MODIFICATION TO FETAL ASSIST

K020390 · Huntleigh Diagnostics , Ltd. · LQK · Apr 19, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020390
• Device Name: MODIFICATION TO FETAL ASSIST
• Applicant: Huntleigh Diagnostics , Ltd.
• Product Code: LQK · Obstetrics/Gynecology
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2730
• Device Class: Class 2

Intended Use

The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications The FETAL ASSIST is sullable for use in an othromanaly intended for use in the following specific areas: - antenatal monitoring in the hospital, doctors office, health clinic, home or community. ● - External Labour monitoring. . - Waterbirth monitoring using optional waterproof transducers. . - vvalerbirth monitoring daing optional water in conjunction with standard high-risk care, for the . Hollie Otenne measurement of uterine activity for women with a history of preterm birth. - Domiciliary Non Stress Testing applications. . The FETAL ASSIST is a prescription device.

Device Story

Portable antepartum fetal monitor; produces fetal cardiotocographs (CTGs). Inputs: fetal/maternal physiological signals via transducers. Processing: real-time signal analysis; generates CTG traces. Output: visual display on integral LCD; data reviewable or downloadable to external printer/central location. Used in hospitals, clinics, homes, or community settings; operated by clinicians or patients (following instruction). Benefits: enables remote/home monitoring of fetal health and uterine activity; facilitates timely clinical decision-making for high-risk pregnancies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular, portable fetal monitor. Features integral LCD for real-time CTG display. Power: rechargeable battery pack or AC adapter. Connectivity: supports external printer/central location download. Optional waterproof transducers for waterbirth monitoring.

Indications for Use

Indicated for antepartum fetal monitoring, external labor monitoring, waterbirth monitoring, and home uterine activity monitoring (HUAM) for women with history of preterm birth, and domiciliary non-stress testing. Prescription use only.

Regulatory Classification

Identification

A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.

Special Controls

*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).

Predicate Devices

• FETAL ASSIST (K002548)

Submission Summary (Full Text)

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**APR. 1 9 2002**

APPENDIX A

## 510(K) SUMMARY

# FETAL ASSIST

Ms Audrey A. Witko, Submitter's Name: Vice President - Administration, Compliance & Clinical Affairs Huntleigh Healthcare, 40 Christopher Way Eatontown, NJ 07724-3327 USA [phone] ext. 127 Telephone Nº: [e-mail] e-mail:

Name of Device:

### FETAL ASSIST

Manufactured by:

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

#### Contact Person at Manufacturing Facility:

B.J.Colleypriest

| | Telephone Nº: 011 2920 485885 |
|---------|-----------------------------------------------|
| Fax Nº: | 011 2920 490170 |
| e-mail | [e-mail] |

Date Special 510(k) prepared:

25 January 2002

Classification Name ferindlik Monitoring System 2740 Fetal Uttrasonic Monitor and Accessories (21 CFR § 884.2660) Home Uterine Activity Monitors (21 CFR § 884.2730)

#### Predicate Devices

FETAL ASSIST (K002548)

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#### Device Description

The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs).

age Zofz

relat Cardiotooographs (CTGS).
CTG traces are displayed in real time on the Liquid Crystal Display (LCD) which is integral to the Host Unit. OTG traces are displayed in toal line an and and the Host Unit and can be reviewed or downloaded to an external printer and/or central location.

extential princer and or onlined by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.

#### Intended use

The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications from a THE T LT AUDIO T IS Sullable for ass II an estivaliatly intended for use in the following specific areas:-

Antenatal monitoring in the hospital, doctors office, health clinic, home or community.

External Labour monitoring.

Home Uterine Activity Monitoring (HUAM) and/or Non Stress Testing

NB: Before being used in domiciliary HUAM and/or Non Stress Testing applications the mother would be instructed in the use of the equipment.

The FETAL ASSIST is a prescription device ..

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Audrey Witko Vice President, Administration, Compliance & Clinical Affairs Huntleigh Healthcare, Inc. 40 Christopher Way EATONTOWN NJ 07724-1218

# APR 1 9 2002

Re: K020390

Trade/Device Name: Fetal Assist for Home Uterine Monitoring Regulation Number: 21 CFR 884.2730 Regulation Name: Home uterine activity monitor Regulatory Class: II Product Code: 85 LQK Trade/Device Name: Fetal Assist for Home Non-Stress Test Monitoring Regulatory Number: 21 CFR 884.2740 Regulatory Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 MOH Dated: January 24, 2002 Received: February 6, 2002

Dear Ms. Witko:

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.

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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Huntleigh Diagnostics. The logo consists of a stylized tower-like structure made of horizontal lines, with the name "Huntleigh" written in a serif font above the word "DIAGNOSTICS" in a smaller, sans-serif font. The logo is in black and white.

#### INDICATIONS FOR USE APPENDIX E

510(k) Number

K020390 FETAL ASSIST

Device Name:

Indications for Use

The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications The FETAL ASSIST is sullable for use in an othromanaly intended for use in the following specific areas: -

- antenatal monitoring in the hospital, doctors office, health clinic, home or community. ●
- External Labour monitoring. .
- Waterbirth monitoring using optional waterproof transducers. .
- vvalerbirth monitoring daing optional water in conjunction with standard high-risk care, for the . Hollie Otenne measurement of uterine activity for women with a history of preterm birth.
- Domiciliary Non Stress Testing applications. .

The FETAL ASSIST is a prescription device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over the co

Over the counter use

Daniel A. Ingram

×

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K020390