GERBER DOUBLE ELECTRIC BREAST PUMP

K043098 · Gerber Products Co. · HGX · Dec 15, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K043098
• Device Name: GERBER DOUBLE ELECTRIC BREAST PUMP
• Applicant: Gerber Products Co.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

An electrically powered breast pump with settings, for expressing milk from the breasts of a lactating woman.

Device Story

Gerber Double Electric Breast Pump is a powered system for expressing milk from lactating women. Device consists of a pump base, flexible tubing, funnel assembly, and accessories (bottles, nipples, nursing pads). Powered by a DC variable speed power supply driving a diaphragm pump to create negative pressure. Provides variable vacuum (up to 240 mm Hg) and massage-like motion; capable of single or double pumping. Operated by the user in a home or clinical setting. Output is expressed breast milk collected in bottles. Device includes a microchip for control of pump functions. Benefits include efficient milk expression for breastfeeding mothers.

Clinical Evidence

No clinical tests have been conducted on this device. Bench testing demonstrated that the device meets established requirements for performance and safety.

Technological Characteristics

Powered breast pump (21 CFR 884.5160). Components: diaphragm pump, flexible tubing, funnel assembly. Materials: FDA food contact compliant; biocompatibility tested. Power: DC. Vacuum: 0-240 mmHg. Features: adjustable vacuum, massage mode, single/double pumping. Control: Microchip-based.

Indications for Use

Indicated for lactating women requiring an electrically powered breast pump with adjustable vacuum and massage settings for milk expression.

Regulatory Classification

Identification

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

Predicate Devices

• Medela Pump-in-Style (K031614)
• Ameda Egnell Purely Yours (K973501)
• Playtex Breast Pump (K022594)

Submission Summary (Full Text)

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K043098

Image /page/0/Picture/1 description: The image shows the Gerber logo. The logo features a drawing of a baby's face inside a black circle. Below the circle is the word "Gerber" in a bold, sans-serif font, and below that is the text "GERBER PRODUCTS COMPANY A NON-THING OMPAN".

## DEC 1 5 2004

SURE CO. DEARON L. ARRINGAN, 1971 - 198 2006 - 100 - 100 - 100 - 2004 - 100 - 100 - 100 - 100 - 100 - 100 - 100

### 510(k) Summary September 20, 2004

| Submitter: | Gerber Products Company<br>445, State Street<br>Fremont, MI 49413-0001<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Dr. Nicholas Hether<br>Director, Product Safety & Regulatory Sciences |
| Trade Name: | Gerber Double Electric Breast Pump |
| Common Name: | Electric Breast Pump |
| Classification Name: | Powered Breast Pump<br>21 CFR 884.5160 (85 HGX) Class-II |
| Substantial Equivalence: | The Gerber Double Electric Breast Pump is substantially<br>equivalent to the following legally marketed predicate devices: |

| Company | Product Name | 510(k) clearance# |
|--------------|---------------|-------------------|
| Medela | Pump-in-Style | K031614 |
| Ameda Egnell | Purely Yours | K973501 |
| Playtex | Breast Pump | K022594 |

#### General Description:

The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads).

#### Device Description:

The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.

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#### Design and materials:

All components that may come in contact with the milk are manufactured from materials that meet FDA food contact criteria. The materials that contact the breast have been tested for biocompatibility.

#### Intended Use:

An electrically powered breast pump with settings, for expressing milk from the breasts of a lactating woman.

#### Technological Characteristics of the Device:

The Gerber Double Electric Breast Pump is substantially equivalent to other powered breast pumps that are available for commercial distribution. A chart showing the similarities and differences of the proposed powered breast pump and the predicate powered breast pumps follows:

| Comparison of Predicate Devices | | | | | | |
|-------------------------------------|-----------------------------------------|-------------------------|-------------------------|------------------------------|--|--|
| | New device | K031614 | K022594 | K973501 | | |
| | Gerber<br>DoubleElectric<br>Breast Pump | Medela<br>Pump-in-Style | Playtex Breast<br>Pump | Ameda Egnell<br>Purely Yours | | |
| Intended Use: | Express milk | Express milk | Express milk | Express milk | | |
| Power Source: | DC | DC | DC | DC | | |
| Pump Style: | Diaphragm | Diaphragm | Reciprocating<br>Piston | Reciprocating<br>Piston | | |
| Single/double Pumping: | Both | Both | Both | Both | | |
| Adjustable Suction<br>Levels: | Yes | Yes | Yes | Yes | | |
| Cycle Speed: | Fixed | Variable | Variable | Variable | | |
| Overflow Protection: | No | No | Yes | Yes | | |
| Highest Vacuum Setting<br>- (mmHg): | 240 | 250 | 229 | 170 | | |
| Lowest Vacuum Setting | 0 | 0 | 64 | 31 | | |
| Active Breast Massage: | Yes | No | Yes | No | | |
| Software (microchip) | Yes | Yes | Yes | Yes | | |

#### Discussion of Non-clinical Tests:

Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling.

#### Discussion of clinical tests performed:

No clinical tests have been conducted on this device.

#### Conclusion:

The Gerber Double Electric Breast Pump is safe and effective for its intended use of milk expression and is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 5 2004

Gerber Products Company % Ms. Chantel Carson Manager Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K043098

Trade/Device Name: Gerber Double Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: November 24, 2004 Received: November 30, 2004

Dear Ms. Carson:

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.

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.

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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/cdrb/dsmadsmamain.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:

K_043098 ___ (To be assigned)

Device Name:

Gerber Double Electric Breast Pump

Indications for Use:

An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.

Prescription Use (Per CFR 801.109)

or

Over-the-counter use

. ಇ

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leymann

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