(144 days)
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.
The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single use. This is accomplished by an electrical diaphragm pump generating a suck and release vacuum pattern. The suction strength is adjustable. The pumping device is sealed via a connection ring to a breast shield equipped with a valve separating the breast shield from the bottle.
Here's an analysis of the provided text regarding the NUK Breast Pump (K101157) and its acceptance criteria, focusing on the requested information.
It's important to note that the provided 510(k) summary is for a medical device that does not involve an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this type of document. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards.
Acceptance Criteria and Reported Device Performance for NUK Easy-Flow Single Electric Breast Pump (K101157)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from device specifications or recognized standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Express milk from the breast by a single user | The device is intended for use to express milk from the breast by a single user. (This implies performance meets the intended function) |
| FDA Classification | 21 CFR 884.5160 (Powered breast pump) and Classification Code HGX/HGZ | Complies with 21 CFR 884.5160 and Classification Code HGZ |
| Indication for Use | Powered breast pump to express milk from the breast | The NUK breast pump is intended for use to express milk from the breast of a single user. |
| Intended Users | Lactating women | For use by lactating women |
| Availability | Over-the-counter | Available over the counter |
| Portability | Portable device | Portable |
| Vacuum Range | Functionally appropriate for breast milk expression (Predicate's not specified) | Maximum 250mmHg |
| Suction Mode | Adjustable | Adjustable |
| Type of Pump | Electric/Battery operated | Electric/Battery |
| Closed System | Yes | Yes |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant (as per performance testing) |
| Electrical Safety | IEC 60601-1 / EN 60601-1 compliant (or relevant standard) | ISO 60601-1 compliant (as per performance testing) |
| General Performance | Conformance with internal company specifications (comparable to predicate) | The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. |
Study Proving Device Meets Acceptance Criteria
The document states: "The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate. Additional performance testing was completed for biocompatibility and electrical safety to recognized standards."
This indicates that internal verification and validation studies were conducted according to the company's design control processes and relevant recognized standards. The 510(k) process primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than entirely novel clinical efficacy studies.
Specifically:
- Substantial Equivalence Comparison: A detailed table compares the subject device (NUK Easy-Flow Electric Breast Pump) to the predicate device (miPump Electric Breast Pump K082802) across various specifications (FDA classification, intended use, users, portability, vacuum range, suction mode, pump type, closed system, biocompatibility, electrical safety). The conclusion is that they have "substantially equivalent intended use and technological specifications."
- Biocompatibility Testing: Confirmed compliance with ISO 10993.
- Electrical Safety Testing: Confirmed compliance with ISO 60601-1.
2. Sample Size Used for the Test Set and Data Provenance
Given this is a 510(k) for a hardware medical device (breast pump) and not an AI/ML diagnostic, there isn't a "test set" in the sense of a dataset for an algorithm. The "testing" refers to physical product testing and design verification.
- Sample Size for Test Set: Not specified in terms of a "data set" for an algorithm. It would refer to the number of physical units tested for engineering specifications, durability, etc., but this detail is not provided in a 510(k) summary (which focuses on the conclusion of testing).
- Data Provenance: Not applicable in the context of an AI/ML algorithm's dataset. The "data" here would be test results from manufacturing and engineering verification, originating from the manufacturer's (MAPA GmbH, Germany) internal testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not an AI/ML device requiring expert consensus for a "ground truth" dataset. The "truth" for device performance is established through engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication for a data set is mentioned or relevant for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device does not incorporate AI, therefore, no studies comparing human readers with and without AI assistance were conducted.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device does not incorporate an AI algorithm.
7. Type of Ground Truth Used
Not applicable in the context of an AI/ML algorithm. The "ground truth" for this device's performance is established by engineering specifications, recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 60601-1 for electrical safety), and the functional requirements for a breast pump.
8. Sample Size for the Training Set
Not applicable. This device does not use a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not use a training set for an AI/ML algorithm.
§ 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).