Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty

K150499 · Medela AG · HGX · Apr 21, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150499
• Device Name: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
• Applicant: Medela AG
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.

Device Story

Mobile, double electric breast pump; used by lactating women in home or office environments. System includes motor unit, media separation pump kit, tubing, rechargeable lithium-ion battery, and AC/DC power supply. Operates by applying cyclic negative pressure to one or both breasts. Incorporates 2-Phase Expression technology; utilizes DC motor with membrane aggregate. User interface includes LCD display for session duration and vacuum level; controls allow adjustment of suction levels. Battery recharges automatically when connected to power supply. Output is expressed breast milk collected into containers. Device facilitates milk expression for feeding; supports lactation maintenance.

Clinical Evidence

No clinical testing performed. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), home-use safety (IEC 60601-1-11), and performance testing per EN ISO 10079-1:2009. Bench testing verified vacuum performance, stability, overflow, durability, and temperature.

Technological Characteristics

Powered breast pump; DC motor with membrane aggregate. Suction range 40-245 mmHg; 9 suction settings. 2-Phase Expression technology. Powered by rechargeable Li-Ion battery or AC adapter. LCD user interface. Microcontroller-based cycling control. Backflow protection included. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and EN ISO 10079-1:2009.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user use.

Regulatory Classification

Identification

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

Predicate Devices

• Lansinoh powered electric breast pump (K122474)

Reference Devices

• Medela Symphony (K020518)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

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

April 21, 2015

Medela Ag % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, WI 53118

Re: K150499

Trade/Device Name: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 23, 2015 Received: February 26, 2015

Dear Adrienne Lenz,

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 mav 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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

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# Indications for Use

510(k) Number (if known) K150499

Device Name Freestyle®

Indications for Use (Describe)

The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Medela AG, Freestyle ®

# 510(K) SUMMARY

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# 510(k) Summary

# K150499

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: April 20, 2015

#### SUBMITTER:

Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone [phone] Fax + 41 (0)41 769 51 00

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

Orlando Antunes Vice President Regulatory Affairs Medela AG

#### DEVICE:

TRADE NAME: Freestyle®

COMMON/USUAL NAME: Double electric breastpump

CLASSIFICATION NAMES: 884.5160 Powered breast pump

PRODUCT CODE: HGX

#### PREDICATE DEVICE(S):

Lansinoh powered electric breast pump (K122474)

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#### DEVICE DESCRIPTION:

The Medela Freestyle® double electric breastpump system is comprised of the Freestyle® pump (motor unit), the Freestyle® media separation pump kit including tubing, the rechargeable battery, the AC/DC power supply and soft good accessories (tote bag, cooler bag with ice pack). The Medela Freestyle® pump is a double electric breastpump for pumping breastmilk from a single breast or simultaneously from both breasts of a lactating woman by applying a cyclic negative pressure.

The Freestyle® double electric breastpump is a mobile, personal, medical device that includes Medela's 2-Phase Expression technology and is intended to be used by a single user in a closed space as for example a home or office environment.

The Medela Freestyle® double electric breastpump is AC/DC powered and incorporates a DCmotor with membrane aggregate in its pump motor unit. A user friendly display offers information as for example duration of pump session or set vacuum level. The Freestyle® double electric breastpump is mobile and can be operated by connecting to the power supply and / or by rechargeable battery. The connection port for the power supply is located at the bottom side of the pump unit. The battery compartment is at the back of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. When the Freestyle® pump motor unit is connected to the power supply, the battery is recharged automatically.

A variety of accessories are available for use with the Freestyle® or are intended to be marketed with these pumps.

#### INDICATIONS FOR USE:

The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The Freestyle® double electric breastpump uses the same fundamental technology as the Lansinoh powered electric breast pump (K122474). Its 2-phase expression technology is the same as used in other Medela breast pumps, including the Medela Symphony (K020518).

The table below summarizes the key specifications of the Freestyle® and the predicate devices.

