(72 days)
No
The document describes a standard fetal monitor that displays real-time CTG traces. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing and display. The "Not Found" entries for AI/ML mentions, training/test sets, and performance studies further support this conclusion.
No
The device is described as a fetal monitor used for diagnostic and monitoring purposes, not for treating any condition.
Yes
The device produces fetal cardiotocographs (CTGs) and is used for monitoring, which involves collecting data to assess the status of the fetus and uterine activity. This assessment is a form of diagnosis.
No
The device description explicitly states it is a "modular product that provides a portable antepartum fetal monitor" and mentions a "Host Unit" with an "integral Liquid Crystal Display (LCD)", a "stand-alone rechargeable battery pack", and an "AC-powered supply via a power adapter". These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the FETAL ASSIST is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- FETAL ASSIST Function: The description clearly states that the FETAL ASSIST is a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs). This involves using transducers placed on the mother's abdomen to detect and record fetal heart rate and uterine activity. This is a non-invasive, external monitoring process.
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, the FETAL ASSIST falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
85 LQK, 85 MOH
Device Description
The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (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.
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FETAL ASSIST (K002548)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2730 Home uterine activity monitor.
(a)
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.(b)
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
0
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 (800) 223 1218 ext. 127 Telephone Nº: audreyw@huntleighhealth.com 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 |
| bryn.colleypriest@huntleigh-diagnostics.co.uk |
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)
1
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 ..
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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