· The System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes).The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes and convert the ECG signal into a digital format.

· The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only.

· In 5 electrode mode, the System analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardian Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents.

· The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.

· The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics.

· The System can be used within electro-surgical environments.

· Device is for Adult use.

Device Description

The Universal SmartECG is a device with 10 lead wires attaching to electrodes on a patient's chest and one wire connecting to a computer. The system is able to display, store, and print a 12 lead ECG with 10 electrodes attached to the patient. In addition, The Universal SmartECG incorporates the VectraplexECG software (K102378), to derive up to a 15 lead (standard 12 leads and Frank vector X, Y, and Z leads) ECG from only three measured leads (5 electrodes). The device also monitors, in real-time, ECG changes that may be indicative of acute myocardial ischemic injury, including AMI*, via a displayed index number, the Cardiac Electrical Biomarker (CEB; VectraplexAMI). The system also provides the vector loops. The System's derivation algorithm is able to provide additional information based on geometric principals relating to the placement of electrodes on the body. The Cardiac Electrical Biomarker (CEB) is produced based on an algorithm accounting for the multipolar contributions of the electrical field around the heart, which was FDA cleared via K102378.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Universal SmartECG, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred, with limitations noted due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document states that the new hardware device, the Universal SmartECG, "has been tested to, and passed. 60601-1.-1-2. and 2-25 standards." This implies that the device met the performance requirements of these electrical safety and essential performance standards. However, specific performance metrics (e.g., sensitivity, specificity, accuracy for disease detection) and their acceptance thresholds are not explicitly stated or quantified in this document.

Acceptance Criteria Category	Acceptance Criteria (Quantified if available, otherwise inferred)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1-1-2 standards	Passed
Essential Performance	Compliance with IEC 60601-2-25 standards	Passed
CEB® Functionality	The CEB® algorithm functions as previously cleared (K102378) and produces visual/audible alarms for ECG changes consistent with AMII/AMI. Acceptance criteria for its performance (sensitivity, specificity) are not stated in this document but would have been part of the K102378 clearance.	The CEB® algorithm is unchanged from the previously cleared K102378. The system "analyzes data... and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI)."
ECG Acquisition & Display	Ability to derive, display, and print a derived 12-lead ECG from 3 leads (5 electrodes) and acquire/display standard 12-lead ECG using 10 electrodes.	Performs as intended; the "ECGlib.dll which measures ECG waveform components" was updated for compatibility with new hardware.
Interpretive Software	Software receives, displays, stores, analyzes, and interprets 12-lead ECG signals.	Functions as intended; "updated to be compatible with a new version of hardware."
Electrosurgical Environment Combatibility	Safe and effective operation within electrosurgical environments.	"the device can now be used in electrosurgical environments."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Since this update is not changing the CEB algorithm or the derivation algorithm from the VectraplexECG System it has been determined that no clinical data is necessary to support these functions." This implies that no new clinical test set data was collected for this specific 510(k) submission to demonstrate the performance of the CEB algorithm or the derived ECG. The assessment was based on the fact that existing, previously cleared algorithms and functionalities were not altered in a way that would necessitate new clinical validation for their core performance.

Therefore, sample size, data provenance, retrospective/prospective nature for clinical performance is not applicable to this specific submission. Any previous clinical studies for the predicate device (K102378) would have contained this information.

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)

Not applicable, as no new clinical test set data was collected for this submission. The effectiveness of the CEB® algorithm was previously established during the K102378 submission.

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

Not applicable, as no new clinical test set data was collected for this submission.

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

Not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence of an updated system rather than new clinical effectiveness. The CEB® mode is described as "not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG... for interpretation by a physician." This suggests an assistive role, but no MRMC study details are provided in this document.

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

This document does not specify a standalone performance study. The device's CEB® algorithm is designed to alert users, prompting further physician interpretation. Its performance without human interpretation is integral to its function, but specific standalone metrics are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable to this specific submission for new clinical data. For the original clearance of the CEB® algorithm (K102378), the ground truth for Acute Myocardial Ischemic Injury (AMII) and Acute Myocardial Infarction (AMI) would typically involve a combination of:

Clinical diagnosis: based on patient symptoms, cardiac enzymes (e.g., troponin levels), and serial ECG changes interpreted by cardiologists.
Outcomes data: confirming a myocardial infarction event.

8. The sample size for the training set

The document does not provide information about the training set size for the algorithms within the Universal SmartECG. This information would have been part of the previous 510(k) for the VectraplexECG System (K102378), which included the CEB® algorithm.

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

Not provided in this document. Similar to point 7, the ground truth for the training set of the CEB® algorithm (from K102378) would have been established through a combination of clinical diagnosis, cardiac biomarker levels, and expert cardiologist interpretation.

Summary

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August 28, 2018

VectraCor, Inc. Andrew Schreck Manager of Regulatory Affairs 785 Totowa Rd. Suite 100 Totowa, New Jersey 07512

Re: K173952

Trade/Device Name: Universal SmartECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, MLD Dated: July 26, 2018 Received: July 27, 2018

Dear Andrew Schreck:

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

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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/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 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) K173952

Device Name Universal SmartECG

Indications for Use (Describe)

· The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is tres- mitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only.

