SONICAID SYSTEM 8002

K992607 · Oxford Instruments Medical Systems · HGM · Apr 27, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K992607
• Device Name: SONICAID SYSTEM 8002
• Applicant: Oxford Instruments Medical Systems
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Apr 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Sonicaid System 8002 is for use in pregnancies from 32 weeks gestations owards. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following: - previous questionable fetal heart rate recordings or poor obstetric history - abnormal umbilical blood flow velocity waveforms - suspected fetal anomalies - suspicion of maternal intoxication or assault - intrauterine growth retardation - antepartum haemorrhage - uterine pain - reduced fetal movements - hypertension or pre-eclampsia - reduced amniotic fluid volume The Sonicaid System 8002 is used as an adjunct to and is not intended to replace or substitute the clinical assessment of amniotic fluid amount, Doppler evaluations, and/or biophysical profile.

Device Story

Software accessory for computerized analysis of antepartum cardiotocograms (CTGs); processes fetal heart rate data to determine if CTG meets criteria indicative of normal status; used in clinical settings by healthcare providers; provides automated analysis as adjunct to standard clinical assessments (e.g., biophysical profile, Doppler); assists clinicians in identifying normal fetal heart rate patterns; does not replace clinical judgment.

Clinical Evidence

Clinical validation studies performed to support the use of specific criteria in the determination of a normal CTG. Software verification studies conducted in-house.

Technological Characteristics

Software accessory for computerized analysis of antepartum CTGs. Operates on fetal heart rate data. Intended for use in pregnancies 32 weeks gestation and greater.

Indications for Use

Indicated for pregnant women from 32 weeks gestation onwards, including those with Braxton-Hicks contractions. Not for use in established labor. Used for high-risk pregnancies involving history of questionable fetal heart rate, abnormal umbilical blood flow, suspected anomalies, maternal intoxication/assault, intrauterine growth retardation, antepartum hemorrhage, uterine pain, reduced fetal movements, hypertension, pre-eclampsia, or reduced amniotic fluid.

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

• Sonicaid® Team fetal monitor (K912639)

Submission Summary (Full Text)

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Oxford Instruments Medical Ltd Manor Way, Old Woking, Surrcy GU22 9JU, United Kingdom Fax [phone] Tel [phone]

## 510(k) Summary

General Information 1.

Trade Nume of Device:

Common/Usual Name:

Classification Name:

Submitters Name & Address:

Contact Name:

Manufacturer:

Sonicaid® System 8002

Fetal heart rate analysis software

System, monitoring, perinatal

Oxford Instruments Medical Ltd Manor Way Old Woking Surrey GU22 9JU United Kingdom Tel [phone] Fax [phone]

E. J. Smith Consultant

Oxford Instruments Medical Ltd Manor Way Old Woking Surrey GU22 9JU United Kingdom

#### 2. Device Description

The Sonicaid® System 8002 is a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs) in pregnancies from 32 weeks gestation onwards. It informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG.

### 3 Indications for Use

The Sonicaid® System 8002 is for use in pregnancies from 32 weeks gestation and greater. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following:

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- previous questionable fetal heart rate recordings or poor obstetric history
- abnormal umbilical blood flow vekveity waveforms
- suspected fotal anomalies
- suspicion of maternal intoxication or assault
- intrauterine growth retardation
- antepartum haemorrhage
- -- uterine pain
- reduced fetal movements
- hypertension or pre-eclampsia
- reduced amniotic fluid volume

The Sonicaid® System 8002 is used as an adjunct to and is not intended to replace or substitute The Someation of ammiotic fluid amount, Doppler evaluations, and/or biophysical profile.

## Substantial Equivalence 4.

The Sonicaid® System 8002 is substantially equivalent to the Sonicaid® Team fetal monitor K912639.

### Performance Studies ಳಸ

The Souicaid® System 8002 informs the clinician whether a CTG meets a number of criteria that Indicative of a normal CTG. Software verification studies were performed in-house to are "indeative" of a "homa" Of eria, and clinical validation studies have been performed and documented supporting the use of these criteria in the determination of a normal CTG.

### Conclusion Q.

Based upon the indications for use and performance studies the Sonicaid® System 8002 has been shown to be suitable for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oxford Instruments Medical Ltd c/o Ms. Yolanda Smith Smith Associates FDA Consultants P.O. Box 4341 CROFTON MD 21114

Re: K992607 Sonicaid® System 8002 (software accessory) Dated: March 29, 2001 Received: April 3, 2001 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM

## Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Section 216(k) noutsations for use stated in the enclosure) to legally marketed predicate devices device is substantally of the tice are matesting to the enactment date of the Medical Device Amendments, or to devices markets in millers and Commerce 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 thelevel, maker the device, subject on the Enters, 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, to such additional controls. Existant mayor regulates decemination assumes compliance with the Current Good Manufacturing TIME 21, Patis 800 0 693. A subsaintany odar as Regulation (QS) for Medical Devices: General regulation (21 CFR Part Practice requirentents, as set tour in the Quality of son research (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply with the Gril Tegulation into Tesan in regaratore this response to your premarket notification submission in 1971 concenting your 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 I fills letter will allow you to begally 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 vitto If you desire sponne acries of Compliance at [phone]. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entined, "Misolanding of receited to promation nother (erse even Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

APR 2 7 2001

Image /page/2/Picture/14 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the shape of the bird's body and wings.

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# 510(k) Number (if known): K992607

# Device Name: Sonicaid® System 8002

## Classification Panel: 85HGM

## Indications for Use:

The Sonicaid System 8002 is for use in pregnancies from 32 weeks gestations owards. It The Soncald System 8002 is for use in progriencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the such as labour contractions, pharmaconegical agains. Typical indications for use include the following:

- previous questionable fetal heart rate recordings or poor obstetric history
- abnormal umbilical blood flow velocity waveforms
- suspected fetal anomalies
- suspicion of maternal intoxication or assault
- intrauterine growth retardation
- antepartum haemorrhage
- uterine pain
- reduced fetal movements
- hypertension or pre-eclampsia
- reduced amniotic fluid volume

The Sonicaid System 8002 is used as an adjunct to and is not intended to replace or The Sollicald System over as assessment, Doppler evaluations, and/or biophysical profile.

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

Prescription Use

Over the Counter Use

Yianni A. Sippon

or

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devices

510(k) Number K992607