ZBPro Diagnostic (Version 2.0)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 11, 2026 Zbeats, Inc. % Christopher Ford Consultant Zaliance Medical Solutions, LLC 5153 W. Wooley Rd. Oxnard, California 93035 Re: K261580 Trade/Device Name: ZBPro Diagnostic (Version 2.0) Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO Dated: August 19, 2026 Received: August 19, 2026 Dear Christopher Ford: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261580 - Christopher Ford Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K261580 - Christopher Ford Page 3 Sincerely, JENNIFER W. SHIH -S Jennifer Kozen 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261580/S001 | ? | | Please provide the device trade name(s). | | ? | | ZBPro Diagnostic (Version 2.0) | | | | Please provide your Indications for Use below. | | ? | | ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population.The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead wearable ECG patch configurations that use wet gel electrodes. The device analyzes Lead II, CM5 (Ch 1), Modified-MLII (Ch 2+), or MLII (single lead) but does not perform multi-lead analysis.ZBPro is not intended for use with paced signals or recordings taken from pediatric patients.ZBPro Diagnostic v2.0 can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.ZBPro Diagnostic v2.0 provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis.ZBPro Diagnostic v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices.The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. | | | | Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission # SECTION 5 : 510(K) Summary ## 5.1 Applicant/Submitter | Company Name | : ZBeats, Inc | | --- | --- | | Street Address | : 25 Health Sciences Drive | | City | : Stony Brook NY | | State | : NY | | Zip Code | : 11790 | | Phone Number | : (631) 220-2463 | ## 5.2 Contact Person | Full Name | : Bin Fang | | --- | --- | | Phone | : (631) 220-2463 | ## 5.3 Correspondent Information | Full Name | : Christopher Ford | | --- | --- | | Phone | : (916) 612-9954 | ## 5.4 Date of Preparation Date of Preparation : 05/11/2026 ## 5.5 Device Information | Device Name | ZBPro Diagnostic v2.0 | | --- | --- | | Model Number | | K261580 Page 1 of 7 {5} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission | Common Name | ECG Analysis System | | --- | --- | | Regulation | 21 CFR 870.2800 | | Product Code | MLO | | Reviewing Panel/Branch | Cardiovascular | | Submission Number | K261580 | ### 5.6 Predicate Device(s) Table - 5.1 Predicate Device(s) | Predicate Type | 510(k) Number | Device Name | Manufacturer | Product Code | | --- | --- | --- | --- | --- | | Primary | K243252 | ZBPro Diagnostic (v1.0) | ZBeats, Inc. | DPS, DQK | ### 5.7 Indications for Use ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population. The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead wearable ECG patch configurations that use wet gel electrodes. The device analyzes Lead II, CM5 (Ch 1), Modified-MLII (Ch 2+), or MLII (single lead) but does not perform multi-lead analysis. ZBPro is not intended for use with paced signals or recordings taken from pediatric patients. ZBPro Diagnostic v2.0 can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. ZBPro Diagnostic v2.0 provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis. ZBPro Diagnostic v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. ### 5.8 Device Description ZBPro is cloud-based Software as a Medical Device which aids healthcare professionals in interpreting ambulatory ECG recordings. The software comprises a secure web interface and a backend server hosted on Amazon Web Server (AWS). Authenticated users upload compatible ambulatory ECG recordings via a web browser through an Application Programming Interface (API). ZBPro's proprietary ECG interpretation algorithm analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis. ZBPro provides beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis. K261580 Page 2 of 7 {6} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission ZBPro consists of: 1. A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports. 2. An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis. The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports. ## 5.9 Intended Use/Indications for Use Comparison ZBPro Diagnostic v2.0 (K261580) and ZBPro Diagnostic (K243252) are both cloud-based ECG analysis platforms intended for retrospective review of ambulatory electrocardiogram (ECG) recordings to assist qualified healthcare professionals in detecting and analyzing cardiac arrhythmias. Both systems support integration with external ECG acquisition devices and provide core analytical functions including QRS detection, rhythm classification, ectopic beat detection, and heart rate trend analysis. Both devices are intended for use by qualified healthcare professionals to detect and analyze common cardiac arrhythmias using retrospective ambulatory ECG data. The primary indication (arrhythmia assessment in ambulatory ECG recordings in adult patients) is identical in both devices, and both utilize well-established principles of signal processing, QRS detection, rhythm classification, and clinical data presentation. Both devices support electronic interfacing with other ECG systems and offer nearly identical functional capabilities, including ECG signal processing, ventricular ectopy detection, interval and heart rate analysis, and comprehensive rhythm interpretation. Neither system is intended for use in life-sustaining applications or real-time monitoring, and both clearly state that their results are to be used in conjunction with clinician oversight, not as a standalone diagnostic decision-maker. ZBPro Diagnostic v2.0 is substantially equivalent to its predecessor, ZBPro Diagnostic v1.0 (the predicate). The primary difference relates to recording source compatibility. ZBPro Diagnostic v1.0 compatibility is limited to 3-lead and 5-lead 24/48-hour Holter configurations, whereas ZBPro Diagnostic v2.0 includes a single-lead, single-channel