FETAL MONITORS

K131941 · Guangdong Biolight Meditech Co., Ltd. · HGM · May 15, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K131941
• Device Name: FETAL MONITORS
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: May 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Fetal Monitors are intended for non-invasive monitoring of fetal and maternal physiological parameters during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Device Story

Fetal monitors (F30, F45, F50, F80, F85, F90) provide continuous monitoring, display, and recording of fetal/maternal parameters. Inputs: Pulsed Wave Doppler (PWD) ultrasound for fetal heart rate (FHR); pressure-sensitive tocodynamometer (TOCO) for uterine activity (UA); ECG electrodes for maternal heart rate; SpO2 sensors; temperature sensors; respiration rate via thoracic impedance. Principle: PWD detects frequency shifts from fetal heart motion; TOCO measures abdominal wall pressure; oscillometric method for NIBP; light spectra/volume tracing for SpO2. Output: Real-time waveforms, numerical values, and printed reports. Used in antepartum, labor, and delivery rooms by trained clinicians. Benefits: Continuous physiological surveillance to support clinical decision-making during labor and delivery.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), NEMA UD 2-2004 (acoustic output), IEC 60601-1-8 (alarms), and ISO 10993 (biocompatibility) verified. No clinical data presented.

Technological Characteristics

Multi-parameter monitor; PWD ultrasound (1 MHz); TOCO transducer; ECG (3/5/12-lead); NIBP (oscillometric); SpO2 (LED/optical); temperature (thermal resistance); respiration (thoracic impedance). Connectivity: AC/DC power. Standards: IEC 60601-1, IEC 60601-1-2, NEMA UD 2-2004, IEC 60601-1-8, ISO 10993-5/10. Form factor: Bedside monitor.

Indications for Use

Indicated for non-invasive monitoring of fetal and maternal physiological parameters in pregnant women during antepartum examination, labor, and delivery. Used by trained personnel in clinical settings.

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

• Edan F9 Express Dual Fetal/Maternal Monitor (K100797)

Submission Summary (Full Text)

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Project #: M0212013A

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K131941

- Date of Preparation: 08/19/2013 l.
- 2. Sponsor Identification

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, Jing Position: R&D Director Tel: [phone] Fax: [phone] Email: [e-mail]

## 3. Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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Project #: M0212013A

- Proposed Device Identification 4.
Proposed Device Name: Fetal monitors Proposed Device Model: F30, F45, F50, F80, F85 and F90

Classification:

Regulation No .: 21 CFR part 884.2740; Regulation Name: System, Monitoring, Perinatal; Product Code: HGM: Device Class: Class II;

Intended Use Statement

The Fetal Monitors are intended for non-invasive monitoring of fetal and maternal physiological parameters during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

#### Predicate Device Identification 5.

510(k) Number: K100797 Product Name: Edan F9 Express Dual Fetal/Maternal Monitor Manufacturer: Edan Instrument Inc

## Device Description . 6.

The proposed fetal monitors, including F30, F45, F50, F85 and F90 are intended for providing continuous monitoring, displaying, printing and recording of basic fetal and maternal parameters. including uterine activity (UA), dual fetal heart rate (FHR) and fetal movement (ITM), and extended maternal parameters, including electrocardiograph (ECG), non-invasive blood pressure (NIBP) . Pulse Oxygen Saturation (SpO2) , Pulse Rate (PR), Temperature (TEMP) and Respiration Rate (RESI').

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Salety b) E2-2

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Project #: M0212013A

Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound c) Equipment Revision 3 .
- d) IEC 60601-1-8 Ed. 2:2006-10, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro e) cytotoxicity :
- ISO 10993-10:2002 AMD1 2006, Biological Evaluation of Medical Devices Part 10: Tests for t) irritation and delayed-type hypersensitivity;
- 8. Substantially Equivalent (SE) Discussion

