The FM-3000 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

It provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.

Device Description

With non-invasive ultrasound Doppler, external pressure sensing transducer and direct fetal electrocardiograph technique, the FM-3000 Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity. Alternatively, it can internally monitor one of the fetal heart rate with direct fetal electrocardiograph technique and uterine activity with an Intrauterine Pressure Catheter.

The Fetal monitor can be connected with Central Monitoring System via a RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.

The FM-300 is not intended for use in intensive care units, operating rooms or for home use.

AI/ML Overview

This document describes a 510(k) premarket notification for the FM-3000 Fetal Monitor. The core of this submission is to demonstrate substantial equivalence to a predicate device, the F3 Fetal Monitor (K102140) from EDAN Instruments.

Based on the provided information, the device relies entirely on the demonstration of substantial equivalence to a predicate device, with no new performance data or studies conducted specifically for the FM-3000. Therefore, it does not contain the detailed acceptance criteria and study data as one might expect for a novel device.

Here's a breakdown of the requested information based solely on the provided text:

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

The document explicitly states: "The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing. Therefore, no new testing was needed to support substantial equivalence."

This means there are no new acceptance criteria or reported device performance metrics specifically for the FM-3000 Fetal Monitor because it claims to be identical to its predicate. The acceptance criteria and performance data would have been established and met by the predicate device (F3 Fetal Monitor K102140) to obtain its clearance.

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

Not applicable. No new test set or data was used for the FM-3000 Fetal Monitor. The device claims substantial equivalence to a predicate, implying that previous studies on the predicate device would have established its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No new test set or ground truth establishment was performed for the FM-3000 Fetal Monitor.

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

Not applicable. No new test set or adjudication was performed for the FM-3000 Fetal Monitor.

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. The FM-3000 Fetal Monitor is not an AI-assisted device, and no MRMC study was conducted.

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

Not applicable. The FM-3000 Fetal Monitor is not an algorithm-only device. It is a physical monitoring system for fetal vital signs.

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

Not applicable. No new ground truth establishment was performed for the FM-3000 Fetal Monitor. For the predicate device, it would likely have been clinical validation against established fetal monitoring practices and potentially comparison to other validated monitoring systems, though the document does not provide details on the predicate's original ground truth.

8. The sample size for the training set

Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.

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

Not applicable. The FM-3000 Fetal Monitor is not a machine learning or AI device that requires a training set.

Summary of the K141194 submission for FM-3000 Fetal Monitor:

The manufacturer, Advanced Instrumentations, Inc., successfully argued for 510(k) clearance by demonstrating substantial equivalence to an existing predicate device, the EDAN Instruments F3 Fetal Monitor (K102140). The key argument is that:

"The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing."
"There are no differences in technological characteristics between the two devices."
"The only difference between the predicate device and the FM-3000 Fetal Monitor is the device name and branding in the labeling."

Therefore, the performance of the FM-3000 Fetal Monitor is asserted to be the same as the predicate device, and no new studies or data were deemed necessary to support this claim. The safety and effectiveness of the FM-3000 are directly linked to the established safety and effectiveness of the predicate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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

November 19, 2014

Advanced Instrumentations, Inc. % Jorge Millan, Ph.D. Executive Director Hialeah Technology Center, Inc. 601 West 20 Street Hialeah, FL 33010

Re: K141194

Trade/Device Name: FM-3000 Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Codes: HGM, HGS, HFN, HGP Dated: August 19, 2014 Received: August 22, 2014

Dear Jorge Millan:

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.

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

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Page 2 - Jorge Millan, Ph.D.

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,

Herbert P. Lerner -S

for

Benjamin 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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Indications for Use

510(k) Number (if known): K141194

Device Name:

FM-3000 Fetal Monitor

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Diagnostic Ultrasound indications for Use

Form

Fill out one form for each ultrasound system and each

transducer.

1MHz PW fetal probe

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body

Clinical Application	Mode Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal				N
Abdominal
Intraoperative(specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E Additional Comments: __ The above is a 1MHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED

CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K141194

Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, FI 33166 Telephone: 305-477-6331 Fax: 305-477-5351 Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

November 10, 2014

Device name and classification:

Device Name: FM-3000 Fetal Monitor ●
Classification Name: System, Monitoring, Perinatal ●
Regulation Number: 21 CFR 884.2740 ●
. Requlation Name: Perinatal Monitoring System and Accessories
HGM, HGS (catheter, intrauterine and introducer) o Product code: HFN (transducer, pressure, intrauterine), HGP (electrode, circular (spiral), scalp and applicator)
Regulatory Class: Class II ●

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Predicate Device:

F3 Fetal Monitor K102140 Manufacturer: EDAN Instruments

Device Description:

FM-3000 Fetal Monitor

The FM-300 is not intended for use in intensive care units, operating rooms or for home use.

Accessory	Part Number
Ultrasound Transducer	12.01.109301
TOCO Transducer	12.01.31527
Remote Event Marker	12.01.31112
Belt	11.57.02264
Aquasonic Coupling Gel (0.25ltr bottle)	11.57.78001
Intrauterine Pressure Cable Connecting Wire	01.13.107796
Intrauterine Pressure Cable	11.13.104152
Disposable Intrauterine Pressure Catheter	11.57.104153

Accessories

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Direct ECG Cable	11.13.02148
Disposable Fetal Spiral Electrode	11.57.02145
Disposable Maternal Attachment Pad Electrode	11.57.02146

Patient Contact Materials

Parts		Nature	Biocompatibility analysis
ultrasonictransducer	shell	ABS plastic	The material for this ultrasoundtransducer is cleared underK 040903
	cable	FR-PVC
TOCOTransducer	shell	ABS plastic
	cable	FR-PVC
Remotemarker	shell	ABS plastic
	cable	FR-PVC
Aquasonic Coupling Gel		water solublehypoallergenic	The biocompatibility analysis ofthese accessories is submitted inK 040903 which has been cleared.
Belt		Cotton
Disposable Fetal SpiralElectrode
Disposable MaternalAttachment Pad Electrode			The accessories manufactured byTyco have been cleared under K904745
DECG Cable
Disposable IntrauterinePressure Catheter
Intrauterine Pressure Cable			The accessories manufactured byTyco have been cleared under K910742

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Indications for Use:

lt provides Non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the fetal heart rate using ultrasound and uterine activity via a pressure sensing transducer. Alternatively, it can internally monitor one of the fetal heart rates with an electrocardiograph and uterine activity with an intrauterine pressure catheter.

Performance Data

The FM-3000 Fetal Monitor is identical to the predicate device in terms of design, materials, specifications, and manufacturing. Therefore, no new testing was needed to support substantial equivalence. The FM-3000 Fetal Monitor relied on the biocompatibility, electrical safety, electromagnetic compatibility, software, acoustic output, and bench testing from the predicate device to support substantial equivalence

Comparison to the predicate device:

The FM-3000 Fetal Monitor is identical the predicate device in terms of design, materials, specifications, and manufacturing. There are no differences in technological characteristics between the two devices. The only difference between the predicate device and the FM-3000 Fetal Monitor is the device name and branding in the labeling

Substantially Equivalent Determination:

Since the FM-3000 Fetal Monitor was identical to the predicate device in terms of technological characteristics, including design, materials, specifications, and manufacturing, no new testing was needed. Therefore, descriptive characteristics were precise enough to determine that the FM-3000 Fetal Monitor performs comparably to the predicate device that is currently marketed for the same intended use.

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).