FM20

K110612 · Mediana Co., Ltd. · HGM · Nov 8, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110612
• Device Name: FM20
• Applicant: Mediana Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Nov 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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 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 Story

FM20 is a fetal monitor for antepartum use; measures fetal heart rate (FHR) and uterine contractions. Inputs: ultrasound Doppler signals from fetus; pressure signals from external TOCO transducer. Processing: circuit and digital filter extract FHR and fetal movement; calculates uterine activity. Outputs: numerical values on 7" LCD; real-time strip chart recording; audible fetal heart sounds; RS232 data transmission. Features: twin monitoring via dual ultrasound transducers; event marker for patient use; heart rate limit alarms. Used in clinical settings by healthcare providers to assess fetal status and uterine activity; aids clinical decision-making regarding fetal well-being.

Clinical Evidence

Bench testing only. Performance and safety verified via electrical, mechanical, and environmental testing per EN/IEC 60601-1 and EMC testing per EN/IEC 60601-1-2. No clinical data provided.

Technological Characteristics

Portable fetal monitor; 7" LCD display; thermal strip chart recorder; RS232 connectivity. Sensing: pulsed Doppler ultrasound transducers (1MHz) for FHR; external TOCO transducer for uterine activity. Power: 100-240VAC. Safety standards: EN/IEC 60601-1 (electrical/mechanical), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for pregnant women during antepartum periods for monitoring fetal heart rate (single or twin) via Doppler ultrasound and maternal uterine contractions via external TOCO transducer.

Regulatory Classification

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.

Predicate Devices

• Biosys Co., Ltd. Ultrasonic fetal Monitor, IFM-500 (K994008)
• Bistos Co., Ltd. Ultrasonic Fetal Monitor, BT-300 (K05219)

Submission Summary (Full Text)

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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) [phone] Fax) [phone] 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 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

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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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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 [phone] or [phone] 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:

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.

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | P | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Pheperial | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Lapaloscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| 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