PATIENT MONITOR

K112190 · Mediana Co., Ltd. · MHX · Nov 9, 2011 · Cardiovascular

Device Facts

• Record ID: K112190
• Device Name: PATIENT MONITOR
• Applicant: Mediana Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. - Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters. - Note: The medically skilled and trained user can be any clinicians like doctor and nurse who know how to take and interpret a patient's vital signs. These clinicians must take the direct responsibility for patient life. It can include a care-giver or medically trained interpreter who is authorized under the appropriate clinical facility procedure to support the patient care. Any inappropriate setting, especially the limit alarm notification setting can lead the hazardous situation that injures the patient or harms the patient or threats the patient life. The special attention to assign the trained user who can adjust the patient setting of the patient monitor should be essentially paid.

Device Story

YM6000 is a compact, AC/battery-powered patient monitor for hospital/clinical use. It acquires physiological signals via ECG, NIBP, SpO2, IBP, capnography, and temperature modules. Inputs are processed to display real-time vital signs and status on a TFT-LCD screen. Clinicians (doctors, nurses, technicians) use the device to track patient status and set alarm limits. Output data supports clinical decision-making by providing continuous monitoring of patient stability. Benefits include early detection of physiological changes and timely intervention. The device uses established modules (Mediana ECG, Omron NIBP, Nellcor SpO2, Philips Respironics capnography) to ensure accurate measurement.

Clinical Evidence

Bench testing only. The device underwent system verification and validation (Plan #PAA00-00005) using production-equivalent units. Performance was validated against established standards for each module: AAMI SP-10 and IEC60601-2-30 (NIBP), ISO9919 (SpO2), and IEC60601-2-34 (IBP). No clinical trial data was required or provided.

Technological Characteristics

Compact monitor (341x305x172mm, 5.5kg) with TFT-LCD display. Powered by AC (100-240VAC) or internal rechargeable lead-acid battery. Modules: Mediana MDE-1 (ECG), Omron M3200 (NIBP), Nellcor NELL-3 (SpO2), Philips Respironics Capnostat 5/LoFlo C5 (Capnography), Mediana MDT-1 (Temperature). Connectivity includes physiological signal transmission. Complies with AAMI SP-10, IEC60601-2-30, ISO9919, and IEC60601-2-34.

Indications for Use

Indicated for adult, pediatric, and neonate patients requiring monitoring of ECG, HR, pulse rate, NIBP, SpO2, IBP, respiration, capnography (EtCO2/InCO2), and temperature in hospital and hospital-type settings.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Omron Model HBP-2070 Vital Signs Monitor (K082812)
• Spacelabs Medical Inc. mCare 300 Vital Signs Monitors, Model 91220 (K062095)
• Omron Healthcare Inc. Colin Press Mate Model BP-S510 (K063690)
• Mediana Co., Ltd. Lucon M-Series Patient Monitor, Model M20 and M30 (K100217)

Reference Devices

• Capnostat 5 (K042601)
• LoFlo C5 (K053174)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

### Submitter

Mediana Co.,Ltd.

Wonju Medical Industry Park, 1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel: [phone] (82) 33 742 5400 Fax: [phone] (82) 33 742 5483 Company Contact: Amy M.H.KIM, Manager of Regulatory Affairs Rachel J.E.OH, Specialist of Regulatory Affairs

Date Summary Prepared: May 5th, 2011

#### Device Name

| Trade Name: | YM6000, patient monitor |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Patient Monitor |
| Classification Name: | Monitor, Physiological, Patient (with arrhythmia dete ction or alarms)<br>(21CFR870.1205) also contains<br>Monitor, Cardiac (including cardiotachometer and rate ala rm)<br>(21CFR870.2300)<br>System, measurement, blood-pressure, non-invasive<br>(21CFR870.1130),<br>Electrocardiograph (21CFR870.2340)<br>Oximeter (21CFR870.2700)<br>Analyzer, gas, carbon-dioxide, gaseous-phase (21CFR868.1400)<br>Computer, Blood-Pressure (21CFR870.1110)<br>Transmitters and receivers, physiological signal, radiofrequency<br>(21CFR870.2910) |
| Classification: | Class II |
| Product code: | MHX |

