FREEMIE (R)

K111411 · Dao Health · HGX · Feb 1, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K111411
• Device Name: FREEMIE (R)
• Applicant: Dao Health
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Feb 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.

Device Story

Freemie is a breast milk collection system designed to replace standard collection kits for electric breast pumps. The device consists of a funnel-shaped breast adapter, an internal valve assembly, and a bowl-shaped reservoir. It is worn inside a standard or nursing brassiere during operation. When connected to an electric breast pump, the vacuum extracts milk, which flows through the funnel and valve system into the reservoir cup. After pumping, the user removes the device and transfers the milk to a storage container. The system allows for hands-free milk collection, providing convenience for the lactating woman.

Clinical Evidence

Bench testing only. Testing included breast adapter design, compatibility with various pumps, vacuum performance, and collection capacity. Biocompatibility testing was successfully completed.

Technological Characteristics

System includes funnel-shaped breast adapter, internal valve assembly, and bowl-shaped reservoir. Designed for integration with existing electric breast pump vacuum sources. Materials passed biocompatibility testing. No electronic components; purely mechanical collection accessory.

Indications for Use

Indicated for lactating women requiring expression of human milk using an approved electric breast pump.

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® Advanced Breastpump (K031614)
• Learning Curve Brands miPump™ (K082802)

Submission Summary (Full Text)

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FEB - 1 2012

**K** 1/41

| Submitter: | DAO Health<br>2526 Capitol Avenue<br>Sacramento, CA 95816 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 18, 2011 |
| Contact Person: | Dan Garbez<br>Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| Device Trade Name | Freemie® |
| Device Common Name | Freemie® Breast Pump Collection System |
| Classification Name | Powered Breast Pump |
| Device Classification | Regulatory Class: Class II (two)<br>Product Code: 85 HGX<br>884.5160 |
| Predicate Device(s) | Medela® Pump in Style® Advanced Breastpump (K031614)<br>Learning Curve Brands miPump™ (K082802) |
| Performance Standards | Performance standards have not been promulgated for powered breast pumps. |
| Intended Use | The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk. |
| Device Description | The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use. |
| Biocompatibility | The Freemie Breast Pump Collection System has passed all biocompatibility testing. |
| Performance Data | Performance testing was conducted to demonstrate Safety and<br>Effectiveness and for comparison to the predicate device.<br>Testing included: Breast Adapter Design, Compatible Pumps, Vacuum<br>Performance and Capacity. |
| Summary | The Freemie Breast Pump Collection System is constructed of similar<br>materials, has a similar design and the same indications as the Predicate<br>Devices and other currently marketed accessories for powered breast<br>pumps. Bench and biocompatibility testing have demonstrated<br>equivalence and the safety and effectiveness of the device. |
| Conclusion | The Freemie Breast Pump Collection System is substantially equivalent<br>to the predicate devices and other currently marketed accessories for<br>powered breast pumps. |

510(k) Summary - Freemie® Breast Pump Collection System

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

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

FEB - 1 2012

Mr. Dan Garbez Manager DAO Health 2526 Capitol Avenue SACRAMENTO CA 95816

Re: K111411

Trade/Device Name: Freemie® Breast Pump Collection System (Freemie) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: January 24, 2012 Received: January 27, 2012

Dear Mr. Garbez:

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 your 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 1 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 (reporting of medical

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device-related 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.

Sincerély vours,

Sincerely yours,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K111411

Device Name: Freemie Breast Pump Collection System (Freemie)

Indications for Use:

The Freemie breast pump collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The- Counter

(Optional Format 1-1-96)

Benjamin R. Toth