Search Results

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, the subject device, is an electrically powered breast pump from an external AC-DC power supply or internal, rechargeable batteries; the device is provided non-sterile. The subject device is a cordless version of the predicate device.

The Evolve Breast Pump is intended to be used by lactating women to express and collect mills from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The breast pump is designed as a multi-user breast pump and is available as a cordless model powered by an internal, rechargeable Lithium lon battery or an external AC-DC power supply.

The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women.

The Evolve Breast Pump has a backlit, LCD display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression – and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes.

The Evolve Breast Pump is intended for repeated use by multiple users in the home environment.

The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The provided text is related to an FDA 510(k) premarket notification for a medical device: an Evolve Breast Pump. This document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria for an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study design for AI, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to a different type of medical device submission and evaluation.

The document discusses the following:

• Device: Evolve Breast Pump (K200406)
• Predicate Device: Hygeia Evolve Breast Pump (K190465)
• Key Modification: Addition of an internal rechargeable Lithium Ion battery for cordless operation.
• Performance Data Summary:
  • Risk Analysis (ISO 14971:2007)
  • Electrical Safety (IEC 60601-1:2005 with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 deviations)
  • Electromagnetic Compatibility (IEC 60601-1-2: 2014)
  • Performance Testing: Measurement of vacuum and cycles for minimum and maximum settings in both single and double pumping modes, and for stimulation and expression modes. It also verified battery energy capacity and operation time.
• Conclusion: The performance testing demonstrates that the Evolve Breast Pump is substantially equivalent to the predicate device.

This submission focuses on engineering and safety performance rather than the diagnostic or predictive performance that would be associated with AI/ML devices. Therefore, the specific questions regarding AI/ML performance metrics, ground truth, and expert adjudication are not applicable to this document.

Ask a specific question about this device

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply). The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The provided text describes a 510(k) premarket notification for the Evolve Breast Pump (K190465), comparing it to a predicate device, the Hygeia EnDeare Breast Pump (K081932).

However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) which would typically be relevant for AI/ML devices. This is a breast pump, not a diagnostic device.

Instead, the "acceptance criteria" for a breast pump would relate to its functional performance, electrical safety, electromagnetic compatibility, and software/firmware robustness. The "study" proving it meets these criteria refers to the non-clinical performance data provided to the FDA.

Based on the provided text, here's an attempt to answer your questions, interpreting "acceptance criteria" and "study" in the context of a breast pump's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding performance for each criterion. Instead, it describes general performance specifications that were met. Below is a reconstruction based on the information provided, focusing on the functionality of the breast pump.

The document states, "Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical imaging for AI/ML. For this medical device (a breast pump), the "testing" involves hardware and software performance.

• Sample Size: Not applicable in the traditional sense of patient data. Testing was performed on the device itself.
• Data Provenance: Not applicable. The testing was non-clinical, likely conducted by the manufacturer in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for a breast pump's performance is objective measurement against engineering specifications (e.g., vacuum pressure, cycle rate, electrical safety standards). It does not involve expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a breast pump, not an AI-assisted diagnostic device. No human readers or AI assistance are involved in its primary function.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. While the device contains firmware/software, the "standalone" performance concept typically applies to AI algorithms whose output is a diagnosis or risk assessment. Here, the "standalone" performance would be the pump's mechanical and electronic function, which was tested.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is based on:

• Engineering Specifications and Measurements: Direct physical measurements of vacuum (mmHg) and cycle rates (CPM) against predefined ranges.
• Regulatory Standards: Compliance with international and national standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and risk management (ISO 14971).
• Software Verification & Validation Best Practices: Adherence to FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the typical sense. The firmware/software development process would involve iterative testing and refinement, but not "training" on a dataset to learn patterns.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of AI/ML. The firmware's functionality is designed and verified against established engineering principles and requirements, not learned from a dataset with pre-established ground truth labels.

Ask a specific question about this device