#### Predicate Devices (Legally Marketed Devices)

The predicate devices for Patient monitors, Model YM6000 are:

- . Omron Healthcare Inc. Omron Model HBP-2070 Vital Signs Monitor cleared by FDA through 510(k) No. K082812,
- Spacelabs Medical Inc. mCare 300 Vital Signs Monitors, Model 91220 . • cleared by FDA through 510(k) No. K062095,
- Omron Healthcare Inc. Colin Press Mate Model BP-S510 t cleared by FDA through 510(k) No. K063690,
- Mediana Co., Ltd. Lucon M-Series Patient Monitor, Model M20 and M30 cleared by FDA through 510(k) No. K100217

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### Device Description

The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

#### Intended Use

The YM6000 monitor is intended to be used to mo nitor electrocardiography, heart rate, p ulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen satu ration, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pedi atric and neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technici an, doctor, nurse or medical specialist.

- Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, inten sive and critical care area, within the hospital. Ho spital-type facilities include physician office-based facilities, sleep lab s, skilled nu rsing facilities, surgicenters, and sub-acutecenters.
- Note: The medically skilled and trained user can be any clinicians like doctor and nurse who know how to take and interpret a patient's vital signs. These clinicians must take the direct responsibility for patient life. It can in clude a care-qiver or medically trained interpreter who is authorized under the appropriate clinical facility procedure to support the patient care. Any inappropriate setting, especially the limit alarm notification setting can lead the hazardous situation that injures the patient or harms the patient or threats the patient life. The sp ecial attention to assign the trained user who can adjust the patient setting of the patient monitor should be essentially paid.

### Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)

The Mediana Patient Monitor, Model YM6000 is substantially equivalent to the Colin Press Mate Model BP-S510, Lucon M-series Patient Monitor, Model M20 and M30, Omron M odel HBP-2070 Vital Signs Monitor, and mCare 300 Vital Signs Monitor, Model 91220.

- . The Model YM600 uses the Mediana ECG module, MDE-1 manufactured by Mediana Co., Ltd. which is identical to the module used in the Model M20, M30 and Model HBP-2070. So the Electrocardiogram (ECG) and heart rate specifications for the Model YM600, Model M20, M30 and Model HBP-2070 are identical,
- The Model YM6000 uses the Omron NIBP module M3200 which is identical to the module used in the Model BP-S510, Model M20, M30 and Model HBP-2070. The non-invasive blood pressure (NIBP) and pulse rate specifications for the Model YM6000, Model BP-S510, Model M20, M30 and Model HBP-2070 are identical. The circuitry, algorithm and cuffs in

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both models are the same manufactured by Omron Healthcare Inc. Also, all devices comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same measurement technology,

