The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) 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 V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

Device Description

The Mediana V20, V20a, AVSM3 SNF vital signs monitors are a lightweight and compact device (249 x 211 x 176 (mm) (W×H×D) and 3.1 kg for Standard configuration) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 8″ TFT-LCD screen.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Mediana V20, V20a, AVSM3 SNF vital signs monitors.

Important Note: The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices rather than providing detailed, standalone clinical study results for the new device. As such, direct answers to some of your specific questions (like sample sizes for specific new studies, number of experts for ground truth, or MRMC studies) are not explicitly present. The manufacturer is leveraging data from previously cleared devices and relying on the substantial equivalence principle.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the new devices (V20, V20a, AVSM3 SNF) with corresponding reported performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the new devices should perform equivalently to the cleared predicate devices according to established standards.

The performance characteristics are stated as:

Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR), Pulse Oximetry (SpO2), and Temperature (TEMP): The device's specifications and performance for these parameters are stated to be equivalent to the respective predicate devices.

Table of Acceptance Criteria (Inferred from Substantial Equivalence to Predicates):

Parameter	Inferred Acceptance Criteria	Reported Device Performance (V20, V20a, AVSM3 SNF)
Non-Invasive Blood Pressure (NIBP)	Performance equivalent to Mediana Co., Ltd. V10 vital signs monitors, SunTech LifeWindow LW8 Lite, and AND NIBP modules (supported by their original 510(k) submissions and clinical studies). This implies meeting the performance standards that these predicate devices met.	"The Non-Invasive Blood Pressure (NIBP) measurement specifications and performance are equivalent to Mediana Co., Ltd. vital signs monitors V10 and SunTech LifeWindow LW8 Lite. The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device."
Pulse Rate (PR)	Performance equivalent to Mediana Co., Ltd. V10 vital signs monitors, SunTech LifeWindow LW8 Lite, and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System. This implies meeting the performance standards that these predicate devices met.	"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 V10, SunTech LifeWindow LW8 Lite and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System."
Pulse Oximetry (SpO2)	Performance equivalent to Mediana V10 vital signs monitor and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System. This implies meeting the performance standards that these predicate devices met.	"The Pulse Oximetry (SpO2) specifications and performance are equivalent to Mediana V10 vital signs monitor and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System."
Temperature (TEMP)	Performance equivalent to Covidien Genius 2 thermometer, Covidien Filac 3000 thermometer, and Exergen thermometer. This implies meeting the performance standards that these predicate devices met.	"The Temperature specifications and performance are equivalent to Covidien Genius 2 thermometer, Covidien Filac 3000 thermometer and Exergen thermometer."
Safety and Effectiveness	Substantially equivalent to predicates.	"The Mediana vital signs monitor, Model V20, V20a, AVSM3 SNF substantially has been tested in accordance with the system V & V plan #MDR-EG160311-01 included with the submission using production equivalent units prior to release to market."
Bench Testing	Compliance with relevant standards (Electrical Safety, EMC, Environmental, ISTA 2A).	"The bench testing (electrical safety testing, EMC testing, IEC60068-2-27, IEC60068-2-64, IEC60068-2-1/2-2/2-30 and ISTA 2A test) has been performed and the results all tests demonstrate that the subject device is substantially equivalent to the predicated device."

Study Details:

Sample size used for the test set and the data provenance:
- The document does not provide specific sample sizes for new clinical test sets for the V20, V20a, AVSM3 SNF devices.
- It states that for NIBP, "The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device." This indicates that clinical data from the original predicate device manufacturers (SunTech and AND) are being leveraged. The provenance of that data would be tied to those original submissions, but it's not detailed here. For other parameters (SpO2, PR, Temp), it simply states equivalence, implying reliance on the predicate device's performance data without necessarily conducting new clinical trials for the Mediana V20 series.
- The document mentions "system V & V plan #MDR-EG160311-01" for performance testing, which is likely a combination of bench and possibly some limited clinical testing, but specifics are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Given the reliance on predicate device data and bench testing, direct ground truth establishment for a new clinical test set (as would be typical for an AI/algorithm-focused submission) doesn't seem to be the primary method for this 510(k).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided as there's no detailed description of a new clinical test where expert adjudication would be relevant for these types of vital signs measurements.
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, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic imaging devices. The devices in this submission (vital signs monitors) measure physiological parameters directly and do not involve "human readers" interpreting an AI output in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The devices perform automated measurements (NIBP, SpO2, PR, TEMP). The "performance" described is inherently standalone, as the device calculates and displays these values. However, "standalone performance" in the context of AI usually refers to the algorithm's output before human review. For these vital signs monitors, the measurement algorithm's performance is the device's performance. The document states the "specifications and performance are equivalent" to predicates, implying their algorithms produce comparable results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For such vital signs monitors, the "ground truth" for NIBP, SpO2, PR, and TEMP typically involves direct, invasive, or highly accurate reference measurements (e.g., invasive arterial line for NIBP, co-oximetry for SpO2, EKG for PR, highly accurate reference thermometers for TEMP). The document doesn't explicitly detail the ground truth methods used for the predicate studies it references.
The sample size for the training set:
- This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. Vital signs monitors often rely on traditional signal processing algorithms rather than machine learning models that require distinct training sets. Even if there were some adaptive algorithms, training set details are not mentioned.
How the ground truth for the training set was established:
- This information is not provided, as details about a "training set" in the context of this device are absent.

