(310 days)
Not Found
No
The description focuses on standard signal acquisition, display, recording, and transmission methods without mentioning any AI/ML algorithms for data analysis or interpretation.
No
The device is a monitor designed for measuring and recording, not for treating or providing therapy.
Yes
The device is a perinatal fetal monitor that measures and records maternal contraction and fetal heart rate, which are physiological parameters used to assess the health and well-being of the fetus and mother. While it doesn't state it provides a "diagnosis," the measurement and recording of these physiological parameters are integral to diagnostic assessments in perinatal care. Its function is to provide objective data that aids in the diagnosis of potential issues during pregnancy and labor.
No
The device description explicitly mentions hardware components such as a 7-segment LED display, a strip chart recorder, Pulsed Doppler Ultrasound, and an external TOCO transducer, indicating it is not software-only.
Based on the provided information, the IFM-500 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IFM-500 function: The IFM-500 measures and records maternal contraction and fetal heart rate using external methods (Pulsed Doppler Ultrasound and external TOCO transducer). It does not analyze samples taken from the body.
Therefore, the IFM-500 falls under the category of a medical device used for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Contraction (UC) is measured with an external TOCO transducer.
Product codes (comma separated list FDA assigned to the subject device)
85HGM
Device Description
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Contraction (UC) is measured with an external TOCO transducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed Doppler Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
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.
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
SEP 2 9 2000
510K SUMMARY
1.0 Manufacturer's Name and Address:
BiOSYS Co., Ltd. Medison Venture Tower, 997-4, Daechi-dong, Kangnam-ku, Seoul 135-280, Republic of Korea
Corresponding Official:
Gary J. Allsebrook C/o Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Tel: (510) 276-2648 Fax: (510) 275-3559
- 2.0 Initial Distributor (if manufacturer is overseas): M. T. Kwon, CEO/President, Medison America Inc. 6616 Owens Drive, Pleasanton, CA 94588 Telephone: (510) 463-2646
3.0 Date of Submission:
November 18, 1999
- 4.0 Device Name: IFM-500, Ultrasound Fetal Monitor
- 5.0 Common Name: Perinatal monitor
- 6.0 Classification: Regulatory Class:
Review Category: Device Classification Panel: II Tier II Obstetrics and Gynecology
| FR Number | Product Code | |
|---|---|---|
| Monitor, Ultrasonic, Fetal | 884.2740 | 85HGM |
- 7.0 Establishment Registration Number: Application in Process
8.0 514 Performance Standards:
There are no performance standards established under Section 514 for this device. However, the IFM-500 Ultrasound Fetal Monitor system tested in accordance with
1
European Standard EN / IEC 60601-1. EMC requirement was also tested in accordance with EN / IEC 60601-1-2.
8.0 Special Controls:
510(k) Special Report will be supplied prior to first customer shipment.
9.0 Prescription Status:
Prescription Device.
- Manufacturing Location: 10.0 BiOSYS Co., LTd. 687-3, Sangoan-Ri Hongchun-Kun, Kangwon-Do, Republic of Korea
- 11.0 Sterilization Sites: None
12.0 Reason for Submission:
BiOSYS proposes to introduce into interstate commercial distribution a new device referred to in this document as IFM-500 Ultrasound Fetal Monitor.
13.0 Identification of the TRACK being followed for the submission: Track 1
14.0 Device Description and Intended Use:
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Contraction (UC) is measured with an external TOCO transducer.
15.0 Software:
BiOSYS Company Ltd. certifies that the IFM-500 Fetal Monitor is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
16.0 Hazard Analysis
Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- Identification of potential hazards, their causes, and their effects; �
2
- Development of methodologies to control the occurrence of hazards and to constrain . their effects; and
- Determine any effect on patient safety and system effectiveness. .
The potential hazards associated with this software product are no different than those I the predicate device. These are primarily related to failure of system components, or the proursed wariously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
Substantial Equivalence: 17.0
The following is a summary of the safety and effectiveness data on which the substantial equivalence determination is based:
| Feature | IFM-500 | Model 118
(K934959) |
|----------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indication for Use | - Fetal
(perinatal fetal monitor) | - Fetal
(perinatal fetal monitor)
- Maternal monitor |
| Modes of Operation: | - Ultrasound mode - Uterine Contraction mode | - Ultrasound mode
- Uterine Activity mode
- ECG mode
- Blood Pressure mode
- Pulse Oximetry mode- |
| System Characteristics: | - Portable - LED display & Control Panel
- Strip chart recorder | - Portable
- LCD display & Control Panel
- Strip chart recorder |
| | - AC only
100 -240V, 50/60 Hz,
0.5 - 0.25 A | - AC only
100/120/220/230/240 V,
48-62 Hz, 100 W |
| FHR/UC Monitoring | Yes | Yes |
| Maternal Heart/Pulse Rate,
NBP, SpO2 Monitoring | No | Yes |
| Transducer Type: | - Circular Array
(7 elements) - Tocotransducer | - Circular Array
(9 elements) - Tocotransducer |
| Ultrasound Frequency | 2.0 MHz | 1.151 MHz |
| FHR Detection method | Pulsed-wave Doppler | Pulsed-wave Doppler |
Predicate Device Comparison Chart
3
:
.
| Feature | IFM-500 | Model 118
(K934959) |
|-------------------------------------------------------------|----------------------------------------------|----------------------------------------------|
| FHR Range | 50 - 240 BPM | 50 - 210 BPM |
| UC Range | 00 - 99 relative units
00 - 99 mmHg | 0 - 100 relative units
0 - 100 mmHg |
| UC Detection method | Strain gauge strength | Strain gauge strength |
| Detection of fetal
movement via ultrasound
transducer | No | Yes |
| Alarm | Yes (Audible) | Yes (Audible & Visible) |
| Printer(Recorder) Type | Thermal array ( dots/mm) | Thermal array ( dots/mm) |
| Acoustic Output Display &
FDA Limits: | Less than Track 1 maximum
acoustic values | Less than Track 1 maximum
acoustic values |
| Product Safety Certification | - IEC 60601-1 | - IEC 601-1
- UL 544 |
| EMC Compliance | - IEC 60601-1-2 | |
| Patient Contact Materials | Plastic, ABS AF-302
(intact skin) | Plastic
(intact skin) |
Accessories or Kits
.
| Feature | IFM-500 | Model 118
(K934959) |
|-------------|-----------------------------------------|-----------------------------------------------------------------------------|
| Accessories | - Event marker
- Strip chart (paper) | - Event marker
- Strip chart (paper)
- ECG electrode
- SpO2 sensor |
:
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2000
BiOSYS Co., Ltd. c/o Mr. Gary J. Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116
Re: K994008
BiOSYS IFM-500 Intelligent Fetal Monitor Dated: June 14, 2000 Received: July 3, 2000 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM
Dear Mr. Allsebrook:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Falluse to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as desoribed in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
5
510(k) Number (if known):
Device Name: BiOSYS, IFM-500 Perinatal Fetal Monitor
Indications For Use:
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
David A. Hyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 599 408 510(k) Number .