Medevx

Medical Device Information Database

Perifit Pump

Device Information:

Perifit Pump

The Perifit Pump is a wearable electric breast pump designed for lactating women. It includes an adjustable suction system and a closed design to prevent backflow. The device operates through two modes, stimulation and expression, with eight adjustable vacuum levels. It can be controlled manually or via a smartphone app.

Indications:

The Perifit Pump is intended for lactating women to express breast milk. It is designed for single-user application.

Intended Use:

The device is intended for single-user by lactating women to express milk. It is suitable for home healthcare environments. Users can control suction and vacuum intensity directly on the pump or through a smartphone app.

Availability:

The Perifit Pump is available over the counter.

Study Results:

  • Nonclinical Testing: This Pump passed biocompatibility tests (cytotoxicity, skin sensitization, and irritation). Electrical safety tests were successful, including IEC 60601 standards and battery life evaluations. The device was tested for vacuum level consistency, cycle speed, and backflow prevention.

Regulatory Information:

  • Regulation Number: 21 CFR 884.5160
  • Regulatory Class: Class II
  • Product Code: HGX
  • 510(k) Number: K231785

This device complies with additional regulations, including material requirements under 21 CFR 177.1520 and 21 CFR 177.2600, as well as testing requirements for device safety and performance.

Manufacturer Information:

  • Name: X6 Innovations
  • Address: 128 rue la Boétie, 75008 Paris, France
  • Contact Person: Erica Perrier

Predicate Device Information:

  • Primary Predicate Device: Elvie Stride (K210936)
  • Differences: Both devices operate on the same principle, but the Perifit Pump integrates its pump components within the bra, while the Elvie Stride uses external tubing. The materials used, cycle speed, and vacuum ranges differ from those of the predicate device. The Perifit app includes additional features like milk volume estimates. 

Implications:

The Perifit Pump offers wearable convenience and control over suction modes. Its closed-system design reduces the risk of contamination and provides efficient milk expression in a home healthcare setting.

References:

  1. Perifit Pump. K231785. X6 Innovations: FDA summary link:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231785
  2. Manufacturer website: https://perifit.co/products/perifit-pump

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