The FM-9000 Plus Fetal and Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartumn examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartumn examination rooms, labor and delivery rooms. The FM-9000 Plus Fetal and Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

Device Description

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

Basic parameters: FHR, TOCO, Event Mark, AFM .
Dual FHR monitoring .
Internal parameters: UIP, DECG .
FHR limit alarm .
Following facilities are also provided in addition to the above:
Maternal ECG monitoring ●
Maternal SP02 monitoring ●
Maternal NIBP .
Maternal temperature monitoring ●

AI/ML Overview

{
"1. A table of acceptance criteria and the reported device performance": "The provided text does not contain a table of acceptance criteria or reported device performance for clinical endpoints. It primarily discusses the device's technical aspects and regulatory classification.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document explicitly states: "Clinical testing is not required." Therefore, no test set sample size or data provenance is available for clinical 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)": "As clinical testing was not required, there is no mention of experts or ground truth establishment for a clinical test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Clinical testing was not required, so no adjudication method for a test set is discussed.",
"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": "No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a Fetal and Maternal Monitor, not an AI-assisted diagnostic tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The document states "Clinical testing is not required." Therefore, no standalone performance study was conducted or reported.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Since clinical testing was not required, no specific type of ground truth was used for clinical performance evaluation.",
"8. The sample size for the training set": "The document does not mention a training set or its sample size. The device is a medical monitoring instrument, and the regulatory submission indicates that clinical testing was not required for its approval.",
"9. How the ground truth for the training set was established": "As no training set is mentioned and clinical testing was not required, there is no information on how ground truth for a training set was established."
}

Summary

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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: _ |< || 乙3/7

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: imillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

December 12, 2011

Device name and classification:

Device Name: FM-9000 Plus Fetal and Maternal Monitor .
Classification Name: 884.2740 Perinatal Monitoring System and . Accessories

Product code: HGM

Regulatory Class: Class II

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Predicate Device:

F9 Express Fetal and Maternal Monitor K100797 Manufacturer: EDAN Instruments

Device Description:

FM-9000 Plus Fetal and Maternal Monitor

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

Basic parameters: FHR, TOCO, Event Mark, AFM .
Dual FHR monitoring .
Internal parameters: UIP, DECG .
FHR limit alarm .

Following facilities are also provided in addition to the above:

Maternal ECG monitoring ●
Maternal SP02 monitoring ●
Maternal NIBP .
Maternal temperature monitoring ●

Intended Use:

Effectiveness and Safety Contraindications:

Clinical Test

Clinical testing is not required

{2}------------------------------------------------

Non-clinical test:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor:

Software testing .
Hardware testing .
Safety testing ●
Environment test ●
Risk analysis ●
Final validation ●

Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use as the predicate device.

Substantially Equivalent Determination:

Verification and validation testing was done on the FM-9000 Plus Fetal and Maternal Monitor. This premarket notification submission demonstrates that FM-9000 Plus Fetal and Maternal Monitor is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

DEC 2 1 2011

Re: K112317

Trade/Device Name: FM-9000 Plus Fetal and Maternal Monitor Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: November 16, 2011 Received: November 17, 2011

Dear Dr. 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. Iisting 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 of medical device-related

{4}------------------------------------------------

Page 2

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/ucm115809.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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI12317

Indications for Use

510(k) Number (if known): K112317

Device Name:

FM-9000 Plus Fetal and Maternal 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)

form 33 Whing

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112317

Page 1 of

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Diagnostic Ultrasonic Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Fetal and Maternal Monitor model F9000 Plus

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

Clinical Application	Mode Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging
Ophthalmic
Fetal				N
Abdominal
Intra-operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
PeripheranVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (specify)

N = new indication P=previously cleared by FDA: e=ADDED UNDER appendix E Additional comments: The above is an ultrasound system for the fetal heart rate detection.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Arzu Wh

{7}------------------------------------------------

Diagnostic Ultrasonic Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

1 MHz PW fetal probe- model F9000 Plus

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

Clinical Application	Mode Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal				P
Abdominal
Intra-operative (Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
PeripheranVascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (specify)

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

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Lori M. Whing

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).