The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals.

In basic format, the device performs antepartum fetal monitoring and uterine activity functions.

Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

Device Description

The BD4000 is a fetal monitor, which produces cardiotocographs (CTG) and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the BD4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards. Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1. A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC. Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1.

AI/ML Overview

The provided document (510(k) summary for the Baby Dopplex® 4000) focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and compliance with general medical device standards. It does not contain information about specific clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies that are typically associated with performance evaluation of new medical devices.

Therefore, most of the requested information cannot be extracted from this document.

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

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

Not Available: The document does not specify quantitative acceptance criteria or detailed performance metrics from a study demonstrating the device meets those criteria. It focuses on functional equivalence to predicate devices and compliance with safety standards (IEC601-1, BS EN60601-1, UL2601-1, etc.).

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

Not Available: No clinical or performance study details are provided, so no information on sample size or data provenance is available.

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 Available: Since no specific test set or clinical study is described, there's no mention of experts establishing ground truth.

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

Not Available: No test set or related adjudication method 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 Applicable/Not Available: The Baby Dopplex® 4000 is a fetal monitor that processes ultrasound/electrical signals for cardiotocographs (CTG) and uterine activity. It is not an AI-assisted diagnostic tool that involves human readers interpreting images, so an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not relevant to this device. No such study is mentioned.

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

Not Available: The document describes the device's functionality and its equivalence to predicate devices but does not detail any standalone algorithm performance studies. The device itself is a standalone monitor, but the request refers to performance studies of an algorithm.

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

Not Available: No specific ground truth methodology for performance evaluation is described.

8. The sample size for the training set

Not Applicable/Not Available: This device is not described as an AI/ML device that requires a training set in the conventional sense. The "training set" concept is typically associated with AI model development, which is not discussed for this fetal monitor.

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

Not Applicable/Not Available: As with point 8, this is not relevant to the described device.

Information provided in the document related to "acceptance criteria" and "study":

The document primarily focuses on compliance with international safety and electrical standards as its "acceptance criteria" for market clearance:

Acceptance Criteria (as implied by compliance testing):
- Compliance with IEC601-1 (medical electrical equipment general requirements)
- Compliance with BS EN60601-1
- Compliance with UL2601-1
- Compliance with BS EN 60601-1-2 (electromagnetic compatibility)
- Compliance with BS EN55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
- Compliance with DIN VDE 0750-1
- Compliance with Medical Devices Directive 93/42/EEC (Essential Requirements checklist)
- Biocompatibility assessed in line with BS EN30993-1 & ISO10993-1.
"Study" (as implied by the document): The document states:
- "The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards."
- "Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1."
- "A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC."
- "Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1."

In summary, the provided 510(k) document is a regulatory submission for substantial equivalence based on technical specifications and compliance with general safety standards, not a detailed clinical performance study with specific acceptance criteria as you've outlined for AI/diagnostic devices.

Summary

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JAN 2 4 2000

510(k) Summary

1 of 2

Baby Dopplex® 4000

Submitter's Name:	Ms Audrey A. Witco,Director of Corporate Affairs,Huntleigh Healthcare,227 Route 33 East,Manalapan, NJ 07726USA
Telephone Nº:	(800) 223 1218 ext 127

Fax Nº: (732) 446 1938

Name of Device: Baby Dopplex® 4000 (BD4000)

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

Contact Person at Manufacturing Facility:

B.J.Colleypriest +44 (0) 1222 485885 Telephone Nº: +44 (0) 1222 490170 Fax Nº: bryn.colleypriest@huntleigh-diagnostics.co.uk e-mail:

Date summary prepared: 01 December 1999

Classification Name

Fetal Ultrasonic Monitor and Accessories (21 CFR § 884.2660)

Predicate Devices

Baby Dopplex 3000 (ABD3000) K963711. Hewlett Packard GmbH's Series 50 range of Fetal Monitors Model Nºs M1351A & M1353A (K921957 & K921956 respectively).

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Device Description

In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

Intended use

The BD4000 device performs the same functions as the Hewlett Packard predicate devices. The BD4000 can also monitor twins by linking two unmodified devices together.

The BD4000 is also an upgrade of the predicate ABD3000 (K963711), and includes intrapartum and twins monitoring functions that were not available on the previous model.

The fetal parameters are displayed in the same way as those of the predicate devices.

The following table briefly compares the monitoring characteristics of the applicant device to its predicate devices.

Monitoring Mode	Baby Dopplex®4000	Baby Dopplex®3000(K963711)	Hewlett PackardM1351A(K921957)	Hewlett PackardM1353A(K921956)
Monitoring fetalheart rate usingultrasound	Yes	Yes	Yes	Yes
Monitoring twinfetal heart rateusing ultrasound	Yes(1)	No	Yes(1)	No
Monitor fetal heartrate using FECG	Yes(1)	No	Yes	Yes

NB: (1) optional feature.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2000

Ms. Audrey A. Witco Director of Corporate Affairs Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726

Re: K990569 Baby Dopplex® 4000 Dated: December 1. 1999 Received: December 9, 1999 Requiatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Ms. Witco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kaaooeea 510(k) Number (if known):

Device Name:

Baby Dopplex® 4000

Indications for Use

The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals.

In basic format, the device performs antepartum fetal monitoring and uterine activity functions.

Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

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

(Division Sig
Division of Abdominal, ENT,
and Radiolo
510(k) Number K9905695002
Prescription Use
(Per 21 CFR 801.109)
OR Over the counter use

Regulation Number and Section

§ 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).