The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

Electrocardiography (ECG)
Heart rate (HR)
Noninvasive blood pressure (NIBP)
Functional arterial oxygen saturation (SpO2)
Pulse rate (PR)
Respiration rate (RR)
Temperature (Temp)
Arrhythmia/ST segment (M30 only)
Capnography (M30 only)
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, surgical centers, and sub acute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

Device Description

The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 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.

Electrocardiography (ECG)
Heart rate (HR)
Noninvasive blood pressure (NIBP)
Functional arterial oxygen saturation (SpO2)
Pulse rate (PR)
Respiration rate (RR)
Temperature (Temp)
Arrhythmia/ST segment (M30 only)
Capnography (M30 only)

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical performance targets or a detailed study demonstrating that the device meets these criteria. Instead, it focuses on establishing substantial equivalence to predicate devices for a patient monitor (Mediana Lucon M-series M20, M30).

However, based on the information provided, we can infer the approach used to demonstrate performance and substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document repeatedly states that the Mediana Lucon M-series has "identical" or "similar" specifications and uses "identical technology" or "same technology" as the predicate devices. It also mentions compliance with relevant performance standards.

Acceptance Criteria Category	Reported Device Performance (as inferred from predicate device comparison)
Electrocardiography (ECG)	- ECG module (MDE-1) is identical to that in Omron HBP-2070. - ECG and heart rate specifications are identical to Omron HBP-2070. - ECG measurement performance is similar to Philips SureSigns VM6. - Uses identical technology as predicate devices.
Noninvasive Blood Pressure (NIBP)	- NIBP module (M3200) is identical to that in Omron HBP-2070. - NIBP specifications are identical to Omron HBP-2070. - Complies with AAMI performance standard SP-10 & IEC60601-2-30. - Uses same technology as predicate devices (Omron HBP-2070 and Philips SureSigns VM6).
Functional Arterial Oxygen Saturation (SpO2)	- SpO2 module (NELL-3) is used in Spacelabs mCARE 300, 91220 and Omron HBP-2070. - SpO2 specifications are identical to Omron HBP-2070 and Spacelabs 91220. - Complies with performance standard ISO9919.
Respiration Rate (RR)	- Algorithm of Impedance measurement is identical to Omron HBP-2070. - Respiration specification is identical to Omron HBP-2070. - Respiration measurement (Thoracic Impedance) for Lucon M-series and Spacelabs 91220 are from the same ECG module (designed and manufactured by Mediana).
Capnography (EtCO2)	- Algorithm of Airway Measurement has identical performance to Spacelabs 91220. - Airway Measurement is from Capnography module (Philips Respironics Inc.). - Operation theory of Airway Measurement in Welch Allyn Propaq Encore 200 series is same as Lucon M-series (M30 only) and Spacelabs 91220. - Uses Capnostat 5 and Lo Flo C5 modules (already FDA registered: K042601, K053174) which are identical to modules used in Spacelabs 91220. - Minor differences in Capnography specification between Lucon M-series (M30 only) and identified predicate devices; all three devices have identical technology and operation theory for Capnography.
Temperature (Temp)	- Thermometry MDT-1 module is identical to that in Omron HBP-2070 and Spacelabs 91220. - Temperature measurement technology is equivalent to Omron HBP-2070 and Spacelab 91220. - Uses YSI 400 and 700 probes/probe covers, identical to predicate devices.
Pulse Rate (PR)	- Derived from NIBP channel (M3200 module), identical to Omron HBP-2070. - Derived from SpO2 channel (NELL-3 module), identical to Omron HBP-2070 and Spacelabs 91220.
General Device Functionality	- Internal power source (rechargeable lead acid battery and AC power) is similar to predicate devices. - Overall safety and effectiveness, and compliance with appropriate medical device standards, stated to be substantially equivalent to predicate devices.

Study Details:

The submission highlights a "Summary of Performance Testing" but provides very limited details about the actual studies conducted to prove the device meets acceptance criteria.

