(364 days)
No
The document describes a device that uses mid-infrared spectroscopy to measure components in human milk. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The analysis relies on physical measurements and calculations, not data-driven learning algorithms.
No
The device measures components in human milk to aid in nutritional management but does not directly provide therapy.
Yes
The device "quantitatively measures the concentration of fat, protein, and carbohydrate in human milk" and "These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants." This falls under the definition of a diagnostic device as it provides information used to aid in diagnosis or treatment.
No
The device description explicitly states that the Miris Human Milk Analyzer includes a mid-infrared (mid-IR) spectroscopy system, an instrument casing, a measurement unit, electronics mainboard, and various accessories like syringes and an AC/DC adapter. These are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "quantitatively measure the concentration of fat, protein, and carbohydrate in human milk." It also provides calculated values for total solids and energy. These measurements are used "to aid in the nutritional management of newborns, including preterm, and infants." This directly aligns with the definition of an IVD, which is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or in order to ascertain the susceptibility of a human being to a particular treatment, or in order to monitor therapeutic measures.
- Specimen Type: The device analyzes human milk, which is a specimen derived from the human body.
- Purpose: The purpose is to provide quantitative information about the composition of human milk, which is used to aid in the nutritional management of patients (newborns and infants). This information is used in a clinical context to make decisions about patient care.
- User and Setting: The device is intended for use by "trained healthcare personnel at clinical laboratories" and "personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks." These are typical settings for IVD use.
The device performs in vitro testing on a human specimen to provide information used for clinical decision-making regarding patient management. This clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Newborns, including preterm, and infants
Intended User / Care Setting
healthcare personnel at clinical laboratories; personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Precision Study:
The study followed the CLSI EP05-A3 guideline to evaluate repeatability and reproducibility of the Miris HMA for measuring fat, CP, TP, CHO, TS, and E.
- Sample Size: 5 human milk samples.
- Data Source: Three US human donor milk bank sites: Mothers' Milk Bank (San José, USA), Mid-Atlantic Mothers' Milk Bank 'Three Rivers' (Pittsburgh, USA), and The New York Milk Bank, Inc. (New York, USA).
- Study Design:
- Main site (E): 1 operator, 20 days, 2 runs/day, 2 replicates/sample/run (planned 400 observations).
- Two secondary sites (F, G): 1 device, 2-3 operators, 5 days, 2 runs/day, 3 replicates/sample/run (planned 150 observations per site).
- Key Results: The Miris HMA demonstrated acceptable results for its intended use, similar to the predicate device.
Detection Capability:
Data from DEN180007 demonstrated:
- LoB was below 0.1 g/100 mL for fat, crude protein, and carbohydrate.
- LoB ≤ LoD 1 g/mL
- Carbohydrate, Total solids, Energy ≤3%
Accuracy:
- Fat, Crude protein, True protein, Total solids, Energy ±10%
- Carbohydrate ±13%
Bias:
- Miris HMA bias
§ 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.
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September 29, 2023
Miris AB % John Smith, Partner Hogan Lovell US LLP 555 13th Street NW Washington, District of Columbia 20004
Re: K223085
Trade/Device Name: Miris Human Milk Analyzer (HMA) Regulation Number: 21 CFR 862.1493 Regulation Name: Breast Milk Macronutrients Test System Regulatory Class: Class II Product Code: QEI Dated: August 23, 2023 Received: August 23, 2023
Dear John Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K223085
Device Name
Miris Human Milk Analyzer (HMA)
Indications for Use (Describe)
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 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.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Miris AB's Miris Human Milk Analyzer
510(k) Number K223085
Submitter
Miris AB Danmarksgatan 26 753 23 Uppsala, Sweden Phone: +46 18 14 69 07 Contact Person: John Smith Contact phone: 202-637-3638
Date Prepared: September 19, 2023
Name of Device: Miris Human Milk Analyzer (HMA)
Common or Usual Name: Breast milk macronutrient test system
Classification Name: Breast milk macronutrient test system
Regulatory Class: Class II
Regulation Number: 21 CFR 862.1493
Product Code: QEI
Predicate Devices
Miris Human Milk Analyzer DEN180007
Device Description
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.
Intended Use / Indications for Use
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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.
Summary of Technological Characteristics
Mid-infrared (mid-IR) spectroscopy is the technological principle for both the subject and predicate devices. The subject and predicate devices are based on the following identical technological elements:
- . The Miris HMA device is comprised of a sample cuvette and assisting hardware components. The cuvette is a mid-infrared measurement cell with an inlet and an outlet. Liquids are injected via the inlet and pass between two CaF2 (calcium fluoride) windows separated by a spacer (50 µm). On one side of the windows is an infrared radiation source (emitter) and on the other side is a four-channel detector receiving the radiation transmitted through the liquid. The filters in the detector are selected to absorb only mid-infrared radiation correlated to fat, protein and carbohydrates, respectively. The fourth filter acts as a reference filter.
