Search Results

The Nurture III Breast Pump is intended for use by lactating women to express their rrile Nature in Broad for multiple users as long as each of those users has her own collection kit.

The Nurture III Breast Pump utilizes a diaphragm type vacuum pump operating on either 115 VAC/60 Hz or 220 VAC/50 Hz. The pump is actuated by a six position rotary switch, allowing four positions of varying motor speed and two standby positions. The pump motor is attached to a collection kit consisting of flanges, bottles, tubing, filter, gasket, adapter caps and bottle stands. All materials in proximity to the collected milk are made of food grade plastics.

The Nurture III uses a hydrophobic filter to isolate the collected milk from the pumping mechanism. Further isolation is achieved by the air flow always being away from the collected milk to the pump mechanism, then evacuated to the atmosphere. There is never air flow from the pump to the collected milk.

It is a semi-automatic breast pump, meaning that the release of vacuum pressure is achieved by the user lifting her finger from the vent hole located on top of the collection kit. The vacuum is then built up by covering the hole.

The pump may be used with a single collection kit for the pumping of one breast, or may be used with a double collection kit for the simultaneous pumping of both breasts.

This 510(k) summary describes a breast pump and does not contain the information required to answer your request about acceptance criteria and study data for device performance. The provided text is a regulatory submission for a medical device (a breast pump) and focuses on administrative and descriptive details necessary for 510(k) clearance, not performance study details.

Specifically, it lacks:

• Acceptance Criteria Table: There is no table detailing specific performance metrics and their required thresholds.
• Reported Device Performance: No actual performance data (e.g., flow rates, pressure levels, efficiency, or safety outcomes) is presented.
• Study Details: There's no mention of any clinical or performance study conducted, including sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
• Training Set Information: No details about a training set are provided, as this device is a mechanical breast pump, not an AI/ML-based device.

The document primarily covers:

• Submitter's Identification
• Device Name: Nurture III Breast Pump
• Predicate Device Information: Gerber Precious Care and Medela 015
• Device Description: How the pump works, its components, materials, and operation.
• Intended Use: For lactating women to express milk, with suitability for multiple users with individual collection kits.
• Regulatory Clearance Information: The FDA's letter confirming substantial equivalence and regulatory class.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device