FM-3000 FETAL MONITOR

K141194 · Advanced Instrumentations, Inc. · HGM · Nov 19, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141194
• Device Name: FM-3000 FETAL MONITOR
• Applicant: Advanced Instrumentations, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Nov 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

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 Story

FM-3000 Fetal Monitor performs non-invasive and invasive fetal monitoring. Inputs: ultrasound Doppler signals for fetal heart rate (FHR) and pressure-sensing transducer for uterine activity (external); or direct fetal electrocardiograph (FECG) and intrauterine pressure catheter (internal). Device processes signals to provide real-time monitoring data for clinicians in antepartum, labor, and delivery rooms. Output: visual display of FHR and uterine activity; connectivity via RJ45 to Central Monitoring System or wireless network module for data transmission. Clinicians use output to assess fetal status and guide clinical decision-making during labor and delivery. Benefits include continuous fetal surveillance to support safe delivery.

Clinical Evidence

No clinical data. The device is identical to the predicate; substantial equivalence is supported by reliance on the predicate's bench testing, biocompatibility, electrical safety, electromagnetic compatibility, software, and acoustic output data.

Technological Characteristics

System includes ultrasound transducer (1MHz PW), TOCO pressure transducer, and FECG/IUPC accessories. Materials include ABS plastic shells and FR-PVC cables. Connectivity via RJ45 or wireless network module. Identical to predicate F3 Fetal Monitor (K102140).

Indications for Use

Indicated for non-invasive and invasive fetal monitoring during antepartum examination, labor, and delivery in pregnant women from the 28th week of gestation. 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

• F3 Fetal Monitor (K102140)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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)

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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: [phone] Fax: [phone] Registration # 1066270

#### Official correspondent :

Jorge Millan, PhD Email: [e-mail] 601 West 20 St Hialeah, FL 33010 Phone : [phone]

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

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.

| 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 |
|-------------------------------------------------|-------|---------------------------------|-----------------------------------------------------------------------------------------------------------|
| ultrasonic<br>transducer | shell | ABS plastic | The material for this ultrasound<br>transducer is cleared under<br>K 040903 |
| | cable | FR-PVC | |
| TOCO<br>Transducer | shell | ABS plastic | |
| | cable | FR-PVC | |
| Remote<br>marker | shell | ABS plastic | |
| | cable | FR-PVC | |
| Aquasonic Coupling Gel | | water soluble<br>hypoallergenic | The biocompatibility analysis of<br>these accessories is submitted in<br>K 040903 which has been cleared. |
| Belt | | Cotton | |
| Disposable Fetal Spiral<br>Electrode | | | |
| Disposable Maternal<br>Attachment Pad Electrode | | | The accessories manufactured by<br>Tyco have been cleared under K<br>904745 |
| DECG Cable | | | |
| Disposable Intrauterine<br>Pressure Catheter | | | |
| Intrauterine Pressure Cable | | | The accessories manufactured by<br>Tyco have been cleared under K<br>910742 |

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# Indications for Use:

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.

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.