PE 501 PC-ECG MONITOR

{0}------------------------------------------------ K992584 #### Premarket Notification [510(k)] Summary - Submitted by: NHE, Corporation 7100 Fernwood St. Suite 1902 Richmond, VA 23228 - Contact Person: Sugen Zhang Device: PE 501 PC-ECG Monitor Class II Description: The PE 501 PC-ECG Monitor is a battery-powered, personal computer based electrocardiograph monitoring device. It is designed to acquire, display and record 2 channel ECG signals. The ECG signals are sent to the computer through a serial port and displayed on the computer screen. The ECG signals associated with personal information can be stored into the computer hard disk or floppy disk. Desired segments of the recorded ECG signals can be printed on any Windows compatible printers. The recorded ECG signals can be easily retrieved and can also be transferred to a remote computer with floppy disk, direct machine to machine or E-mail. Intended Use: Acquiring and displaying 2 channel ECG signals through a personal computer. > Storing ECG signals in computer hard disk and/or floppy disk for a selected time. The standard recording time can be selected from 2 minutes (default) to 100 minutes with 1 minute increment. (Longer recording time up to 48 hours is optional). Printing the recorded ECG signals on plain papers. Transferring the recorded ECG signals to a remote computer with floppy disk, direct machine to machine or E-mail. ### Substantially Equivalent (SE) to: ER 700 Series Ambulatory ECG Event Monitor by Braemar Corp., MN, 510(k)# K981394 PC-ECG, by I.P.I. - International Products Inc., the basic model, PC-ECG, of a PC-ECG series of family with no interpretation functions. 510(k)# K963578 ## Technological characteristics: All three devices compared use similar technologies to acquire patient's ECG signals, amplify the signals, perform analog-to-digital conversion and store the signals in a digital format. Both PE 501 and ER 720 acquire 2 channel ECG signals but ER 720 stores the signal in a build-in flash memory and PE 501 stores it in computer hard disk. Both PE 501 and IPI PC-ECG store ECG in computer but PE 501 only records 2 channel ECG and IPI PC-ECG records 12 lead ECG signals. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings and tail feathers. The eagle is facing to the right. #### Public Health Service # JAN 1 3 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Shugen Zhang President NHE, Corporation 7100 Fernwood Street, Suite 1922 Richmond, VA 23228 K992584 Re: PE 501 PC-ECG Monitor Requlatory Class: II (two) Product Code: MWJ November 15, 1999 Dated: November 18, 1999 Received: Dear Mr. Zhang: 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 leqally 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 aqainst 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 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 regulations. {2}------------------------------------------------ Page 2 - Mr. Shugen Zhang 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" (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, Célia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number: K992584 Device Name: NHE Corporation PE 501 PC-ECG Monitor Indications For Use: The PE 501 PC-ECG is indicated for acquiring and displaying 2 channel ECG signals through a personal computer and transferring the recorded ECG signals to a remote computer. It is designed for stationary use and is not for ambulatory use. It is intended for use primarily in out-patient clinics. The PE 501 PC-ECG device should be operated by a licensed healthcare practitioner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off on Sign-Off n of Cardiovascular. Respiratory and Neurological De 510(k) Number Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)