BIOSYS FETAL MONITOR, MODEL IFM-500

K994008 · Biosys Co. , Ltd. · HGM · Sep 29, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K994008
• Device Name: BIOSYS FETAL MONITOR, MODEL IFM-500
• Applicant: Biosys Co. , Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Sep 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

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 Activity is measured with an external TOCO transducer.

Device Story

IFM-500 is a portable perinatal fetal monitor used in clinical settings to measure fetal heart rate (FHR) and uterine contractions (UC). Device inputs include pulsed-wave Doppler ultrasound signals for FHR and strain gauge signals from an external TOCO transducer for UC. The system processes these inputs to display real-time data on a 7-segment LED panel and generates a hard-copy record via a thermal array strip chart recorder. Data can be transmitted over telephone lines to a remote receiver. The device is operated by healthcare professionals to monitor fetal well-being during labor or prenatal assessment. Output allows clinicians to observe FHR patterns and contraction frequency/intensity, facilitating clinical decision-making regarding fetal status and labor progression.

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Acoustic output was verified to be within Track 1 FDA limits.

Technological Characteristics

Portable monitor with 7-segment LED display and thermal array recorder. FHR sensing via 2.0 MHz pulsed-wave Doppler (7-element circular array); UC sensing via strain gauge tocotransducer. Connectivity includes telephone line transmission. Materials: ABS AF-302 plastic (intact skin contact). Power: 100-240V AC. Safety standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for perinatal fetal monitoring, specifically measuring and recording fetal heart rate (single or twin) and maternal uterine contractions in a clinical setting.

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

• Model 118 (K934959)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

- 2.0 Initial Distributor (if manufacturer is overseas): M. T. Kwon, CEO/President, Medison America Inc. 6616 Owens Drive, Pleasanton, CA 94588 Telephone: [phone]
#### 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

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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; �

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- 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<br>(K934959) |
|----------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indication for Use | - Fetal<br>(perinatal fetal monitor) | - Fetal<br>(perinatal fetal monitor)<br>- Maternal monitor |
| Modes of Operation: | - Ultrasound mode<br>- Uterine Contraction mode | - Ultrasound mode<br>- Uterine Activity mode<br>- ECG mode<br>- Blood Pressure mode<br>- Pulse Oximetry mode- |
| System Characteristics: | - Portable<br>- LED display & Control Panel<br>- Strip chart recorder | - Portable<br>- LCD display & Control Panel<br>- Strip chart recorder |
| | - AC only<br>100 -240V, 50/60 Hz,<br>0.5 - 0.25 A | - AC only<br>100/120/220/230/240 V,<br>48-62 Hz, 100 W |
| FHR/UC Monitoring | Yes | Yes |
| Maternal Heart/Pulse Rate,<br>NBP, SpO2 Monitoring | No | Yes |
| Transducer Type: | - Circular Array<br>(7 elements)<br>- Tocotransducer | - Circular Array<br>(9 elements)<br>- Tocotransducer |
| Ultrasound Frequency | 2.0 MHz | 1.151 MHz |
| FHR Detection method | Pulsed-wave Doppler | Pulsed-wave Doppler |

### Predicate Device Comparison Chart

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:

-

.

| Feature | IFM-500 | Model 118<br>(K934959) |
|-------------------------------------------------------------|----------------------------------------------|----------------------------------------------|
| FHR Range | 50 - 240 BPM | 50 - 210 BPM |
| UC Range | 00 - 99 relative units<br>00 - 99 mmHg | 0 - 100 relative units<br>0 - 100 mmHg |
| UC Detection method | Strain gauge strength | Strain gauge strength |
| Detection of fetal<br>movement via ultrasound<br>transducer | No | Yes |
| Alarm | Yes (Audible) | Yes (Audible & Visible) |
| Printer(Recorder) Type | Thermal array ( dots/mm) | Thermal array ( dots/mm) |
| Acoustic Output Display &<br>FDA Limits: | Less than Track 1 maximum<br>acoustic values | Less than Track 1 maximum<br>acoustic values |
| Product Safety Certification | - IEC 60601-1 | - IEC 601-1<br>- UL 544 |
| EMC Compliance | - IEC 60601-1-2 | |
| Patient Contact Materials | Plastic, ABS AF-302<br>(intact skin) | Plastic<br>(intact skin) |

## Accessories or Kits

.

| Feature | IFM-500 | Model 118<br>(K934959) |
|-------------|-----------------------------------------|-----------------------------------------------------------------------------|
| Accessories | - Event marker<br>- Strip chart (paper) | - Event marker<br>- Strip chart (paper)<br>- ECG electrode<br>- SpO2 sensor |

:

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

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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.

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# 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 .