(361 days)
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.
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.
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.
§ 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).