FM-1000 PLUS FETAL MONITOR

K112187 · Advanced Instrumentations, Inc. · HGM · Sep 21, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K112187
• Device Name: FM-1000 PLUS FETAL MONITOR
• Applicant: Advanced Instrumentations, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The FM-1000 Plus Fetal Monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.

Device Story

FM-1000 Plus Fetal Monitor provides antepartum fetal monitoring; inputs include FHR (ultrasound), TOCO (uterine activity), fetal movement (remote marker/automatic), optional fetal stimulator, DECG, and IUP. Device features 5.7" LCD for real-time display of trends and parameters; built-in thermal recorder for data documentation. Used in hospitals, clinics, and home settings by trained medical personnel or patients under prescription. Output allows clinicians to assess fetal well-being during non-stress tests, facilitating clinical decision-making regarding fetal health.

Clinical Evidence

No clinical data; clinical testing is not required.

Technological Characteristics

5.7" LCD display; built-in thermal recorder; supports ultrasound (FHR), TOCO, DECG, and IUP sensors. Connectivity includes remote marker and optional fetal stimulator. Device is a perinatal monitoring system (21 CFR 884.2740).

Indications for Use

Indicated for monitoring fetal well-being during the antepartum period (non-stress test) in clinical settings or patient homes via prescription.

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

• Cadence II Fetal Monitor (K073221)

Submission Summary (Full Text)

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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: ≤ ≤ ≤ ≤ ≤ ≤ 7

## Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: [phone] Fax:

Registration # 1066270

## Official correspondent :

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

Date Prepared:

July 27, 2011

## Device name and classification:

- . Device Name: FM-1000 Plus Fetal Monitor
- Classification Name: 884.2740 System, Monitoring, Perinatal . Product code: HGM

.

- Regulatory Class: ● Class II

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### FM-1000 Plus Fetal Monitor

## Predicate Device:

Cadence II Fetal Monitor K073221 Manufacturer: EDAN Instruments

## Device Description:

### FM-1000 Plus Fetal Monitor

The FM-1000 Plus Fetal Monitor can provide different configurations according to different user requirements, FHRI (USI), FHR2 (US2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), fetal stimulator (optional),DECG (direct fetal ECG, optional), and JUP(Intra-uterine Pressure, optional). The user can select the monitors according to requirements. FM-1000 Plus adopts 5.7" LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

#### Intended Use:

The FM-1000 Plus Fetal Monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.

#### Effectiveness and Safety Contraindications:

#### Clinical Test

Clinical testing is not required

## 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-1000 Plus Fetal Monitor. This premarket notification submission demonstrates that FM-1000 Plus Fetal Monitor is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 St HIALEAH FL 33010

SEP 2 1 2011

Re: K112187

Trade/Device Name: FM-1000 Plus Fetal Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: September 13, 2011 Received: September 15, 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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Paris 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known):

#### Device Name:

FM-1000 Plus Fetal Monitor

#### Indications for Use:

The FM-1000 Plus Fetal Monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physician's offices and in the patient's home by prescription or doctors orders.

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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Division of Radiolog Office of In Vitro Diagnostic Device

510K K112182