VectraCor's VectraplexECG System with VectraplexAMI 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 infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
The VectraplexECG 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. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics.
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, and interpret the 12 lead ECG signal only.
Device is for Adult use.

Device Description

The VectraplexECG System will be able to display and print a 12 lead ECG with 10 electrodes attached. In Addition, VectraplexECG will be able to derive up to a 15 fead ECG from only three measured leads (5 electrodes) and monitor the ECG changes that may be consistent with 12 lead ECG signs of acute myocardial infarction, via a displayed index number, VectraplexAMI.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the VectraplexECG System with VectraplexAMI, based on the provided 510(k) summary:

This 510(k) summary provides limited detail on specific acceptance criteria and the comprehensive study methodology. The information primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance measures against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Derived 15-lead ECG graphs vs. Measured ECG graphs (for substantial equivalence)	"Substantially equivalent with no difference in clinical outcome"	"The derived 15 lead ECG graphs were compared to measured ECG graphs to determine whether they are substantially equivalent with no difference in clinical outcome." (Implies successful comparison, but no quantitative metric given.)
Conformance to design specifications	Implied: Must conform to design specifications	"VectraCor has determined, based on the performance testing, that the VectraplexECG System with VectraplexAMI conforms to the design specifications"
Safety and effectiveness vs. predicate devices	Implied: As safe and effective as predicate devices	"The device, as designed, is as safe and effective as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The summary mentions "ECG databases" were used for validation, but the number of cases within these databases for the test set is not provided.
Data Provenance: Not explicitly stated. The type of ECG databases (e.g., specific clinical trials, publicly available datasets) and their country of origin are not mentioned. It is also not specified whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. The summary does not detail how the ground truth for the "ECG databases" was established or if expert review was involved for the comparison of derived vs. measured ECGs.

4. Adjudication Method for the Test Set

Not applicable/Not described. The summary focuses on comparing derived and measured ECG graphs, not on expert adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study to evaluate human reader improvement with AI assistance was not explicitly described or indicated in the provided summary. The device's primary function is to derive ECGs and monitor for AMI signs, prompting a standard 12-lead for physician interpretation, rather than directly assisting in human reader interpretation of complex findings.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance evaluation was done. The summary states, "The derived 15 lead ECG graphs were compared to measured ECG graphs to determine whether they are substantially equivalent with no difference in clinical outcome." This indicates that the algorithm's output (derived ECGs) was directly compared to a reference (measured ECGs) without human intervention in the interpretation of the derived output for this comparison.
- For the VectraplexAMI component, it "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 infarction." This is a standalone function of the algorithm, though it prompts human action rather than providing a definitive diagnosis.
- For the interpretive software (only available for standard 12-lead ECGs), it "contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only." This is also a standalone algorithmic interpretation.

7. Type of Ground Truth Used

The ground truth used for the comparison of derived 15-lead ECGs was the measured ECG graphs. This implies that actual 12-lead ECGs (acquired with 10 electrodes) were considered the reference standard against which the algorithm's derived 15-lead ECGs (from 5 electrodes) were validated.

8. Sample Size for the Training Set

The sample size for the training set is not provided in the summary. The summary only mentions "ECG databases" were used for validation, without distinguishing between training and test data or specifying their sizes.

9. How Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary. The summary does not discuss the establishment of ground truth for any training data.

Summary

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K102378

510K Summary

NOV - 2 2011

as required per 807.92(c)

510(k) Notification

VectraCor's VectraplexECG System with VectraplexAMI

1. Submitters Name, Address:

Brad S. Schreck VectraCor, Inc. 169 Union Blvd. Totowa, NJ 07512 Tel: 973-768-0402 e-mail: bschreck@vectracor.com

Official Correspondent: Brad Schreck, President

Contact Person for this Submission: Brad Schreck

Date submission was prepared: August 11, 2011

2. Trade Name, Common Name and Classification Name:

a. Trade Name:

