(212 days)
The Hi bebeplus, model BT-100, electric breast pump is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
The Hi bebeplus, model BT-100, is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.. The pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The Hi bebeplus, model BT-100 also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery. The Hi bebeplus, model BT-100 has two operating functions: basic massage/expression function and memory function to save the operating sequence. The Hi bebeplus, model BT-100, is capable of providing vacuum levels from 32-227 mmHg with cycling rates up to 63 cycles per minute.
This document is a 510(k) premarket notification for a powered breast pump (Hi bebePlus, model BT-100). The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Medela Ag Freestyle Deluxe, K150499).
Therefore, this document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance or diagnostic accuracy, as it is a breast pump, not a diagnostic or AI-powered medical device.
The information provided relates to non-clinical tests conducted to ensure safety and performance equivalence to a predicate device, which are standard for such medical devices seeking market clearance.
Here's an analysis of what is available in relation to your request, adapted for the context of this device:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance specifications that were tested. While not explicitly called "acceptance criteria" in a table format, these are the parameters against which the device's performance was measured.
| Performance Parameter | Acceptance Criteria / Predicate Performance (K150499) | Reported Device Performance (Hi bebePlus BT-100) |
|---|---|---|
| Adjustable Vacuum (expression) | 45-245 mmHg (predicate) | 32-227 mmHg ±10% |
| Maximum Vacuum | 270 mmHg (predicate) | 250 mmHg |
| Cycles per minute (expression) | 49.8 - 81.6 (predicate) | 27 - 63 ±5% |
| Suction Settings | 9 (predicate) | 10 |
| Cycle Speed | Not explicitly stated as a numerical criterion for the new device, but tested for design requirements. | Met specifications |
| Suction Pressure | Not explicitly stated as a numerical criterion for the new device, but tested for design requirements. | Met specifications |
| Battery Operating Time | Not explicitly stated as a numerical criterion, but tested for design requirements. | Met specifications |
| Battery Recharging Time | Not explicitly stated as a numerical criterion, but tested for design requirements. | Met specifications |
| Operating life | Not explicitly stated as a numerical criterion, but tested for design requirements. | Met specifications |
Non-Clinical Acceptance Criteria (Compliance with Standards):
- Biocompatibility: In accordance with AAMI / ANSI / ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity) and AAMI / ANSI / ISO 10993-10:2010 (irritation and skin sensitization).
- Electrical Safety: In accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, and IEC 60601-1-11:2015.
- Electromagnetic Compatibility (EMC): In accordance with IEC 60601-1-2:2007.
- Software Verification and Validation: As recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life) are noted as having been conducted "under conditions of single and double pumping mode and for the varying power sources." However, the specific number of units tested or the number of test cycles is not mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. For a breast pump, "ground truth" as it relates to expert consensus for diagnostic accuracy (e.g., radiologist reads) is not relevant. The ground truth for performance characteristics would be direct measurements against engineering specifications.
4. Adjudication method
This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data by multiple readers to establish a consensus ground truth, which is not relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices. This device is a breast pump and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
For the performance tests (Cycle Speed, Suction Pressure, Battery Operating Time, Battery Recharging Time, Operating life), the "ground truth" would be the engineering specifications and direct measurements. For the compliance tests (biocompatibility, electrical safety, EMC, software V&V), the "ground truth" is adherence to published national and international standards.
8. The sample size for the training set
This information is not applicable. There is no mention of a training set, as this device does not utilize machine learning or AI that would require one.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned for this device.
§ 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).