(439 days)
No
The summary mentions "proprietary software algorithms" and "derived" ECGs, but there is no explicit mention of AI, ML, or related terms. The description of performance studies focuses on comparing derived ECGs to measured ECGs and substantial equivalence, not on training or testing AI/ML models.
No
The device is used for analysis and monitoring of ECG changes, not for treating any condition. Its purpose is to prompt further diagnostic action, not to provide therapy.
Yes
The device analyzes ECG data and produces alarms for changes that may indicate acute myocardial infarction, though it explicitly states it does not provide a diagnosis. However, by prompting the user to acquire a standard 12-lead ECG for physician interpretation based on its analysis, it functions as a tool that aids in the diagnostic process. Furthermore, the "12 lead interpretive software" is intended to interpret electrocardiograms, which is a diagnostic function.
No
The device description explicitly states that the system includes the capability to acquire standard 12-lead ECG using 10 electrodes and derive a 15-lead ECG from 3 leads (5 electrodes), implying the use of hardware for signal acquisition. While it includes software for interpretation and analysis, it is not solely software.
Based on the provided text, the VectraCor's VectraplexECG System with VectraplexAMI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The text describes the VectraplexECG System as analyzing data from ECG leads (electrical signals from the heart) and producing visual and audible alarms based on these signals. It does not mention the analysis of any biological specimens like blood, urine, or tissue.
- The intended use is focused on monitoring and prompting further action. The device analyzes ECG changes and prompts the user to acquire a standard 12-lead ECG for physician interpretation. It explicitly states that it "does not provide a diagnosis of acute myocardial infarction." This aligns with a monitoring or diagnostic aid function, not an in vitro diagnostic test.
- The device description and intended use focus on electrical signal acquisition and analysis. The system acquires and displays ECG signals, derives leads, and has interpretive software for standard 12-lead ECGs. This is consistent with an electrocardiograph device, not an IVD.
Therefore, the VectraplexECG System with VectraplexAMI falls under the category of a medical device used for physiological monitoring and diagnostic aid based on electrical signals, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS, MLD, LOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 consistent with 12 lead ECG signs of acute myocardial infarction. The device, as designed, is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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 |
1
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
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.
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:
2
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
- Philips EASI ECG Algorithm-(K033513 is incorporated into several Philips o systems)
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
3
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
4
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
5
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
6
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
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