(134 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard vital sign monitoring technologies.
No.
Explanation: The device is intended for monitoring vital signs and not for treating any condition.
No
The device is intended to monitor vital signs and patient data, not to diagnose a condition or disease. It is used for continuous observation rather than providing a medical diagnosis.
No
The device description explicitly states it is a "lightweight and compact device" with physical dimensions and weight, powered by AC mains and an internal battery, and provides data on "TFT-LCD displays." This indicates it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a patient monitor that measures physiological parameters directly from the patient's body (ECG, NIBP, SpO2, Temperature, etc.). It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for monitoring patients in a clinical setting, not for performing laboratory tests on samples.
Therefore, the Lucon M-series is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MHX
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) 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
Monitor users should be skilled at the level of a technician. 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.
in all areas of a hospital and hospital-type facilities. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082812, K080495, K012451, K062095
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Affairs |
| Won 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 contains |
| Monitor, 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
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) 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)
1
Intended Use
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) 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,
2
- 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.
3
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 -
4
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.
5
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
6
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 -