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 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.

AI/ML Overview

The provided text does not contain a detailed study design with specific acceptance criteria and device performance metrics in the format requested. The document is a 510(k) summary for a Fetal Monitor, primarily focusing on demonstrating substantial equivalence to a predicate device and compliance with general safety standards.

However, based on the information provided, here's a breakdown of what can be extracted and what is missing relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for features like FHR range, UC range, or the specific performance metrics (e.g., accuracy, sensitivity, specificity) that would typically be found in an acceptance criteria table. Instead, it compares the IFM-500's specifications to those of a predicate device (Model 118).

Feature	Acceptance Criteria (Implied)	Reported Device Performance (IFM-500)
FHR Range	Comparable to predicate device (50 - 210 BPM for Model 118)	50 - 240 BPM
UC Range	Comparable to predicate device (0 - 100 relative units/mmHg)	00 - 99 relative units / 00 - 99 mmHg
FHR Detection Method	Pulsed-wave Doppler (as per predicate)	Pulsed-wave Doppler
UC Detection Method	Strain gauge strength (as per predicate)	Strain gauge strength
Acoustic Output Display & FDA Limits	Less than Track 1 maximum acoustic values (as per predicate)	Less than Track 1 maximum acoustic values
Product Safety Certification	IEC 601-1 / UL 544 (as per predicate)	IEC 60601-1
EMC Compliance	Implied compliance to relevant standards	IEC 60601-1-2
Software Validation	Designed, developed, tested, and validated to written procedures	Certifies procedures for design, development, testing, validation, and field maintenance, with responsible individuals identified.
Hazard Analysis	Identification, control, and effect determination	Performed throughout development, no new hazards beyond predicate, "Minor" Level of Concern.

2. Sample size used for the test set and the data provenance

The document does not provide information regarding a specific "test set" sample size or data provenance for performance evaluation. The submission relies on comparative data against a predicate device and compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information about experts used to establish ground truth. This type of detail is typically associated with clinical studies involving interpretation of results, which are not described here.

4. Adjudication method for the test set

The document does not describe an adjudication method as no specific test set or human reader evaluation criteria are mentioned.

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

The document does not describe a MRMC comparative effectiveness study. The device is a "monitor" measuring and recording physical parameters (FHR, UC), not an AI-assisted interpretation or diagnostic tool for which such a study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The description of the device details its function of measuring and recording FHR and UC. While there's an implied "algorithm" in its measurement capabilities (e.g., Pulsed-wave Doppler for FHR detection), the document does not present a standalone performance study for this algorithm in isolation from the hardware. The "performance" described is about the device's adherence to specifications and safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for performance evaluation. For a device like a fetal monitor, the "ground truth" for FHR and UC measurements would typically be established against reference instruments or established physiological principles during testing and calibration, rather than expert consensus or pathology in the clinical diagnostic sense. The document refers to testing against European Standard EN / IEC 60601-1 and EMC requirement EN / IEC 60601-1-2, implying these standards define the criteria for acceptable measurement accuracy and safety.

8. The sample size for the training set

The document does not mention a training set sample size. As a physiological monitor, its core functionality isn't based on machine learning models that require training data sets in the typical sense.

9. How the ground truth for the training set was established

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary

{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 only100 -240V, 50/60 Hz,0.5 - 0.25 A	- AC only100/120/220/230/240 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 units00 - 99 mmHg	0 - 100 relative units0 - 100 mmHg
UC Detection method	Strain gauge strength	Strain gauge strength
Detection of fetalmovement via ultrasoundtransducer	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 maximumacoustic values	Less than Track 1 maximumacoustic 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:

(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)

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 .

Regulation Number and Section

§ 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).