CARDIMAX MODEL FX-2111

{0} K955416 JUL 15 1996 # Section 2 ## 510(k) Summary for the ## FUKUDA DENSHI Model FX-2111 Single Channel Electrocardiograph ### Submitter: FUKUDA DENSHI AMERICA CORP. 7102 180th Ave NE, Bldg. A-101 Redmond WA 98052 Tel: 206/881-7737 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 be 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 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. 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 guarantee 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 November 20, 1995 page 3 of 4