(231 days)
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No
The device description and performance studies focus on standard electrocardiograph functionality and electrical/environmental testing, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used for evaluation and diagnosis of the cardiovascular system by producing a recording of electrical signals and displaying heart rate, not for providing therapy.
Yes
The device is described as an "Electrocardiograph (EKG)" which produces "a thermally printed recording of the electrical signals produced by the heart." It is used for "evaluation of the cardiovascular system." These functions are inherently diagnostic as they provide information about the patient's physiological state to assist in identifying a medical condition. Furthermore, it explicitly states additional testing was performed to demonstrate compliance with "ANSI/AAMI EC11-1991, 'Diagnostic Electrocardiographic Devices'."
No
The device description explicitly states it is a "portable, single channel, automatic or manual electrocardiograph" that "produce[s] a thermally printed recording" and "incorporates the ability to store fifteen programmable settings". This indicates the device is a physical hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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 FX-2111 is an electrocardiograph (EKG). An EKG measures the electrical activity of the heart by placing electrodes on the surface of the body. This is an in vivo measurement, meaning it's taken from within the living body, not from a sample outside the body.
- Intended Use: The intended use is for the "evaluation of the cardiovascular system" by measuring electrical signals produced by the heart. This aligns with the function of an EKG, not an IVD.
Therefore, the FX-2111 is a medical device used for in vivo diagnostic purposes, specifically for evaluating the heart's electrical activity, and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended to be used for the evaluation of the cardiovascular system. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The FX-2111 is intended to be used in a doctors office; all hospital environments; ER ICU, CCU, OR, etc .; or similar settings. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
Product codes
74DPS
Device Description
The model FX-2111 Single Channel Electrocardiograph is a portable, single channel, automatic or manual electrocardiograph. This electrocardiograph (EKG) is designed to produce a thermally printed recording of the electrical signals produced by the heart. A digital value of the heart's rate is also displayed. The FX-2111 incorporates the ability to store fifteen programmable settings that define the printout format and operating conditions of the device. These settings are maintained even when power has been turned OFF and the device unplugged from the wall. In its automatic mode, the FX-2111 will produce a 12 lead standard or Cabrera formatted EKG without operator intervention. This light weight unit is portable and may be operated from AC or an optional rechargeable battery.
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
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Indicated Patient Age Range
neonate, pediatric, or adult
Intended User / Care Setting
by or on the order of a physician or similarly qualified health care professional. The FX-2111 is intended to be used in a doctors office; all hospital environments; ER ICU, CCU, OR, etc .; or similar settings.
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)
Laboratory testing was conducted to validate and verify that the FUKUDA DENSHI Model FX-2111 Single Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model FX-1201. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices and ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus". Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.
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.
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
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
Section 2 510(k) Summary
JUL 1 5 1996
for the
FUKUDA DENSHI Model FX-2111
Single Channel Electrocardiograph
Submitter:
i
FUKUDA DENSHI AMERICA CORP. 7102 180th Ave NE, Bldg. A-101 Redmond WA 98052 206/881-7737 Tel: Fax: 206/869-2018
Contact Person:
David J. Geraghty Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 7102 180th Ave NE, Bldg. A-101 Redmond WA 98052 Tel: 206/881-7737 Fax: 206/869-2018
Date Prepared:
November 16, 1995
Device Name:
Proprietary Name:
Model FX-2111 Single Channel Electrocardiograph
Common Name:
Electrocardiograph
Classification Name:
Electrocardiograph; Product Code 74DPS
Legally Marketed Device:
FUKUDA DENSHI model FX1201 Single Channel Electrocardiograph; K884992
Description:
The model FX-2111 Single Channel Electrocardiograph is a portable, single channel, automatic or manual electrocardiograph. This electrocardiograph (EKG) is designed to produce a thermally printed recording of the
FX-2111 510(k) Submittal Section 2
November 20, 1995 page 1 of 4
1
electrical signals produced by the heart. A digital value of the heart's rate is also displayed. The FX-2111 incorporates the ability to store fifteen programmable settings that define the printout format and operating conditions of the device. These settings are maintained even when power has been turned OFF and the device unplugged from the wall. In its automatic mode, the FX-2111 will produce a 12 lead standard or Cabrera formatted EKG without operator intervention. This light weight unit is portable and may be operated from AC or an optional rechargeable battery.
Intended Use:
This device is intended to be used for the evaluation of the cardiovascular system. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The FX-2111 is intended to be used in a doctors office; all hospital environments; ER ICU, CCU, OR, etc .; or similar settings. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
The FX-2111 may be operated from battery power (optional) and the improved mechanical and electrical design quarantee portability.
Technological Characteristics
The FX-2111 incorporates the latest in microprocessor, thermal printer, and LCD display technology. The predicate device utilized analog and discrete logic components to perform its operations as well as a heated stylus for recording. The predicate device included no display capabilities for heart rate or operator messaging.
These technological differences do not effect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are addressed in the systems hazard analysis and in the system validation.
Testing:
Laboratory testing was conducted to validate and verify that the FUKUDA DENSHI Model FX-2111 Single Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model
FX-2111 510(k) Submittal Section 2
November 20, 1995 page 2 of 4
2
FX-1201. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices and ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus". Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation.
Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of the device may be critical to the proper management of the patient.
The other area of concern is the safety of the patient, in that the device is attached to the body through conducting electrodes.
The areas of risk for this device, and other devices in this class, are the following:
- . Cardiac arrhythmias or electrical shock Excessive electrical leakage current can disturb the normal electrophysiology of the heart, and possibly leading to the onset of cardiac arrhythmias.
- Misdiagnosis
Inadequate design of the EKG signal processing circuitry or program can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
The design of the FX-2111 has taken into account all the above
Conclusion:
The conclusions drawn from the laboratory testing of the FUKUDA DENSHI Model FX-2111 Single Channel Electrocardiograph demonstrate that the device is as safe as effective, and performs as well as or better than the legally marketed predicate device, the FUKUDA DENSHI model FX-1201.
FX-2111 510(k) Submittal Section 2