- . The radiation from an IR-source penetrates the transparent cuvette containing the liquid sample. After passing through the cuvette chamber the quantities of radiation absorbed by specific functional groups of fat, protein and carbohydrate, respectively, are evaluated. The quantitative determination of fat, protein and carbohydrate is performed according to Beer's law - the absorbance is proportional to concentration. The Miris HMA software processes the measurement data by the internal calibration and the results are presented to the user.
There are no technological differences between the subject and predicate device.
A table comparing the key features of the subject and predicate devices is provided below.
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Miris AB's
Miris Human Milk Analyzer (HMA)
Substantial Equivalence Chart
| | Miris HMA
(K223085) | Miris HMA
De novo
(DEN180007) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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) 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. |
| Indications for Use | See above | See above |
| User Population | Newborns, including preterm, and infants | Same |
| Technological
Characteristics | Mid-infrared transmission spectroscopy system | Same |
| Major Components | A sample cuvette, hardware consisting of a mainboard and CPU (Central Processing Unit) board, a display, touch button, fan, case, and accessories. The hardware electronics consists of a mainboard with a CPU-board, detector board and emitter board. | Same |
| Accessories | AC/DC adapter (Input 100-240 VA, 2.3 A, output 18 V, 5.6 A)
Power cable
USB optical mouse
Zero-setting solution: Miris Check
Quality control solution: Miris Calibration Control Kit
Cleaning agent: Miris Cleaner
Syringes for injection of sample and solutions
Outlet tubes | Same |
| | Miris HMA
(K223085) | Miris HMA De novo
(DEN180007) |
| | USB flash memory
USB hub
Sample tubes
Heating bath
Ultrasonic processing device | |
| Dimensions (l x w x h) | 11 x 26 x 31 cm | 9 x 26 x 31 cm |
| Weight | 3.8 kg | 3.1 kg |
| Power Source | AC/DC adapter (Input 100-240 VA, 2.3 A, output 18 V, 5.6 A | Same |
| Software | Application software, version 3.10 | Application software, version 3.09 |
| Standards with which the Device Complies | IEC 61010-1:2010
IEC 61010-2-101:2015 | IEC 61010-1:2001 |
| Components tested | Fat, Crude Protein, True Protein, Carbohydrate [g/100mL] | Same |
| Components calculated | Total solids (TS) [g/100 mL], Energy [kcal/100 mL] | Same |
| Measuring range | Fat 0.6 - 6 g/100 mL
Crude protein 0.8 - 3 g/100 mL
True protein 0.6 - 2.4 g/100 mL
Carbohydrate 6.6 - 8.7 g/100 mL | Fat 0.6 - 4 g/100 mL
Crude protein, True protein and Carbohydrate measuring ranges are the Same. |
| Measurement performance | Repeatability (CV):
Fat, Crude protein, True protein ≤5% at concentration 1 g/mL;
Carbohydrate, Total solids, Energy ≤3%
Accuracy:
Fat, Crude protein, True protein, Total
solids, Energy ±10%;
Carbohydrate ±13% | Same |
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Performance Data
Precision Study
Repeatability and reproducibility of the Miris HMA for measuring fat, CP, TP, and CHO content in a human milk sample was evaluated following the CLSI EP05-A3 guideline. The calculated parameters TS and E were also evaluated.
The study was performed at three US human donor milk bank sites (one main site, two secondary sites) in February and March 2022. The Main site (E:) was the Mothers' Milk Bank (San José, USA).
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The Secondary site (F) was Mid-Atlantic Mothers' Milk Bank 'Three Rivers' (Pittsburgh, USA). The Secondary site (G) was The New York Milk Bank, Inc., (New York, USA).
Study design, precision and reproducibility
| Site type | Number of
sites | Number of
samples | Number of
days | Runs/day | Replicates/sample/
run |
|------------------|--------------------|----------------------|-------------------|----------|---------------------------|
| Main (E) | 1 | 5 | 20 | 2 | 2 |
| Secondary (F, G) | 2 | 5 | 5 | 2 | 3 |
At the main site (E), 5 human milk samples were tested on 1 operator over 20 days, with 2 runs per day, and 2 replicates of each sample per run (i.e., planned 400 observations).
At each of the two secondary sites (F, G), the same 5 samples were tested on 1 device by 2-3 operators over 5 days, with 2 runs per day, and 3 replicates of each sample per run (i.e., planned 150 observations per site).
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.
These results confirm earlier results included in the Miris HMA DEN180007 and support use of Miris HMA in human donor milk banks.
Detection Capability
Data concerning the Miris HMA detection capabilities were included in DEN180007. These studies demonstrated the following:
- LoB was below 0.1 g/100 mL for fat, crude protein and carbohydrate. ●
- . LoB ≤ LoD