(219 days)
Not Found
No
The description details signal processing and algorithmic checks for data quality, but does not mention any AI or ML techniques for interpretation or analysis beyond basic signal processing and mapping.
No.
The device is indicated for recording electrocardiographic signals and creating maps for evaluation, which are diagnostic functions, not therapeutic.
Yes
The device records electrocardiographic signals and creates maps for evaluating cardiac repolarization properties, and a clinical study specifically demonstrated its ability to provide information for improved diagnosis of AMI. These functions inherently involve the identification of medical conditions.
No
The device description clearly outlines hardware components including an 80-lead disposable electrode array (vest/harness), printed lead lines, pre-applied gel, anatomical markers, and an 80-channel recording device that attaches to the vest. While software is used for signal processing, display, and mapping, the system relies on significant physical hardware to acquire the initial data.
Based on the provided information, the PRIME ECG device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for the recording of electrocardiographic signals on the body surface." This describes a device that measures electrical activity from the body, not a device that examines specimens taken from the body (like blood, urine, or tissue).
- Device Description: The description details the collection of electrical signals from electrodes placed on the patient's skin. It does not mention any interaction with biological samples.
- Input Modality: The input is "Electrocardiographic signals," which are electrical signals from the body, not a biological specimen.
- Anatomical Site: The anatomical site is the "Body surface," again indicating a non-invasive measurement from the patient directly.
IVD devices are specifically designed to examine specimens in vitro (outside of the living body) to provide information for diagnosis, monitoring, or screening. The PRIME ECG operates in vivo (within the living body) by recording electrical signals directly from the patient.
N/A
Intended Use / Indications for Use
The PRIME ECG is indicated for the recording of electrocardiographic signals on the body surface.
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
Product codes
74 DPS
Device Description
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest or harness. The electrodes are screen-printed onto a clear plastic substrate. The section of the vest applied to the anterior side of the patient (anterior harness, applied to chest area) contains channels 1 to 55 and 59 to 64. The section applied to the posterior side of the patient (posterior harness, applied to the patient's back) contains channels 65 to 80. Channels 56, 57 and 58 are applied to the right arm, left arm and left leg, respectively.
Signals are conducted along pathways that are also printed, eliminating the need for conventional lead wires. The electrode array or " vest" features pre-applied gel to assure good conductivity and secure attachment. Anatomical markers provide for consistent location on different size patients. The vest can be applied in less than 5 minutes.
An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.
The system measures the ECG recordings simultaneously for all 80 channels. For practical reasons only eight channels are displayed at one time, so the operator may scroll through 10 screens to visualize all active channels. The system contains an algorithm that identifies (with color, words and symbols) any individual electrode that may be suspect, allowing the operator to make adjustments before recording. Once satisfied, the operator activates the recording and the system retains 10.0 seconds of data. If the recording contains any poor signals, the algorithm alerts the operator who must determine whether to accept the recording. The number of poor quality leads may not exceed 6 on the anterior harness. If the signals from any 2 adjacent electrodes, or any posterior electrode, are bad, the maps are not accepted. It is possible for the operator to accept a recording which contains channels that have low quality, but resulting maps contain the legend "Unacceptable Quality" and each poor quality channel is marked in red.
Because the electrode vest covers most of the torso, electrode locations include those for a standard 12-lead ECG. This means that among the 80 leads individual locations are consistent with required placement necessary to result in a conventional 12-lead recording and display. There is a user-selected option for displaying these leads, (e.g., the channels are automatically selected and displayed which correspond to a Lead II ECG), although the operator may designate specific electrodes to reflect preferred locations for display.
Once the 80-lead recording is accepted, the system creates a series of isopotential and isointegral images (maps) for specific segments of a single beat. Measuring signal strength at a specific time interval of the beat creates Isopotential maps. The resulting strengths and locations of these signals are plotted against an "unwrapped" image of the torso. For example, the unwrapped torso image can be oriented with an x and y axis. At a given point in time, an voltage measurement in millivolts is collected at each location (x,y). This voltage can be plotted along the z axis. If lines are drawn on this plot to connect points with the same voltage z, isopotential contour maps are created. Isopotential maps can be created at any point in time during the cardiac cycle to reflect the cyclic polarization and repolarization of the heart.
Isopotential maps reflect what is happening to the heart at a selected point in time, while isointegral maps are an attempt to provide a look at what is happening over the cycle, as a body surface distribution of the ventricular gradient. At each location (x,y) the potential z changes over the time of the cardiac cycle. Integrating the areas under the QRST of each lead gives the gradient at each point. The gradient at each point is then mapped. Joining points on the plot with the same calculated gradient produces the isointegral contour map. The isointegral map allows evaluation of repolarization properties.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso, chest area, back, right arm, left arm, left leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
6 2002 MAR
PRIME ECGTM System
Common/Classification Name: Electrocardiograph as classified under 21 CFR 870.2340
Meridian Medical Technologies 10240 Old Columbia Road Columbia, MD 21046
410-309-6830 Telephone: 410-309-1475 Fax:
:
Jamil F. LaHam Contact: General Manager, Cardiopulmonary Systems
Prepared: July 25, 2001
Legally Marketed Predicate Devices A.
