CARDIOTOUCH-3000

{0}------------------------------------------------ ## NOV 1 4 2002 # 510(k) Summary As Required by 21 section 807.92 ( c ) KO23034 p. L/3 1-Submitter Name: BIONET Co., LTD - 2-Address: #501. KICOX Venture Center. 188-5. Guro-Dong, Guro-Gu - Seoul, South Korea - +82 2 6300 6419 / +82 2 6300 6418 3-Phone: - 4-Fax: +82 2 6300 6425 5-Contact Person: Dong-Joo Kang, CEO 6-Date summary prepared: September 6th, 2002 7- Official Correspondent: Mansour Consulting LLC - 1308 Morningside Park Dr 8- Address: - Alpharetta, GA 30022 USA - 9- Phone: (678) 908-8180 (425) 795-9341 - 10- Fax: - 11- Contact person: Jay Mansour, president - 12-Device Trade or Proprietary Name: CARDIOTOUCH-3000 13-Device Common or usual name: ECG 14-Device Classification Name: System, ECG Analysis 15-Substantial Equivalency is claimed against the following device: Bionet's EKG-2000 Cardio Care, 510k #k011328 (refer to Appendix 2 for FDA website printout) This notification for CARDIOTOUCH-3000 is of the SPECIAL type 16-Description of the Device: (as per User Manual pages17 and 18) As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency. Product features: - It prints out 12-channel ECG waveforms on an A-4 size report in . various channel forms including 3ch+1rhy, 6ch+1rhy, and 12ch rhy. - It records 1ch rhy for 60 seconds and prints it on an A4-size report - - It displays 12ch rhy simultaneously and continuously in real-time. - - -It automatically calculates heart rate, PR interval, QRS interval, QT interval, QTc, and P-R-T axis for diagnosis and displays all of them with electrocardiogram on the report. - Twenty-five diagnoses are available through auto diagnosis ・ - It helps a diagnosis with the changing once-recorded electrocardiogram in a filter setup, signal size, printing speed, channel form and rhythm form and then printing them. - With a built-in battery, it is easy to carry. - - Managing a chart is easy and improved because it prints information on a patient and operator at the same time. 3/1 {1}------------------------------------------------ Basic configuration and accessories: - 1- CARDIOTOUCH-3000 body - 2- Patient cable (1 EA) - 3- User Manual (1 VOL.) - 4- ECG Paper (2 EA) - 5- Power cable (1 EA) ## Options: - 1- Battery (built-in type) - 2- Protective Ground wire (1 EA) - 3- Electrode (10 EA) - 4- ECG cream (1 EA) - 5- Hanger (1 EA) - 6- Cart (1 EA) 17-Intended use of the device: (Indications for use typed on a separate FDA form) The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use. 18-Safety and effectiveness of the device: This device is safe and effective as the predicate device, being a deviation from the previously cleared Bionet's product EKG-2000 Cardio Care. This is better expressed in the tabulated comparison (Paragraph 19 below) 19-Summary comparing technological characteristics with other predicate device: Please find below a tabulated comparison supporting that CARDIOTOUCH-3000 is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached. | FDA file reference number | 510k #k011328 | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attachments inside<br>notification submission file | 510k summary print out | | TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result | | Indications for use | Identical:<br>Both CardioCare-2000 and CardioTouch-3000<br>are detecting and measuring as below parameters<br>to provide and help doctors for making figure out<br>the patient's vital condition.<br>• Accurate Heart Rate<br>• Electrocardiograph wave<br>• Printing the current ECG wave and related<br>numeric values | | Target population | Identical:<br>Predicate device and this device are used by<br>cardiologist and sports expert etc. for watching<br>heart patient condition. | | | K023034<br>p.313 | | Design | Similar:<br>CardioCare-2000 have 2line 16character LCD<br>and CardioTouch-3000 have 320 X 200 dot with<br>back lit LCD. | | Materials | Identical:<br>CardioCare-2000 and CardioTouch-3000 are<br>made of ABS materials. | | Performance | Identical:<br>ECG leads : Standard 12 leads<br>Sensitivity : 5,10,20, Auto<br>Input circuit : floting input, isolated and<br>defibrillation protected.<br>Input impedence : $\geq$ 10MΩ<br>Input circuit current : $\leq \pm$ 5mV<br>Calibration Voltage : 1mV±2%<br>Time Constant : 100dB or better<br>Frequency response : 0.05~150Hz within -3dB | | Sterility | Not applicable | | Biocompatibility | Identical:<br>Both of them are satisfied Biocompatibility<br>through using disposable electrode. | | Mechanical safety | Identical:<br>A coarse surface and a sharp corners of a device<br>which has cause of patient damage of device are<br>removed and covered. | | Chemical safety | Not applicable | | Anatomical sites | Not applicable | | Human factors | Not applicable | | Energy used and/or delivered | Identical:<br>Both of them use the rechargeable battery<br>(100V~240Vac 50/60 Hz and Built-in). | | Compatibility with<br>environment and other<br>devices | CardioCare-2000 and CardioTouch-3000 are<br>suitable for EMI and EMC test. | | Where used | Identical: Private Check, ER, Hospitals. | | Standards met | Identical | | Electrical safety | Identical | | Thermal safety | Identical | | Radiation safety | Identical | {2}------------------------------------------------ 3/3 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Bionet Company Ltd. c/o Mr. Jay Mansour President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022 Re: K023034 Trade Name: CARDIOTOUCH-3000 Regulation Number: Unclassified Regulation Name: ECG Analysis System Product Code: LOS Dated: October 8, 2002 Received: October 21, 2002 Dear Mr. Mansour: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ ### Page 2 - Mr. Jay Mansour Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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, Elias Mallis Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## 510(k) Number (if known): KO23034 ## Device Name: CARDIOTOUCH-3000 ## Indications for Use: The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardio information from adult population. The device is not intended for home use. The device is not designated for intracardial use. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ---------------------------------------------------- Concurence of CDRH, Office of Device Evaulation (ODE) X (Optional Format 3-10-98) 8) Dias Malli Division of Cardiovascular & Respiratory Devices 510(k) Number K023034 C3 Prescription Use (Per 21 C.