MEDELA SYMPHONY BREAST PUMP, MODEL 024

K020518 · Medela, Inc. · HGX · Mar 7, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020518
• Device Name: MEDELA SYMPHONY BREAST PUMP, MODEL 024
• Applicant: Medela, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Mar 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

Device Story

Symphony Powered Breast Pump is an electrically powered device for milk expression. It utilizes a motor-driven diaphragm pump system to generate negative pressure (suction) for single or double breast expression. The device is controlled by a programmable microcontroller; users select pumping programs via a credit-card-sized chip inserted into the pump. A control knob allows vacuum adjustment (0 to 250 mmHg). The device features two modes: 'Stimulation' (fast cycles) and 'Expression' (slower cycles). It is intended for use by lactating women. The output is collected milk; the device assists in lactation management by facilitating milk removal.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Powered breast pump; 21 CFR 884.5160; Class II. Materials meet FDA/international food contact and biocompatibility standards. Employs diaphragm pump mechanism; vacuum range 0-250 mmHg; cycle rates variable. Controlled by programmable microcontroller using external chip cards. Electrical power source.

Indications for Use

Indicated for lactating women to express and collect breast milk.

Regulatory Classification

Identification

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

Predicate Devices

• Medela® Classic™ Breast Pump (K801862)
• Egnell Elite Breast Pump (K950531)

Submission Summary (Full Text)

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# KO20518

# MAR

7 2002 MAR

Medela Inc., 1101 Corporate Drive, McHenry, IL 60050 Applicant: Marcel Felber, Tel [phone] ext. 423; Fax [phone] Contact Person: [e-mail] 510(k) Submission for Medela® Symphony® Breastpump

# Medela Powered Breast Pump Symphony®

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

Sponsor: Medela Inc. 1101, Corporate Drive McHenry, IL 60050 [phone] ext. 423 Ph: [phone] Fax:

Contact Person: Marcel Felber Vice President Quality Management

Correspondent: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland [phone] Ph: Fax: [phone]

Contact Person Wemer Frei Manager Regulatory Affairs

Date Summary Prepared: October 31st, 2001

#### 2. Name of Device:

Medela® Symphony® Powered Breast Pump Trade Name: Powered Breast Pump Common Name: Classification Name: Powered Breast Pump (Classified Class II, per 21 CFR section 884.5160).

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

- Medela® Classic™ Breast Pump, by Medela Inc., K801862 .
- Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), . K950531

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K020518

Medela Inc., 1101 Corporate Drive, McHenry, IL 60050 Applicant: Marcel Felber, Tel [phone] ext. 423; Fax [phone] Contact Person: [e-mail] 510(k) Submission for Medela® Symphony® Breastpump

#### 4. Description of Device:

The Symphony Powered Breast Pump is intended to express the mother's milk of a The Symphony T owned Broad. The performed on one breast or on both breasts at lacialing woman. THE pamping vanloyed to drive both diaphragm pumps, one for the Same time. A B O motor gm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a required to extract the broad. The mother can potentially select from a number of programmable microcontroller, the micher sumping programs are stored on separate pumping (Suction) programs. The Tents into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.

The Symphony Powered Breast Pump employs a control knob, for the user to adjust The Symphony T owned Broad. Famp Chip Ship Ship Ship Shown bevels from C the applied vacuum. The breast pump is capable of providing vacuum levels from 0 constant of variable: 710 broad. Polo cycles per minute. Configured with a to 2001.11.11 Tig, Mill oyeast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.

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

#### 5. Intended Use of the Device:

The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices.

## 6. Summary of Technological Characteristics:

The technology of the Symphony® powered breast pump is identical to the predicate The lectinology of the Oymphony® perceive areast particle would raise new aspects regarding safety and effektiveness.

#### 7. Conclusion:

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

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains a symbol in the center that resembles three curved lines stacked on top of each other. The text "HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, and the text "U.S. DEPARTMENT OF" is arranged around the bottom half of the circle.

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

7 2002 MAR

> Medela, Inc. % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K020518

Trade/Device Name: Medela Symphony Electrically Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: February 12, 2002 Received: February 19, 2002

Dear Mr. Job:

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 (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); 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 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancv 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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Page 1 _ of 1

510(k) Number (if known): KC20516

Device Name: Symphony

Indications For Use:

The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) o
Division of Reproductive,
and Radiological Devices
510(k) Number K020518

(Optional Format 3-10-98)

**Over-the-Counter Use**