- ్రామం నుండి 10 కి.మీ. దూర
The PRIME ECG System is substantially equivalent to the Hewlett Packard M1700A cleared under K911139. Both systems have the same intended use, which is to record electrocardiographic signals.
Device Description B.
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest or harness. The electrodes are screen-printed onto a clear plastic substrate. The section of the vest applied to the anterior side of the patient (anterior harness, applied to chest area) contains channels 1 to 55 and 59 to 64. The section applied to the posterior side of the patient (posterior harness, applied to the patient's back) contains channels 65 to 80. Channels 56, 57 and 58 are applied to the right arm, left arm and left leg, respectively.
Signals are conducted along pathways that are also printed, eliminating the need for conventional lead wires. The electrode array or " vest" features pre-applied gel to assure good conductivity and secure attachment. Anatomical markers provide for consistent location on different size patients. The vest can be applied in less than 5 minutes.
An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.
1
The system measures the ECG recordings simultaneously for all 80 channels. For practical reasons only eight channels are displayed at one time, so the operator may scroll through 10 screens to visualize all active channels. The system contains an algorithm that identifies (with color, words and symbols) any individual electrode that may be suspect, allowing the operator to make adjustments before recording. Once satisfied, the operator activates the recording and the system retains 10.0 seconds of data. If the recording contains any poor signals, the algorithm alerts the operator who must determine whether to accept the recording. The number of poor quality leads may not exceed 6 on the anterior harness. If the signals from any 2 adjacent electrodes, or any posterior electrode, are bad, the maps are not accepted. It is possible for the operator to accept a recording which contains channels that have low quality, but resulting maps contain the legend "Unacceptable Quality" and each poor quality channel is marked in red.
Because the electrode vest covers most of the torso, electrode locations include those for a standard 12-lead ECG. This means that among the 80 leads individual locations are consistent with required placement necessary to result in a conventional 12-lead recording and display. There is a user-selected option for displaying these leads, (e.g., the channels are automatically selected and displayed which correspond to a Lead II ECG), although the operator may designate specific electrodes to reflect preferred locations for display.
Once the 80-lead recording is accepted, the system creates a series of isopotential and isointegral images (maps) for specific segments of a single beat. Measuring signal strength at a specific time interval of the beat creates Isopotential maps. The resulting strengths and locations of these signals are plotted against an "unwrapped" image of the torso. For example, the unwrapped torso image can be oriented with an x and y axis. At a given point in time, an voltage measurement in millivolts is collected at each location (x,y). This voltage can be plotted along the z axis. If lines are drawn on this plot to connect points with the same voltage z, isopotential contour maps are created. Isopotential maps can be created at any point in time during the cardiac cycle to reflect the cyclic polarization and repolarization of the heart.
Isopotential maps reflect what is happening to the heart at a selected point in time, while isointegral maps are an attempt to provide a look at what is happening over the cycle, as a body surface distribution of the ventricular gradient. At each location (x,y) the potential z changes over the time of the cardiac cycle. Integrating the areas under the QRST of each lead gives the gradient at each point. The gradient at each point is then mapped. Joining points on the plot with the same calculated gradient produces the isointegral contour map. The isointegral map allows evaluation of repolarization properties.
2
Indications for Use ਂ
The PRIME ECG is indicated for the recording of electrocardiographic signals on the body surface.
Ko12414
p 313
Substantial Equivalence Summary D.
The PRIME ECG conforms to EC 11 standard for diagnostic ECG systems and LEC 60601 standards for electrical safety. It is substantially equivalent to marketed ECG systems.
In addition, a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems.
Technological Characteristics E.
See Device Description, above.
F. Testing
The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard. The (incrading to sucpatibility testing of the patient contact material is safe for use. Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. This testing demonstrates that the PRIME ECG System meets electrical and environmental safety standards for safe use.
G. Conclusions
Meridian Medical Technologies has demonstrated through its testing that the PRIME ECG is equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 6 2002
Mr. Jamil F. LaHam General Manager. Cardiopulmonary Systems Meridian Medical Technologies, Ltd. 10240 Old Columbia Road Columbia, MD 21046
Re: K012414
Trade/Device Name: Electrocardiograph Trade Name: PRIME ECG Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: 74 DPS Dated: December 4, 2001 Received: December 6, 2001
Dear Mr. LaHam:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
4
Page 2 - Mr. Jamil F. LaHam
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
L. Dork Teller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): _ KOLZYIY
Device: PRIME ECG ™ System
:
Indications for Use:
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K062414
(Optional Format 1-2-96)