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The FIT Pro Breast Pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The FIT Pro Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium-ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The FIT Pro Breast Pump utilizes a DC-powered motor driving a diaphragmtype vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The FIT Pro Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four softtouch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, and control vacuum strength within each mode (6 levels of vacuum strength in stimulation mode and 12 levels in expression mode). The FIT Pro Breast Pump is intended for a single user in the home environment. When properly connected, the Hygeia PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. The base model of the FIT Pro Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard.

This document is a 510(k) summary for the FIT Pro Breast Pump, a medical device. It does not describe an AI medical device or software. Therefore, the requested information about acceptance criteria and study details for an AI/software device cannot be extracted from this document, as it does not pertain to such a device. This document focuses on the substantial equivalence of the breast pump to a predicate device, based on non-clinical performance testing.

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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.

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