K Number

Device Name

FETAL MONITORS

Manufacturer

GUANGDONG BIOLIGHT MEDITECH CO., LTD

Date Cleared

2014-05-15

(322 days)

Product Code

HGM

Regulation Number

884.2740

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 Description

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').

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100797

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard physiological monitoring parameters and functions.

Therapeutic

No
The device is described as a "monitor" intended for "non-invasive monitoring" and "displaying, printing and recording" of physiological parameters, rather than for treatment or therapy.

Diagnostic

Yes
The device monitors fetal and maternal physiological parameters, which are used to assess health status, thereby serving a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components (F30, F45, F50, F85, F90) and mentions monitoring various physiological parameters requiring physical sensors (UA, FHR, ITM, ECG, NIBP, SpO2, PR, TEMP, RESI'). The performance studies also reference hardware-related standards like IEC 60601-1.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is a fetal monitor that uses non-invasive methods (Pulsed Wave Doppler, ECG, NIBP, SpO2, etc.) to monitor physiological parameters directly from the patient's body. It does not analyze samples taken from the body.
Intended Use: The intended use is for monitoring during antepartum examination, labor, and delivery, which involves direct patient monitoring, not laboratory analysis of specimens.

The information provided consistently points to a device that interacts directly with the patient to gather physiological data, which is characteristic of a non-IVD medical device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HGM

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Pulsed Wave Doppler (PWD)

Anatomical Site

Fetal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

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)

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 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;

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100797

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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.
1. 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: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn

3. Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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

Predicate Device Identification 5.

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

Device Description . 6.

1. 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

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;
1. 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
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.	F9 Express fetal & maternal monitor is
intended for monitoring physiological
parameters of pregnant women during
ante-parturn examination, labor and
delivery. It is intended to be used
only by trained and qualified personnel
in antepartum examination rooms, labor
and delivery rooms. F9 Express fetal &
maternal monitor is intended for
providing NonStress testing or fetal
monitoring for pregnant women from
the 28th week of gestation. In addition, it
provides a solution for maternal vital signs
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
Doppler (PWD). The transducer will emit
ultrasonic beam with low energy; Due to the beat
of the fetal heart, there will be a relative motion
between the fetal heart and ultrasonic beam,
which will cause the frequency change of the
reflection ultrasonic wave compared with the
transmission ultrasonic wave. Fetal heart rate can
be calculated based on this frequency change.	The proposed fetal monitors adopt Pulsed
Wave Doppler (PWD). The transducer will
emit ultrasonic beam with low energy; Due
to the beat of the fetal heart, there will be a
relative motion between the fetal heart and
ultrasonic beam, which will cause the
frequency change of the reflection ultrasonic
wave compared with the transmission
ultrasonic wave. Fetal heart rate can be
calculated based on this frequency change.
	Manual
Fetal
Movement	A kick counter is provided with the proposed
fetal monitors. A pregnant woman may count the
numbers of movements she feels her fetus make,
by kicking the counter. The monitor will record,
display and print the number kicked.	A kick counter is provided with the proposed
fetal monitors. A pregnant woman may
count the numbers of movements she feels
her fetus make, by kicking the counter. The
monitor will record, display and print the
number kicked.
	Automatic
Fetal
Movement	FM THRESHOLD (Fetal movement threshold):
threshold of the occurrence of automatic fetal
movement, can be adjusted from 10% to 80%,
FM THRESHOLD represents the percentage of
fetal activity intensity, when select 10%, a slight
variation of the fetus means a fetal movement;
while when select 80%, a strong variation of the
fetus means a fetal movement, and it is advised
to set to 40%-60%. When FM COUNT is set for
AUTO, it means in case of automatic fetal
movement, the set is effective.
Fetal movement: when the FM COUNT is set for
AUTO, if the former and later difference of the
fetal movement curve value is more than or
equal to the set FM threshold, then the system
will automatically add up a FM count. When it
frozen, the value has no meaning.
AFM (fetal movement curve): display or close
AFM on the interface. AFM is a yellow curve	FM THRESHOLD (Fetal movement
threshold): threshold of the occurrence of
automatic fetal movement, can be adjusted
from 10% to 80%, FM THRESHOLD
represents the percentage of fetal activity
intensity, when select 10%, a slight variation
of the fetus means a fetal movement; while
when select 80%, a strong variation of the
fetus means a fetal movement, and it is
advised to set to 40%-60%. When FM
COUNT is set for AUTO, it means in case
of automatic fetal movement, the set is
effective.
Fetal movement: when the FM COUNT is
set for AUTO, if the former and later
difference of the fetal movement curve value
is more than or equal to the set FM
threshold, then the system will automatically
add up a FM count. When it frozen, the
value has no meaning.

