(133 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on standard in vitro diagnostic components and measurements.
No.
The device measures components in human milk to aid in nutritional management, but it does not directly treat or prevent a disease or condition. It is an in vitro diagnostic device used for information gathering, not therapeutic intervention.
Yes
The device measures concentrations of protein, fat, and carbohydrates in human milk to aid in nutritional management, and the device description explicitly states it is an "in vitro diagnostic device."
No
The device description explicitly lists multiple hardware components beyond the software (iPhone, test strips, reference card, pipettes, tubes, lightbox).
Yes, based on the provided information, the Emily's Care Nourish Test System (Model 1) is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Device Description" section explicitly states: "The Emily's Care Nourish Test System (Model 1) is an in vitro diagnostic device that consists of the following..."
- Intended Use: The "Intended Use / Indications for Use" describes the device as quantitatively measuring components (protein, fat, carbohydrates) in human milk, which is a biological sample. This analysis is performed in vitro (outside the body).
- Purpose: The measurements are used "to aid in the nutritional management of newborns, including preterm, and infants," which is a diagnostic purpose.
- Components: The components listed (test strips, reference card, pipettes, tubes) are typical of IVD systems used for analyzing biological samples.
- Predicate Device: The listed predicate device, DEN180007 - Miris Human Milk Analyzer (HMA), is also an IVD, indicating the regulatory classification of similar devices.
All these points strongly support the classification of the Emily's Care Nourish Test System as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Emily's Care Nourish Test System (Model 1) quantitatively measures the concentration of protein, fat (triglycerides), and carbohydrates (lactose) in human milk. It also provides calculated values for calories (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 point of care or clinical laboratory settings.
The device is for prescription use only.
Product codes
QEI
Device Description
The Emily's Care Nourish Test System (Model 1) is an in vitro diagnostic device that consists of the following:
- iPhone models 12 mini. 12 pro. 12 pro max. 13. 13 pro max, 14 or 14 pro max running iOS 16 or 17
- Free Emily's Care app to be downloaded on the iPhone app store
- Single-use test strips, in a desiccant-lined vial
- Single-use reference card to place the test strip on to be read
- Pipettes and tubes to collect milk
- Lightbox
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Newborns, including preterm, and infants.
Intended User / Care Setting
Healthcare by trained healthcare personnel at point of care or clinical laboratory settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench Testing Summary for Emily's Care Nourish Test System:
The Emily's Care Nourish Test System underwent bench testing to evaluate its performance characteristics, including precision, accuracy (bias), linearity, sensitivity, and interference.
The sponsor also performed flex testing to evaluate the effect of temperature, humidity, and suboptimal handling of the samples or strips. The results showed that the device is adequately robust to conditions that may reasonably be expected in the intended use environment.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
May 3, 2024
Lactation Lab Inc. Stephanie Canale CEO 2611 Palm Avenue Manhattan Beach, California 90266
Re: K234088
Trade/Device Name: Emily's Care Nourish Test System (Model 1) Regulation Number: 21 CFR 862.1493 Regulation Name: Breast Milk Macronutrients Test System Regulatory Class: Class II Product Code: QEI Dated: April 1, 2024 Received: April 3, 2024
Dear Stephanie Canale:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K234088
Device Name Emily's Care Nourish Test System (Model 1)
Indications for Use (Describe)
Emily's Care Nourish Test System (Model 1) quantitatively measures the concentration of protein, fat (triglycerides), and carbohydrates (lactose) in human milk. It also provides calculated values for calories (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 point of care or clinical laboratory settings.
The device is for prescription use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) number: K234088 Date Prepared: May 2, 2024
Submitter:
Lactation Lab Inc. 2611 Palm Avenue Manhattan Beach, CA 90266
Contact Information:
Stephanie Canale, M.D. CEO and Founder of Lactation Lab Inc. Phone: 310-508-5265 Email: scanale@lactationlab.com
Device Proprietary Name: Emily's Care Nourish Test System (Model 1)
Regulatory Information:
Regulation section: 21 CFR 862.1493 Breast Milk Macronutrients Test System Classification: Class II (Special Controls) Product code(s): QEI Panel: Clinical Chemistry (75)
Predicate Device:
DEN180007 - Miris Human Milk Analyzer (HMA)
Device Description: The Emily's Care Nourish Test System (Model 1) is an in vitro diagnostic device that consists of the following:
-
- iPhone models 12 mini. 12 pro. 12 pro max. 13. 13 pro max, 14 or 14 pro max running iOS 16 or 17
-
- Free Emily's Care app to be downloaded on the iPhone app store
-
- Single-use test strips, in a desiccant-lined vial
-
- Single-use reference card to place the test strip on to be read
-
- Pipettes and tubes to collect milk
-
- Lightbox
Intended Use:
Emily's Care Nourish Test System (Model 1) quantitatively measures the concentration of protein, fat (triglycerides), carbohydrates (lactose) in human milk. It also provides calculated values for calories (energy). These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants.
4
This device is intended for use in healthcare by trained healthcare personnel at point of care or clinical laboratory settings.
The device is for prescription use only.
Substantial Equivalence Comparison
Similarities
| Item | Candidate Device: K234088
Emily's Care Nourish Test System
(Model 1) | Predicate Device: DEN180007
Miris HMA |
|------------------------|-----------------------------------------------------------------------------------------|------------------------------------------|
| Intended Use | Quantitative measurement of
macronutrients in breast milk. | Same |
| Intended
population | Newborns, including preterm, and infants | Same |
| Contraindications | Not designed for use with infant formula,
other milk feeding products or fortifiers. | Same |
| Sample Type | Breast milk in liquid form (room
temperature) | Same |
Differences
| Testing
Environment | Prescription use in Point Of Care settings | Prescription use in Clinical
Laboratories and HMBANA
accredited Human Milk Banks |
|----------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Calibration | Not required by the end user. | Calibration is performed by the end
user prior to analyzing human milk
samples. |
| Measuring Range | Fat: 0.6 - 6.0 g/dl
Protein: 0.6 - 2.4 g/dl
Carbohydrates/ Lactose 4.5 - 9.5 g/dl | Fat: 0.6 - 6.0 g/dl
Crude Protein: 0.8 - 3.0 g/dl
True Protein: 0.6 - 2.4 g/dl
Carbohydrates: 6.6 - 8.7 g/dl |
| Principles of
Operation | Colorimetric | Mid-infrared (mid-IR) transmission
spectroscopy |
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Bench Testing Summary for Emily's Care Nourish Test System:
The Emily's Care Nourish Test System underwent bench testing to evaluate its performance characteristics, including precision, accuracy (bias), linearity, sensitivity, and interference.
The sponsor also performed flex testing to evaluate the effect of temperature, humidity, and suboptimal handling of the samples or strips. The results showed that the device is adequately robust to conditions that may reasonably be expected in the intended use environment.
Conclusion:
Based on the information provided in this 510(k), the Emily's Care Nourish Test System (Model 1) is substantially equivalent to the predicate and raises no new issues of safety and effectiveness. The testing performed demonstrates that the candidate device is safe and effective for its intended use.