The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 port to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.

Device Description

FM20 is the fetal monitor that measures uterine contractions and fetal heart rate (FHR) which may be used to predict fetal status. To detect the Doppler frequency signal reflected from the heart of the fetus, FM20 irradiates ultrasound wave to the abdomen of a pregnant woman. FM20 analyzes this signal and displays the heart rate by LCD. Also, FM20 provides the sound from the heart of fetus. FM20 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FM20 prints the heart rate of the fetus and the values of uterine contraction. FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter. FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. FM20 has a free voltage(100 - 240VAC input) power adaptor. FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter. FM20 has Event marker function so that the patient can record the time of important events. FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.

AI/ML Overview

The provided text describes a 510(k) submission for the Mediana FM20 Fetal Monitor, focusing on its substantial equivalence to predicate devices. The document highlights the device's technical characteristics, indications for use, and safety testing but does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics. It primarily states that "All test results were satisfactory" for safety, EMC, and performance testing according to standards EN/IEC 60601-1 and EN/IEC 60601-1-2.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the specifications and performances (FHR monitoring, UC monitoring, Transducer type, ultrasound frequency, FHR range, FHR accuracy, Detection of fetal movement via ultrasound transducer) of Mediana Model FM20 are equivalent to the predicate devices (Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500). However, it does not explicitly list numerical acceptance criteria or the specific performance values achieved by the FM20.

Acceptance Criteria (Example)	Reported Device Performance (Example)
FHR Accuracy: [Not specified]	Equivalent to predicate devices
UC Monitoring: [Not specified]	Equivalent to predicate devices
Ultrasound Frequency: [Not specified]	Equivalent to predicate devices
FHR Range: [Not specified]	Equivalent to predicate devices
Fetal Movement Detection: [Not specified]	Equivalent to predicate devices
Electrical Safety: EN/IEC 60601-1	Satisfactory
EMC Testing: EN/IEC 60601-1-2 (2001)	Satisfactory

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify any sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for a clinical study. The information provided heavily relies on the equivalence to predicate devices and adherence to electrical/EMC standards, rather than new clinical performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical characteristics and safety standards, not on direct comparison of human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes the device as a "Fetal Monitor," implying it's a standalone monitoring device. However, it doesn't detail performance studies for the algorithm in isolation. Its performance is stated as "equivalent" to predicate devices, which are also standalone fetal monitors. The device does have features like "Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter" and "capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay," which represent algorithm-driven functions. However, quantitative standalone performance metrics for these functions are not provided.

7. The Type of Ground Truth Used:

Ground truth, in the context of clinical performance evaluation (e.g., pathology, outcomes data, expert consensus), is not explicitly mentioned or used in this submission. The "ground truth" for the device's acceptable performance appears to be its adherence to established electrical, mechanical, and environmental safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2) and its technical equivalence to previously cleared predicate devices.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe a machine learning algorithm that would require a training set in the conventional sense. The device's "Fetal movement detection function" uses a "circuit and digital filter," suggesting a more traditional signal processing approach rather than a machine learning model requiring a large training dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a training set for a machine learning algorithm is not described.

Summary

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NOV - 8 2011 K110612
Page 1 of 3
Submission – EM20

Mediana Co.,Ltd.510(k)

Submission - FM

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter

Mediana Co., Ltd. Dongwha Medical Instrument Complex, 1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel) +82-70-7092-9964 Fax) +82-2-542-7447 Company Contact: Amy M.H. Kim Date Summary Prepared: October 26, 2010

Device Name

Trade Name:	FM20
Common Name:	System, Monitoring, Perinatal
Classification Name:	System, Monitoring, Perinatal (21CFR 884.2740, HGM.)
Classification:	Class 2

Predicate Device (Legally Marketed Devices)

The predicate devices for Fetal Doppler, Model FM20 are:

Biosys Co., Ltd. Ultrasonic fetal Monitor, IFM-500 cleared by FDA through 510(k) No. K994008 (Decision Date - Sep. 29. 2000), and
. Bistos Co., Ltd. Ultrasonic Fetal Monitor, BT-300 cleared by FDA through 510(k) No. K05219 (Decision Date - Oct. 4. 2005)

Device Description

FM20 measures the uterine contraction of a pregnant woman by pressure sensors and

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Submission - FM20

displays the numerical values.

And FM20 prints the heart rate of the fetus and the values of uterine contraction.

FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter.
FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers.
FM20 has a free voltage(100 - 240VAC input) power adaptor.
FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter.
FM20 has Event marker function so that the patient can record the time of important events.
FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.

Indications for Use

The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.

Summary of Indications and Technical characteristics of the Device compared to the Predicate Device (Legally Marketed Devices)

The Mediana Fetal Doppler, Model FM20 is substantially equivalent to the Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500.

-Indications

The intended use and indications are equivalent to the Bistos Co.,Ltd. Model BiOSYS BT-300. and Co.,Ltd, Model IFM-500. The mode of operation(Ultrasound mode, Contraction), Uterine System characteristics(Portable, Strip chart recorder, Power sources) of Mediana Model FM20 is same as those of the Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500.

Technical characteristics

The specifications and performances(FHR monitoring, UC monitoring, Transducer type, ultrasound frequency, FHR range, FHR accuracy, Detection of fetal movement via ultrasound transducer) of Mediana Model FM20 are

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K110612
Page 3 of 3

Submission - FM20

equivalent to the Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500.

Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Mediana Co., Ltd. concludes that FM20 are safe and effective and substantially equivalent to predicate devices as described herein.

Mediana Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.

End of Section

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

NOV - 8 2011

Mediana Co., Ltd. % Mr. Marc M. Mouser Engineering Manager & FDA Office Coordinator, Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K110612

Trade/Device Name: FM20 Fetal Monitor Regulation Number: 21 CFR& 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: October 7, 2011 Received: October 24, 2011

Dear Mr. Mouser:

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 of medical device-related

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Page 2

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Leuner MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110612

FM20 Fetal Monitor Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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FM20 Fetal Monitor

510(k) Submission · .

Appendix·F

Diagnostic Ultrasound Indications For Use Form

Fill out one form for each ultrasound system and each transducer.

1MHz PW DOPPLER FETAL PROBE – MODEL : FM20

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as 14 1 follows: ,

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(Specify)
Ophthalmic
Fetal				P
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Pheperial
Vascular
Lapaloscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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Additional Comments :

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUT ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Deyce Evaluation(ODE)

Hulsteen

Prescription Use(Part 21 CFR 801.109)

ivision Sign-Off) n of Reproductive. Gastro-Re

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).