MAX PULSE SYSTEM

{0}------------------------------------------------ PI/CI JUN 1 3 2011 ## 510(k) Summary (21 CFR 807.92) "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. "The assigned 510(k) number is KIJ 0374 _" (applicant leave blank) Premarket Notification [510(k)] Summary [1]]. The summary contains the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared: Submitter's Name: Medicore Co., Ltd. Submitter's Address: 1F, Delice B/D B, 135-5, Sangdeawon-dong, Jungwon-gu, Sungnam-si, Gyunggi-do, Korea Phone Number: 82-2-2056-2650 Fax Number: 82-2-2056-2688 Name of Contact Person: Mr. Byung-kuk Yoo Date the Summary was prepared: November 8, 2010 [2]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if know. Product Name: Max Pulse System Common Name: Pneumatic Plethysmograph {1}------------------------------------------------ Classification: JOM; Class II; Regulation Number: CFR 21 870.2780 [3]. An identification of the legally marketed device to which your firm is claiming substantial equivalence. Predicate Device: McPulse by Meridian Co. Ltd. [4] A description of the device Description of Device: The device is to measure the heart rate with photoelectric measurement techniques. It is to be connected with a desktop PC or laptop PC. It is operated with a mouse or a keyboard of PC which is used to enter the patient information as well as to operate the system and review the resulting analysis. | | Predicate Device | Subject Device | |------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | McPulse<br>Meridian Co. Ltd | Max Pulse<br>Medicore, Co., Ltd. | | | K023238 | | | Classification | Class II | Class II | | Classification Code | JOM | JOM | | Intended Use | Measures pulse waveform;<br>SpO2 and heart rate by<br>photoelectric plethysmograph | Measures pulse waveform;<br>SpO2 and heart rate by<br>photoelectric<br>plethysmograph | | Intended Users | Professional use only | Professional use only | | Mode | Non invasive | Non invasive | | Display | Digital LCD display | No | | Power Source | AC (100-240Vac, 50/60 Hz) | 100-240VAC<br>Phase: Single<br>Frequency 50/60Hz<br>Current less than 1.0A | | Type of Sensor | LED - photodiode/finger<br>probe | LED - photodiode/finger<br>probe<br>MD-10 finger type reusable<br>sensor<br>Accuracy±2%<br>Shape Clip type<br>Led specification<br>Red & infrared, nominal<br>Photodiode Active area :<br>$5mm^2

lt;br>Responsibility : 0.18Min | | Recorder Outputs | Pulse waveform<br>Heart rate | Pulse waveform<br>Heart rate | | Heart Rate Range | 30-230 bpm | 30-240 bpm | | Size (unit:mm) | 305.5 W x 296 H x 92.5 D | 150x 130x 35 | | Weight | Approx 5.5 kg | Approx. 650g | | Safety features | Compliant with applicable<br>safety standards | Compliant with applicable<br>safety standards | | Environmental<br>Conditions<br>Operation | Not specified in product<br>labeling | Temperature 10-35°C<br>Relative humidity 20-<br>95%RH<br>Atmospheric Pressure 700-<br>1060hPa | | Environmental<br>Conditions<br>Storage | Not specified in product<br>labeling | -20~60°C(-4~140°F)<br>10~90% RH @ -25~65°C(-<br>13~149°F)<br>700~1060hPa | {2}------------------------------------------------ : : {3}------------------------------------------------ [5]. The summary describes the intended use of the device. Intended Use: The device provides noninvasive measurement of heart rate by photoelectric probe. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices [6] A brief discussion of the nonclinical submitted, reference, or relied on in the premaket notification submission for a determination of substantial equivalence. Clinical data is not needed for Max Pulse system or for most devices cleared by the 510(k) process. [7] Performance: The device has completed performance testing showing that the functions are substantially equivalent to the predicate. In addition the device meets the same safety and performance standards as the predicate. [8]The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). The Medicore Max Pulse System is substantially equivalent1 to the McPulse device manufactured by Meridian Co. Ltd. that received clearance through 510(k) Premarket Notification K023238 and currently in commercial distribution. ¹ The term "substantially equivalent" as used in this submission is intended to convey only a determination of substantial equivalence pursuant to the requirements of the FD&C Act. It is not intended to have any bearing whatsoever in determining what is patentable or on the resolution o patent infringement suits or any other patent matter. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Medicore Co., Ltd. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25" Street NW Buffalo, MN 55313 JUN 1 3 2011 Re: K110374 Trade/Device Name: Max Pulse Regulation Number: 21 CFR 870.2780 Regulation Name: Photoelectric, Pneumatic, or Hydraulic Plethysmograph Regulatory Class: Class II (two) Product Codes: JOM Dated: May 27, 2011 Received: May 31, 2011 Dear Mr. Job: 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 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. 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 {5}------------------------------------------------ Page 2 - Medicore Co., Ltd., c/o Mr. Mark Job 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. \$\beta\$ Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): Device Name: Max Pulse Indications For Use: The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices Prescription Use (Per 21CFR 801) | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON | |----------------------------------------------------| | ANOTHER PAGE IF NEEDED) | | (ODE) | Concurrence Of CDRH, Office Of Device Evaluation | |--------------------|--------------------------------------------------| | Division(Sign-Off) | Division of Cardiovascular Devices | | 510(k) Number | K110374 |