(250 days)
K994008, K05219
Not Found
No
The description focuses on standard signal processing (Doppler Ultrasound, digital filter) and basic monitoring functions with alerts based on preset limits, not AI/ML algorithms.
No.
The device is a monitor that measures and records maternal contraction and fetal heart rate; it does not provide any therapy.
Yes
The device is a fetal monitor that measures fetal heart rate and uterine contractions, which are used to predict fetal status, thus providing diagnostic information.
No
The device description explicitly mentions hardware components such as a front panel LCD, strip chart recorder, RS232 port, Doppler Ultrasound transducers, TOCO transducer, pressure sensors, thermal printer, and a power adaptor. It is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the FM20 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the living body ("in vitro").
- FM20 Function: The FM20 is a fetal monitor that uses Doppler Ultrasound applied to the abdomen of a pregnant woman to measure fetal heart rate and uterine contractions. This is a non-invasive procedure performed on the living body ("in vivo").
The device description clearly states it uses ultrasound and pressure sensors applied externally to the patient. It does not involve the analysis of biological specimens.
N/A
Intended Use / 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (PWD)
Product codes (comma separated list FDA assigned to the subject device)
HGM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler Ultrasound
Anatomical Site
abdomen of a pregnant woman (fetus), Uterine
Indicated Patient Age Range
pregnant woman
Intended User / Care Setting
Not Found
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)
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.
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.
K994008, K05219
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
§ 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).
0
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 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
1
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
2
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
3
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
4
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
5
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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6
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | P | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(specify) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Pheperial | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Lapaloscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
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