FETALGARD 3000 FETAL MONITOR

K983395 · Analogic Corp. · HGM · Aug 12, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983395
• Device Name: FETALGARD 3000 FETAL MONITOR
• Applicant: Analogic Corp.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. This data is intended to aid in assessing the well-being of the fetus during pregnancy (antepartum), and labor and delivery (intrapartum). The modifications described in this submission do not implement any changes in intended use.

Device Story

Fetalgard 3000 is a perinatal monitoring system used in clinical settings to assess fetal well-being. Inputs include uterine contraction data (via external tocotonometer or intrauterine pressure transducer), fetal heart rate (via external pulsed Doppler ultrasound or spiral scalp electrode), and maternal heart rate/respiration (via ECG electrodes). The device processes these signals to display graphical and digital representations of maternal labor and fetal heart rate on an LCD/chart recorder and LED displays. Clinicians use this output to monitor fetal status during pregnancy and labor. Modifications include redesigned tocotonometer for reliability, updated ultrasound transducer housing material, and software revisions to improve fetal heart rate detection under adverse conditions.

Clinical Evidence

Bench testing only. Verification and validation testing performed using simulated input signals and tape recordings of actual physiological waveforms to confirm that modifications did not adversely affect device safety or performance.

Technological Characteristics

Perinatal monitoring system. Inputs: tocotonometer, intrauterine pressure transducer, pulsed Doppler ultrasound, spiral scalp electrode, ECG electrodes. Outputs: LCD display, chart recorder, LED digital display. Software: evolutionary revisions for signal detection. Materials: ultrasound transducer housing material equivalent in mechanical properties and biocompatibility to predicate.

Indications for Use

Indicated for assessing fetal well-being during pregnancy, labor, and delivery by monitoring uterine contractions and fetal heart rate.

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

• Fetalgard 3000 Fetal Monitor (K950420)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 12 1999

### 510(k) Summary for Analogic Corporation Modifications to Fetalgard 3000 Fetal Monitor

## DATE THIS SUMMARY WAS PREPARED: September 11, 1998

#### SUBMITTER'S NAME AND ADDRESS:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

#### CONTACT PERSON:

| Steven Clarke, Regulatory Specialist | |
|--------------------------------------|------------------------------|
| Telephone | [phone] extension 2388 |
| Facsimile | [phone] |

### DEVICE NAME:

| Proprietary Name: | Fetalgard 3000 Fetal Monitor (Modification to |
|----------------------|-----------------------------------------------|
| Common Name: | Perinatal Monitoring System |
| Classification Name: | Perinatal Monitoring System and Accessories |

### PREDICATE DEVICE:

The legally marketed device to which equivalence is being claimed is:

Fetalgard 3000 Fetal Monitor

### DEVICE DESCRIPTION:

.

The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements.

K98395

{1}------------------------------------------------

Uterine contractions are monitored using an external tocotonometer or an intrauterine pressure transducer.

Fetal heart rate is measured using an external pulsed Doppler ultrasound transducer or directly with a spiral scalp electrode.

Maternal heart rate and respiration are measured using standard ECG electrodes.

Heart rate, respiration rate, and uterine activity are presented graphically on an LCD display or chart recorder and digitally on LED displays.

### INTENDED USE:

The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. This data is intended to aid in assessing the well-being of the fetus during pregnancy (antepartum), and labor and delivery (intrapartum). The modifications described in this submission do not implement any changes in intended use.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The modified Fetalgard 3000 Fetal Monitor is nearly identical to the predicate Fetalgard 3000 Fetal Monitor which was cleared for marketing under Premarket Notification K950420.

The tocotonometer has been redesigned using the same principle of operation. with changes in the design details to enhance reliability and improve ease of manufacture.

The top housing of the ultrasound transducer will be manufactured out of a different material, which is equivalent in terms of mechanical properties and biocompatibility.

The system software has undergone several evolutionary revisions to improve the detection and display of fetal heart rate under adverse conditions.

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

#### NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The modifications to the device have undergone a subset of the original verification and validation test scenarios to show that all functions that may have been affected by the modifications are still in compliance with the original user requirements, and that safety and performance have not been adversely affected. This involved the use of both simulated input signals and tape recordings of actual physiological waveforms.

# CONCLUSIONS FROM NONCLINICAL TESTING:

The testing of the modified Fetalgard 3000 Fetal Monitor demonstrates the performance is substantially equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Steven A. Clarke, RAC Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Peabody, MA 01960

Re: K983395 Fetalguard 3000 Fetal Monitor Dated: July 29, 1999 Received: July 30, 1999 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Mr. Clarke:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

[signature]

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): 1

Device Name: _ Fetalgard 3000 Fetal Monitor

Indications For Use:

The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. This data is intended to aid in assessing the well-being of the fetus during pregnancy, labor, and delivery.

David C. Seppam
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

Analogic Corporation Fetalgard 3000 510(k)