(160 days)
Not Found
No
The document describes a standard interpretive electrocardiograph and does not mention AI, ML, or related concepts. The performance studies focus on electrical safety and equivalence to a predicate device, not on the performance of an AI/ML algorithm.
No
The device is an electrocardiograph that records and interprets electrical signals from the heart for diagnostic purposes, providing information to clinicians for confirmation by a physician. It does not provide any form of therapy or treatment to the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "diagnostic statements" and aids the clinician in interpreting arrhythmia, indicating its role in diagnosis.
No
The device description explicitly states it is a "portable, multi channel, interpretive, automatic or manual electrocardiograph" with physical dimensions and weight, and that it produces a "thermally printed recording." This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, 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 FX-4010 is an electrocardiograph. It measures the electrical activity of the heart from the body's surface using electrodes. This is a non-invasive procedure that does not involve testing samples taken from the body.
- Intended Use: The intended use clearly describes recording electrical events within the myocardium using waveforms recorded from the body's surface. This aligns with the function of an electrocardiograph, not an IVD.
Therefore, the FX-4010 is a medical device used for diagnostic purposes, but it falls under the category of in vivo diagnostic devices (measuring within the living body) rather than in vitro diagnostic devices (measuring outside the living body).
N/A
Intended Use / Indications for Use
This Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph is intended to be used for the evaluation of the cardiovascular system. The FX-4010 will acquire and record ECG waveforms. Also, the FX-4010 can provide ECG interpretation. The FX-4010 is to be used by or on the order of a physician or similarly qualified health care professional. The FX-4010 may be used in all hospital environments; ER, OR, ICU, etc .; doctors' offices; clinics; or similar settings. This device is intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient.
The interpretive feature is to be used on any patient, at least one (1) year old, where the placement of EKG electrodes does not interfere with of complicate the treatment of the patient. This device is not intended for home use.
Use of this device is indicated where a physician or healthcare professional requires information about the electrical events within the myocardium using waveforms recorded from the body's surface during depolarization and repolarization of the atrium and ventricles. The FX-4010 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. Also, can provide measurement data, R to R timing measurements with trend information and interpretation of arrhythmia to the clinician.
The basic EKG and recording features of this device are intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. The interpretive feature of this device is intended to be used on any patient, at least one (1) year old, 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
74 LOS
Device Description
The Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph is a portable, multi channel, interpretive, automatic or manual electrocardiograph. This electrocardiograph is designed to produce a thermally printed recording of the electrical signals produced by the heart. The size of the unit is 37.8(W) x 33.8(D) x 10.1(H) cm and weighs approximately 8 kg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The basic EKG and recording features of this device are intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. The interpretive feature of this device is intended to be used on any patient, at least one (1) year old, where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient.
Intended User / Care Setting
The FX-4010 is to be used by or on the order of a physician or similarly qualified health care professional. The FX-4010 may be used in all hospital environments; ER, OR, ICU, etc .; doctors' offices; clinics; or similar settings. This device is not intended for home use.
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)
Subjected to laboratory testing to validate and verify the Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model FCP-2155. 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 ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus," ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices". 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.)
Not Found
Predicate Device(s)
FCP-2155, Multi Channel Interpretative ECG (K971440)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 3 1 1998
Section 2 510(k) Summary Fukuda Denshi model FX-4010
Multi Channel Electrocardiograph
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 807.92.
K981066 The assigned 510(k) number is:
Submitter:
FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St. Bldg C Redmond, WA 98052-4911 Tel: 425/881-7737 425/869-2018 Fax:
Contact Person:
Richard A. Queen Regulatory Affairs Specialist FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St. Bldg C Redmond, WA 98052-4911 425/881-7737 Tel: Fax: 425/869-2018
Date Prepared:
March 10, 1998
Device Name:
Proprietary Name:
Fukuda Denshi: CardioMax, model FX-4010 Multi Channel Electrocardiograph
Common Name:
Multi Channel Interpretive Electrocardiograph
Classification Name:
Electrocardiograph
Legally Marketed Device:
FCP-2155, Multi Channel Interpretative ECG (K971440)
FX4010 Reve Additional Information 40102a
1
Description:
The Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph is a portable, multi channel, interpretive, automatic or manual electrocardiograph. This electrocardiograph is designed to produce a thermally printed recording of the electrical signals produced by the heart. The size of the unit is 37.8(W) x 33.8(D) x 10.1(H) cm and weighs approximately 8 kg.
