(311 days)
The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
The Electric Breast Pump (Model 918 and HF918) are powered breast pumps intended to express and collect milk from a lactating woman's breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum level.
The Electric Breast Pump has five basic modes: Stimulation mode, Expression mode, Two-in-one mode, Dual-Frequency mode, and Simulation mode has 5 suction levels (vacuum levels: 60-217.5 ± 20 mmHg; cycle speed: 39-123 ± 5 cycles/min), expression mode (vacuum levels: 105-285 ± 20 mmHg; cycle speed: 24-84 ± 5 cycles/min), dual-frequency mode (vacuum levels: 67.5-277.5 ± 20 mmHg; cycle speed: 39-85 ± 5 cycles/min), and two-in-one mode (vacuum levels: 75-285 ± 20 mmHg; cycle speed: 59-123 ± 5 cycles/min) have seven suction levels, and simulation mode (vacuum levels: 187.5 ± 20 mmHg; cycle speed: 14 ± 5 cycles/min) has one suction level. Stimulation mode is for massaging the breast to stimulate breast milk secretion. Expression mode is for pumping breast milk. Dual Frequency mode is for cycling between strong and weak pumping strengths. Two-in-One mode cycles between massaging for 5 cycles and expressing breast milk for 1 cycle. Simulation mode operates at a single suction level to stimulate milk secretion.
The subject devices are available in two models: 918 and HF918. The hands-free (HF) model (HF918) is designed to be placed inside a user's bra and connect to the external pump unit. The milk collection cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit.
The Electric Breast Pumps are intended for a single user.
The provided document describes the substantial equivalence claim for an Electric Breast Pump (Models 918, HF918) against a predicate device (Electric breast pump, Models: RH-228 and RH-338). It does not contain information about acceptance criteria and study results in the typical format of a diagnostic device or AI/ML product.
Specifically, it does not provide the following information:
- A table of acceptance criteria and reported device performance (for a diagnostic or AI device)
- Sample size used for the test set or data provenance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method for the test set
- Whether an MRMC study was done or its effect size
- Whether standalone performance was evaluated
- The type of ground truth used (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How the ground truth for the training set was established
Instead, the document details non-clinical tests performed to demonstrate substantial equivalence for a medical device (an electric breast pump). The acceptance criteria are implicitly that the device meets relevant safety and performance standards for its type.
Here's what the document does provide regarding "acceptance criteria" and "study" for this specific product, formatted as closely as possible to your request, but reflecting the nature of a breast pump clearance documentation rather than a diagnostic AI study:
1. A table of acceptance criteria and the reported device performance
For an electric breast pump, acceptance criteria primarily relate to safety, electrical performance, biocompatibility, and meeting design specifications. The performance is reported as compliance with these standards and specifications.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (General requirements for basic safety and essential performance) | Complied with the standard. |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility) | Complied with the standard. | |
| IEC 60601-1-11:2010, AMD1:2013 (Home healthcare environment requirements) | Complied with the standard. | |
| IEC 62133:2012 (Secondary cells and batteries safety) | Complied with the standard. | |
| Biocompatibility | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complied with the standard. |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complied with the standard. | |
| Software Verification | FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005 | Verified in accordance with the guidance. |
| Functional Performance | Suction strength: Demonstrate subject device meets design specifications throughout use life. | |
| Predicate Suction Ranges: | ||
| Stimulation mode: RH-228: 60-150 mmHg, RH-338: 45-165 mmHg | ||
| Expression mode: RH-228: 120-275 mmHg, RH-338: 110-300 mmHg | ||
| Massage mode: RH-338: 135-255 mmHg (This specific mode not in subject device comparison, but predicate has it) | ||
| Subject device reported ranges: | ||
| Stimulation: 60-217.5 ± 20 mmHg | ||
| Expression: 105-285 ± 20 mmHg | ||
| Two-in-one: 75-285 ± 20 mmHg | ||
| Dual-frequency: 67.5-277.5 ± 20 mmHg | ||
| Simulation: 187.5 ± 20 mmHg | All test results complied with the design specifications of the subject device throughout the use life. (The subject device's ranges are within or comparable to the predicate for shared modes, and it introduces new modes.) | |
| Backflow protection: No liquid backflow into tubing/pump motor even if bottle is over-filled. | No backflow during the test. | |
| Cycle speed: Demonstrate subject device meets design specifications throughout use life. | ||
| Subject device reported ranges: | ||
| Stimulation: 39-123 ± 5 cycles/min | ||
| Expression: 24-84 ± 5 cycles/min | ||
| Two-in-one: 59-123 ± 5 cycles/min | ||
| Dual-frequency: 39-85 ± 5 cycles/min | ||
| Simulation: 14 ± 5 cycles/min | All test results complied with the design specifications of the subject devices throughout the use life. | |
| Battery performance: Battery remains functional during stated use-life. | Demonstrated battery remains functional. | |
| Battery status indicator: Indicator remains functional during stated battery life. | Demonstrated indicator remains functional. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The "tests" are engineering and regulatory compliance tests, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" in the clinical diagnostic sense for a breast pump's functional testing. Electrical safety, biocompatibility, and functional performance are assessed against established standards and design specifications by accredited labs and engineers.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
The "ground truth" equivalent here is compliance with recognized international standards (e.g., IEC 60601 series, ISO 10993 series) and the manufacturer's own validated design specifications for functional parameters (suction strength, cycle speed, backflow).
8. The sample size for the training set
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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).