FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH

{0}------------------------------------------------ # Section 2 510(k) Summary Fukuda Denshi model FCP-2155 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. K971440 The assigned 510(k) number is : ______________________________________________________________________________________________________________________________________________ #### Submitter: FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St. Bldg C Redmond, WA 98052-4911 425/881-7737 Tel: 425/869-2018 Fax: #### Contact Person: David J. Geraghty Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St. Bldg C Redmond, WA 98052-4911 Tel: 425/881-7737 425/869-2018 Fax: Date Prepared: November 25, 1997 #### Device Name: Proprietary Name: Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph #### Common Name: Multi Channel, Interpretive Electrocardiograph #### Classification Name: Electrocardiograph #### Legally Marketed Device: FCP-4101 Interpretative EKG, K913811 {1}------------------------------------------------ #### Description: DEC - 2 1997 ( The Fukuda Denshi model FCP-2155 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. A digital value of the heart rate is also produced. If selected by the operator, the FCP-2155 is able to provide an interpretation of the EKG and to trend R-R interval. Numeric values of measurements made may also be printed. The FCP-2155 incorporated the ability to store program 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 has been unplugged from the wall. In its automatic mode, the FCP-2155 will produce a 12 lead standard or Carbrera formatted EKG without operator intervention. Interpretation of these waveforms may be included in the printout for review and final analysis by a trained physician. This light weight unit is portable and may be operated from AC power or its internal, rechargeable battery. ### Intended Use: This Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph is intended to be used for the evaluation of the cardiovascular system. The FCP-2155 will acquire and record EKG waveforms and data in either standard 12 lead or cabrera format. The FCP-2155 is also intended to provide EKG interpretation and R-R interval measurement values, on an informational basis, to the physician who is asked to overread this data. The FCP-2155 is to be used by or on the order of a physician or similarly qualified health care professional. The FCP-2155 may be used in all hospital environments; ER, OR, ICU, etc.; doctors offices; clinics; or similar settings. 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 docs not interfere with or complicate the treatment of the patient. This device is not intended for home use. The FCP-2155 may be operated from battery and is portable. K971440 {2}------------------------------------------------ ## Technological Characteristics The Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph incorporates the latest in microprocessor, thermal printer, and LCD technology similar to the predicate device. The FCP-2155 utilizes a smaller format paper and does not display EKG waveform data on its LCD. A rechargeable battery is standard with this device. 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. ## Testing: Laboratory testing was conducted to validate and verify the Fukuda Denshi model FCP-2155 Multi Channel Electrocardiograph met all design specifications and was substantially equivalent to the FUKUDA DENSHI model FCP-4101A. 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 ANSVAAMI ES1-1993, "Safe current limits for electromedical apparatus," ANSI/AAMI EC11-1991, "Diagnostic Electrocardiographic Devices" and AAMI ECAR-1987 "Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms" 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. {3}------------------------------------------------ - . 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 FCP-2155 has taken into account all the above. The device is designed to meet UL 601, CSA 22.2 and AAMI standards for electrical safety for medical equipment to prevent the possibility of excessive electrical leakage current to the patient. ### Conclusion: The conclusions drawn from clinical and laboratory testing of Fukuda Denshi model FCP-2155 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-4101A Multi Channel Electrocardiograph (K913811) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, with a human profile visible within the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 2 1997 Mr. David J. Geraghty Fukuda Denshi America Corporation 17725 NE 65th Street 98052 Redmond, Washington Re : K971440 The Fukuda Denshi Model FCP-2155 Multi Channel Electrocardiograph Regulatory Class: III (three) 74 LOS Product Code: September 8, 1997 Dated: September 10, 1997 Received: Dear Mr. Geraghty: 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 regulations. {5}------------------------------------------------ Page 2 - Mr. David J. Geraghty 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, 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 સ્ટ્રે {6}------------------------------------------------ ## Indications for Use Statement | 510(k) Number (if known): | K971440 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Fukuda Denshi model FCP-2155<br>Multi Channel Electrocardiograph | | Indications For Use: | Use of this device is indicated where a physician or healthcare<br>professional requires information about the electrical events within<br>the myocardium using waveforms recorded from the body's<br>surface during depolarization and repolarization of the atrium and<br>ventricles. The FCP-2155 is indicated where a clinician seeks<br>advisory interpretive measurement, and diagnostic statements that<br>would require confirmation by a physician. This device is<br>indicated where the clinician seeks R to R timing measurements<br>and trend information.<br><br>The basic EKG and recording features of this device are intended<br>to be used on any patient; neonate, pediatric, or adult; where the<br>placement of EKG electrodes does not interfere with or complicate<br>the treatment of the patient. The interpretive feature of this device<br>is intended to be used on any patient, at least one (1) year old,<br>where the placement of EKG electrodes does not interfere with or<br>complicate the treatment of the patient. This device is not intended<br>for home use.<br><br>The FCP-2155 may be operated from battery or AC power | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)M. Puga (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices **510(k) Number** Prescription Use (Per 21 CRF 801.109) ✓ ਪ Over-The-Counter Use __ ូវ