Sample size used for the test set and the data provenance:
- The document states that the device "substantially have been tested... with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market."
- No specific sample size for a test set is mentioned.
- No information on data provenance (e.g., country of origin, retrospective or prospective) is provided. The testing seems to be internal verification and validation (V&V) against design specifications and predicate device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The testing described involves technical performance characteristics, not clinical interpretation that would require expert ground truth.
Adjudication method for the test set:
- Not applicable/Not mentioned. Given the nature of the technical performance testing described, an adjudication method like 2+1 or 3+1 would not be relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a patient monitor, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Performance Testing" refers to the device's technical specifications and how it performs in measuring various physiological parameters. This would be standalone performance of the device's modules and algorithms. The core argument for substantial equivalence relies on the identical/similar technology and specifications to the predicate devices, which suggests an evaluation of the device's intrinsic measurement capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of device would typically be reference standards or highly accurate measurement equipment used to validate the accuracy and precision of each physiological parameter (ECG, NIBP, SpO2, Temp, RR, EtCO2). For example, NIBP accuracy might be validated against an invasive arterial line or a calibrated simulator. The document also mentions compliance with specific performance standards (e.g., AAMI SP-10, IEC60601-2-30, ISO9919), which define test methods and acceptance criteria.
The sample size for the training set:
- Not applicable/Not mentioned. This device does not appear to use a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement technologies, often implemented as modules from reputable manufacturers (Omron, Nellcor, Philips Respironics).
How the ground truth for the training set was established:
- Not applicable/Not mentioned. As there's no mention of a traditional training set for an AI algorithm, this question is not relevant. The performance is validated against established medical device standards and the performance of predicate devices.

Summary

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JUN - 8 2010

510(k) Summary of Safety and Effectiveness

Submitter

Mediana Co.,Ltd.
	Dongwha Medical Instrument Complex, 1650-1, Donghwa-ri, Munmak-eup,
Wonju-si, Gangwon-do, Korea
Tel) +8270-7092-9983	Fax) +822-542-7447
Company Contact:	Amy M.H.KIM, Manager of Regulatory AffairsWon W.N.LEE, Specialist of Regulatory Affairs
Date Summary Prepared:	November 2nd, 2009
Device Name
Trade Name:	Lucon M-series (M20, M30) patient monitor
Common Name:	Patient Monitor
Classification Name:	Cardiac Monitor (21CFR870.2300) also containsMonitor, Physiological, Patient (21CFR870.2300)(including arrhythmia detection or alarms),Arrhythmia Detector and alarm (21CFR870.1025)(including ST-segment measurement and alarm),NIBP measurement system (21CFR870.1130),Electrocardiograph (21 CFR870.2340)

Class II Classification:

Predicate Devices (Legally Marketed Devices)

The predicate devices for Vital signs monitors, Model Lucon M-series (M20, M30) are:

Non-invasive pulse oximetry, SpO2 (21CFR870.2700) and Clinical electronic thermometer (21CFR870.2910)

Omron Health care Co.,Ltd. Vital Signs Monitors, Model HBP-2070 cleared by FDA through 510(k) No. K082812, and
Philips Medical Systems Co.,Ltd. Patient Monitors, SureSigns VM6 series . cleared by FDA through 510(k) No. K080495, and
Welch Allyn Protocol Inc. Cardiac Monitors, Propaq Encore 200 series . cleared by FDA through 510(k) No. K012451, and
Spacelabs Healthcare Inc. Vital Signs Monitors, Model 91220 . cleared by FDA through 510(k) No. K062095.

Device Description

Electrocardiography (ECG) i
Heart rate (HR) .
Noninvasive blood pressure (NIBP) .
Functional arterial oxygen saturation (SpO2)
Pulse rate (PR)
Respiration rate (RR) .
Temperature (Temp)
Arrhythmia/ST segment (M30 only) .
Capnography (M30 only)

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Intended Use

Electrocardiography (ECG)
Heart rate (HR)
Noninvasive blood pressure (NIBP) ı
Functional arterial oxygen saturation (SpO2)
Pulse rate (PR) .
Respiration rate (RR) .
Temperature (Temp)
Arrhythmia/ST segment (M30 only)
Capnography (M30 only)
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, surgical centers, and sub acute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

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

The Mediana patient monitors, Model Lucon M-Series (M20, M30) are substantially equivalent to the HBP-2070 of Omron Healthcare(No. K082812), SureSigns VM6 series of Philips Medical Systems (No. K080495), and Propag Encore Model 200 series of Welch Allyn Inc (No. K012451). and mCARE 300, Model 91220, Vital Signs Monitor of Spacelabs Medical(No. K062095).

The Lucon M-series (M20, M30) monitors use the Mediana ECG module, MDE-1 which is identical to the module used in the HBP-2070. The Electrocardiegram(ECG) and heart rate specifications for the Lucon M-series (M20, M30) and HBP-2070 are identical. The ECG measurement performance in VM6 is similar to those in the Lucon M-series (M20, M30) monitors. Because those devices are used identical technology to measure the ECG parameter,
The Lucon M-series (M20, M30) monitors use the Omron NIBP module M3200 which is identical to the module used in the HBP-2070. The Non-invasive blood pressure (NBP) specifications for the Lucon M-series (M20, M30) and HBP-2070 are identical. And these devices and SureSigns VM6 series comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same technology to measure the NIBP parameter,

