(188 days)
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.
Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:
- Massage mode: Helps to relax the muscle around the breast and prepare for suction.
- Normal mode: Suction patterns are characterized by low vacuum to start milk flow.
In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:
- Rapid mode: Suction patterns are characterized by high vacuum to express more milk.
Model BF100 is capable of single and double pumping and has two modes only:
- Letdown mode: Helps to relax the muscle around the breast and prepare for suction.
- Expression mode: Suction patterns are characterized by high vacuum to express more milk.
This document is a 510(k) summary for a powered breast pump (Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump). It describes testing conducted to demonstrate substantial equivalence to a predicate device, but it does not provide acceptance criteria or detailed study results in the format requested for an AI model evaluation.
Therefore, I cannot extract the specific information about acceptance criteria and study detailed performance as per your request because it is not present in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical testing against industry standards, rather than reporting device performance against specific, quantifiable acceptance criteria with a documented study for an AI model.
Here's what I can tell you based on the document's content regarding the type of information you requested:
- Acceptance Criteria & Reported Device Performance: This information is not explicitly provided in a table or detailed study report format. The document states that "Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate."
- Sample Size for Test Set and Data Provenance: Not applicable as this is a physical device, and the testing described is non-clinical bench testing.
- Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance (Algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., vacuum, cycle speed) matching design specifications and industry standards.
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of Non-Clinical Testing Performed (as provided in the document):
The document lists the following categories of non-clinical testing performed:
- Electromagnetic Compatibility, Electrical Safety, and Battery Safety: Tested in compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133-2.
- Biocompatibility: Patient-contacting components were tested in compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10).
- Software Verification: Software documentation was provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
- Performance Testing (Bench testing): Conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in worst-case scenario), battery performance, backflow protection, and overflow protection using internal test protocols.
The conclusion states that these tests demonstrate the devices are "as safe and effective as the predicate device and supports a determination of substantial equivalence." However, specific numerical performance results or explicit acceptance criteria values for these tests are not detailed in this summary.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).