Not Found
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for monitoring vital signs and does not provide any therapeutic function like treating or preventing a disease.
Yes
The device is intended to monitor physiological parameters (blood pressure, SpO2, pulse rate, temperature), which are used by medical professionals to assess a patient's health status and aid in 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 "7-segment and LED 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:
- Intended Use: The intended use clearly states that the device is used to monitor vital signs (blood pressure, SpO2, pulse rate, temperature) directly from the patient.
- Device Description: The description reinforces that it's a vital signs monitor that takes measurements from the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly monitor physiological parameters on the body.
N/A
Intended Use / Indications for Use
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) 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, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
Note: Hospital use typically includes such 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 how 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 vital signs monitor.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, FLL
Device Description
The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana V10 vital signs monitor is a lightweight and compact device (298 × 218 × 172 (mm) (W×H×D) and 3.4 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment and LED displays.
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, doctor, nurse or medical specialist.
in all areas of a hospital and hospital-type facilities. Hospital use typically includes such 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 monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 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 developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21CFR820, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051375, K100225, K142825, K102426, K060649
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
Mediana Co., Ltd % Mr. Charlie Mack, President International Regulatory Consultants, LLC 77325 Joyce Way Echo. Oregon 97826
Re: K152659 Trade/Device Name: V10 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, FLL Dated: July 11, 2016 Received: July 25, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152659
Device Name
V10
Indications for Use (Describe)
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) 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, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
Note: Hospital use typically includes such as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the 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 how 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 vital signs monitor.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary of Safety and Effectiveness
Submitter
Mediana Co., Ltd 132, Donghwagongdan-Ro, Munmak-Eup, Wonju-Si, Gangwon-Do, Korea Tel) +82-33-742-5400 Fax) +82-33-742-5483
Company Contact: Min-hye, Kim
Date Summary Prepared: July 31th, 2015
Device Name
| Trade Name: | V10 |
|---|---|
| Common Name: | Vital Signs Monitor |
| Classification Name: | NIBP measurement system (21CFR870.1130), also contains |
| non-invasive pulse oximetry, SpO2 (21CFR870.2700) and | |
| clinical electronic thermometer (21CFR880.2910) | |
| Classification: | Class II |
| Product Code: | DXN, DQA, FLL |
Predicate Devices (Legally Marketed Devices)
The predicate device for the V10 are:
- . Mediana Co., Ltd. Vital Signs Monitors, Model ARGUS VCM Cleared by FDA through 510(k) No. K051375, and
- = Mediana Co., Ltd. Pulse Oximeters, Model P10 Cleared by FDA through 510(k) No. K100225, and
- " Covidien LLC. Pulse Oximeters, Model Nellcor Bedside SpO2 Patient Monitoring System, K142825, and
- = GE Healthcare. Vital Signs Monitors, Model CARESCAPE V100 Cleared by FDA through 510(k) No. K102426, and
- = Tyco Healthcare Group, LP. Infrared Tympanic Thermometers, Model Kendall Genius 2 Cleared by FDA through 510(k) No. K060649
Device Description
The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana V10 vital signs monitor is a lightweight and compact device (298 × 218 × 172 (mm) (W×H×D) and 3.4 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment and LED displays.
4
Intended Use
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) 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, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
- Note: Hospital use typically includes such 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 how 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 vital signs monitor.
Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)
The Mediana vital signs monitor, Model V10 is substantially equivalent to Mediana Co., Ltd. vital signs monitors Model ARGUS VCM, Mediana Co., Ltd. Pulse Oximeter Model P10, Covidien LLC. Pulse Oximeter Model Nellcor Bedside SpO2 Patient Monitoring System, GE Healthcare vital signs monitors Model CARESCAPE V100 and Tyco Healthcare Group, LP. Infrared tympanic thermometers Model Kendall Genius2.
- The Non-Invasive Blood Pressure (NIBP) measurement specifications and = performance are equivalent to Mediana Co., Ltd. vital signs monitors Model ARGUS VCM. Mediana Co., Ltd. vital signs monitors Model ARGUS VCM complies the same AAMI SP10 standard as Mediana vital signs monitor, Model V10.
- = The Pulse rate specifications and performance derived from either Non-Invasive Blood Pressure (NIBP) or Pulse Oximetry (SpO2) are equivalent to Mediana Co., Ltd. vital signs monitors Model ARGUS VCM, Mediana Co., Ltd. Pulse Oximeter Model P10, Covidien LLC. Pulse Oximeter Model Nellcor Bedside SpO2 Patient Monitoring System.
- = The Pulse Oximetry (SpO2) specifications and performance are equivalent to Mediana Co., Ltd. Pulse Oximeter Model P10, Covidien LLC. Pulse Oximeter Model Nellcor Bedside SpO2 Patient Monitoring System.
- The Temperature specifications and performance are equivalent to GE Healthcare vital signs monitors Model CARESCAPE V100 and Tyco Healthcare Group, LP. Infrared tympanic thermometers Model Kendall Genius2.
5
Summary of Performance Testing
The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 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 developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21CFR820, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas).
Conclusions
As stated above, the V10 is safe and effective, complies with the appropriate medical device guidance and standards and is substantially equivalent to the predicate device.