		relative amounts of diagram, which is related to
fetal heart rate and fetal heart amplitude. When
one of them has changed, can cause fluctuation
in the energy diagram.	close AFM on the interface. AFM is a
yellow curve displayed in TOCO area,
which means the energy diagram of fetal
movement. It is a kind of relative amounts of
diagram, which is related to fetal heart rate
and fetal heart amplitude. When one of them
has changed, can cause fluctuation in the
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
the internal pressure, thereby providing a
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	regular ECG.
		cables, the monitor examines the changes of	Through many electrodes connected with
		body-surface potential caused by the heart of	ECG cables, the monitor examines the
		patient, observes the ECG activities, records the	changes of body-surface potential caused by
		ECG waveform, and calculates the HR. The	the heart of patient, observes the ECG
		monitor can achieve 3-lead and 5-lead and	activities, records the ECG waveform, and
		12-lead monitoring.	calculates the HR. The monitor can achieve
3-lead and 5-lead and 12-lead monitoring.
	NIBP	The monitor uses the oscillometric method for
		measuring NIBP. It is applicable for adult,	The monitor uses the oscillometric method
for measuring NIBP. It is applicable for
		pediatric and neonatal patients. The method of	adult, pediatric and neonatal patients. The
		oscillometric indirectly estimates the systolic and	method of oscillometric indirectly estimates
		diastolic pressures within the blood vessels by	the systolic and diastolic pressures within
		measuring the change of the pressure within	the blood vessels by measuring the change
		blood pressure cuff along with the volume of the	of the pressure within blood pressure cuff
		arteries and calculates the average pressure.	along with the volume of the arteries and
			calculates the average pressure.
Principle of
Operation	SpO₂	The measurement of oxygen saturation of arterial
blood (also known as pulse oxygen saturation,
usually shortened as SpO₂) adopts the principles
of light spectra and volume tracing. The LED
emits lights with two specific wavelengths,
which are selectively absorbed by oxygenated
hemoglobin and deoxyhemoglobin. The optical
receptor measures the changes in the light
intensity after the light passes the capillary
network and estimates the ratio of oxygenated
hemoglobin and the total hemoglobin.	The measurement of oxygen saturation of
arterial blood (also known as pulse oxygen
saturation, usually shortened as SpO₂)
adopts the principles of light spectra and
volume tracing. The LED emits lights with
two specific wavelengths, which are
selectively absorbed by oxygenated
hemoglobin and deoxyhemoglobin. The
optical receptor measures the changes in the
light intensity after the light passes the
capillary network and estimates the ratio of
oxygenated hemoglobin and the total
hemoglobin.
	Temperature	The monitor measures Temperature with
Temperature sensors, and it uses the Thermal
resistance method.	The monitor measures Temperature with
Temperature sensors, and it uses the
Thermal resistance method.
	Respiration
Rate	For the respiratory measurement (Resp), the
monitor measures the thoracic impedance
between two ECG electrodes on the patient's
chest. Changes in the impedance due to thoracic
movement produce the Resp waveform on the
monitor screen. The monitor counts the
waveform cycles to calculate the respiration rate
(RR).	N.A.

Table 3-1 Comparison of Technology Characteristics

E2-3

・

1-2-5

Additional Information II for K 13194 l

9. Substantially Equivalent (SE) Conclusion

The proposed devices and predicate device share same classification information, similar intended use, technical specifications and safety performance.

Therefore, the proposed devices, Fetal Monitors, are determined to be Substantially Equivalent (SE) to the predicate device, as identified above.

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2014

Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 China

Re: K131941

Trade/Device Name: Fetal Monitors Models: F30, F45, F50, F80, F85 and F90 Regulation Number: 21 CFR$ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: April 15, 2014 Received: April 16, 2014

Dear Diana Hong,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - Diana Hong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm | 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/7/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black, and the background is white. The letters "P" and "L" are stylized with a decorative design around them.

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Section 2 Indications for Use

510(k) Number: K131941 Device Name: Fetal Monitors Models: F30, F45, F50, F80, F85 and F90

Indications for Use:

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OR

OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 2

Herbert P. Lern 2014.05.15 י (י 116:5

Diagnostic Ultrasound Indications for Use Form

SYSTEM: Feta! Monitors, F30, F45, F50, F80, F85 and F90

Transducer: Triple sensor (1 MHz, PWD)

| Indented Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific	A	B	M	PWD	CWD	Color
Doppler	Combined
(B/M)	Other
(specify)
(track 1 Only)	(Track 1 and Track 3)
Ophthalimic	Ophthalmic
Fetal Imaging &
Other	Fetal				N
	Abdominal
	Intraoperative (specify)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

Indented Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Comments: