(139 days)
The electric breast pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for a single user, not for hospital use.
The electric breast pump is designed and manufactured by the Shantou Xinghe Electrical Apparatuses Co., Ltd. It is intended to express and collect milk from breast from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for a single user, not for hospital use. Model XN-2201M1, XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 are included in this submission. The electric breast pump imitates a baby's sucking action to express milk with help of Single-Chip Microcomputer. It has multiple stimulation levels for breast massage, and multiple milk quantity of a baby's suction. The keyboard of the device control panel is soft. The screen is an LCD, and allows for process viewing.
The document provided is a 510(k) premarket notification for an Electric Breast Pump (K143585). It details the device's substantial equivalence to a predicate device, rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical or algorithm validation study.
Therefore, the requested information elements related to clinical studies, algorithmic performance (standalone, MRMC), ground truth establishment, expert adjudication, and sample sizes for test and training sets are not applicable (N/A) in this context, as this submission did not involve such studies.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating that the proposed device's specifications (technology, performance parameters, etc.) are substantially equivalent to the predicate device and meet general safety and performance standards through bench testing.
| Feature/Test | Acceptance Criteria (Predicate Device K122474) | Reported Device Performance (Proposed Device K143585) | Acceptance Status |
|---|---|---|---|
| Specifications (Comparative Equivalence) | |||
| Device name | LANSINOH Powered Electric Breast Pump | Electric Breast Pump | Equivalent1 |
| Indications for Use | Express and collect breast milk for feeding. Single user. | Express and collect milk, alleviate engorgement, maintain lactation, provide milk for future feedings. Single user, not for hospital use. | Equivalent2 |
| Patient Population | Breastfeeding women | Breastfeeding women | Equivalent |
| Pump Style | Diaphragm-type vacuum pump | Diaphragm-type vacuum pump | Equivalent |
| Stimulation velocity | 93~144 T/min | 95~105 T/min | Within range3 |
| Stimulation intensity | -0.007~-0.019MPa | -0.002~-0.019MPa | Comparable4 |
| Sucking velocity | 36.6~91.2 T/min | 20~65 T/min | Comparable5 |
| Suction intensity | -0.011~-0.029 MPa | -0.011~-0.033 MPa | Comparable6 |
| Backflow protection | Yes | Yes | Equivalent |
| Overflow protection | No | No | Equivalent |
| Adjustable Suction Levels | Yes | Yes | Equivalent |
| Software | Yes | Yes | Equivalent |
| Anatomical Sites | Breast | Breast | Equivalent |
| Environment of Use | Hospital, institutions, home | Home and not for hospital use | Subset/Different7 |
| Non-Clinical Tests (Regulatory Compliance) | |||
| Performance within specifications | Device performs within specifications | Performed within specifications | Met |
| Biocompatibility (in vitro cytotoxicity, irritation, sensitization) | Met acceptance criteria (no adverse biological reactions) | Met acceptance criteria | Met |
| Electrical safety | Met acceptance criteria | Met acceptance criteria | Met |
| EMC testing | Met acceptance criteria | Met acceptance criteria | Met |
Footnotes for Table:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: N/A (No clinical test set was required or presented for substantial equivalence).
- Data Provenance: N/A. The non-clinical tests were bench tests performed by the sponsor (Shantou Xinghe Electrical Apparatuses Co., Ltd.) in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A (No ground truth established by experts for a test set in this context).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A.
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
- N/A. This is a physical medical device, not an AI/software as a medical device (SaMD) requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission largely relies on established engineering standards for performance, electrical safety, EMC, and biocompatibility, as well as the specifications and performance of the legally marketed predicate device (K122474). Therefore, the ground truth is derived from regulatory standards, predicate device characteristics, and internal bench test results demonstrating compliance with specifications.
8. The sample size for the training set
- N/A (No training set for an AI/ML algorithm was involved).
9. How the ground truth for the training set was established
- N/A.
Footnotes
-
The device names are different, but the fundamental function is the same, indicating equivalence in purpose. ↩
-
The proposed device's indications extend to alleviating engorgement and maintaining lactation, which are considered consistent with and an elaboration of the predicate's general use for breast milk expression. The "not for hospital use" is a difference in the environment of use, but not in the core indication. ↩
-
The proposed device's stimulation velocity (95
105 T/min) falls within the range of the predicate (93144 T/min), indicating technical equivalence for this parameter. ↩ -
The proposed device's stimulation intensity (-0.002~-0.019MPa) overlaps significantly with the predicate's (-0.007~-0.019MPa), indicating comparable functionality. The slightly shallower minimum (less intense) could be a design choice but doesn't preclude substantial equivalence. ↩
-
The proposed device's sucking velocity (20
65 T/min) is within a similar order of magnitude as the predicate's (36.691.2 T/min), indicating comparable performance. The lower end of the range is different, but not noted as a safety or effectiveness concern in this type of submission. ↩ -
The proposed device's suction intensity (-0.011~-0.033 MPa) largely overlaps with and extends slightly beyond the predicate's (-0.011~-0.029 MPa) on the more intense end. This is considered comparable or an improvement not raising new safety/effectiveness concerns. ↩
-
The predicate mentions "Hospital, institutions and home" while the proposed device specifies "Home and not for hospital use." This is a difference in environment of use, which the FDA implicitly accepts as not affecting substantial equivalence based on the final decision. ↩
§ 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).