ECG patch configuration and up to 14-day analysis duration. These differences reflect scope of validation rather than underlying technological capabilities and do not impact substantial equivalence. Therefore, these distinctions do not impact the substantial equivalence of the two systems in their shared core function to provide automated ECG interpretation support for adult ambulatory ECG monitoring data. ## 5.10 Comparison of Technological Characteristics with Predicate The subject device has the same intended use and substantially equivalent technological characteristics as compared to the predicate device that do not raise questions of safety or effectiveness. Table - 5.2 Feature Comparison: ZBPro Diagnostic to the predicate device illustrates a comparison of detection features between ZBPro Diagnostic and the cited predicate. Table - 5.2 Feature Comparison: ZBPro Diagnostic to the predicate device | Feature | ZBPro Diagnostic v2.0 | ZBPro Diagnostic K243252 | | --- | --- | --- | | Heart rate determination for non-paced adult | Yes | Yes | | QRS Detection | Yes | Yes | | Non-paced arrhythmia interpretation for adult patients | Yes | Yes | | Non-paced ventricular arrhythmia calls | Yes | Yes | | R-R Intervals measurements | Yes | Yes | | Ventricular ectopic beat detection | Yes | Yes | K261580 Page 3 of 7 {7} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission | Patient Population | Adult | Adult | | --- | --- | --- | Table - 5.3 Comparison of technological characteristics: ZBPro Diagnostic to the predicate device provides a comparison of the technological characteristics of the ZBPro Diagnostic with the cited predicate. Table - 5.3 Comparison of technological characteristics: ZBPro Diagnostic to the predicate device | | ZBPro Diagnostic v2.0 | ZBPro Diagnostic (v1.0) | Comparison to predicate device | | --- | --- | --- | --- | | Device Trade Name | ZBPro Diagnostic | ZBPro Diagnostic | N/A | | Manufacturer | ZBeats, Inc. | ZBeats, Inc. | N/A | | 510(K) No. | K261580 | K243252 | N/A | | Regulation Number | 21 CFR 870.2800 | 21 CFR 870.2340 21 CFR 870.1425 | Same | | Product Code | MLO | DQK, DPS | Same | | Class | 2 | 2 | Same | | Device Class/Name | Electrocardiograph, ambulatory, with analysis algorithm | Electrocardiograph | Same | | Indications for Use | ZBPro Diagnostic v2.0 is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in ambulatory ECG data in the adult population. The product supports downloading and retrospectively analyzing single-lead ambulatory ECG data up to 14 days in duration, recorded with compatible 3-lead and 5-lead Holter and single-lead/single-channel wearable ECG patch configurations using wet gel electrodes. The device analyzes Lead II, CM5 (Ch 1), Modified-MLII (Ch 2+), or MLII (single lead) but does not perform multi-lead analysis. ZBPro is not intended for use with paced signals or recordings taken from pediatric patients. ZBPro Diagnostic v2.0 can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. ZBPro Diagnostic v2.0 provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis. | ZBPro Diagnostic is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in Holter ECG data in the adult, non-paced population. The product supports downloading and analyzing Lead II, CM5 (Ch 1), or Modified-MLII (Ch 2+) on retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings collected using standard Ag/AgCl wet electrodes in adult, non-paced patients. ZBPro is not intended for use with multi-lead analysis, wearable patches, or pediatric/paced recordings. ZBPro Diagnostic can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. ZBPro Diagnostic provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis. ZBPro Diagnostic is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring | Both devices have the same intended use as cloud-based medical devices for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in retrospective ambulatory ECG data in the adult, non-paced population. ZBPro Diagnostic v1.0 is limited to retrospective analysis of 24–48 hour Holter ECG recordings using 3-lead and 5-lead configurations. ZBPro Diagnostic v2.0 expands this capability to include single-lead, single-channel wearable ECG patch recordings and extended monitoring durations of up to 14 days. Both devices analyze a single ECG vector (Lead II or Lead II-equivalent configurations) and do not perform multi-lead analysis. Both devices exclude paced and pediatric populations and are not intended for real-time monitoring or life-supporting applications. These differences represent an expansion of supported input configurations and recording durations and do not alter the intended use or fundamental analytical function of the device. Therefore, these differences do not impact substantial equivalence. | K261580 Page 4 of 7 {8} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission | | ZBPro Diagnostic v2.0 (this submission) | ZBPro Diagnostic (v1.0) | Comparison to predicate device | | --- | --- | --- | --- | | | ZBPro Diagnostic v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. | devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. | | | **Fundamental scientific technology** | ZBPro v2.0 consists of: A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports. An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis. The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports. | ZBPro consists of: A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports. An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis. The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports. | Same. | ZBPro Diagnostic v2.0 and ZBPro Diagnostic v1.0 are based on the same fundamental scientific technology, software architecture, and analytical methodology. Both versions consist of a cloud-based Software as a Medical Device (SaMD) platform that includes a web-based user interface, a backend processing environment hosted on Amazon Web Services (AWS), and a proprietary ECG interpretation algorithm designed for retrospective analysis of ambulatory ECG