(213 days)
Not Found
No
The summary describes a standard electrocardiograph device that processes and displays electrical signals. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as processing electrical signals from the heart to produce a visual display and record, which is characteristic of a diagnostic device (an electrocardiograph) rather than a therapeutic one. It monitors, but does not treat.
Yes
The device processes electrical signals from the heart and produces a visual display and record, which are used to assess the heart's function. This process aligns with the definition of a diagnostic device, as it provides information for determining a medical condition.
No
The device description and performance studies clearly indicate this is a hardware device (ECG-9320A Cardiofax device) that includes software for processing and displaying ECG signals. The testing includes electromagnetic, environmental, and safety testing, which are typical for hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used to process electrical signals from electrodes placed on the body to produce a visual display and record of the heart's electrical activity. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description reinforces the intended use of processing electrical signals from electrodes, not analyzing biological samples.
Therefore, the device described is an electrocardiograph, which is a medical device used for in vivo (within the living body) measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart.
Product codes
Not Found
Device Description
Common names for the ECG-9320A Cardiofax device include electrocardiograph and Cardiograph.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.
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)
The ECG-9320A Cardiofax device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
NIHON KOHDEN AMERICA, INC. April 1, 1996
510(k) NOTIFICATION ECG-9320A CARDIOFAX
NOV - 1 1996
SECTION 2 - 510(K) SUMMARY
K9612722
Name and Address of Applicant Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92715-1601
Contact Person and Telephone Mr. Gary Reasoner Director of Technical Operations (714) 250-3959 ext. 3387
The device has been classified as Class II by the Division of Cardiovascular. Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per part 74 DPS, 21 CFR.
Common names for the ECG-9320A Cardiofax device include electrocardiograph and Cardiograph.
The predicate devices are the Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Hewlett-Packard M1700A PageWriter XLi Cardiograph per 510(k) #K895520, commercial distribution certification dated July 17, 1990
Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.
To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.
The ECG-9320A Cardiofax device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the ECG-9320A Cardiofax is substantially equivalent to the Nihon Kohden ECG-8340A Cardiofax and the Hewlett-Packard M1700A PageWriter XLi cardiograph.