Summary

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October 9, 2020

Mediana Co., Ltd. % Charlie Mack Principal Engineer International Regulatory Consultants 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K200434

Trade/Device Name: V20, V20a, AVSM3 SNF Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, FLL Dated: August 30, 2020 Received: September 10, 2020

Dear Charlie 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200434

Device Name V20, V20a, AVSM3 SNF

Indications for Use (Describe)

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 ambulance, 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 notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatent'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 )
	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter

Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea Tel) +82-33-742-5400 Fax) +82-33-742-5483

Company Contact: Dana Mun

Date Summary Prepared: January 10th 2020

Device Name

Trade Name:	V20, V20a, AVSM3 SNF
Common Name:	Vital Signs Monitor
Classification Name:	NIBP measurement system (21CFR870.1130), also containsNon-invasive pulse oximetry, SpO2 (21CFR870.2700) andclinical electronic thermometer (21CFR880.2910)
Classification:	Class II
Product Code:	DXN, DQA, FLL

Predicate Devices (Legally Marketed Devices)

The predicate device for the V20, V20a, AVSM3 SNF are:

Mediana Co., Ltd. Vital Signs Monitors, V10 and AVSM2 . Cleared by FDA through 510(k) No. K170497
. Covidien, Nellcor™ Bedside Respiratory Patient Monitoring System Cleared by FDA through 510(k) No. K141518
. SunTech Cardiac Monitor, LifeWindow LW8 Lite Cleared by FDA through 510(k) No. K183687
. Covidien, Filac 3000 Thermometer Cleared by FDA through 510(k) No. K003313
. Exergen Termometer Cleared by FDA through 510(k) No. K011291

Device Description

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Intended Use

The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO-), pulse rate (PR) and temperature (TEMP) 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 V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

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 dinicians 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 subject device (Mediana vital signs monitor, Model V20, V20a, AVSM3 SNF, is substantially equivalent to Mediana vital signs monitor V10, Covidien Nellcor™ Bedside Respiratory Patient Monitoring System, SunTech Cardiac Monitor LifeWindow LW8 Lite, Covidien Filac 3000 Thermometer, Exergen Thermometer.

They have the same technological characteristics and material, and they are comparable in kev safety and effectiveness features and software design and have the same intended uses and basic operation modes as the predicate device.

The Non-Invasive Blood Pressure (NIBP) measurement specifications and performance are equivalent to Mediana Co., Ltd. vital signs monitors V10 and SunTech LifeWindow LW8 Lite. The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device.
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 V10, SunTech LifeWindow LW8 Lite and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System.
The Pulse Oximetry (SpO₂) specifications and performance are equivalent to Mediana V10 vital signs monitor and Covidien Nellcor™ Bedside Respiratory Patient Monitoring System.

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The Temperature specifications and performance are equivalent to Covidien Genius 2 thermometer, Covidien Filac 3000 thermometer and Exergen thermometer.

Summary of Performance Testing

The Mediana vital signs monitor, Model V20, V20a, AVSM3 SNF substantially has been tested in accordance with the system V & V plan #MDR-EG160311-01 included with the submission using production equivalent units prior to release to market.

The bench testing (electrical safety testing, EMC testing, IEC60068-2-27, IEC60068-2-64, IEC60068-2-1/2-2/2-30 and ISTA 2A test) has been performed and the results all tests demonstrate that the subject device is substantially equivalent to the predicated device.

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, ISO 13485 certified by BSI.

Conclusions

As stated above, the V20, V20a, AVSM3 SNF all comply with the appropriate medical device guidance and standards and are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).