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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Medela Freestyle® double electric breast pump, seeking to demonstrate substantial equivalence to a predicate device. As such, it does not contain a study proving the device meets acceptance criteria in the way this request typically implies (i.e., performance thresholds for AI/ML algorithms).

Instead, the document details a comparison of the Freestyle® breast pump to a predicate device (Lansinoh powered electric breast pump, K122474) and references non-clinical tests to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where applicable, and noting where the information is not present due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm. Instead, it presents a comparison table of technical specifications and performance characteristics between the Medela Freestyle® and its predicate device to demonstrate substantial equivalence. The "Discussion" column in this table serves as the "reported device performance" against the implicitly accepted standards of the predicate device.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Freestyle®)	Discussion/Equivalence
Indications for Use	Express and collect breast milk from a nursing woman for feeding a baby; single user.	Express and collect milk from lactating women; single user.	Equivalent
Intended Use	Express and collect milk	Express and collect milk	Identical
Single user device	Yes	Yes	Identical
Environment of Use	Home	Home	Identical
User Interface	Hardware interfaces	Hardware interfaces	No specific discussion, but implied equivalent to predicate
User Control	On-off switch, Vacuum-adjustment control, Cycle-adjustment control	On-off switch, Vacuum/Cycle-adjustment control (single control for both)	Equivalent
Visual Indicator	LCD display	LCD display	Equivalent
Pumping Options	Single or Double	Single or Double	Equivalent
Accessories	Collection, Storage, Breast care, Power, Carrying	Collection, Storage, Breast care, Power, Carrying, Cleaning, Feeding	Equivalent
Media Separation	Yes	Yes	Equivalent
Power Supply	6 AA batteries or AC adaptor	Li-Ion battery or AC adaptor	Equivalent
Suction Levels (stimulation)	55 - 140 mmHg	40 - 140 mmHg	Equivalent
Cycles per Second (stimulation)	1.55 - 2.4	1.7 - 1.93	Equivalent
Suction Levels (expression)	80 - 220 mmHg	45 – 245 mmHg	Equivalent
Cycles per Section (Expression)	0.61 - 1.52	0.83 - 1.36	Equivalent
Maximum vacuum	Not available (for predicate)	270 mmHg	Equivalent
Suction Settings	8	9	Equivalent
Adjustable Suction Levels	Yes	Yes	Identical
Let-Down Button	Yes	Yes	Identical
Cycling Control Mechanism	Microcontroller	Microcontroller	Equivalent
Back Flow Protection	Yes	Yes	Equivalent
2-phase expression	Yes	Yes	Equivalent

2. Sample size used for the test set and the data provenance

This information is not applicable and not provided. This document describes a medical device (breast pump), not an AI/ML algorithm requiring a test set of data. The "testing" involved non-clinical performance and safety evaluations of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML algorithm submission.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used

Not applicable. For a physical device, performance is evaluated against engineering specifications, safety standards, and equivalence to a predicate device's established performance, rather than "ground truth" labels. The "truth" here relates to meeting established physical and electrical safety standards and functional equivalence.

The document mentions several non-clinical tests that form the basis of proving compliance and equivalence:

Risk Analysis
Cleaning Validation
Biocompatibility Evaluation
Software Validation
Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2
Safety testing for use in the home per IEC 60601-1-11
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 vacuum performance (minimum and maximum vacuum levels, vacuum stability, overflow performance, durability, pump temperatures during operation) compared to the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 +41 (0)41 769 51 51 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:

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 electricbreast pump, nowmarketed as LansinohAffinity Pro (K122474)	Discussion
Indications forUse	The Freestyle® is a poweredbreastpump to be used bylactating women to expressand collect milk from theirbreasts. The Freestyle® isintended for a single user.	The Powered Breast Pumpis intended to express andcollect the breast milk of anursing woman for thepurpose of feeding thecollected milk to a baby.The Powered Breast Pumpis intended for a single user.	Equivalent. Both devicesexpress and collect milk.Both devices are intendedfor a single user.
Intended Use	Express and collect milk	Express and collect milk	Identical
Single userdevice	Yes	Yes	Identical
Environment ofUse	Home	Home	Identical
User Interface	Hardware interfaces	Hardware interfaces
User Control	On-off switchVacuum/Cycle-adjustmentcontrol	On-off switchVacuum-adjustment controlCycle-adjustment control	Equivalent - Affinity Pro hastwo independent controlsfor vacuum and cycles.Freestyle's® uses a singlecontrol to adjust vacuumand cycles together.Freestyle's® controls are thesame as referenceSymphony (K020518).
Visual Indicator	LCD display	LCD display	Equivalent
PumpingOptions	Single or Double	Single or Double	Equivalent
Accessories	A variety of accessories for:• Collection of milk• Storage of milk• Breast care• Providing Power• Carrying• Cleaning• Feeding	A variety of accessories for:• Collection of milk• Storage of milk• Breast care• Providing Power• Carrying	Equivalent - both systemscome with or makeavailable a variety ofaccessories that can beused with the pump forcollection and storage ofbreast milk, providingpower, carrying and breastpump. Freestyle® hasadditional accessories forcleaning its componentsand feeding stored milk.
MediaSeparation	Yes	Yes	Equivalent
Device name	Freestyle® Breastpump	Lansinoh powered electricbreast pump, nowmarketed as LansinohAffinity Pro (K122474)	Discussion
Specifications
Power Supply	Li-Ion battery or AC adaptor provided	6 AA batteries or AC adaptor provided	Equivalent
Suction Levels(stimulation)	40 - 140 mmHg	55 - 140 mmHg	Equivalent - vacuum levelsare user adjustable, withFreestyle® having the abilityto pump at a lower vacuum
Cycles perSecond(stimulation)	1.7-1.93	1.55 - 2.4	Equivalent
Suction Levels(expression)	45 – 245 mmHg	80 - 220 mmHg	Equivalent - vacuum levelsare user adjustable, withFreestyle® having the abilityto pump at a lower vacuum
Cycles perSection(Expression)	0.83-1.36	0.61-1.52	Equivalent
Maximumvacuum	270 mmHg	Not available	Equivalent
Suction Settings	9	8	Equivalent
AdjustableSuction Levels	Yes	Yes	Identical
Let-DownButton	Yes	Yes	Identical
Cycling ControlMechanism	Microcontroller	Microcontroller	Equivalent
Back FlowProtection	Yes	Yes	Equivalent
Device name	Freestyle® Breastpump	Lansinoh powered electricbreast pump, nowmarketed as LansinohAffinity Pro (K122474)	Discussion
2-phaseexpression	Yes	Yes	Equivalent. Both devicesoffer an initial simulationphase that moves toexpression phase after twominutes. Freestyle's® 2-phase expressiontechnology is alsoequivalent to referencedevice Symphony(K020518). Refer to Exhibit12.1 for additionaldiscussion.

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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.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).