(322 days)
Not Found
No
The 510(k) summary describes a standard electric breast pump with adjustable suction and cycle speed. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, performance studies, or key metrics. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
A breast pump, while used for health-related purposes (expressing milk for infant feeding), is generally considered a supportive device rather than a therapeutic one that treats or prevents a disease, injury, or other medical condition. Its primary function is to facilitate a natural biological process.
No
Explanation: The device description states its purpose is to "express milk from the breasts" and it functions as an "electrical pump system generating a suck and release vacuum pattern." There is no mention of analysis, diagnosis, detection, or monitoring of any medical condition.
No
The device description clearly outlines physical components like an electrical pump system, tubing, breast shields, flap valve, and a voltage adaptor, indicating it is a hardware device with electrical and mechanical components, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The NUK Expressive Double Electric Breast Pump is designed to physically extract milk from the breast. It does not perform any tests on biological samples to diagnose or monitor a medical condition.
- Intended Use: The intended use is clearly stated as "to express milk from the breasts." This is a mechanical function, not a diagnostic one.
The description focuses on the mechanical operation of the pump, the vacuum system, and safety testing related to electrical and biocompatibility standards, all of which are typical for a medical device that interacts with the body but is not an IVD.
N/A
Intended Use / Indications for Use
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: Lactating women
Available over the counter: Yes
Care Setting: Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The NUK device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. Suction pressure was tested and recorded to verify that the NUK Expressive Double Electric Breast Pump was equivalent to the predicate device using both single and double pumping options. All tissue contact components were tested for biocompatibility according to ISO 10993. The device was also tested for electrical safety testing according to IEC 60601-1. The specifications do not include any significant differences from those of the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary Revised April 4, 2013
Submitted by: MAPA GmbH, Industriestrasse 21-25, 27404 Zeven, Germany
Contact Person: Reinhold Jaeger-Waldau
Telephone: 049-4281-73-0, 049-4281-73-420
email: Reinhold Jaeger-Waldau@mapa.de
Product Name: NUK Expressive Double Electric Breast Pump
Common Name: Electric Breast Pump
Classification: Breast Pump, HGX, 21 CFR 884.5160
Predicate Device: K973501 - Ameda Egnell Powered Breast Pumps (Expresse and Premier), Purely Yours
Description of Device:
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.
Indication for Use.
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.
5 2013 APR
Image /page/0/Picture/14 description: The image shows handwritten text that appears to be an identifier or code, followed by a page number. The text "K121478" is written on the top line. Below that, the text "pg. 1 of 2" is written, indicating that this is page 1 of a 2-page document. The handwriting is clear and legible.
APR 5 207
1
K121478
PG. 2 of 2
Comparison with Predicate Devices:
The submission device and the predicate device have substantially equivalent intended use and technological specifications.
| Predicate Device | Subject Device | |
|---|---|---|
| Ameda Egnell Powered | ||
| Breast Pumps (Expresse and | ||
| Premier) | NUK Expressive Double | |
| Electric Breast Pump | ||
| 510(k) Number | K973501 | K121478 |
| FDA classification | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Classification Code | HGX | HGX |
| Indication for Use | The Battery Breast Pumps, | |
| Expresse and Premier, are | ||
| intended to express and collect | ||
| the mother's milk from the | ||
| breasts of a nursing woman, for | ||
| the purpose of feeding the | ||
| collected milk to a baby. | The NUK Expressive Double | |
| Electric Breast Pump is | ||
| intended to express milk from | ||
| the breasts. It is intended for | ||
| use by a single user. | ||
| Intended Users | Lactating women | Lactating women |
| Available over the counter | Yes | Yes |
| Portable | Yes | Yes |
| Vacuum range | adjustable, |