DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570

{0}------------------------------------------------ DEC - 6 1999 # 510 (k) SUMMARY ### l. ADMINISTRATIVE - Submitter: Maersk Medical A/S Niko Business Unit Engmosen 1 DK-3540, Lynge Denmark Phone No.: 011 45 48 16 70 30 Contact Person: Mr. Christian Pelch Date of Preparation: July 28, 1999 ### II. DEVICE NAME Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode ### lll. PREDICATE DEVICE Disposable ECG Monitoring Electrode Models 4535 (K950470) and 4570 (K950478); Nikomed USA, Inc. ## IV. DEVICE DESCRIPTION Pregelled electrodes are of Aq/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box. ### V. INTENDED USE As short-term (<24 hours) electrical conductor applied to the surface of the body of infants (Models 4520, 4535 and 4570), neonates (Model 4520) or adults (Model 4535) to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. {1}------------------------------------------------ ### VI. TECHNOLOGICAL CHARACTERISTICS The Niko ECG Monitoring Electrodes Models 4520, 4535 and 4570 are identical in composition, function and design, and have the same intended use as legally marketed disposable ECG monitoring electrodes, such as Models 4535 and 4570 (K950470 and K950478; Nikomed USA, Inc.) The biocompatibility of skin-contact components has been established in standard safety tests. Accordinqly, Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4520, 4535 and 4570 are safe and effective for their intended use and perform at least as well as other disposable ECG monitoring electrodes. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image contains a black and white logo. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of an eagle's head with three parallel lines extending from the back of the head, resembling feathers or wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 6 1999 Mr. Richard A. Hamer Consultant to Maersk Medical A/S Richard Hamer Associates, Inc. P.O. Box 16598 Ft. Worth, TX 76132 Re: K990111 Disposable ECG Monitoring Electrodes Models 4520, 4535 and 4570 Requlatory Class: II (two) Product Code: DRX Dated: October 28, 1999 November 3, 1999 Received: Dear Mr. Hamer: 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 Requlations, 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 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 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 regulations. {3}------------------------------------------------ Page 2 - Mr. Richard A. Hamer 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" (21CFR 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, Daith lia M. Witten, Ph.D., M.D. Actinq Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 510(k) Number (if known): K990111 Niko ECG Monitoring Electrodes, Models 4520, 4535 and 4570 Device Name: ## Indications for Use: Short-term (< 24 hrs) ECG monitoring of infants in operating room and emergency situations (Model 4570); short-term (< 24 hrs) ECG monitoring of infants and neonates in operating room and emergency situations (Model 4520); short-term (< 24 hrs) ECG monitoring of adults and infants under anesthesia (Model 4535). (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |-------------------------------------------------------------------------------------|---------| | (Division Sign-Off)Division of Cardiovascular, Respiratory,and Neurological Devices | | | 510(k) Number | K990111 | | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use | |------------------------------------------|----|----------------------| |------------------------------------------|----|----------------------| (Optional Format 1-2-96) (Optional Format 1-2-96)