BABY DOPPLEX 4000, MODEL BD 4000

K990569 · Huntleigh Healthcare, Inc. · HGM · Jan 24, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K990569
• Device Name: BABY DOPPLEX 4000, MODEL BD 4000
• Applicant: Huntleigh Healthcare, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jan 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations. In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

Device Story

BD4000 is a fetal monitor processing ultrasound and electrical signals to produce cardiotocographs (CTG) and uterine activity data. Basic unit performs antepartum monitoring; optional modules enable intrapartum monitoring. Two units can be linked for simultaneous twin monitoring. Used in clinical settings by healthcare professionals. Output displayed for clinician review to support fetal status assessment and clinical decision-making during pregnancy and labor.

Clinical Evidence

Bench testing only. Compliance with IEC601-1, BS EN60601-1, UL2601-1, BS EN 60601-1-2, BS EN55011, and DIN VDE 0750-1. Biocompatibility assessed per BS EN30993-1 and ISO10993-1.

Technological Characteristics

Fetal monitor utilizing ultrasound and electrical signal processing. Modular design for intrapartum and twin monitoring. Compliant with IEC601-1, BS EN60601-1, UL2601-1, BS EN 60601-1-2, BS EN55011, DIN VDE 0750-1. Biocompatibility per BS EN30993-1/ISO10993-1.

Indications for Use

Indicated for antepartum and intrapartum fetal monitoring and uterine activity assessment in pregnant patients, including twin pregnancies.

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

• Baby Dopplex 3000 (K963711)
• Hewlett Packard Series 50 Fetal Monitors Model M1351A (K921957)
• Hewlett Packard Series 50 Fetal Monitors Model M1353A (K921956)

Submission Summary (Full Text)

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JAN 2 4 2000

# 510(k) Summary

1 of 2

# Baby Dopplex® 4000

| Submitter's Name: | Ms Audrey A. Witco,<br>Director of Corporate Affairs,<br>Huntleigh Healthcare,<br>227 Route 33 East,<br>Manalapan, NJ 07726<br>USA |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Nº: | [phone] ext 127 |

Fax Nº: [phone]

Name of Device: Baby Dopplex® 4000 (BD4000)

Huntleigh Diagnostics Ltd Manufactured by: 35, Portmanmoor Road, Cardiff South Glamorgan CF24 5HN Wales, U.K.

#### Contact Person at Manufacturing Facility:

B.J.Colleypriest [phone] Telephone Nº: [phone] Fax Nº: [e-mail] e-mail:

Date summary prepared: 01 December 1999

## Classification Name

Fetal Ultrasonic Monitor and Accessories (21 CFR § 884.2660)

#### Predicate Devices

Baby Dopplex 3000 (ABD3000) K963711. Hewlett Packard GmbH's Series 50 range of Fetal Monitors Model Nºs M1351A & M1353A (K921957 & K921956 respectively).

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## Device Description

The BD4000 is a fetal monitor, which produces cardiotocographs (CTG) and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the BD4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards. Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1. A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC. Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1.

### Intended use

The BD4000 device performs the same functions as the Hewlett Packard predicate devices. The BD4000 can also monitor twins by linking two unmodified devices together.

The BD4000 is also an upgrade of the predicate ABD3000 (K963711), and includes intrapartum and twins monitoring functions that were not available on the previous model.

The fetal parameters are displayed in the same way as those of the predicate devices.

The following table briefly compares the monitoring characteristics of the applicant device to its predicate devices.

| Monitoring Mode | Baby Dopplex®<br>4000 | Baby Dopplex®<br>3000<br>(K963711) | Hewlett Packard<br>M1351A<br>(K921957) | Hewlett Packard<br>M1353A<br>(K921956) |
|---------------------------------------------------------|-----------------------|------------------------------------|----------------------------------------|----------------------------------------|
| Monitoring fetal<br>heart rate using<br>ultrasound | Yes | Yes | Yes | Yes |
| Monitoring twin<br>fetal heart rate<br>using ultrasound | Yes(1) | No | Yes(1) | No |
| Monitor fetal heart<br>rate using FECG | Yes(1) | No | Yes | Yes |

NB: (1) optional feature.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2000

Ms. Audrey A. Witco Director of Corporate Affairs Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726

Re: K990569 Baby Dopplex® 4000 Dated: December 1. 1999 Received: December 9, 1999 Requiatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Ms. Witco:

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 (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 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), please 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.

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

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Kaaooeea 510(k) Number (if known):

Device Name:

Baby Dopplex® 4000

# Indications for Use

The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals.

In basic format, the device performs antepartum fetal monitoring and uterine activity functions.

Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sig
Division of Abdominal, ENT,
and Radiolo
510(k) Number K9905695002
Prescription Use
(Per 21 CFR 801.109)
OR Over the counter use