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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: NUK Expressive Double Electric Breast Pump

Intended Use: To express milk from the breasts, intended for use by a single user.

Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than setting new, explicit acceptance criteria for performance beyond what is comparable to the predicate. The "acceptance criteria" can be inferred from the comparison points and the tests conducted to show equivalence.

Here's a table based on the comparison and performance sections:

Table: Acceptance Criteria (Inferred from Predicate Equivalence) and Reported Device Performance

Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (NUK Expressive Double Electric Breast Pump)
I. Functional Equivalence
Intended Use: Express milk from breasts	Intended to express milk from the breasts. Intended for use by a single user. (Substantially equivalent to predicate)
Intended Users: Lactating women	Lactating women (Substantially equivalent to predicate)
Portability	Yes (Substantially equivalent to predicate)
Available over the counter	Yes (Substantially equivalent to predicate)
Single or double pumping capability	Single or double pumping (Substantially equivalent to predicate)
Vacuum range: adjustable, <100 to 360 mbar	Adjustable, <100 to 360 mbar (Substantially equivalent to predicate)
Suction cycles: 30-60 cycles per minute	30-90 cycles per minute (Similar to predicate's 30-60 cpm range)
Power supply	AC adaptor (Predicate also offered batteries, car adaptor; NUK only AC adaptor, but still considered substantially equivalent)
II. Safety & Compliance
Biocompatibility of materials with tissue contact	ISO 10993 compliant (Predicate did not specify in labeling, NUK provides explicit compliance)
Electrical Safety	IEC 60601-1 and IEC 60601-1-2 compliant. UL File Number E339441 for Voltage Adapter. (Predicate had UL and CSA file numbers)

Study Details

The document describes device verification testing to demonstrate conformance with specifications and equivalence to the predicate device. This is typical for a 510(k) submission.

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of devices or number of human participants. The document mentions "device verification testing" and tests for "suction pressure," "biocompatibility," and "electrical safety." These typically involve testing multiple units of the device and material samples, but specific numbers are not provided.
- Data Provenance: The tests were conducted internally by MAPA GmbH ("the company's Design Control Process"). The country of origin for the data is Germany (MAPA GmbH is in Zeven, Germany). The nature of the studies (e.g., suction pressure testing, electrical safety testing) is an engineering and material compliance assessment, not a clinical trial in the traditional sense. It's an internal verification process.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable in the context of this device's verification. The "ground truth" for electrical safety is defined by IEC standards, for biocompatibility by ISO 10993, and for suction pressure by engineering specifications and comparison to the predicate device's measured parameters. These are objective engineering and regulatory standards, not subjective expert consensus on clinical findings.
Adjudication method for the test set:
- Not applicable. The tests involve objective measurements against established specifications/standards, not subjective assessments requiring expert adjudication.
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 device is a breast pump, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical/electrical medical device, not an algorithm. The device performance (e.g., suction pressure) is inherent to its design and operation.
The type of ground truth used:
- Objective Engineering Specifications and Standards:
  - Suction pressure: Measured values compared against the predicate device's established range and the device's own internal specifications.
  - Biocompatibility: Results of tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 standards.
  - Electrical Safety: Conformance with IEC 60601-1 and IEC 60601-1-2 standards.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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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:

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

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APR 5 207

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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 PoweredBreast Pumps (Expresse andPremier)	NUK Expressive DoubleElectric 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, areintended to express and collectthe mother's milk from thebreasts of a nursing woman, forthe purpose of feeding thecollected milk to a baby.	The NUK Expressive DoubleElectric Breast Pump isintended to express milk fromthe breasts. It is intended foruse by a single user.
Intended Users	Lactating women	Lactating women
Available over the counter	Yes	Yes
Portable	Yes	Yes
Vacuum range	adjustable, <100 to 360 mbar	adjustable, <100 to 360 mbar
Suction cycles	30-60 cycles per minute	30-90 cycles per minute
Power supply	AC adaptor, batteries, caradaptor	AC adaptor
Breast pumping option	Single or double pumping	Single or double pumping
Biocompatibility of materialswith tissue contact	Not specified in device labeling	ISO.10993 compliant
Electrical Safety	UL File Number E189700CSA File Number LR76525	IEC 60601-1 and IEC 60601-1-2 compliant.UL File Number E339441 forVoltage Adapter

Performance:

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.

Conclusion:

This submission demonstrates that the NUK Expressive Double Electric Breast Pump is substantially equivalent to the predicate device. It provides evidence that shows the NUK device fits the same classification code definition as the predicate device; the technology for the same for both devices; the intended users are the same; and performance characteristics such as the vacuum range and suction cycles of both devices are similar.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2013

NUK USA LLC % Mr. Mark Wozniak Quality Engineer MAPA GmbH 728 Booster Blvd. REEDSBURG WI 23959

Re: K121478

Trade/Device Name: NUK® Expressive™ Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: March 25, 2013 Received: March 28, 2013

Dear Mr. Wozniak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert PM grner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX A - Indications for Use

510(k) Number (if known): K121478

Device Name: NUK® Expressive™ Double Electric Breast Pump

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert PDWerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K121478 510(k) Number

Regulation Number and Section

§ 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).