· In 5 electrode mode, the System analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardian Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presentinewith chest pain or other presumed anginal equivalents.

· The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.

· The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics.

· The System can be used within electro-surgical environments.

· Device is for Adult use.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510k Summarv

Image /page/3/Picture/1 description: The image shows the VectraCor logo. The logo consists of the word "VECTRACOR" in blue, with a red line underneath. Below the line is the text "Diagnosing Better Care" in a smaller font. To the right of the text is a red heartbeat line.

Submitters Name and Address: 1.

VectraCor, Inc. 785 Totowa Rd. Suite 100 Totowa, NJ 07512 Tel: 973-904-0444 Fax: 973-904-0411 e-mail: ajschreck@vectracor.com Official Correspondent: Andrew Schreck, Manager or Regulatory Affairs

Contact Person for this Submission: Andrew Schreck

Date submission was prepared: November 30, 2017

2. Trade Name, Common Name and Classification Name:

a. Trade Name: Universal SmartECG
b. Product Code: Z-7000-0500
Common Name: Electrocardiogram, ECG, EKG C.
Classification Name and Product Code: ರ.

ECG	DPS Class II	21 CFR 870.2340
ST Segment Monitor & Alarm	MLD Class II	21 CFR 870.1025

3. Predicate Device Identification:

VectraplexECG System with VectraplexAMI (K102378) O
Universal ECG (K990266) O

4. Device Description:

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based on an algorithm accounting for the multipolar contributions of the electrical field around the heart, which was FDA cleared via K102378.

*There will be times when the ECG shows signs consistent with AMI and the CEB shows signs consistent with AMI, but Troponin may not be completed or available at that time.

5. Indications for use:

· The System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes).The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes and convert the ECG signal into a digital format.
· The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only.
· In 5 electrode mode, the System analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury, including Acute Myocardial Infarction . This mode is not intended to be a sole means of diagnosis, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardiac Electrical Biomarker (CEBS) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
· The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
· The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics.
· The System can be used within electro-surgical environments.
· Device is for Adult use.

Prescription Use YES Over-The-Counter Use Prescription Use______________________________________________________________________________________________________________________________________________________________ NO (21 CFR 801 Subpart C)

6. Comparison to Predicate Device:

The new Universal SmartECG System is the same principle device as the previous version of hardware, the Universal ECG (K990266). The databases for the VectraplexECG and Office Medic software modules, which are currently FDA-cleared, have been combined in this product. The technological characteristics (design, material, chemical composition, energy source) of the device are the same as the predicate.

The software, Office Medic and VectraplexECG, have been updated to be compatible with a new version of hardware, the Universal SmartECG (previously the Universal ECG). VectraCor has periodically released minor updates for the VectraplexECG System over the past few years.

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The new Universal SmartECG System is the same principle device as the previous version of hardware, the Universal ECG (K990266). New hardware is designed to be compliant with IEC 60601-2-25:2011 standard. The Universal SmartECG system includes the hardware and 2 ECG software modules, VectraplexECG (K102378) and Office Medic. The Office Medic module has 2 components including ECG and spirometry functions. This 510k submission only affects the ECG component of Office Medic. The ECG component of Office Medic was previously known as CardioView 3000 (K083749) and was incorporated by Office Medic. The VectraplexECG and ECG component of Office Medic, which are FDA cleared and are currently 2 separate software programs, will share a database in the Universal SmartECG release. The technological characteristics (design, material, chemical composition, energy source) of the device are the same as the predicate.

Prior to this 510k submission, VectraCor has periodically released minor updates for the VectraplexECG System over the past few years. All updates have been considered in relation to the FDA memorandum "Deciding When to Submit a 510(k) for a Change to an Existing Device" and were determined that at the time a 510(k) was not necessary. These updates as well as enhancements to the new system include:

Note to file enhancements
Operating System upgrades(compatibility with new Windows versions)	Added reports to increase physician productivity with use of the VectraplexECG System
SQL Database upgrades	Added drivers and updates for better compatibility to the hardware device
Added a graph of the CEB over time

Changes necessitated new 510k submission
• Updated software for compatibility tonew data acquisition hardware (newrevision of the previous hardware)	• The 2 ECG modules, VectraplexECGand Office Medic, will share adatabase in the new release
• Due to changes in the new hardware(Universal SmartECG) the device cannow be used in electrosurgicalenvironments	• Updated the ECGlib.dll whichmeasures ECG waveformcomponents
• An outer silicone strip has beenadded to the outside seams of thecase

7. Testing and Conclusions:

Verification, validation and testing procedures were performed to assure that the new device works and is substantially equivalent to the predicate. Testing supported the proposed label.

The new hardware device, the Universal SmartECG, has been tested to, and passed. 60601-1.-1-2. and 2-25 standards.

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Since this update is not changing the CEB algorithm or the derivation algorithm from the VectraplexECG System it has been determined that no clinical data is necessary to support these functions.

VectraCor has determined, based on the performance testing, that the Universal SmartECG conforms to the design specifications and is substantially equivalent to the predicate devices, Universal ECG and VectraplexECG, for acquiring ECG leads and for monitoring a patient for ECG changes that may be consistent with 12 lead ECG signs of myocardial ischemic injury, including AMI. The device, as designed, is substantially equivalent to the predicate devices.

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).