The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.

The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).

The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.

The Freestyle Flex ™ breast pump provides the following user features:

. Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
"Let-down" control to change between stimulation phase and expression phase. .
Option of either single or double breast pumping. .

AI/ML Overview

This document is a 510(k) Summary for the Medela Freestyle Flex™ breast pump and focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle® Breast Pump K150499) rather than presenting a study to prove performance against specific acceptance criteria in the traditional sense of clinical performance measures (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Therefore, some of the requested information regarding acceptance criteria and study design (especially related to expert ground truth, adjudication, MRMC, and standalone performance metrics) is not applicable or cannot be directly extracted from this type of regulatory submission for a powered breast pump. This submission is primarily concerned with safety and effectiveness through technological comparison and conformance to standards.

However, I can extract information related to the technical specifications and non-clinical testing performed to support the substantial equivalence claim.

Here's the closest representation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a breast pump, "acceptance criteria" primarily revolve around meeting technical specifications for functionality, safety standards, and equivalence to a predicate device. The "reported device performance" refers to the device adhering to these specifications during testing.

Acceptance Criteria (Specification)	Reported Device Performance (as stated in submission)
General Device Characteristics
Indications for Use (same as predicate)	The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. Intended for a single user in a home environment. (Identical to predicate)
Single user device	Yes (Identical to predicate)
Environment of Use	Home (Identical to predicate)
Regulation Number	21 CFR 884.5160 (Identical to predicate)
Product Code	HGX (Identical to predicate)
Device Class	II (Identical to predicate)
Sterility	Not sterile (Identical to predicate)
Functional Specifications
Adjustable Suction Levels	Yes (Identical to predicate)
Suction Settings (Pump Levels)	9 (Identical to predicate)
Suction Levels (stimulation)	-45 to -140 mmHg (Predicate: -40 to -140 mmHg. Small difference noted but deemed not to raise new questions of safety/effectiveness). The Freestyle Flex™ breast pump is capable of providing vacuum levels from -45 to -245 mmHg.
Cycles per Second (stimulation)	1.85 (Predicate: 1.7-1.93. Difference noted but deemed not to raise new questions of safety/effectiveness). The powered breast pump is capable of providing cycle rates up to 111 cycles per minute (1.85 cycles/sec).
Suction Levels (expression)	45 - 245 mmHg (Identical to predicate) The Freestyle Flex™ breast pump is capable of providing vacuum levels from -45 to -245 mmHg.
Cycles per Second (Expression)	0.75-1.25 (Predicate: 0.83-1.36. Difference noted but deemed not to raise new questions of safety/effectiveness). The powered breast pump is capable of providing cycle rates up to 111 cycles per minute.
Maximum vacuum	-270 mmHg (Identical to predicate)
Let-Down Button	Yes (Identical to predicate)
Back Flow Protection	Yes - connector with membrane provide media separation to protect against backflow. (Identical to predicate)
2-phase expression	Yes (Identical to predicate)
Safety and Performance Standards
Electrical Safety	Complies with AAMI / ANSI ES60601-1:2005/A1:2012
EMC	Complies with IEC 60601-1-2:2014
Home Healthcare Environment Use	Complies with IEC 60601-1-11:2015
Battery Safety	Complies with IEC 62133-2: 2017
Medical Suction Equipment	Complies with ISO 10079-1: 2015
Risk Analysis	Complies with ISO 14971:2007
Software Validation	Complied with FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Vacuum Levels and Cycle Rate	Met specifications for vacuum levels and cycle rate, for single and double pumping with all breast shield sizes and both battery and AC power.
Battery and Pump Use Life Testing	Conducted to demonstrate the device maintains its specifications throughout its use life under varying power sources (AC, battery).
Biocompatibility	No new testing required, all patient-contacting materials identical to those in cleared Medela breast pumps (K181937), compliant with ISO-10993.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not specify a "test set" in the context of clinical data. The performance claims are based on non-clinical bench testing. Therefore, sample sizes for human subjects or data provenance (country/retrospective/prospective) are not applicable or provided here. The tests are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth from experts is not a concept used in this type of non-clinical bench testing for a breast pump. Performance is measured against predefined engineering specifications and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

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 not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant for a breast pump's regulatory submission.

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

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to bench testing of the pump's physical and electrical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests are the engineering specifications and established international safety and performance standards for powered breast pumps and electrical medical equipment. For example, a vacuum level output of -245 mmHg is measured directly against a known standard.

8. The sample size for the training set

Not applicable. This device does not use machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2019

Medela AG % Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street. N.W., Suite 1200 Washington, D. C. 20005

Re: K191653

Trade/Device Name: Freestyle Flex™ Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 17, 2019 Received: September 17, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191653

Device Name Freestyle Flex™

Indications for Use (Describe)

The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Freestyle Flex™ breast pump is intended for a single user.

The breast pump is intended to be used in a home environment.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary - K191653

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

DATE: October 17, 2019

SUBMITTER

Medela AG Lättichstrasse 4b 6340 Baar / Switzerland Phone: +41 (0) 41 562 5151 Fax: +41 (0) 41 562 5100

PRIMARY CONTACT PERSON

Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. Phone: 202-737-4292 Fax: 202-737-9329 Email: alenz@hpm.com

SECONDARY CONTACT PERSON

Judith Bernardo Global Regulatory Affairs Director Medela AG Phone +41 (0)41 562 16 56 Email: Judith.Bernardo@medela.ch

DEVICE

Trade/Device Name: Freestyle Flex™ Regulation Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Common Name: Powered Breast Pump Product Code: HGX Regulatory Class: II

PREDICATE DEVICE

K150499 Manufacturer: Medela AG

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Device Name: Freestyle® