(297 days)
The PC-ECG system is a fully featured, non-invasive, real-time, 12-lead ECG system capable of recording, display and storage of data using a PC (personal computer). It is used in doctor's offices by cardiologists to record the clectrical heart signals (electrocardingram) of patients in order to detect abnormal heart conditions.
Patients are hooked up to the PC-FCG system via cables connected to the extremities and the chest using rubberized disks which contain in a small central depression a paste.
The device is for prescription use only.
Versatile 12-lead electrocardiograph system (ECG) for use with PCs.
Recording and display of 1, 3, 6, 12 channels
Monitoring of up to 12 channels with acoustic, analogue and digital pulse signal
Single user system or network ready
Storage of unlimited number of 10 sec. ECGs
High quality print of 6, 12 leads with variable speed
Patient database
The provided document, K963578, is a Premarket Notification [510(k)] Summary for a device called "PC-ECG." It is a 1997 submission so the details on the acceptance criteria and the study that proves the device meets the acceptance criteria are not as granular as modern submissions.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PC-ECG device. The submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (CC Cardio-Card, Nasiff Associates). The letter from the FDA confirms this determination of substantial equivalence.
The "Technological characteristics" section states: "The two systems compared are very similar in their design. Both units measure the low-voltage signals generated by the heart, amplify the signals, perform an analog/digital conversion and transmit the data to a personal computer (PC) for display and evaluation. The main differences are in the features provided by the software."
This implies that the acceptance criterion was likely that the PC-ECG device performs comparably to the predicate device in its fundamental functions (measuring, amplifying, converting, and transmitting ECG data) and that its software features either do not negatively impact safety and effectiveness or offer equivalent functionality. However, no specific performance values are given.
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 does not provide any information regarding the sample size used for a test set, nor does it specify the data provenance (country of origin, retrospective/prospective). This level of detail was not typically required or included in 510(k) summaries from 1997, which often relied on comparative claims to predicate devices rather than extensive clinical trial data for substantial equivalence.
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)
The document does not mention the use of experts to establish ground truth for a test set. Given the nature of a 510(k) submission from this era focusing on substantial equivalence for an electrocardiograph, it's highly unlikely that an independent expert panel was used to establish ground truth in the way it might be for a novel diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method. This type of detail is usually associated with studies involving human interpretation and clinical endpoints, which are not described in this 510(k) summary.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device, "PC-ECG," is an electrocardiograph system for recording, display, and storage of ECG data, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with or without AI assistance. Therefore, there is no mention of effect size for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a measurement and display tool. Its "performance" would likely be related to the accuracy of its electrical signal acquisition and display, which is not specifically quantified in the summary, beyond the claim of substantial equivalence to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify a type of ground truth used, as it doesn't describe a study where ground truth for a diagnostic endpoint against a device's classification was established. The "ground truth" for an ECG device would inherently be the true electrical activity of the heart, measured against established physiological principles and comparison to a legally marketed predicate device accepted as accurately capturing this activity.
8. The sample size for the training set
The document does not mention a training set or its sample size. This device is a measurement and display system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth would have been established.
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Premarket Notification [510(k)] Summary
Submitter: JUN 30 1997
I.P.I.- International Products Inc. 8106 Meadow Springs CT Vienna, VA 22182 phone: (703) 356-6351 fax: (703) 356-5964 e-mail: ipiuwe@erols.com
| Contact person: | Uwe Klotz |
|---|---|
| President |
Summary was prepared on August 31*, 1996
| Name of device: | PC-ECG |
|---|---|
| Classification Name: | Electrocardiograph870.2340 |
| Legally marketed device: | CC Cardio-Card (Nasiff Associates) |
| Distributor: | Syracomp, Inc.phone: (315) 458-0098 |
| Description: | Versatile 12-lead electrocardiograph system (ECG) for usewith PCs. |
| Intended use: | Recording and display of 1, 3, 6, 12 channelsMonitoring of up to 12 channels with acoustic, analogue anddigital pulse signalSingle user system or network readyStorage of unlimited number of 10 sec. ECGsHigh quality print of 6, 12 leads with variable speedPatient database |
Technological characteristics:
The two systems compared are very similar in their design. Both units measure the low-voltage signals generated by the heart, amplify the signals, perform an analog/digital conversion and transmit the data to a personal computer (PC) for display and evaluation. The main differences are in the features provided by the software.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, superimposed over a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Uwe Klotz International Products Inc. 1106 Meadow Springs Court の 2007年 10月 10時 Vienna, Virqinia 22182
Re: K963578 PC Based Electrocardiograph System (PC-ECG Software Version 4.12) Regulatory Class: II (two) Product Code: 74 DPS Dated: June 4, 1997 Received: June 9, 1997
Dear Mr. Klotz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Uwe Klotz
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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International Products Inc.
X H F B P P S B P C S A M C C C S A N N N N N N N N N S P X X N N N N N N N N N S A K R OC R X T O OR X T O OR X T O OR X T O OR X TO OF X TO OF X TO OF X TO OF X TO OF X TO
New: 8106 Meadow Springs CT Vicnna, VA 22182 phone: (703) 356-5351 fax: (703) 356-5964 e-mail: ipiuwe@crols.com
INDICATIONS FOR USE STATEMENT
510(k) Number: K 963578
Device Name:
PC based Electrocardiograph System (PC-ECG) This application is for SW Version 4.12
Indication for use:
The PC-ECG system is a fully featured, non-invasive, real-time, 12-lead ECG system capable of recording, display and storage of data using a PC (personal computer). It is used in doctor's offices by cardiologists to record the clectrical heart signals (electrocardingram) of patients in order to detect abnormal heart conditions.
Patients are hooked up to the PC-FCG system via cables connected to the extremities and the chest using rubberized disks which contain in a small central depression a paste.
The device is for prescription use only.
Wasington R. Phelps
§ 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).