(352 days)
FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Twelve hours of tracing may be stored and later retrieved for printing. It intended to be used by trained healthcare personnel. It is not intended for home use.
FC-1400 is a fetal monitor, providing continuous monitoring, displaying, printing and recording of twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) for antepartum testing and monitoring. FC-1400 irradiates the ultrasound from the external abdomen, and detects the Doppler effect signal reflected from the heart of the fetus. FC-1400 detects the Doppler effect signal reflected from the heart of the fetus and provides the fetal heart beat sound with internal speaker. FC-1400 measures the UA of a pregnant woman using TOCO sensor. FC-1400 displays FHR, UA and FM with waveforms and numbers in a real time on the color LCD viewer, and also stores them in internal flash memory and prints a part of them with high speed to review in details. It provides the most accurate and continuous obstetrical measurements enduring and rigorous hospital environment. FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) and Uterine Activity (UA) in a real time on the color LCD viewer, and also provides the fetal heart beat sound with internal speaker. Twelve hours of tracing may be stored and later retrieved for printing. It is not intended for home use.
The provided 510(k) summary for the BioNet FC-1400 Perinatal Monitor does not include information about specific acceptance criteria or performance studies comparing the device against such criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (FETALGARD Lite and Philips Avalon CTS Cordless Fetal Transducer System) by comparing technological characteristics and adherence to safety and electromagnetic compatibility standards.
Here's an breakdown of the requested information based on the provided text, highlighting what is not available:
-
A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify quantitative acceptance criteria for parameters like FHR accuracy, FM detection sensitivity, or UA measurement accuracy. It generally states the device provides "accurate and continuous obstetrical measurements" but does not provide specific performance metrics against defined targets.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "NONCLINICAL TESTS" for electrical safety, EMC, and biocompatibility, but these are not performance studies related to the clinical function of FHR, FM, or UA monitoring. No details about clinical test sets, sample sizes, or data provenance (country, retrospective/prospective) are provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. As no clinical performance study involving a test set and ground truth is described, this information is absent.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. No clinical test set or adjudication method is described.
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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
- Not Applicable. This device is a perinatal monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs functions (detecting and displaying FHR, FM, UA). However, the document does not describe a standalone performance study (algorithm only) with quantitative results against specific criteria. The focus is on demonstrating equivalence to predicate devices through design characteristics and safety standards, rather than direct, standalone clinical performance measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. As no clinical performance study involving a test set and ground truth is described, this information is absent.
-
The sample size for the training set
- Not Applicable. This type of device (a monitor) typically does not involve a "training set" in the context of machine learning or AI algorithms as diagnostic tools would. Its performance is based on sensor technology, signal processing, and display, not on being "trained" on data.
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How the ground truth for the training set was established
- Not Applicable. See point 8.
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DEC 1 6 2005
510(k) Summary
(As required by 21 CFR 807.92(c))
| SUBMITTER BY | BIONET CO., LTD. | ||
|---|---|---|---|
| 401 Kikox Venture Tower | |||
| 188-5 Guro-Dong, Guro-Gu | |||
| Seoul, REPUBLIC OF KOREA | |||
| (PHONE) | 82-2-6300-6410 | ||
| (FAX) | 82-2-6300-6425 | ||
| CONTACT PERSON | (NAME) | Hyun-Joo Kwon | |
| (TITLE) | Regulatory Affairs Engineer | ||
| (PHONE) | 82-2-6300-6433 | ||
| (FAX) | 82-2-6300-6425 | ||
| US AGENT | (NAME) | Mr. Steven Minn | |
| (ADDRESS) | BIONET AMERICA, INC. | ||
| 3345 Wilshire Blvd., Suite 811 | |||
| Los Angeles, CA 90010 | |||
| (PHONE) | 888-292-6060 | ||
| (FAX) | 213-389-0036 | ||
| DATE OF SUMMARY | December 24, 2004 | ||
| DEVICE NAME | (Proprietary Name) | FC-1400 | |
| (Common Name) | FC-1400 | ||
| (Classification Name) | Perinatal monitoring system and accessories | ||
| (Regulation Number) | 21 CFR §884.2740 | ||
| (Regulatory Class) | II | ||
| (Product Code) | HGM | ||
| PREDICATE DEVICES | 510(k) Number: K002503 | ||
| Device Name: | FETALGARD Lite | ||
| Submitter by: | Analogic Corporation |
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6043598
DEVICE DESCRIPTION
FC-1400 is a fetal monitor, providing continuous monitoring, displaying, FC-1400 is a lefal monton, providing continuous (FHR), Fetal Movement
printing and recording of twin Fetal Heart Rate (FHR), Fetal Movement
manitaring of twin Fetal Heart Ra printing and recording of twin I can really rait (esting and monitoring.
(FM) and Uterine Activity (UA) for antepartum testing and monitoring ond (FM) and Uterme Activity (Ort) for anternal abdomen, and PC-1400 Ifradiates the unrasound from the heart of the fetus.
detects the Doppler effect signal reflected from the heart of the the delects the Doppier Chect signal checked and provides the fetal heart beat sound with internal speaker. FC-1400 measures the UA of a pregnant woman using TOCO
sensor.
sensor.
