSI EC 57:2012, the databases are generally retrospective and come from various sources (e.g., hospitals, research studies) globally, but often with a strong representation from North American data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Ground Truth Establishment: The document states: "The test results from the ZOLL ECG Analysis Software are compared to the reference results (which are available as part of the databases) using the comparison applications."
Number/Qualifications of Experts: The document does not specify the number or qualifications of experts used by ZOLL to establish ground truth. However, for the reference databases standardized by AAMI/ANSI EC 57:2012, the ground truth annotations (often called "truth files" or "reference annotations") are typically established through a rigorous, multi-expert consensus process by the creators of those databases (e.g., cardiologists, electrophysiologists, and experienced ECG technicians). The expertise would be in cardiology/electrophysiology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not explicitly stated. The ground truth comes "as part of the databases," implying that the adjudication for these standard databases was performed previously by their original creators, often using methods like "2+1" or multi-reader consensus.

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

MRMC Study: No, the document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI assistance. The study described is a standalone performance test of the software against a reference standard. The software is intended for use by "qualified medical professionals for the assessment of arrhythmias," implying human oversight, but no study on human-in-the-loop performance is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, a standalone performance test was done. The "Performance Test" section explicitly states, "the ZOLL ECG Analysis Software is applied to the ECG databases required by the standard." This is an algorithm-only evaluation against predefined reference annotations.

7. The type of ground truth used

Type of Ground Truth: The ground truth used was expert consensus / reference annotations provided as part of the standard ECG databases (e.g., MIT-BIH, AHA) specified by AAMI/ANSI EC 57:2012. These databases have pre-established "reference results" for beat classifications and arrhythmias.

8. The sample size for the training set

Training Set Sample Size: The document does not provide any information about the training set used for the ZOLL ECG Analysis Software. It focuses solely on the verification and validation (V&V) activities.

9. How the ground truth for the training set was established

Training Set Ground Truth Establishment: No information is provided regarding the training set or how its ground truth was established, as the document only details the V&V activities.

Summary

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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). 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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,

Arielle Drummond -S

for
Bram D. Zuckerman, M.D.
Director 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) K182093

Device Name ZOLL ECG Analysis Software

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
[x] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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7. 510(k) Summary

510(k) Owner:	ZOLL Manufacturing Corporation121 Gamma DrivePittsburgh, PA 51238U. S. A.
Contact:	Zachary NelsonSr. Regulatory Affairs EngineerPhone: 412-968-3333 x14814Fax: 412-592-0953Email: 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(K062282)The predicate device has not been subjected to recall.

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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 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.

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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 AnalysisSoftware(Subject Device)	Monebo(Predicate Device)	Comparison
Product Code	DPS	DPS	Same
DeviceClassification	Electrocardiograph	Electrocardiograph	Same
RegulationNumber	870.2340	870.2340	Same
Device Class	II	II	Same
Intended Use	ECG signal analysis andinterpretation	ECG signal analysisand 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 allbeats as "N" (Normal),("V") Ventricular EctopicBeat, or ("A")Supraventricular EctopicBeat.	Classifies and labels allbeats as Normal (N) orVentricular (V).V is a VentricularEctopic Beat.	Similar.Both the ZOLL ECG AnalysisSoftware and Monebo classify andlabel Normal, VEB and SVEB.Monebo uses the term APC (AtrialPremature Contraction under theirrhythm interpretation section),which is equivalent to SVEB. ZOLLECG Analysis Software adopts theterm SVEB following AAMI/ANSI EC57:2012.
Measurement	Heart Rate	- Heart Rate- PR interval- QRS duration- QT interval	Similar.Both the ZOLL ECG AnalysisSoftware and Monebo measureHeart Rate. Monebo additionallyprovides PR interval, QRS durationand QT interval, lacking of whichdoes not affect the safety andeffectiveness of the ZOLL ECGAnalysis Software. Both the ZOLLECG Analysis Software and Moneboare subjected to EC57 testing toverify the accuracy of Heart Ratemeasurement. Test resultsdemonstrate that the ZOLL ECGAnalysis Software is at least as safeand effective as Monebo.
ArrhythmiaDetection	- 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	- Normal Sinus Rhythm(NSR)- Bradycardia- Tachycardia- Nodal Rhythm- Pause- Premature- VentricularComplexes (PVC)- Atrial PrematureContraction (APC)- Atrial Fibrillation orFlutter- Ventricular- Tachycardia- Supraventricular- Tachycardia- Ventricular Flutter- AV Blocks	Similar.Arrhythmia detected by the ZOLLECG Analysis Software is a subset ofMonebo. Those arrhythmiadetected by Monebo but not by theZOLL ECG Analysis Software areunderlined, lacking of which doesnot affect the safety andeffectiveness of the ZOLL ECGAnalysis Software.Note that the ZOLL ECG AnalysisSoftware does not explicitly labelNSR, and that VEB and SVEB areequivalent to PVC and APC. ZOLLECG Analysis Software adopts theterm VEB and SVEB followingAAMI/ANSI EC 57:2012.
ZOLL ECG AnalysisSoftware(Subject Device)	Monebo(Predicate Device)	Comparison
	- Bundle Branch Block- Ventricular Trigeminy- Ventricular Bigeminy- AcceleratedIdioventricularRhythm	Both the ZOLL ECG AnalysisSoftware and Monebo aresubjected to EC57 testing tovalidate their arrhythmia detectioncapability. Test resultsdemonstrate that the ZOLL ECGAnalysis Software is at least as safeand effective as Monebo.

Table 7-1: Comparison Chart between the ZOLL ECG Analysis Software and Monebo

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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.

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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.

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Table 7-2:Verification andValidationActivitiesTitle	Description
Unit Tests	In this verification activity, the smallest testable parts of the ZOLLECG Analysis Software are individually and independentlyscrutinized for proper operation. The test cases simulate variousoperation conditions and error conditions of the ZOLL ECGAnalysis Software. Each test case has an input test vector and anexpected output. The actual output of each test case iscompared to the expected output. All unit tests pass.
Functional Tests	Also a part of the verification activities, functional tests areconducted at the integration level. This testing verifies that eachfunction of the ZOLL ECG Analysis Software operates inconformance with the requirement specification when programunits are combined. Similar to the unit tests, each functional testcase simulates the operation conditions and boundary conditionsof the ZOLL ECG Analysis Software. Each test case has an inputtest vector and an expected output. The actual output of eachtest case is compared to the expected output. All functional testspass.
API Test	As the sole function of the API is to correctly transfer the inputand output parameters into and out of the ZOLL ECG AnalysisSoftware, the API Test therefore is a simple atomic test to verifythat the API transfers the input and output parameters correctly.Test result demonstrates that the API correctly transfer the inputand output parameters.
Performance Test	Performance test is the validation activity conducted for the ZOLLECG Analysis Software. It is a system level testing thatdemonstrates the detection capability of the software. FollowingAAMI/ANSI EC 57:2012 Testing and Reporting PerformanceResults of Cardiac Rhythm and ST Segment MeasurementAlgorithms, the ZOLL ECG Analysis Software is applied to the ECGdatabases required by the standard. The ZOLL ECG AnalysisSoftware is required to generate an attribute file with the analysisresults. The test results from the ZOLL ECG Analysis Software arecompared to the reference results (which are available as part ofthe databases) using the comparison applications. Results fromthe EC 57 testing demonstrates that the performance of the ZOLLECG Analysis Software meets the clinical requirements forarrhythmia detection and heart rate estimation.

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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.

Regulation Number and Section

§ 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).