FREEMIE BREAST COLLECTION SYSTEM

K130349 · Dao Health · HGX · Sep 6, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130349
• Device Name: FREEMIE BREAST COLLECTION SYSTEM
• Applicant: Dao Health
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Sep 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

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

Device Story

Freemie Breast Pump Collection System serves as a replacement for standard breast pump collection kits. Device consists of a funnel-shaped breast funnel, internal valve assembly, and bowl-shaped reservoir cup. User connects device to an approved powered breast pump; device is supported within a nursing brassiere during operation. Vacuum from the pump extracts milk through the funnel and valve system into the reservoir cup. After pumping, user removes device and transfers milk to storage. Available in two cup styles (Standard/Round and Formed/Natural) and three funnel sizes (25mm, 28mm, 32mm). Device allows hands-free milk collection, potentially increasing convenience for the lactating woman.

Clinical Evidence

No clinical data. Bench testing only, including evaluation of breast funnel design, pump compatibility, vacuum performance, capacity, leakage, and ability to be supported in a brassiere. Biocompatibility testing passed.

Technological Characteristics

Collection system comprising breast funnel, internal valve, and reservoir cup. Materials are consistent across variants. Funnel sizes: 25mm, 28mm, 32mm. Cup variants: Standard (Round) and Formed (Natural). Interfaces between cup and cone are identical. Passive mechanical system; no energy source or software.

Indications for Use

Indicated for lactating women requiring breast milk expression using an approved powered breast pump.

Regulatory Classification

Identification

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

Predicate Devices

• Freemie Breast Pump Collection System (K111411)
• Medela® Pump in Style Advanced® Breastpump (K031614)

Submission Summary (Full Text)

{0}------------------------------------------------

. .

・

K130349

| Submitter | DAO Health<br>1345 Easy Ln<br>El Dorado Hills, California, 95762 | Device Description | The device is to be used by connection to an approved breast pump, and<br>will be used in place of the pump's original breast milk collection<br>equipment. The device has a funnel-shaped breast funnel, internal valve<br>assembly and enclosing reservoir shaped like a bowl. Additional<br>accessories, associated with the device to replicate the functional and<br>performance characteristics necessary for use with some pump brands,<br>will be sold separately but in conjunction with the sale of the Freemie<br>when those specific brands are identified by the user. The Freemie<br>device is designed to be supported within a woman's ordinary or nursing<br>brassiere, and held in place there while the lactating woman is pumping.<br>When the pump extracts milk, the milk flows out through the end of the<br>funnel and enclosing valve system, where it gathers and is collected in<br>the cup. When the lactating woman is done pumping, she turns off the<br>pump, removes the Freemie from her brassiere and transfers the milk to<br>a storage container for later use.<br>The Freemie device is available with two cup variations. The first<br>(identified as "Round" or "Standard") is similar in shape to the predicate<br>Freemie (K111411). The second (referred to as "Shaped" or "Natural"<br>or "Formed") is a shaped cup that is intended to approximate a shape<br>that, for aesthetic purposes, more resembles the natural shape of a breast<br>supported by an ordinary brassiere. Both variants are made from the<br>same materials, function identically and use the same valve and funnel<br>assembly and will be chosen by the user based on individual preference.<br>The interfaces where the cup and cone variants attach to each other are<br>identical.<br>The Freemie will also be available in 3 funnel variants, a 25mm (similar<br>to the predicate Freemie), identified by DAO Health as FG008<br>(Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 1, 2013 (original)<br>August 8, 2013 (S002) | | Standard and FG012 for the Form Shape) and 32mm (FG010 for<br>Standard and FG013 for the Form Shape) funnels. All funnel sizes are<br>made from the same material, fit with either of the cup variants and use<br>the same universal valve assembly. |
| Contact Person | Dan Garbez<br>Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] | Biocompatibility | The Freemie Breast Pump Collection System has passed all<br>biocompatibility testing. |
| Device Trade Name | Freemie® Breast Pump Collection System | Performance Data | Performance testing was conducted to demonstrate Safety and<br>Effectiveness and for comparison to the predicate device.<br>Testing included: Breast Funnel Design, Compatible Pumps, Vacuum<br>Performance and Capacity and Freedom from Leakage, Ability to be<br>Supported. |
| Classification Name | Powered Breast Pump | 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>Device(s) 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. |
| Device Classification | Regulatory Class: Class II (two)<br>Product Code: 85 HGX<br>884.5160 | 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. |
| Predicate Device(s) | Freemie Breast Pump Collection System (K111411)<br>Medela® Pump in Style Advanced® Breastpump (K031614) | | |
| Performance Standards | Performance standards have not been promulgated for powered breast<br>pumps. | | |
| Intended Use | The Freemie breast pump collection system is intended to be used in<br>conjunction with an approved powered breast pump for the purpose of<br>expressing human milk. | | |

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

SEP 06 2013

.

{1}------------------------------------------------

.

.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

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

September 6. 2013

DAO Health % Dan Garbez Manager 1345 Easy Ln El Dorado Hills, CA 95762

Re: K130349

Trade/Device Name: Freemie Breast Pump Collection System Regulation Number: 21 CFR\$ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 8. 2013 Received: August 13, 2013

Dear Dan 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 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.

{3}------------------------------------------------

Page 2 - Dan Garbez

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 device-related adverse events) (21 CFR 803); 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.

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/ucm 1 15809.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,

## Herbert P. Lerner -S

for

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

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K130349

Device Name: Freemie® Breast Pump Collection System

| Freemie Catalog/<br>Model Number | Cup Type | Funnel Size |
|----------------------------------|------------|-------------|
| FG008 | Standard | 25mm |
| FG009 | Standard | 28mm |
| FG010 | Standard | 32mm |
| FG011 | Form Shape | 25mm |
| FG012 | Form Shape | 28mm |
| FG013 | Form Shape | 32mm |

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

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

## Herbert P. Lerner -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________