VectraplexECG System with VectraplexAMI

Product Code: V100V100

b. Common Name, Classification Name, Regulation Number

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

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3. Predicate Device Identification:

Micromedical 12 lead simultaneous Cable 510K K990266. o
Primary Care Physicain Platform LLC, dba QRS Diagnostic, LLC. Cardioview / 0 Office Medic - 510K # K083749 - This is the interpretive software- received 510K clearance ~Feb/Mar 2009. Previous 510k cleared was K974352 (Cardioview ECG Interpretative Software)
Philips EASI ECG Algorithm 510K K033513 0

4. Device Description

5. Indications for use :

VectraCor's VectraplexECG System with VectraplexAMI 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 infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents. .
The VectraplexECG 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. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, . Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics.
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 ECG recording, which is transmitted either simultaneous locally 12 lead transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only.
Device is for Adult use. ●

6. Comparison to Predicate Device:

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The VectraplexECG System with VectraplexAMI is similar to Predicate devices:

Same intended use as a 12 lead ECG monitor. .
Philips allows for derived ECG to be obtained by the use of 5 electrodes as does . VectraplexECG.
Philips, QRS Diagnostic and VectraCor calculate ST segments/ECG changes ●
Are available in the same configurations ●
Have the similar safety features ●
Are made from the similar components and materials .
Use Identical electrodes .
All Three companies derive leads III, aVR, aVL, aVF .
Indications for use similarities .
- Philips EASI ECG Algorithm-(K033513 is incorporated into several Philips o systems)
  - Derive a 12 lead ECG from 5 electrodes r
  - I Monitor ST segment changes of Adult patients
- o QRS Diagnostic
  - Office Medic Interpretive software is a windows-based program to L interpret electrocardiograms. Office Medic receives, displays and stores a single or standard 12 lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a monitor using proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
  - The 12 lead Simultaneous Cable acquires a patient's ECG via 10 leads 체 connected to a patient's chest, converts the ECG signal into digital format, and transfers this information to a monitor or software system using a proprietary digital transfer protocol. K990266
  - The proposed device is intended to be used to acquire a patient's ECG . signal and transmit it to a monitor or to a PC for display. K990266

7. Testing and Conclusions:

Verification, validation and testing procedures were performed to assure that the new device works and is substantially equivalent to the predicates. Testing supported the proposed label. VectraplexECG system with VectraplexAMI is designed to meet the design specifications and was validated using ECG databases.

The derived 15 lead ECG graphs were compared to measured ECG graphs to determine whether they are substantially equivalent with no difference in clinical outcome.

VectraCor has determined, based on the performance testing, that the VectraplexECG System with VectraplexAMI conforms to the design specifications and is substantially equivalent to the predicate devices for acquiring ECG leads and for monitoring a patient for ECG changes that may be

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consistent with 12 lead ECG signs of acute myocardial infarction. The device, as designed, is as safe and effective as the predicate devices.

September 1998 - 1999

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 2 2011

Vectracor, Inc. c/o Mr. Brad S. Schreck President and CEO 35 Battle Ridge Trail Totowa, NJ 07512

Re: K102378

Trade Name: Vectraplexecg system with vectraplexami Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS, MLD, LOS Dated: September 7, 2011 Received: October 19, 2011

Dear Mr. 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. 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

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Page 2 - Mr. Brad Schreck

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for use Statement:

510(k) Number (if Known): K102378

Device Name: VectraplexECG system with VectraplexAMI

Indications for Use:

VectraCor's VectraplexECG System with VectraplexAMI 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 infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
The VectraplexECG 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. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, . Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics.
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 lead simultaneous ECG recording, which is transmitted either locally 12 or transtelephonically from an ECG monitor using a proprietary digital data transmission. protocol. The device contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only.
Device is for Adult use. .

Prescription Use yes AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off ·

Evaluation and Safety

Office of In Vitro Diagnostic Device

(Division Sian-Off) Division of Cardiovascular Devices 510(k) Number K162378

510(k) K102378

Page 1 of 1

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).