(297 days)
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No
The summary describes a standard ECG system for recording, displaying, and storing data, with no mention of AI or ML capabilities for analysis or interpretation.
No
The device is described as an ECG system used to record and display electrical heart signals to detect abnormal heart conditions, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used "in order to detect abnormal heart conditions," which clearly indicates a diagnostic purpose.
No
The device description explicitly mentions physical components like "cables connected to the extremities and the chest using rubberized disks" which are hardware components necessary for acquiring the ECG signal.
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.
- Device Function: The description clearly states that the PC-ECG system is a non-invasive device that records the electrical heart signals of patients directly from the body using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is to record electrical heart signals to detect abnormal heart conditions, which is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DPS
Device Description
PC-ECG is a versatile 12-lead electrocardiograph system (ECG) for use with PCs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Heart (electrical heart signals)
Indicated Patient Age Range
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Intended User / Care Setting
doctor's offices by cardiologists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
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: | Electrocardiograph |
| 870.2340 | |
| Legally marketed device: | CC Cardio-Card (Nasiff Associates) |
| Distributor: | Syracomp, Inc. |
| phone: (315) 458-0098 | |
| Description: | Versatile 12-lead electrocardiograph system (ECG) for use |
| with PCs. | |
| Intended use: | 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 |
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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Image /page/3/Picture/2 description: The image shows a black square with the letters "I.P.I." in white. The letters are in a serif font and are arranged horizontally in the center of the square. There are white rectangles above and below the black square. The image is a black and white drawing.
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