(352 days)
FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.
It intended to be used by trained healthcare personnel. It is not intended for home use.
FC-700 is the fetal monitor that measures the fetal heart rate and uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction.
This is a 510(k) summary for a medical device and describes a comparison to a predicate device, not a study evaluating the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from this document.
The document states that the FC-700 is "substantial equivalent to predicated device COROMETRICS MONITOR (K991905)". This means that the device's safety and effectiveness are deemed equivalent to the predicate device based on its similarity in technological characteristics, rather than a new clinical study with specific acceptance criteria.
However, I can provide what's available and point out what's missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document as such for FC-700 performance) | Reported Device Performance (as presented for FC-700) |
|---|---|
| Not explicitly stated. The document implies equivalence to the predicate device's performance. | Fetal Heart Rate (FHR): Measures and displays numerical values. |
| Not explicitly stated. | Uterine Contraction (UC): Measures and displays numerical values. |
| Not explicitly stated. | Fetal Movement Detection: Provides this function. |
| Not explicitly stated. | High/Low Heart Rate Alarm: Provides this function. |
| Not explicitly stated. | Printing Monitoring Results: Prints graphically. |
| Not explicitly stated. | Interface through RS232: Provides this function. |
| Electrical Safety (Implied: Compliance with IEC60601-1) | Tested for electrical safety according to IEC60601-1. |
| Electromagnetic Compatibility (Implied: Compliance with IEC60601-1-2) | Tested for electromagnetic compatibility according to IEC60601-1-2. |
| Biocompatibility (Implied: Compliance with ISO10993) | Tested for biocompatibility in accordance with International Standard: Biological Evaluation of Medical Devices (ISO10993). |
Missing Information and Reasoning:
- 1. A table of acceptance criteria and the reported device performance: As explained above, the document doesn't provide specific quantitative acceptance criteria for the FC-700's performance (e.g., accuracy, precision for FHR or UC measurements) and corresponding reported performance metrics from a formal study. Instead, it relies on substantial equivalence to a predicate device. The performance characteristics listed are functions the device performs, not quantitative performance metrics against acceptance criteria.
- 2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set. The evaluation is based on technological characteristics comparison.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance study is described.
- 4. Adjudication method for the test set: Not applicable. No clinical performance study is described.
- 5. 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 is a medical device (fetal monitor), not an AI-based diagnostic tool. There is no mention of an MRMC study or AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a fetal monitor, not an algorithm, and its use inherently involves human interaction (trained healthcare personnel).
- 7. The type of ground truth used: Not applicable. No clinical performance study is described. The "ground truth" for this submission is the performance and safety profile of the predicate device.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that involves a training set.
- 9. How the ground truth for the training set was established: Not applicable. No training set is involved.
Summary:
This 510(k) submission establishes substantial equivalence to a predicate device (COROMETRICS MODEL 171 AND 172 FETAL MONITOR, K991905) by comparing technological characteristics and adherence to recognized standards for safety and EMC. It does not present a standalone clinical performance study with specific acceptance criteria and detailed quantitative results as would be typical for more novel devices or those undergoing a PMA pathway.
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DEC 1 6 2005
K043597
<
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-700 | |
| (Common Name) | FC-700 | ||
| (Classification Name) | Perinatal monitoring system and accessories | ||
| (Regulation Number) | 21 CFR §884.2740 | ||
| (Regulatory Class) | II | ||
| (Product Code) | HGM | ||
| PREDICATE DEVICES | (510(k) Number) | K991905 | |
| (Device Name) | COROMETRICS MODEL 171 AND 172 | ||
| FETAL MONITOR | |||
| (Submitter by) | GENERAL ELECTRIC MEDICALSYSTEMS INFORMATION |
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FC-700 is the fetal monitor that measures the fetal heart rate and DEVICE DESCRIPTION uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction. FC-700 is the fetal monitor that measures, displays numerical value of
INTENDED USE measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.
It intended to be used by trained healthcare personnel. It is not intended for home use.
COMPARISION OF TECHNOLOGICAL CHARACTERISTICS
| Comparison Areas | FC-700 | Predicate Device |
|---|---|---|
| Indications for use | FC-700 is the fetal monitor that measures,displays numerical value of measuredresults by LED, prints graphically the fetalheart rate and uterine contraction of apregnant woman, and also provides fetalmovement detection and fetal heart sound. Itis intended to aid comprehensive assessmentfor the well being of single fetus. | Identical |
| Where used | Used by trained healthcare personnel. It isnot intended for home use. | Identical |
| Performance | Fetal Heart Rate (FHR)Uterine Contraction (UC)Fetal Movement DetectionHigh/Low Heart Rate AlarmPrinting Monitoring ResultsInterface through RS232 | Similar |
| Standard met | -Electrical safety: IEC60601-1-EMC: IEC60601-1-2) so on.-Biocompatibility: ISO10993 | Similar |
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It has tested for electrical safety according to IEC60601-1, NONCLINICAL TESTS It has tested for croomatibility according to IEC60601-1-2 and eiectromagnetic compansions e with the guidelines of International Drocompationity in accordantion: Biological Evaluation of Medical Devices.
FC-700 is substantial equivalent to predicated device COROMETRICS CONCLUSION I C-700 is substantial equivalen MONITOR(K991905) of GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
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: K043597
DEC 1 6 2005
Trade/Device Name: FC 700 Fetal 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 market the device referenced we nave reviewed your becalent of t (-) personalially equivalent (for the indications for use stated in above and nave decommissarketed predicate devices marketed in interstate commerce prior to the cherosure for regary manteese production Device Amendments, or to devices that have been reay 20, 1770, the charminenth the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordance approval application (PMA). You may, therefore, market the do not require approvation of a provisions of the Act. The general controls provisions of the Act device, subject to the general registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is classified (500 such additional controls. Existing major regulations affecting your Apploval), it the you 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 I Toast be devisou that reize complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I caran statues are regulating, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
. This letter will anow you to ocgin marketing your and equivalence of your device to a legally marketed notification. The FDA Inding of Sabstanning of 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 device on our bers, 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 entitle, "Ansolution on your responsibilities under the Act from the 807.97). You may obtain other general information of the years 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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
BIONET CO., LTD. APPLICANT
K043597 510(k) NUMBER
FC-700 DEVICE NAME
INDICATIONS FOR USE
.
FC-700 is the fetal monitor that measures, displays numerical value of measured results by I C 700 is the count and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus.
for the world bealthcare 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)
| Prescription Use _ | OR | Over-The-Counter Use _ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Nancy C. Bogdon
minal,
K04 3597
§ 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).