The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications. The FETAL ASSIST is specifically 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. - Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the 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 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 and can be reviewed or downloaded to an external printer and/or central location. The Assist can be powered by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.

AI/ML Overview

The provided text describes the "FETAL ASSIST" device and its intended uses, along with the FDA's acknowledgement of its substantial equivalence to predicate devices. However, the document is a 510(k) summary and FDA clearance letter, which typically does not include detailed study results, acceptance criteria, or performance data in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

Not provided. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria or study outcomes in a quantitative manner. No performance attributes or measurements are mentioned against any acceptance thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document does not mention any specific test set, sample sizes, or data provenance for any studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. No information regarding experts or ground truth establishment for a test set is included.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. No adjudication method for a test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not provided. The "FETAL ASSIST" is described as a fetal monitor that produces and displays cardiotocographs (CTGs). It is not an AI-assisted diagnostic device, and thus, a multi-reader multi-case comparative effectiveness study with AI assistance would not be applicable or expected for this device based on the description.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not provided. The FETAL ASSIST is a monitoring device that generates CTGs for human interpretation. It is not an algorithm for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not provided. The document does not discuss the establishment of ground truth as it pertains to performance studies.

8. The sample size for the training set

Not provided. No information about a training set is included, as this is a monitoring device, not a machine learning model.

9. How the ground truth for the training set was established

Not provided. No information about a training set or its ground truth is included.

Summary

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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 (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
e-mail	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)

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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	(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

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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

Regulation Number and Section

§ 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).