EXPRESSE AND PREMIER POWERED BREAST PUMPS

K973501 · Ameda Medizintechnik AG · HGX · Dec 11, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K973501
• Device Name: EXPRESSE AND PREMIER POWERED BREAST PUMPS
• Applicant: Ameda Medizintechnik AG
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

Device Story

The Expresse and Premier are portable, battery-powered breast pumps designed for nursing women to express milk from one or both breasts. The device uses a microprocessor-controlled vacuum system to generate suction; users adjust vacuum strength (<100 to 360 mbar) and cycle rhythm (30 to 60 cycles per minute) via control knobs. The Premier and Expresse models are functionally identical, with the Expresse featuring specialized bottle holders for freezer bags. The device is intended for personal use; it operates on rechargeable NiCd batteries, AA alkaline batteries, AC power, or a 12V vehicle adapter. By automating the expression process, the device facilitates milk collection for later infant feeding, providing a portable alternative to larger, non-portable clinical pumps.

Clinical Evidence

Bench testing only.

Technological Characteristics

Microprocessor-controlled vacuum pump; suction range <100-360 mbar; cycle range 30-60 cycles/min; power options include rechargeable NiCd batteries, 6 AA alkaline batteries, AC adapter, or 12V vehicle adapter. Form factor is portable (1.1 lbs).

Indications for Use

Indicated for nursing women to express and collect breast milk for infant feeding.

Regulatory Classification

Identification

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

Predicate Devices

• Medela Lactina Breast Pump (K875300)
• Medela Pump In Style Breast Pump (not known)
• Egnell Elite Breast Pump (K950531)

Submission Summary (Full Text)

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DFC | 1997

Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font next to a geometric symbol. The symbol is a stylized cross or asterisk shape, composed of several short, thick lines arranged symmetrically around a central void. The text and symbol are both black and appear to be slightly distressed or textured, giving them a vintage or worn look.

Hollister Incorporated 2009 Hollister Drive Libertyville, Illinois 60048-3781 1102

97350

# Ameda Egnell Powered Breast Pumps Expresse and Premier

## 510(k) Summary

### 1. Sponsor's name, Address and Contact Person

- Contact Person Sponsor Joseph S. Tokarz AMEDA AG Manager, Regulatory Affairs Medizin-Technik Hollister Incorporated Bösch 106 2000 Hollister Drive CH-6331 Hünenberg Libertyville, IL 60048 Switzerland [phone] Ph: [phone] Fax:
Date Summary Prepared - September 12, 1997

#### 2. Name of Device:

Expresse and Premier Powered Breast Pumps

#### 3. Name of Predicate Device(s)

- · The Medela Lactina Breast Pump by Medela, K875300, April 6, 1988
- · The Medela Pump In Style Breast Pump (not known)
- · Egnell Elite Breast Pump by Ameda/Egnell, K950531, September 22, 1995

#### 4. Description of Device

The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between <100 and 360 mbar. Another control knob adjusts the suction rhythm (cycle) to one of 4 settings from 30 to 60 cycles per minute.

The difference between the Premier and Expresse are the special bottle holders on the Expresse for using Freezer bags. All other features are substantially equivalent (Software, size, suction capacity, control knobs, weight, noise level and power supply.)

#### 5. Statement of Intended Use

The Battery Breast Pumps, Expresse and Premier, are intended to express and collect the mother's milk from the breasts of a nursing woman, for the purpose of feeding the collected milk to a baby.

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Image /page/1/Picture/0 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a snowflake or a stylized flower. To the right of the shape is the word "Hollister" in a serif font.

14:10:10 :

K973501

P2072

## Ameda Egnell Powered Breast Pumps Expresse and Premier

### 6. Statement of Technological Characteristics of the Device

The Expresse and Premier Powered Breast Pumps are substantially equivalent to other powered breast pumps that are in commercial distribution. A chart showing the similarities and differences of the proposed powered breast pumps and the predicate powered breast pumps follows:

| | Proposed devices | | Predicate Devices | | |
|--------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Characteristics | Expresse | Premier | Egnell Elite<br>K950531 | Medela Lactina<br>Select K875300 | Medela Pump in<br>Style |
| Intended Use | as described in 21<br>CFR 884.5160 | as described in 21<br>CFR 884.5160 | as described in 21<br>CFR 884.5160 | as described in 21<br>CFR 884.5160 | as described in 21<br>CFR 884.5160 |
| Suction Levels<br>Single pumping | <100-360 mbar | <100-360 mbar | 0-360 mbar | 80-240 mmHg | 80-240 mm Hg |
| Double Pumping | <100-265 mbar | <100-265 mbar | 0-360 mbar | | |
| Suction Cycles | 30-60 cycles per<br>minute | 30-60 cycles per<br>minute | 30-60 cycles per<br>minute | 42-60 cycles per<br>minute | 48 per minute |
| Power Supply | a) rechargeable<br>NiCd batteries<br>b) 6 AA alkaline<br>batteries | a) rechargeable<br>NiCd batteries<br>b) 6 AA alkaline<br>batteries | a) rechargeable<br>NiCd battery | a) rechargeable<br>battery | a) rechargeable<br>battery |
| | c)AC adapter<br>d) 12 V adapter<br>for use in a motor<br>vehicle | c)AC adapter<br>d) 12 V adapter<br>for use in a motor<br>vehicle | b) AC power cord<br>c) 12 V adapter<br>for use in motor<br>vehicle | b) AC adapter<br>c) 12 V adapter<br>for use in a motor<br>vehicle | b) AC adapter<br>c) 12 V adapter<br>for use in a motor<br>vehicle |
| Cycling/Suction<br>control mechanism | Microprocessor | Microprocessor | Microprocessor | Mechanical<br>cycling suction<br>regulator | Mechanical<br>cycling suction<br>regulator |
| Breast pumping<br>option | Single or double<br>pumping | Single or double<br>pumping | Single or double<br>pumping | Single or double<br>pumping | Single or double<br>pumping |
| Weight | 1.1 pounds | 1.1 pounds | 6.5 pounds | 5 pounds | 7 pounds |

### 7. Conclusion

Based on the information presented above it is concluded that the proposed Expresse and Premier Powered Breast Pumps are safe and effective for their intended use and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister, Inc. 2000 Hollister Drive Libertyville, Illinois 60048-3781 Re: K973501

Ameda Egnell Powered Breast Pumps, Lactaline Personal (Expresse and Premier) Dated: September 12, 1997 Received: September 16, 1997 Regulatory Class: II 21 CFR 8884.5160/Product Code: 85 HGX

DEC I I 1997

Dear Mr. Tokarz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ameda Egnell Powered Breast Pumps, Lactaline Personal (Premier and Expresse)

# b. Statement of Intended Use

510(k) Number (if Known): Device Name:

K973501 Ameda Egnell Powered Breast Pumps, Lactaline Personal (Premier/Expresse)

## Intended Use:

The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter-Use

Robert D. Satterfield/

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number _

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