(244 days)
No
The document describes proprietary software algorithms and geometric principles for ECG derivation and analysis, but does not mention AI, ML, or related concepts. The focus is on established signal processing and algorithmic approaches.
No.
The device is used to derive, display, and print ECGs and analyze ECG changes for diagnostic purposes, not to provide therapy.
Yes
The device explicitly states its intended use to "derive, display and print a derived 12 lead ECG" and "interpret electrocardiograms." It also mentions producing "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)," and provides the Cardiac Electrical Biomarker (CEB) which is an "index number" to monitor for such changes. These functions are inherently diagnostic as they provide information for the identification or assessment of a disease or condition. While one mode states it "is not intended to be a sole means of diagnosis," the overall purpose of interpreting ECGs and indicating potential cardiac events points to a diagnostic function.
No
The device description explicitly states "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." and mentions testing of a "new hardware device, the Universal SmartECG". This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: This device directly measures electrical activity of the heart on the patient's body using electrodes. It acquires, displays, stores, and interprets ECG signals.
- Lack of Specimen Analysis: The device does not analyze any biological specimens (blood, urine, etc.) taken from the patient. Its function is based on capturing and processing electrical signals from the body surface.
Therefore, while it is a medical device used for diagnosis and monitoring, it falls under the category of a physiological monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS, MLD
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.
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, or trained personnel where ECG monitoring /acquisition is 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 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.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
1
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 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 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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3
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:
4. 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
4
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.
5
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 to | |
| new data acquisition hardware (new | |
| revision of the previous hardware) | • The 2 ECG modules, VectraplexECG |
| and Office Medic, will share a | |
| database in the new release | |
| • Due to changes in the new hardware | |
| (Universal SmartECG) the device can | |
| now be used in electrosurgical | |
| environments | • Updated the ECGlib.dll which |
| measures ECG waveform | |
| components | |
| • An outer silicone strip has been | |
| added to the outside seams of the | |
| case |
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.
6
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.