MEDELA SWING BREAST PUMP

K053052 · Medela AG · HGX · May 2, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K053052
• Device Name: MEDELA SWING BREAST PUMP
• Applicant: Medela AG
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Medela® Swing™ breastpump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus it is identical to the predicate devices.

Device Story

Medela Swing is a powered, single-breast pump for lactating women. Device utilizes a diaphragm-type vacuum pump driven by a DC motor. A microcontroller supervises motor speed for vacuum creation and a solenoid for vacuum release. User interface consists of vacuum-adjust buttons allowing control over vacuum levels (0-250mmHg) and cycling rates (up to 130cpm). The microcontroller executes a control program to deliver two specific pumping curves. Device operates via batteries or AC/DC power supply. Intended for use by the lactating woman to facilitate milk expression. All patient-contact materials meet food contact and biocompatibility regulations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diaphragm-type vacuum pump; DC-motor driven; microcontroller-based control; vacuum range 0-250mmHg; cycling rates up to 130cpm; battery or AC/DC power; biocompatible materials for milk/skin contact.

Indications for Use

Indicated for lactating women to express and collect milk from their breasts.

Regulatory Classification

Identification

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

Predicate Devices

• Medela® Symphony® Breastpump (K020518)
• Medela® Mini Electric® Breastpump (K901344)

Submission Summary (Full Text)

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K053052

# Section E - 510(k) Summary

#### 2 2006 MAY

# Medela® Swing™ Breastpump

### 1. Sponsor's Name, Address and Contact Person:

Medela AG Laettichstr. 4b 6341 Baar Switzerland [phone] Ph: [phone] Fax:

Contact Person: Werner Frei Manager Requlatory Affairs

Date Summary Prepared: July 20, 2005

#### 2. Name of Device:

Swing™ Trade Name: Common Name: Powered Breast Pump Powered Breast Pump (Classified Class II, per 21 CFR Section 884.5160) Classification Name:

### 3. Name of Predicate Device:

Medela® Symphony® Breastpump, by Medela AG, K020518 Medela® Mini Electric® Breastpump, by Medela AG, K901344

#### 4. Description of Device:

The Medela® Swing™ Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time.

The Swing™ breastpump can operate off common batteries or off an AC/DC power supply. The Swing™ breastpump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).

The control program resides in a microcontroller, inside the Swing™ breastpump and provides the necessary a) time and b) vacuum parameters. By depressing the vacuum-adjust buttons, the microcontroller changes the vacuum and time parameters of the breast pump is capable of providing vacuum levels from 0 to 250mmHg, with cycling rates up to 130cpm. The program residing on the microcontroller is designed to deliver two pumping curves.

All materials with milk contact or components with human breast/skin contact are manufactured from' materials that meet the appropriate FDA and international requlations concerning food contact and/or biocompatibility.

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# 5. Intended Use of the Device:

The Medela® Swing™ breastpump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus it is identical to the predicate devices.

## 6. Summary of Technological Characteristics:

The technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness.

#### 7. Conclusion:

Based upon the information presented above, it is concluded that the proposed Medela® Swing™ breastpump is safe and effective for the intended use, and is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

2 2006 MAY

Medela AG % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 25112-1891

Re: K053052

Trade/Device Name: SwingTM Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: April 13, 2006 Received: April 17, 2006

Dear Mr. Preiss:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular with the words "1906-2006" at the top and "Centennial" in the middle. The words "Protecting and Promoting Public Health" are written in a fancy font below the logo. The logo is black and white.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|-----------------|-----------------------------------------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon

Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

(if known): K0534

Device Name: Swing™

Indications For Use:

The Swing™ breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

e-Counter Use
R 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Bradon

(Division Stan-Division of Reproductive, and Radiological Device 510(k) Number

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