(633 days)
Not Found
No
The description focuses on computerized analysis based on predefined criteria, with no mention of AI/ML terms or learning processes.
No
The device is described as a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs) to inform the clinician whether a CTG meets criteria indicative of a normal CTG. It is used as an adjunct and is not intended to replace or substitute other clinical evaluations. It assists in diagnosis and monitoring but does not directly treat a condition.
Yes
The device aids clinicians in determining whether a cardiotocogram (CTG) meets criteria indicative of a normal CTG, which is a diagnostic assessment of fetal well-being during pregnancy.
Yes
The device description explicitly states it is a "software accessory" for the analysis of cardiotocograms (CTGs). While it processes data likely generated by a hardware device (a fetal monitor, as suggested by the predicate device), the device itself is described solely as software performing analysis.
Based on the provided text, the Sonicaid® System 8002 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices analyze samples taken from the human body (like blood, urine, tissue). The Sonicaid® System 8002 analyzes cardiotocograms (CTGs), which are recordings of fetal heart rate and uterine contractions obtained externally from the pregnant woman.
- The description focuses on analyzing physiological signals. The device processes data from a fetal monitor, not biological samples.
- The intended use and device description clearly indicate external monitoring and analysis of physiological data.
Therefore, the Sonicaid® System 8002 falls under the category of a medical device used for monitoring and analysis of physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / 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:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HGM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
from 32 weeks gestation and greater
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
Oxford Instruments Medical Ltd Manor Way, Old Woking, Surrcy GU22 9JU, United Kingdom Fax +44 (0)1483 727193 Tel +44 (0)1483 770331
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 +44 (0)1483 770331 Fax +44 (0)1483 727193
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:
1
- 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.
2
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 (301) 594-4639. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
3
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