Search Results

The Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Perifit Pump is an electrically powered wearable single breast pump consisting of the following key components: a housing ("hub") containing pump electronics (motor, valve, PCB, rechargeable battery and associated components), and detachable milk-contacting components: a silicone flange (breast shield), a plastic (polypropylene) connector, silicone diaphragm, a silicone duckbill valve, a plastic bottle. Accessories provided with the Perifit Pump include a screw-on container lid, a USB charging cable, and bra adjustment buckle. The Perifit pump is a closed-system breast pump.

The hub user interface allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 8 vacuum levels, capable of providing suction from 30 to 285 mmHg, with cycle speeds ranging from 68 to 120 cycles per minute in stimulation mode and 28 to 80 cycles per minute in expression mode.

The Perifit Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1500mAh). The breast pump cannot be operated while it is being charged. The Perifit Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment.

An optional smartphone app may be used with the Perifit Pump. The app may be used to control the operation of the breast pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Perifit Pump.

The Perifit Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.

The Perifit Pump, a wearable electric breast pump, underwent various non-clinical performance tests to demonstrate its substantial equivalence to the predicate device, the Elvie Stride (K210936). The acceptance criteria for these tests were based on relevant international and national standards, as well as FDA guidance documents.

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size for any of the non-clinical tests conducted. It generally states that "Performance testing... included" these tests, implying empirical evaluation. The data provenance is also not explicitly stated regarding whether it was retrospective or prospective, or country of origin. However, given the nature of the tests (biocompatibility, electrical safety, mechanical performance), they are typically conducted prospectively in a laboratory setting.

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

This information is not applicable to the described non-clinical performance and safety testing. These tests rely on established scientific and engineering standards and measurements, not expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for human interpretation of medical images or data. The described tests are based on objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not explicitly stated or described. The document focuses on non-clinical performance and safety testing to demonstrate substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.

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

This question is largely not applicable in the context of the Perifit Pump as a physical medical device. While the device does use embedded software and has an optional smartphone app, the "standalone performance" typically refers to the diagnostic accuracy of AI algorithms without human intervention. The software in the Perifit Pump is for controlling pump operations, saving history, and estimating milk volume, not for diagnostic purposes. The software verification and validation would confirm its functionality and adherence to specifications, which is a form of standalone testing for the software component.

7. The type of ground truth used

The ground truth for the non-clinical tests was based on established physical, chemical, and electrical standards and specifications. For instance:

• Biocompatibility: In vitro and in vivo testing against established criteria for cytotoxicity, sensitization, and irritation.
• Electrical Safety & EMC: Compliance with limits and requirements defined in IEC and AAMI standards.
• Material Compliance: Adherence to specific chemical composition and safety requirements outlined in 21 CFR.
• Performance Testing: Measured vacuum levels, cycle speeds, and other operational parameters against predefined engineering specifications. For backflow protection, the ground truth is the absence of liquid in the air-pumping system. For use life, it's maintaining performance over a specified duration.

8. The Sample Size for the Training Set

This information is not applicable as the document describes non-clinical performance and safety testing, not the development or evaluation of a machine learning algorithm.

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

This information is not applicable as the document describes non-clinical performance and safety testing, not the development or evaluation of a machine learning algorithm.

Ask a specific question about this device