- The Model YM6000 uses the Nelloor SpO2 module, NELL-3, which is identical to the module used in the Model BP-S510, Model M20, M30 and Model HBP-2070. The SpO2 specifications for the Model YM6000, Model M20, M30 and Model HBP-2070 are identical. The circuitry, algorithm and sensors are the same as SpO2 module used in above monitors, is anufactured by Nellcor Inc. Also, all devices comply with the performance standard 1509919,
- The respiration can be obtained from either the Electrocardiogram (ECG) channel or the Capnography (EtCO2) channel. The algorithm of Impedance measurement in the Model M20, M30 and Model HBP-2070 is identical to that in Model YM6000 and the respiration specification for the Model YM6000, Lucon M-series (Model M20, M30) and Model HBP-2070 are identical because the respiration measurement (Thoracic Impedance) for Model YM6000, Lucon M-series (Model M20, M30) and Model HBP-2070 is from ECG module that are the same module designed and manufactured by Mediana Co., Ltd.,
- And also Lucon M-series (Model M20, M30) and Model 91220 have identical performance of respiration measurement (Airway Measurement) with Model YM6000. Because respiration measurement (Airway Measurement) is from Capnography module and these devices use the same Capnography module which manufactured by Philips Respironics Inc.,
- The Model YM6000 uses the thermometry MDT-1 module which is identical to used in the Lucon M-series (Model M20, M30) and Model HBP-2070. The temperature measurement method for the Model YM6000, Lucon M-series (Model M20, M30) and Model HBP-2070 are equivalent. Also all of device uses the YSI probes/probe covers,
- The pulse rate derived from the non-invasive blood pressure (NIBP) channel is from M3200 NIBP module in the Model YM6000. This M3200 module is identical to that in the Model BP-S510, Lucon M-series (Model M20, M30) and Model HBP-2070. And the pulse rate derived from the Pulse Oximetry (SpO2) channel is from NELL-3 Spo2 module in the Model YM6000. This NELL-3 module is identical to that in the Model BP-S510, Lucon M-series (Model M20, M30) and Model HBP-2070,
- The Model YM6000 uses the Respironics Capnography module, Capnostat 5 and LoFio C5 which have already been registered in FDA by Philips Respironics Inc. (#K042601 is for Capnostat 5, #K053174 is for LoFlo C5). Both modules are identical to the modules used in the Lucon M-series (Model M20, M30) and Model 91220. All devices have identical technology and operation of theory in Capnography module,
- The Model YM6000 uses the same measurement technology with the Model BP-S510 for Invasive Blood Pressure. The IBP technology is most traditional and typical method among measuring the patient parameter. The Invasive blood pressurement performance of the Model YM6000 is similar to the Model BP-S510 by using same measurement technology. And both devices comply with the IBP performance standard, IEC60601-2-34.
- The YM6000 monitor as well as the predicate devices has internal power source, a rechargeable lead acid battery and AC power.

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The Mediana patient monitor, Model YM6000 substantially have been tested in accordance with the system V & V plan (#P AA00-00005) and summary included with the submission using production equivalent units prior to release to market.

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A risk a nalysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21 CFR820, ISO13485 and CMDCAS ISO13485 certified by DNV (Det Norske Veritas).

## Conclusions

As stated above, the Mediana patient monitors, Model YM6000 is safe and effective and comply with the appropriate medical device standards and are substantially equivalent to the earl ier identified predicate devices.

- End of Section -

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

NOV - 9 2011

Mediana Co., Ltd. c/o Ms. Charlie Mack President International Regulatory Consultants 7325 Joyce Way Echo, OR 97826

Re: K112190

> Trade/Device Name: YM6000, Patient Monitor Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms)
> Pogulatory Class - H ( Regulatory Class: II (two) Product Code: 74 MHX Dated: October 16, 2011 Received: October 24, 2011

Dear Ms. Mack:

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 (Act (Act that the provise 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.

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Page 2 - Ms. Charlie Mack

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); 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applicant:

Mediana Co.,Ltd. Wonju Medical Industry Park, 1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do. Korea Tel: [phone] (82) 33 742 5400 Fax: [phone] (82) 33 742 5483

510(k) Number:

Device Name: YM6000, Patient Monitor

#### Indications for Use:

The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

- Note: Hospital use typically includ es such areas as gen eral care floors, opera ting rooms, special proced ure areas, intensive and critical care area, within the hospital. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
- Note: The medically skilled and trained user can be any clinicians like doctor and nurse who know how to take a nd interpret a patient's vital signs. T hese clinicians must take the direct respon sibility for pati ent life. It can include a care - -giver or medically trained interp reter who is authorize d under the appropria te clinical facility procedure to support the patient care. Any i nappropriate setting. especially the limit alarm or alarm notification setting can lead the hazardous situation that injures the patient or harms the patient or threats the patient life. The special attention to assign the trained user who can adjust the patient setting of the patient monitor should be essentially paid.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR Over-The-Counter | |
|------------------------------------|---------|---------------------|--|
| (Per 21CFR801.109) | | | |
| (Division Sign-Off) | | | |
| Division of Cardiovascular Devices | | | |
| 510(k) Number | K112190 | | |