The following table compares the Fetal Monitors to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Devices | Predicate Devices | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HGM | HGM | |
| Regulation Number | 21 CFR 884.2740 | 21 CFR 884.2740 | |
| Intended Use | The Fetal Monitors are intended for non-invasive<br>monitoring of fetal and maternal physiological<br>parameters during antepartum examination, labor<br>and delivery. They are intended to be used only<br>by trained and qualified personnel in antepartum<br>examination rooms, labor and delivery rooms. | F9 Express fetal & maternal monitor is<br>intended for monitoring physiological<br>parameters of pregnant women during<br>ante-parturn examination, labor and<br>delivery. It is intended to be used<br>only by trained and qualified personnel<br>in antepartum examination rooms, labor<br>and delivery rooms. F9 Express fetal &<br>maternal monitor is intended for<br>providing NonStress testing or fetal<br>monitoring for pregnant women from<br>the 28th week of gestation. In addition, it<br>provides a solution for maternal vital signs<br>monitoring. | |
| Sterile | No | No | |
| Single Use | No | No | |
| Energy Source | AC Power / DC Power | AC Power / DC Power | |
| Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | |
| Acoustic Output | Track 1 | Track 1 | |
| Alarming | Comply with NEMA UD2 | Comply with NEMA UD2 | |
| Biocompatibility | Comply with IEC 60601-1-8 | Comply with IEC 60601-1-8 | |
| | No cytotoxicity, irritation and sensitization | No cytotoxicity, irritation and sensitization | |
| Principle of Operation | Fetal Heart Rate | The proposed fetal monitors adopt Pulsed Wave<br>Doppler (PWD). The transducer will emit<br>ultrasonic beam with low energy; Due to the beat<br>of the fetal heart, there will be a relative motion<br>between the fetal heart and ultrasonic beam,<br>which will cause the frequency change of the<br>reflection ultrasonic wave compared with the<br>transmission ultrasonic wave. Fetal heart rate can<br>be calculated based on this frequency change. | The proposed fetal monitors adopt Pulsed<br>Wave Doppler (PWD). The transducer will<br>emit ultrasonic beam with low energy; Due<br>to the beat of the fetal heart, there will be a<br>relative motion between the fetal heart and<br>ultrasonic beam, which will cause the<br>frequency change of the reflection ultrasonic<br>wave compared with the transmission<br>ultrasonic wave. Fetal heart rate can be<br>calculated based on this frequency change. |
| | Manual<br>Fetal<br>Movement | A kick counter is provided with the proposed<br>fetal monitors. A pregnant woman may count the<br>numbers of movements she feels her fetus make,<br>by kicking the counter. The monitor will record,<br>display and print the number kicked. | A kick counter is provided with the proposed<br>fetal monitors. A pregnant woman may<br>count the numbers of movements she feels<br>her fetus make, by kicking the counter. The<br>monitor will record, display and print the<br>number kicked. |
| | Automatic<br>Fetal<br>Movement | FM THRESHOLD (Fetal movement threshold):<br>threshold of the occurrence of automatic fetal<br>movement, can be adjusted from 10% to 80%,<br>FM THRESHOLD represents the percentage of<br>fetal activity intensity, when select 10%, a slight<br>variation of the fetus means a fetal movement;<br>while when select 80%, a strong variation of the<br>fetus means a fetal movement, and it is advised<br>to set to 40%-60%. When FM COUNT is set for<br>AUTO, it means in case of automatic fetal<br>movement, the set is effective.<br>Fetal movement: when the FM COUNT is set for<br>AUTO, if the former and later difference of the<br>fetal movement curve value is more than or<br>equal to the set FM threshold, then the system<br>will automatically add up a FM count. When it<br>frozen, the value has no meaning.<br>AFM (fetal movement curve): display or close<br>AFM on the interface. AFM is a yellow curve | FM THRESHOLD (Fetal movement<br>threshold): threshold of the occurrence of<br>automatic fetal movement, can be adjusted<br>from 10% to 80%, FM THRESHOLD<br>represents the percentage of fetal activity<br>intensity, when select 10%, a slight variation<br>of the fetus means a fetal movement; while<br>when select 80%, a strong variation of the<br>fetus means a fetal movement, and it is<br>advised to set to 40%-60%. When FM<br>COUNT is set for AUTO, it means in case<br>of automatic fetal movement, the set is<br>effective.<br>Fetal movement: when the FM COUNT is<br>set for AUTO, if the former and later<br>difference of the fetal movement curve value<br>is more than or equal to the set FM<br>threshold, then the system will automatically<br>add up a FM count. When it frozen, the<br>value has no meaning. |
| | | | |
| | | relative amounts of diagram, which is related to<br>fetal heart rate and fetal heart amplitude. When<br>one of them has changed, can cause fluctuation<br>in the energy diagram. | close AFM on the interface. AFM is a<br>yellow curve displayed in TOCO area,<br>which means the energy diagram of fetal<br>movement. It is a kind of relative amounts of<br>diagram, which is related to fetal heart rate<br>and fetal heart amplitude. When one of them<br>has changed, can cause fluctuation in the<br>energy diagram. |
| Principle of | Uterine | A pressure-sensitive contraction transducer, | A pressure-sensitive contraction transducer, |
| Operation | Activity | called tocodynamometer (TOCO), is employed | called tocodynamometer (TOCO), is |
| | | in the UA measurement. This TOCO sensor has a | employed in the UA measurement. This |
| | | flat area that is fixed to the skin of a pregnant | TOCO sensor has a flat area that is fixed to |
| | | woman by a band around the belly. The pressure | the skin of a pregnant woman by a band |
| | | required to flatten a section of the wall correlates | around the belly. The pressure required to |
| | | with the internal pressure, thereby providing a | flatten a section of the wall correlates with<br>the internal pressure, thereby providing a<br>measurement of it. |
| | | measurement of it. | |
| | ECG | Before mechanical systole, the heart firstly | Before mechanical systole, the heart firstly |
| | | produces electrical excitement, which results in | produces electrical excitement, which results |
| | | biological current, and conducts the current to | in biological current, and conducts the |
| | | the body surface through tissue and humour. | current to the body surface through tissue |
| | | Different potential changes take place at various | and humour. Different potential changes take |
| | | parts of the body, thus body-surface potential | place at various parts of the body, thus |
| | | differences are formed. Record the changing | body-surface potential differences are |
| | | potential differences to form the dynamic curve, | formed. Record the changing potential |
| | | i.e. ECG, also called body-surface ECG or | differences to form the dynamic curve, i.e. |
| | | regular ECG. | ECG, also called body-surface ECG or |
| | | Through many electrodes connected with ECG…