(167 days)
The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring and showing graphically abdominal contractions, fetal heart rate, maternal non-invasive blood pressure, and maternal heart rate by means of display on a non-permanent graphical display and optionally on a printer. This data is to aid in assessing the well-being of the fetus and mother during the final trimester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home.
The FETALGARD Lite-NIBP is a compact, lightweight device for measuring, processing, displaying, and printing information derived from four physiological measurements:
- Fetal Heart Rate. Two types of ultrasound transducers can be used to monitor single or twins fetal heart rate and display real-time on the LCD screen or permanently recorded on the optional printer.
- Uterine Activity. Uterine pressure changes via a tocotonometer are used to monitor uterine contractions. The waveforms are displayed real-time on the LCD screen or permanently recorded on the optional printer.
- Maternal non-invasive blood pressure. Blood pressure is measured non-invasively (NIBP) by the oscillometric method.
- Maternal heart rate. The algorithm used to derive maternal heart rate is identical to the derived heart rate parameter used in the C3 Patient Monitor when the NIBP module is the measurement source.
A printer records fetal heart rate and tocotonometer waveforms, maternal non-invasive blood pressure value, and maternal heart rate value.
The FETALGARD Lite-NIBP is powered by internal sealed lead-acid batteries or from the mains supply via an external battery eliminator. A fully charged battery will power the monitor for two hours minimum.
The provided document is a 510(k) Summary for the Analogic Corporation's FETALGARD Lite-NIBP. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance: The document cites various IEC and ANSI/AAMI standards that the device will be tested against, but it does not provide specific acceptance criteria or the numerical results of these tests in a table form.
- Sample size used for the test set and data provenance: No test set is described in terms of sample size or origin.
- Number of experts and their qualifications for ground truth: Ground truth establishment by experts is not mentioned for non-clinical testing.
- Adjudication method for the test set: No adjudication method is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The document focuses on non-clinical testing.
- Standalone (algorithm only) performance: As this is a medical device, the focus is on the integrated system rather than a standalone algorithm.
- Type of ground truth used: For the non-clinical tests mentioned, the "ground truth" would be compliance with the standards, not clinical outcomes or pathology.
- Sample size for the training set: There is no mention of a "training set" as the device is not an AI/ML algorithm that requires training data in the typical sense.
- How ground truth for the training set was established: Not applicable, as there's no mention of a training set.
What the document does describe in terms of testing and "acceptance" (equivalence):
The document outlines a series of non-clinical tests to demonstrate compliance, performance, and reliability, thereby supporting its substantial equivalence to predicate devices. These tests are primarily focused on safety, electromagnetic compatibility, alarm systems, and specific performance for non-invasive blood pressure monitoring.
Key statements regarding "acceptance criteria" (though not explicitly stated in a quantitative table):
- Compliance with Standards: The device must comply with a range of international and national standards, which serve as its de facto acceptance criteria for various aspects (safety, performance). These include:
- IEC 60601-1 (and Amendments 1 & 2): Medical Electrical Equipment - General Requirements for Safety
- IEC 60601-1-2: 2001: Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B
- IEC 60601-1-4: Medical electrical equipment – Programmable electrical medical systems
- IEC 60601-1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment
- IEC 60601-2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
- IEC 60601-2-49: Particular requirements for the safety of multifunction patient monitoring equipment
- ANSI/AAMI SP10: Manual, Electronic, or Automated Sphygmomanometers
- IEC 60068 series of standards: Mechanical shock and vibration tests
- ISTA; Project 2A: Shipping container transportation tests (packaging)
- Other Tests:
- Altitude tests (to ensure operation at higher altitudes does not adversely affect electrical safety or performance).
- Tests to verify enclosure material robustness and resistance to cleaning materials.
Study Proving Acceptance (Substantial Equivalence):
The document refers to a "test schedule" of non-clinical tests that will be performed. The conclusion drawn is that "The test schedule of the FETALGARD Lite-NIBP combined with 'Information for Manufacturers,' September 1997, Track 1 tests already performed demonstrate that the FETALGARD Lite-NIBP and its associated safety and effectiveness is substantially equivalent to the performance of the FETALGARD Lite and the C3 Patient Monitor predicate devices cited in Section 5 of this summary."
In summary, for a 510(k) submission like this, "acceptance criteria" are generally understood as compliance with recognized standards and the demonstration of equivalent performance and safety to a predicate device through non-clinical bench testing. Specific quantitative performance metrics or clinical study results are typically not required unless a significant difference in technological characteristics or a new indication for use is introduced that cannot be assured through non-clinical data.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).