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').

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device, which typically does not include detailed clinical study data in the public summary. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device based on technical characteristics and adherence to recognized standards. Therefore, many of your requested details about studies, ground truth, and expert evaluation will likely not be present in this type of document.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table (Table 3-1) where the "acceptance criteria" are implied by compliance with various international standards, and the "reported device performance" is a statement of compliance. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device's medical functions, as the submission relies on demonstrating equivalent technical specifications to a predicate device.

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (Statement of Compliance)
Comply with IEC 60601-1 (Safety)	Comply with IEC 60601-1
Comply with IEC 60601-1-2 (EMC)	Comply with IEC 60601-1-2
Comply with NEMA UD2 (Acoustic Output)	Comply with NEMA UD2
Comply with IEC 60601-1-8 (Alarming)	Comply with IEC 60601-1-8
Biocompatibility (No cytotoxicity, irritation, sensitization)	No cytotoxicity, irritation and sensitization

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The document focuses on non-clinical tests (e.g., electrical safety, EMC, biocompatibility) rather than clinical performance data from a test set of patient cases.

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

Not provided. This information would be relevant for a clinical performance study, which is not detailed here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not provided. This information would be relevant for a clinical performance study, which is not detailed here.

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

Not applicable / Not provided. This device is a fetal monitor for measuring physiological parameters, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.

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

Not applicable / Not provided. This device is a monitoring system and does not appear to involve a standalone algorithm in the sense of AI performance evaluation. The "non-clinical tests" mentioned (IEC and NEMA standards) are performed on the device itself to verify its design specifications and electrical/biocompatibility safety.

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

Not explicitly stated in the context of clinical accuracy. For the non-clinical tests, "ground truth" would be the established specifications and limits defined by the referenced standards (e.g., a specific threshold for electromagnetic emissions, a defined limit for acoustic output).

8. The sample size for the training set

Not applicable / Not provided. This document describes a traditional medical device (fetal monitor) rather than an AI/ML-based device that would require a "training set."

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

Not applicable / Not provided. As above, no training set for an AI/ML model is involved here.

Summary

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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.
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

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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

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

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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;
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-invasivemonitoring of fetal and maternal physiologicalparameters during antepartum examination, laborand delivery. They are intended to be used onlyby trained and qualified personnel in antepartumexamination rooms, labor and delivery rooms.	F9 Express fetal & maternal monitor isintended for monitoring physiologicalparameters of pregnant women duringante-parturn examination, labor anddelivery. It is intended to be usedonly by trained and qualified personnelin antepartum examination rooms, laborand delivery rooms. F9 Express fetal &maternal monitor is intended forproviding NonStress testing or fetalmonitoring for pregnant women fromthe 28th week of gestation. In addition, itprovides a solution for maternal vital signsmonitoring.
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 WaveDoppler (PWD). The transducer will emitultrasonic beam with low energy; Due to the beatof the fetal heart, there will be a relative motionbetween the fetal heart and ultrasonic beam,which will cause the frequency change of thereflection ultrasonic wave compared with thetransmission ultrasonic wave. Fetal heart rate canbe calculated based on this frequency change.	The proposed fetal monitors adopt PulsedWave Doppler (PWD). The transducer willemit ultrasonic beam with low energy; Dueto the beat of the fetal heart, there will be arelative motion between the fetal heart andultrasonic beam, which will cause thefrequency change of the reflection ultrasonicwave compared with the transmissionultrasonic wave. Fetal heart rate can becalculated based on this frequency change.
	ManualFetalMovement	A kick counter is provided with the proposedfetal monitors. A pregnant woman may count thenumbers 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 proposedfetal monitors. A pregnant woman maycount the numbers of movements she feelsher fetus make, by kicking the counter. Themonitor will record, display and print thenumber kicked.
	AutomaticFetalMovement	FM THRESHOLD (Fetal movement threshold):threshold of the occurrence of automatic fetalmovement, can be adjusted from 10% to 80%,FM THRESHOLD represents the percentage offetal activity intensity, when select 10%, a slightvariation of the fetus means a fetal movement;while when select 80%, a strong variation of thefetus means a fetal movement, and it is advisedto set to 40%-60%. When FM COUNT is set forAUTO, it means in case of automatic fetalmovement, the set is effective.Fetal movement: when the FM COUNT is set forAUTO, if the former and later difference of thefetal movement curve value is more than orequal to the set FM threshold, then the systemwill automatically add up a FM count. When itfrozen, the value has no meaning.AFM (fetal movement curve): display or closeAFM on the interface. AFM is a yellow curve	FM THRESHOLD (Fetal movementthreshold): threshold of the occurrence ofautomatic fetal movement, can be adjustedfrom 10% to 80%, FM THRESHOLDrepresents the percentage of fetal activityintensity, when select 10%, a slight variationof the fetus means a fetal movement; whilewhen select 80%, a strong variation of thefetus means a fetal movement, and it isadvised to set to 40%-60%. When FMCOUNT is set for AUTO, it means in caseof automatic fetal movement, the set iseffective.Fetal movement: when the FM COUNT isset for AUTO, if the former and laterdifference of the fetal movement curve valueis more than or equal to the set FMthreshold, then the system will automaticallyadd up a FM count. When it frozen, thevalue has no meaning.

		relative amounts of diagram, which is related tofetal heart rate and fetal heart amplitude. Whenone of them has changed, can cause fluctuationin the energy diagram.	close AFM on the interface. AFM is ayellow curve displayed in TOCO area,which means the energy diagram of fetalmovement. It is a kind of relative amounts ofdiagram, which is related to fetal heart rateand fetal heart amplitude. When one of themhas changed, can cause fluctuation in theenergy 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 withthe internal pressure, thereby providing ameasurement 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 achieve3-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 methodfor 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 ofOperation	SpO₂	The measurement of oxygen saturation of arterialblood (also known as pulse oxygen saturation,usually shortened as SpO₂) adopts the principlesof light spectra and volume tracing. The LEDemits lights with two specific wavelengths,which are selectively absorbed by oxygenatedhemoglobin and deoxyhemoglobin. The opticalreceptor measures the changes in the lightintensity after the light passes the capillarynetwork and estimates the ratio of oxygenatedhemoglobin and the total hemoglobin.	The measurement of oxygen saturation ofarterial blood (also known as pulse oxygensaturation, usually shortened as SpO₂)adopts the principles of light spectra andvolume tracing. The LED emits lights withtwo specific wavelengths, which areselectively absorbed by oxygenatedhemoglobin and deoxyhemoglobin. Theoptical receptor measures the changes in thelight intensity after the light passes thecapillary network and estimates the ratio ofoxygenated hemoglobin and the totalhemoglobin.
	Temperature	The monitor measures Temperature withTemperature sensors, and it uses the Thermalresistance method.	The monitor measures Temperature withTemperature sensors, and it uses theThermal resistance method.
	RespirationRate	For the respiratory measurement (Resp), themonitor measures the thoracic impedancebetween two ECG electrodes on the patient'schest. Changes in the impedance due to thoracicmovement produce the Resp waveform on themonitor screen. The monitor counts thewaveform cycles to calculate the respiration rate(RR).	N.A.

Table 3-1 Comparison of Technology Characteristics

E2-3

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・

1-2-5

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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.

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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.

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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

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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

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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	ColorDoppler	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)
PeripheralVessel	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:

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).