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Medela AG Freestyle® double electric breast pump

| Device name | Freestyle® Breastpump | Lansinoh powered electric<br>breast pump, now<br>marketed as Lansinoh<br>Affinity Pro (K122474) | Discussion |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Freestyle® is a powered<br>breastpump to be used by<br>lactating women to express<br>and collect milk from their<br>breasts. The Freestyle® is<br>intended for a single user. | The Powered Breast Pump<br>is intended to express and<br>collect the breast milk of a<br>nursing woman for the<br>purpose of feeding the<br>collected milk to a baby.<br>The Powered Breast Pump<br>is intended for a single user. | Equivalent. Both devices<br>express and collect milk.<br>Both devices are intended<br>for a single user. |
| Intended Use | Express and collect milk | Express and collect milk | Identical |
| Single user<br>device | Yes | Yes | Identical |
| Environment of<br>Use | Home | Home | Identical |
| User Interface | Hardware interfaces | Hardware interfaces | |
| User Control | On-off switch<br>Vacuum/Cycle-adjustment<br>control | On-off switch<br>Vacuum-adjustment control<br>Cycle-adjustment control | Equivalent - Affinity Pro has<br>two independent controls<br>for vacuum and cycles.<br>Freestyle's® uses a single<br>control to adjust vacuum<br>and cycles together.<br>Freestyle's® controls are the<br>same as reference<br>Symphony (K020518). |
| Visual Indicator | LCD display | LCD display | Equivalent |
| Pumping<br>Options | Single or Double | Single or Double | Equivalent |
| Accessories | A variety of accessories for:<br>• Collection of milk<br>• Storage of milk<br>• Breast care<br>• Providing Power<br>• Carrying<br>• Cleaning<br>• Feeding | A variety of accessories for:<br>• Collection of milk<br>• Storage of milk<br>• Breast care<br>• Providing Power<br>• Carrying | Equivalent - both systems<br>come with or make<br>available a variety of<br>accessories that can be<br>used with the pump for<br>collection and storage of<br>breast milk, providing<br>power, carrying and breast<br>pump. Freestyle® has<br>additional accessories for<br>cleaning its components<br>and feeding stored milk. |
| Media<br>Separation | Yes | Yes | Equivalent |
| Device name | Freestyle® Breastpump | Lansinoh powered electric<br>breast pump, now<br>marketed as Lansinoh<br>Affinity Pro (K122474) | Discussion |
| Specifications | | | |
| Power Supply | Li-Ion battery or AC adaptor provided | 6 AA batteries or AC adaptor provided | Equivalent |
| Suction Levels<br>(stimulation) | 40 - 140 mmHg | 55 - 140 mmHg | Equivalent - vacuum levels<br>are user adjustable, with<br>Freestyle® having the ability<br>to pump at a lower vacuum |
| Cycles per<br>Second<br>(stimulation) | 1.7-1.93 | 1.55 - 2.4 | Equivalent |
| Suction Levels<br>(expression) | 45 – 245 mmHg | 80 - 220 mmHg | Equivalent - vacuum levels<br>are user adjustable, with<br>Freestyle® having the ability<br>to pump at a lower vacuum |
| Cycles per<br>Section<br>(Expression) | 0.83-1.36 | 0.61-1.52 | Equivalent |
| Maximum<br>vacuum | 270 mmHg | Not available | Equivalent |
| Suction Settings | 9 | 8 | Equivalent |
| Adjustable<br>Suction Levels | Yes | Yes | Identical |
| Let-Down<br>Button | Yes | Yes | Identical |
| Cycling Control<br>Mechanism | Microcontroller | Microcontroller | Equivalent |
| Back Flow<br>Protection | Yes | Yes | Equivalent |
| Device name | Freestyle® Breastpump | Lansinoh powered electric<br>breast pump, now<br>marketed as Lansinoh<br>Affinity Pro (K122474) | Discussion |
| 2-phase<br>expression | Yes | Yes | Equivalent. Both devices<br>offer an initial simulation<br>phase that moves to<br>expression phase after two<br>minutes. Freestyle's® 2-<br>phase expression<br>technology is also<br>equivalent to reference<br>device Symphony<br>(K020518). Refer to Exhibit<br>12.1 for additional<br>discussion. |

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# SUMMARY OF NON-CLINICAL TESTS:

The Freestyle® double electric breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following quality assurance measures were applied to the development of the system:

- Risk Analysis ●
- Cleaning Validation
- Biocompatibility Evaluation
- Software Validation
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards, respectively
- Safety testing for use in the home per IEC 60601-1-11 standard
- Usability evaluation and validation.
- . Performance testing demonstrating compliance with EN ISO 10079-1: 2009 Particular requirements for the safety of electrically powered suction equipment
- . Performance Testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, overflow performance, durability and pump temperatures during operation.

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# SUMMARY OF CLINICAL TESTS:

Clinical testing was not required to demonstrate the substantial equivalence of the Freestyle® double electric breast pump to its predicate device. However, published research studies are referenced support marketing claims.

### CONCLUSION:

The differences between the Freestyle® double electric breast pump and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.

From the results of nonclinical testing described, Medela AG concludes that the Freestyle® double electric breast pump is substantially equivalent to the legally marketed predicate device.