Intended Use:
This Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph is intended to be used for the evaluation of the cardiovascular system. The FX-4010 will acquire and record ECG waveforms. Also, the FX-4010 can provide ECG interpretation. The FX-4010 is to be used by or on the order of a physician or similarly qualified health care professional. The FX-4010 may be used in all hospital environments; ER, OR, ICU, etc .; doctors' offices; clinics; or similar settings. This device is intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient.
The interpretive feature is to be used on any patient, at least one (1) year old, where the placement of EKG electrodes does not interfere with of complicate the treatment of the patient. This device is not intended for home use.
Technological Characteristics
The Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph incorporates the microprocessor, thermal printer, input and output channels, measurement and interpretive analysis, and LCD technology similar to the predicate device. The FX-4010 has a port for plugging in a 2-megabyte memory card for storing data. Also, the 4010 has the ability to have accessory cartridges and modules to enables its basic ECG functions. A rechargeable battery is available on both devices.
These technological differences do not affect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are addressed in the system's hazard analysis and the system validation.
2
Testing:
Laboratory testing was conducted to validate and verify the Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model FCP-2155. 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 ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus," ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices". 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.
So, the areas of risk for this device are the same as the predicate device and other devices in this class, and are the following:
-
. Electrical shock
Excessive electrical chassis leakage current can disturb the normal electrophysiology of the heart, and possibly leading to the onset of cardiac arrhythmias. -
Misdiagnosis .
- Inadequate design of the signal processing and measurement 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.
- Inadequate design of the device's software, used to make various measurements, 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-4010 has taken into account all the above. The device is designed to meet UL 2601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient.
3
Conclusion:
The conclusions drawn from clinical and laboratory testing of Fukuda Denshi model FX-4010 Multi Channel Electrocardiograph demonstrates 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 FCP-2155 Multi Channel Electrocardiograph (K971440).
FX4010 Reve Additional Information 40102a
:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads and flowing lines representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1998
Mr. Richard Queen Fukuda Denshi America Corporation 17725 NE 65th Street Redmond, WA 98052
K981066 Re: Fukuda Denshi CardioMax Model FX-4010, Multi Channel Electrocardiograph Requlatory Class: III (three) Product Code: 74 LOS Dated: July 8, 1998 Received: July 15, 1998
Dear Mr. Queen:
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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Requlation (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 assumptions. Failure to comply with the GMP regulation may result in 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.
5
Page 2 -- Mr. Richard Queen
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 regulation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Chllahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
| Device Name: | Fukuda Denshi: CardioMax, model FX-4010,
Multi Channel Electrocardiograph |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Use of this device is indicated where a physician or healthcare
professional requires information about the electrical events within
the myocardium using waveforms recorded from the body's
surface during depolarization and repolarization of the atrium and
ventricles. The FX-4010 is indicated where a clinician seeks
advisory interpretive measurement, and diagnostic statements that
would require confirmation by a physician. Also, can provide
measurement data, R to R timing measurements with trend
information and interpretation of arrhythmia to the clinician. |
| Indications For Use: | The basic EKG and recording features of this device are intended
to be used on any patient; neonate, pediatric, or adult; where the
placement of EKG electrodes does not interfere with or complicate
the treatment of the patient. The interpretive feature of this device
is intended to be used on any patient, at least one (1) year old,
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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K981066 510(k) Number_
Prescription Use (Per 21 CRF 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________