E-BASIC SINGLE BREAST PUMP

K101157 · Mapa GmbH · HGX · Sep 17, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K101157
• Device Name: E-BASIC SINGLE BREAST PUMP
• Applicant: Mapa GmbH
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.

Device Story

NUK Easy-Flow Single Electric Breast Pump is a powered, portable, electric/battery-operated device for lactating women to express breast milk. It utilizes an electrical diaphragm pump to generate an adjustable suck-and-release vacuum pattern (maximum 250mmHg). The system is closed, featuring a breast shield connected to a bottle via a valve. Used by the patient in a home or personal setting. The device assists in milk expression, potentially benefiting the patient by facilitating breastfeeding or milk collection. Operation is manual via adjustable suction controls.

Clinical Evidence

Bench testing only. Verification testing confirmed conformance with design specifications. Biocompatibility testing performed per ISO 10993; electrical safety testing performed per ISO 60601-1.

Technological Characteristics

Powered electric/battery-operated diaphragm pump; closed system design; maximum vacuum 250mmHg; adjustable suction. Biocompatibility per ISO 10993; electrical safety per ISO 60601-1. Portable form factor.

Indications for Use

Indicated for lactating women to express milk from the breast. Single-user device.

Regulatory Classification

Identification

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

Predicate Devices

• miPump Electric Breast Pump (K082802)

Submission Summary (Full Text)

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## K101157 - NUK Breast Pump - Mapa GmbH

## SEP 1 7 2010

## 510(k) Summary Prepared August 12, 2010

Submitted by: MAPA GmbH Industriestrasse 21-25 Zeven, GERMANY 27404 Contact Person: Reinhold Jaeger-Waldau Telephone: [phone] e-mail: [e-mail] Product Name: NUK Easy-Flow Single Electric Breast Pump Common Name: Electric Breast Pump Classification: Breast Pump, HGX, 21CFR 884.5160 miPump Single Electric Breast Pump Predicate Device:

### Description of Device:

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.

#### Intended Use:

The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user.

### Comparison with Predicate Devices:

The submission device and the predicate device have substantially equivalent intended use and technological specifications.

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K101157 page 2 of 2

# K101157 - NUK Breast Pump - Mapa GmbH

| | Predicate Device | Subject Device |
|----------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------|
| | miPump Electric Breast Pump<br>by Learning Curve K082802 | NUK Easy-Flow Electric Breast Pump<br>MAPA GmbH |
| FDA classification | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Classification Code | HGZ | 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 | Lactating women |
| Available over the counter | Yes | Yes |
| Portable | Yes | Yes |
| Vacuum range | Not specified in device labeling | Maximum 250mmHg |
| Suction mode | adjustable | Adjustable |
| Type of pump | Electric/Battery | Electric/Battery |
| Closed System | Yes | Yes |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant |
| Electrical Safety | Not specified in device labeling | ISO 60601-1 compliant |

### Performance:

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.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white. The text is centered in the image.

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

Sheila W. Pickering, Ph.D. Consultant Mapa GmbH 2081 Longden Circle LOS ALTOS CA 94024

Re: K101157

> Trade Name: NUK Easy-Flow Single Electric Breast Pump Regulation Number: 21 CFR \$884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 16, 2010 Received: August 24, 2010

SEP 1 7 2010

Dear Dr. Pickering:

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'. 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 of medical device-related

Image /page/2/Picture/10 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

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### Page 2

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

#### Enclosure

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K101157

K101157 - NUK Breast Pump - Mapa GmbH

# SEP 1 7 2010

510(k) Number (if known): K101157

Device Name: NUK Easy-Flow Single Electric Breast Pump

Indications For Use:

"The NUK® Easy-Flow™ Single Electric Breast Pump is intended. for use to express milk from the breast by a single user."

Prescription Use OR Over-The-Counter Use (Per 21CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Of CDRH, Office Of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

027