FC-1400 displays FHR, UA and FM with waveforms and numbers FC-1400 displays Frir, Or use them in internal flash memory and prints a part of them with high speed to review in details. prints a part of them with mgn speca securate and continuous obstetrical measurements
enduring and rigorous hospital environment.
FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal PC-1400 uctects and Uterine Activity (UA) in a real time on the color Movement (FM) and Otcrine Act. 115 (Cheat sound with internal
LCD viewer, and also provides the fetal heart beat sound with internal LCD viewer, and also provides and loter recined and later retrieved for speaker. Tweive nours of tracing may or a healthcare personnel. It is not intended for home use.
COMPARISION OF TECHNOLOGICAL CHARACTERISTICS
INTENDED USE
| Comparison Areas | FC-1400 | Predicate Device |
|---|---|---|
| Indications for use | This detects and displays twin Fetal Heart Rate(FHR), Fetal Movement (FM) and UterineActivity (UA) in a real time on the color LCDviewer, and also provides the fetal heart beatsound with internal speaker. Through the colorLCD viewer user can trace a stored data for 12hours easily and print a part of them with highspeed to review in details. It provides the mostaccurate and continuous obstetrical measurementsenduring noisy and rigorous hospital environment. | Similar |
| Where used | It intended to be used by trained healthcarepersonnel. It is not intended for home use. | Identical |
| Performance | Fetal Heart Rate (FHR) for single or twinUterine Contraction (UC)Printing Monitoring ResultsInterface through RS232 | Similar |
| Standard met | -Electrical safety: IEC60601-1-EMC: IEC60601-1-2) so on.-Biocompatibility: ISO10993 | Similar |
It has tested for electrical safety according to IEC60601-1, NONCLINICAL TESTS it has tested for crecuried. Sility according to IEC60601-1-2, and electromagnetic compansions with the guidelines of International blocompationity in accordance was areas and are and of Medical Devices.
FC-1400 is substantial equivalent to predicated device FETALGARD CONCLUSION FC-1400 is substantial equivalent to production and Philips Avalon CTS
Lite(K002503) of Analogic Corporation and Philips Avalon CTS Ene(K002305) of Fridler System(K023931) of Philips.
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Ko43598
| NONCLINICAL TESTS | It has tested for electrical safety according to IEC60601-1,electromagnetic compatibility according to IEC60601-1-2, andbiocompatibility in accordance with the guidelines of InternationalOrganization for Standardization: Biological Evaluation of MedicalDevices. |
|---|---|
| CONCLUSION | FC-1400 is substantial equivalent to predicated device FETALGARDLite(K002503) of Analogic Corporation and Philips Avalon CTSCordless Fetal Transducer System(K023931) of Philips. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioNet/BioNet America, Inc. % Mr. Sun-Young Jeong Regulatory Affairs Engineer Research Institute for Medical Instruments Medical Industry Techno Tower R205, 1272 Maeji Heungup Wonju, Kwangwon-Do Republic of Korea
Re: K043598
DEC 16 2005
Trade/Device Name: FC-1400 Perinatal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: November 22, 2005 Received: November 22, 2005
Dear Mr. Jeong:
We have reviewed your Section 510(k) premarket notification of intent to make the device referenced in We have reviewed your Section 510(x) premainter institutions for use stated in
above and have determined the device is substantially equivalent (for use stated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to regary marketed predical Device Amendments, or to devices that have been May 28, 1976, the chacultient date of the Federal Food, Duy, and Cosmetic Act (Act) that reclassified in accordance with the provisions of any its and a you may, therefore, market the A do not require approval of a prematics approval approval controls provisions of the Act
device, subject to the general controls provisions of the Act. The general controls p device, subject to the general controls of the real " in governments on the mactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into entrols. Existing major regulations affecting your Approval), it may be subject to such additional vontrols. Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Part device can be found in the Couc of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issualice of a substanning with other requirements of the Act or ally
FDA has made a determination that your device complies with other sepply wi FDA has made a determination mar your device concess. You must comply with all the Federal statues and regulations administer of other the registration and listing (21 CFR Part 807); abouting (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801), good manufacturing practice request radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nothication. The PDA midnig of succession for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do research of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entities, "Thisorial on your responsibilities under the Act from the 807.97). You may obtain outer general information on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
BIONET CO., LTD. APPLICANT
Ko4 3598 510(k) NUMBER
FC-1400 DEVICE NAME
INDICATIONSFOR USE
FC-1400 detects and displays twin Fetal Heart Rate (FHR), Fetal Movement (FM) r C-1400 detects and displays than time on the color LCD viewer, and also allo Otenne Actrity (OTY) in a real unto vith internal speaker. Twelve hours of tracing provides the rear noart bear oved for printing. It intended to be used by trained healthcare personnel. It is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , *** な
§ 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).