The Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs ("CTG"), i.e., fetal monitoring. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.

Device Description

The Baby Dopplex® 3000 is supplied complete with the following components: the main unit, a single crystal transducer, a contractions or uterine activity transducer, a patient event marker, an integral thermal printer, paper, belts, gel, a detachable power cord, and a user manual. The Baby Dopplex® 3000 includes all the basic functions and features that are internationally recognized as essential requirements for fetal monitors. With the exception of the power switch, all user controls and displays on the Baby Dopplex® 3000 main unit are arranged on a control panel which is located on the top face of the unit. Controls take the form of membrane type push buttons with tactile feedback. The Baby Dopplex® 3000 utilizes ultrasound energy at 2 MHz to detect the fetus. The power level, frequency, pulse duration and repetition rate are all preset at the manufacturing stage and there are no user controls or adjustments affecting any of these parameters.

AI/ML Overview

The provided document is a 510(k) summary for the Huntleigh Healthcare's Baby Dopplex® 3000 fetal monitor, dated August 16, 1996. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the Baby Dopplex® 3000 itself.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) for the Baby Dopplex® 3000. It instead provides a comparison of its technological characteristics with a predicate device.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Baby Dopplex® 3000)
Intended Use	Fetal monitoring to perform cardiotocographs, excluding internal scalp clip monitoring and/or intrauterine pressure measurement	Intended for use as a fetal monitor to perform cardiotocographs, excluding internal scalp clip monitoring and/or intrauterine pressure measurement.
Principle of Operation	Transmit and receive ultrasonic energy using pseudo-continuous wave (Doppler)	Transmit and receive ultrasonic energy using pseudo-continuous wave (Doppler).
Chart Speeds	1, 2, or 3 cm/min	1, 2, or 3 cm/min (user selectable).
Displays	LED display for fetal heart rate and uterine activity; computer interface	LED display for fetal heart rate and uterine activity; computer interface.
Fetal Heart Rate (FHR) Range	1351A: 50 to 210 bpm (based on 30 bpm/cm US standard)	50 to 210 bpm (based on 30 bpm/cm US standard).
Electrical Safety Standards	Conforms to UL544 and IEC601-1	Conforms to UL544 and IEC601-1.
Transducer Technology	Annular array of crystals at 1 MHz	Single crystal with a divergent lens at 2 MHz. (Note: This is a difference from the predicate, but the document argues it does not raise new questions of safety or effectiveness).
Power Level, Frequency, Pulse Duration, Repetition Rate	Not explicitly stated for predicate but assumed to be safe and effective	Preset at manufacturing stage; no user controls or adjustments.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the context of performance evaluation (e.g., diagnostic accuracy). The submission is a 510(k) premarket notification, which often relies on comparison to a legally marketed predicate device rather than de novo clinical trials unless significant technological differences or new safety/effectiveness questions arise.

Sample Size: Not applicable/not reported for a performance test set.
Data Provenance: Not applicable/not reported for a performance test set. The document originates from Huntleigh Healthcare in Manalapan, NJ, USA, and was reviewed by the FDA in Rockville, MD, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no specific "test set" for performance evaluation is described, this information is not available.

4. Adjudication Method for the Test Set

Not applicable, as no specific performance test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use.

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

The Baby Dopplex® 3000 is a fetal monitor that measures and displays fetal heart rate and uterine activity. While it uses ultrasound technology and processing, it is not an AI algorithm in the modern sense that would typically have a "standalone" performance evaluation for diagnostic purposes. Its use inherently involves a human (healthcare professional) interpreting its output (cardiotocographs). Therefore, a standalone algorithm-only evaluation, as often understood for AI devices, is not applicable to this type of device and not reported.

7. The Type of Ground Truth Used

No explicit "ground truth" (e.g., pathology, outcomes data) for performance evaluation is mentioned, as a formal performance study is not described. The basis for the 510(k) is substantial equivalence to a predicate device (Hewlett Packard GmbH Model 1351A Fetal Monitor), which implies that the predicate device's established safety and effectiveness serve as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The Baby Dopplex® 3000 is a hardware device utilizing established ultrasonic principles, not a machine learning or AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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6963711 page 1/2

SEP 1 2 1997

510(k) SUMMARY

FOR HUNTLEIGH HEALTHCARE'S

BABY DOPPLEX® 3000

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Audrey Witko Compliance Officer Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726

(908) 446-2500 Phone: Facsimile: (908) 446-1938

Contact Person: same as above

August 16, 1996 Date Prepared:

Name of Device and Name/Address of Sponsor

Baby Dopplex® 3000

Huntleigh Healthcare 227 Route 33 East Manalapan, NJ 07726

Classification Name

Fetal Ultrasonic Monitor and Accessories (21 C.F.R. § 884.2660)

Predicate Device

Hewlett Packard GmbH Model 1351A Fetal Monitor (K921957/A)

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Intended Use

Huntleigh Healthcare's Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.

Technological Characteristics and Substantial Equivalence

With the exception of the power switch, all user controls and displays on the Baby Dopplex® 3000 main unit are arranged on a control panel which is located on the top face of the unit. Controls take the form of membrane type push buttons with tactile feedback. The Baby Dopplex® 3000 utilizes ultrasound energy at 2 MHz to detect the fetus. The power level, frequency, pulse duration and repetition rate are all preset at the manufacturing stage and there are no user controls or adjustments affecting any of these parameters.

The Baby Dopplex® 3000 is substantially equivalent to Hewlett Packard GmbH's Model 1351A Fetal Monitor ("HP 1351A") (K921957/A). The Baby Dopplex® 3000 and the HP 1351A each have the same intended uses and principles of operation. As with its predicate device, the Baby Dopplex® 3000 is designed to transmit and receive ultrasonic energy into and from a pregnant woman, by means of a pseudo-continuous wave (Doppler).

Both the Baby Dopplex® 3000 and its predicate device offer three user selectable chart speeds of 1, 2 or 3 cm/min. Each device provides an LED display for fetal heart rate and uterine activity and each incorporates a computer interface. Based on a U.S. standard of 30 bpm/cm, both units measure fetal heart rate ("FHR") over the range of 50 to 210 bpm. Both devices conform to electrical safety standards UL544 and IEC601-1. As with its predicate device, the Baby Dopplex® 3000 has a PC/ABS alloy plastic casing.

As with its predicate device, the Baby Doplex® 3000 incorporates the use of a transducer that is held in place on the abdomen by elastic straps. While the HP 1351A utilizes an annular array of crystals operating at 1 MHz, the Baby Dopplex® 3000 utilizes a single crystal with a divergent lens operating at 2 MHz.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 2 1997

Ms. Audrey Witko Compliance Manager Huntleigh Healthcare, Inc. A Huntleigh Technology Inc. Company 227 Route 33 East Manalapan, New Jersey 07726

Re: K963711 Baby Dopplex® 3000 Fetal Monitoring Device Dated: June 13, 1997 Received: June 16, 1997 Regulatory Class: II 21 CFR & 884.2740/Product Code: 85 HGM

Dear Ms. Witko:

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 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, 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 (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 requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (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 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 question 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/dsmamain.html".

Sincerely yours.

W.Liau Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known):

Baby Dopplex® 3000 Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K9637 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

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).