NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP

K121478 · Mapa GmbH · HGX · Apr 5, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K121478
• Device Name: NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
• Applicant: Mapa GmbH
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended 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.

Device Story

NUK Expressive Double Electric Breast Pump is an electrical device for expressing breast milk. System consists of an electrical pumping unit connected via silicone tubing to breast shields and NUK breast milk containers. Device generates an adjustable suck-and-release vacuum pattern; suction strength and cycles per minute (30-90 cpm) are user-adjustable. Flap valve separates breast shield from container to prevent backflow. Intended for single-user, home-based operation. Healthcare provider does not operate device; output is collected milk for infant feeding. Benefits include efficient milk expression for nursing mothers.

Clinical Evidence

Bench testing only. Verification testing confirmed device performance against specifications, including suction pressure equivalence in single and double pumping modes. Biocompatibility testing performed per ISO 10993. Electrical safety testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Powered breast pump; 21 CFR 884.5160; Class II. Materials: ISO 10993 compliant. Energy source: AC adaptor. Vacuum range: <100 to 360 mbar. Suction cycles: 30-90 cycles/min. Connectivity: None. Form factor: Portable, single or double pumping capability. Electrical safety: IEC 60601-1 and IEC 60601-1-2 compliant.

Indications for Use

Indicated for lactating women to express milk from the breasts. Intended for single-user, over-the-counter use.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Ameda Egnell Powered Breast Pumps (Expresse and Premier) (K973501)

Submission Summary (Full Text)

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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: [phone]

email: Reinhold [e-mail]

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

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APR 5 207

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### 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<br>Breast Pumps (Expresse and<br>Premier) | NUK Expressive Double<br>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,<br>Expresse and Premier, are<br>intended to express and collect<br>the mother's milk from the<br>breasts of a nursing woman, for<br>the purpose of feeding the<br>collected milk to a baby. | The NUK Expressive Double<br>Electric Breast Pump is<br>intended to express milk from<br>the breasts. It is intended for<br>use 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, car<br>adaptor | AC adaptor |
| Breast pumping option | Single or double pumping | Single or double pumping |
| Biocompatibility of materials<br>with tissue contact | Not specified in device labeling | ISO.10993 compliant |
| Electrical Safety | UL File Number E189700<br>CSA File Number LR76525 | IEC 60601-1 and IEC 60601-1-<br>2 compliant.<br>UL File Number E339441 for<br>Voltage 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 [phone] or [phone] 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

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