AMEDA PLATINUM BREAST PUMP

K100435 · Evenflo Company, Inc. · HGX · May 28, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100435
• Device Name: AMEDA PLATINUM BREAST PUMP
• Applicant: Evenflo Company, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: May 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

Device Story

Ameda Platinum Breast Pump is an electric or battery-operated powered breast pump; used in hospitals, institutions, and homes by lactating women. Device utilizes a piston-style pump mechanism to express milk; suction levels are adjustable (30-250 mmHg) with cycle speeds of 30-80 cycles per minute. System uses the Ameda HygieniKit for milk collection. Device assists in alleviating engorgement and maintaining lactation when mother and baby are separated. Healthcare providers or patients operate the device to collect milk for future feedings.

Clinical Evidence

Bench testing only. Testing included vacuum performance and life cycling to demonstrate the device performs within specifications.

Technological Characteristics

Powered breast pump; piston-style pump mechanism; AC or battery power source. Adjustable suction (30-250 mmHg) and cycle speed (30-80 cycles/min). Uses Ameda HygieniKit for milk collection. Software-controlled operation.

Indications for Use

Indicated for lactating women to express and collect breast milk, alleviate engorgement, and maintain lactation.

Regulatory Classification

Identification

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

Predicate Devices

• Medela Symphony (K020518)
• Ameda Elite breast pump (K950531)
• Evenflo Elan breast pump (K052909)
• Ameda HygieniKit (K011519)

Submission Summary (Full Text)

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#### Premarket Notification 510(k) Section 5 - 510(k) Summary

Eventlo

510(k) Summary Page 1 of 2 12-Feb-2010

\$\overline{K100435}\$

MAY 2 8 2010

Evenflo Company, Inc. 225 Byers Road Miamisburg, OH 45342

Tel – [phone] Fax - [phone]

Powered breast pump

Amy Neff -- Associate General Counsel

Proprietary or Trade Name:

Ameda Platinum Breast Pump

Classification Name:

Common/Usual Name:

Official Contact:

Powered breast pump HGX - CFR 884.5760

Predicate Devices:

K020518 - Medela Symphony K950531 - Ameda Elite breast pump K052909 - Evenflo Elan breast pump K011519 - Ameda HygieniKit

#### Device Description:

The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.

#### Indications for Use:

The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

Patient Population: . Lactating women

Environment of use:

None

**Environment of use:**

# Hospitals, institutions and home

Contraindications:

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#### Premarket Notification 510(k) Section 5 - 510(k) Summary

#### 510(k) Summary Page 2 of 2 12-Feb-2010

| Attribute | Ameda Platinum |
|---------------------------|---------------------------------|
| Intended Use | Express milk |
| Patient population | Lactating women |
| Environment of use | Hospital, institutions and home |
| Power Source | AC<br>Battery |
| Pump Style | Piston |
| Single/double Pumping | Both |
| Adjustable Suction Levels | Yes |
| Cycle Speed | 30 - 80 |
| Overflow Protection | No |
| Vacuum range - (mmHg) | 30 - 250 |
| Uses HygieniKit | Yes |
| Software | Yes |

The Ameda Platinum breast pump is viewed as substantially equivalent to the predicate devices because:

#### Indications -

Similar to predicates – Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps

#### Technology -

Similar to predicates – Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps

#### Materials -

Materials in contact with the user and expressed milk are identical to predicate – Ameda HygieniKit (K011519)

#### Environment of Use -

Identical to predicates - Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps

#### Patient Population -

Identical to predicates - Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps

#### Performance Testing and Differences

We have performed bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling. There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.

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

## MAY 2 8 2010

Mr. Steve Nowak Engineering Manager, Ameda Breastfeeding products Evenflo Company, Inc. 225 Byers Road MIAMISBURG OH 45342

Re: K100435

Trade/Device Name: Ameda Platinum Breast Pump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pumps Regulatory Class: II Product Code: HGX Dated: April 29, 2010 Received: April 30, 2010

Dear Mr. Nowak:

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

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/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,

Janine M. Morris

Acting 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 Statement

Page 1 of 1

510(k) Number:

# K100435 (To be assigned)

Device Name:

Ameda Platinum Breast Pump

Indications for Use:

The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

Prescription Use or (Part 21 CFR 801 Subpart D)

Over-the-counter use XX (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sh. Lhe

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K100435

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