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The Lucon M-series (M20, M30) monitors use the Nellcor Sp02 module, NELL-3 which is used in the mCARE 300, 91220 and HBP-2070. The Pulse Oximetry (SpO2) specifications for the model Lucon M-series (M20, M30), HBP-2070 and 91220 are identical. Also, all devices comply with the performance standard ISO9919.
The Respiration can be obtained from either the Electrocardiogram (ECG) channel or the Capnography (EtCO2) channel. The algorithm of Impedance measurement in HBP-2070 is identical to that in Lucon M-series (M20, M30) and the respiration specification for the Lucon Mseries (M20, M30) and HBP-2070 are identical Because the respiration measurement (Thoracic Impedance) for HBP-2070 and 91220 are from ECG module that are the same module designed and manufactured by Mediana Co.,Ltd.,
The Capnography (EtCO2) module is installed to Lucon M-series (M30 only), The algorithm of Airway Measurement in 91220 has identical performance of Lucon M-series (M30 only). Because Airway Measurement is from Capnography module which is manufactured by Philips Respironics Inc. The operation theory of Airway Measurement in Propaq Encore 200 series is same as those in Lucon M-series (M30 only) and 91220 for respiration measurement,
The Lucon M-series (M20, M30) monitors use the thermometry MDT-1 module which is identical to used in HBP-2070 and 91220. The Temperature measurement technology is equivalent for the model Lucon M-series (M20, M30), HBP-2070 and 91220. Also YSI 400 and 700 probes/probe covers are used for all of these device,
The Pulse rate derived from the non-invasive blood pressure (NIBP) channel is from M3200 NIBP module in Lucon M-series (M20, M30). Also, this M3200 module is used for HBP-2070 . And the pulse rate derived from the Pulse Oximetry (SpO2) channel is from NELL-3 SpO2 modules in Lucon M-series (M20, M30). Also, this NELL-3 module is used for HBP-2070 and 91220 too.
The Lucon M-series (M30 only) monitors use the Capnostat 5 and Lo Flo C5 which have already been registered in FDA by Philips Respironics Inc. (#K042601 is for Capnostat 5, #K053174 is for Lo Flo C5). The Capnography measurement module in Lucon M-series (M30 only), is from Respironics Capnography module, both modules are identical to the modules used in the 91220. Also the difference of Propaq Encore 200 series in Capnography specification is minor between the identified predicate devices for all measurements. All 3 devices have identical technology and operation of theory for Capnography,
- The model Lucon M-series (M20, M30) monitors as well as the predicate devices have internal power source, a rechargeable lead acid battery and AC power.

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Summary of Performance Testing

The Mediana vital signs monitors, Model Lucon M-series (M20, M30) substantially have been tested The Mediance with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market.

A risk analysis identifying potential hazards and documenting mitigation of the hazards has been A risk analysis lochitrying potential nazards and documenting andigations's quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas).

Conclusions

As stated above, the Mediana patient monitors, Model Lucon M-Series (M30, M20) are safe and I its survey and comply with the appropriate medical device standards and are substantially equivalent to the earlier identified predicate devices.

End of Section -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.

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

Mediana Co., Ltd. c/o Mr. Charles Mack Principal Engineer International Regulatory Consultants, LLC 77325 Joyce Way Echo, OR 97826

JUN - 8 2010

Re: K100217

Trade/Device Name: Lucon M-series (M20, M30) Patient Monitor Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: May 15, 2010 Received: May 19, 2010

Dear Mr. 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) 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.

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Page 2 - Mr. Charles 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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. Dongwha Medical Instrument Complex, 1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Telephone: (82) 70 7092 9983 Fax: (82) 33 742 5498

510(k) Number: : _

Device Name: Lucon M-series (M20,M30), patient monitor

Indications for Use:

The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediative mass about The Lucon M-Scrites (M20, NE07 is interest and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

· Electrocardiography (ECG)
· Heart rate (HR)
· Noninvasive blood pressure (NIBP)
· Functional arterial oxygen saturation (SpO2)
· Pulse rate (PR)
· Respiration rate (RR)
· Temperature (Temp)
· Arrhythmia/ST segment (M30 only)
· Capnography (M30 only)
Note: Hospital use typically includes such areas as general care filosos, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital Special procedure arous, intonian office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.

Note: The medically skilled and trained user can be clinicians like doctors and nurses who I he medically skilled and interpret a patient's vital signs. These clinicians must take direct Know now to take and micrpret a pattent's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to interpreters who are authorized under the uppropriate setting, especially the alarm support pattent care. Ally mappropriate setting, coposially and injures the patient, harms the notification settings, can read to a nazzingous should only be operated by trained users who can adjust the settings of the patient monitor.

(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 Devices
510(k) Number	K060214

Prescription Use (Per 21CFR801.109)	X	OR Over-The-Counter
-------------------------------------	-----------------------------------------	---------------------

End of Section -

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.