(364 days)
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.
The Miris Human Milk Analyzer (HMA) includes a mid-infrared (mid-IR) spectroscopy system and a man-machine interface (MMI). The user is guided by the interactive MMI, via the screen, through the measurement process by use of the six-button controlled menu system. Milk samples are injected into the measuring unit (cuvette) via the instrument inlet using a syringe (sample volume 3 mL), excess sample and waste exiting via the outlet.
The device consists of the following components and accessories: an instrument casing with sample inlet and outlet holding a measurement unit and electronics mainboard, with AC/DC adapter, syringes for injection of sample, zero-setting solution, quality control solutions, and cleaning agent, waste container (not provided by the manufacturer), and outlet tubes.
The Miris Human Milk Analyzer (HMA) is a medical device that quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. It also provides calculated values for total solids and energy, which can be used alongside other clinical assessments to aid in the nutritional management of newborns and infants. The device is intended for use by trained healthcare personnel in clinical laboratories and by personnel in Human Milk Banking Association of North America (HMBANA) accredited human milk banks.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance characteristics. Below is a table summarizing the acceptance criteria and the device's reported performance where available and explicitly stated. For some categories, the acceptance criteria are implied by the "acceptable" or "met all expected performance" statements as explicit numerical criteria are not always provided.
| Performance Characteristic | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision | Repeatability (CV): Fat, Crude protein, True protein ≤5% at 1 g/mL; Carbohydrate, Total solids, Energy ≤3% Accuracy: Fat, Crude protein, True protein, Total solids, Energy ±10%; Carbohydrate ±13% | "The results of the precision study show that Miris HMA demonstrated acceptable results for the intended use of the device similar to the predicate device." "In all instances, the Miris HMA functioned as intended and the precision in the milk bank setting... was as expected." The exact CV and Accuracy values are not detailed in this section, but the overall conclusion affirms acceptance compared to predicate. |
| Detection Capability | LoB below 0.1 g/100 mL for fat, crude protein, and carbohydrate. LoB ≤ LoD |
§ 862.1493 Breast milk macronutrients test system.
(a)
Identification. A breast milk macronutrients test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) An appropriate traceability plan, as determined by FDA, to minimize the risk of drift in the breast milk macronutrient test system results over time.
(ii) Data that demonstrate appropriate precision, as determined by FDA, of the breast milk macronutrients test system. Precision studies must include assessment of a minimum of three breast milk specimens containing different concentrations (low, medium, and high levels) of fat, carbohydrates, and protein. Precision data must include breast milk specimen measurements that are collected at a minimum of three laboratory sites.
(iii) Data that demonstrate appropriate measurement accuracy, as determined by FDA, of fat, carbohydrates, and protein in breast milk. Measurement accuracy data must include breast milk specimen measurements that are collected at a minimum of one laboratory site.
(iv) Data from studies appropriate, as determined by FDA, to demonstrate that the device is free from significant interference from substances that could be present in human milk, including hemoglobin, and medications that are used by breastfeeding subjects.
(2) The labeling required under § 809.10 of this chapter must include a limiting statement indicating that the results should be used only as an aid in the nutritional management of infants and not as the sole basis for making nutrition decisions.