recordings. K261580 Page 5 of 7 {9} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission Both versions utilize the same core signal processing techniques, including QRS detection, ventricular ectopic beat detection, R-R interval measurement, heart rate calculation, and rhythm classification based on a single-channel ECG input. The algorithmic framework, rule-based logic, and clinical interpretation approach remain unchanged between versions. The primary differences between ZBPro Diagnostic v2.0 and v1.0 relate to expanded input compatibility and validated use conditions. ZBPro Diagnostic v1.0 was limited to retrospective analysis of 24–48 hour Holter ECG recordings using 3-lead and 5-lead configurations. ZBPro Diagnostic v2.0 extends this capability to include: - Single-lead, single-channel wearable ECG patch recordings - Extended monitoring durations of up to 14 days - Additional validated Lead II-equivalent input configurations These modifications represent an expansion of validated input sources and use conditions rather than a change in the underlying technology or algorithmic function. ZBPro Diagnostic continues to analyze a single ECG channel using the same detection and classification methods as the predicate device. The software architecture, user interface, data processing workflows, and reporting capabilities remain substantially unchanged. Any differences in system performance are attributable to the broader range of validated input configurations and have been addressed through additional performance validation and cross-device equivalence testing. All identified differences between ZBPro Diagnostic v2.0 and v1.0 have been evaluated through design controls, risk management, and verification and validation activities. These differences do not impact substantial equivalence. Therefore, ZBPro Diagnostic v2.0 is substantially equivalent to ZBPro Diagnostic v1.0 with respect to its technological characteristics. ### 5.11 Summary of Performance Data Performance tests have been performed in compliance with the following recognized consensus standards: - AAMI ANSI IEC 62304 2006 - Medical device software - Software life-cycle processes - IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Application of usability engineering to medical devices. - AAMI ANSI EC57:2012 - Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms - AAMI ANSI IEC60601-2-47:2012 - Medical Electrical Equipment - Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems ### 5.12 Software verification and validation Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard. No residual anomalies were observed during verification and software validation testing. Certified cardiovascular technicians performed general usability tests to assess users' ability to import, display, store, analyze, distribute, and manage ECG data, and they met all requirements in ZBPro Diagnostic v1.0. All software validation testing was completed successfully and met all requirements. ZBPro Diagnostic v2.0 uses the same user interface as ZBPro Diagnostic v1.0; therefore, additional user interface validation was not required. ZBPro v1.0 was tested throughout development, validating the effectiveness of risk control measures associated with the user interface. ZBeats conducted usability testing of the ZBPro user interface with Certified Cardiovascular Technicians to evaluate the effectiveness of the design, labeling, and associated risk controls. These evaluations addressed the testable technical requirements defined in the User Interface Specification. Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database in accordance with ANSI/AAMI EC57 and IEC 60601-2-47 reporting conventions, as detailed in the ZBPro Diagnostic v2.0 Performance Validation Report. K261580 Page 6 of 7 {10} ZBeats, Inc. ZBPro Diagnostic Traditional 510(K) Submission To support adding compatibility with ML II configuration recordings obtained from wearable ECG patch devices, ZBeats performed algorithm regression testing, patch-specific performance validation, controlled noise-stress testing, and device and ECG input-configuration equivalence testing. Regression testing repeated the applicable ZBPro Diagnostic v1.0 performance tests using public reference databases, methods, exclusions, label mappings, and performance metrics. All 42 applicable tests passed, and ZBPro Diagnostic v2.0 produced results identical to the v1.0 baseline for beat detection, rhythm classification, atrial fibrillation/flutter detection, heart-rate measurement, heart-rate variability, and shutdown/failure detection. Patch-specific performance validation was conducted using adjudicated ECG data from adult, non-paced patient samples collected with two FDA-cleared wearable ECG patch recorder models in the 1L/1C, ML II configuration. The source recordings represented monitoring durations of 3 to 14 days. Testing evaluated beat detection, ventricular beat classification, heart-rate and RR-interval accuracy, supported rhythm classification, and handling of unclassified rhythms. Noise robustness was additionally evaluated using noise-stressed ECG samples derived from adjudicated patch recordings and tested at four prescribed signal-to-noise levels. Device and ECG input-configuration equivalence testing compared performance of the added 1L/1C patch configuration with the previously validated 3L/1C, 3L/3C, and 5L/2C Holter configurations. Performance was evaluated at the configuration, source-device, and overall population levels. No unresolved finding demonstrated a clinically meaningful device-specific or configuration-specific performance limitation, and the expanded v2.0 validation population remained consistent with the previously established v1.0 performance basis. The testing therefore supports use of ZBPro Diagnostic v2.0 with the added ML II-equivalent wearable ECG patch configuration. ### 5.13 Conclusion Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, ZBPro Diagnostic v2.0 has been shown to be substantially equivalent to the cited predicate. K261580 Page 7 of 7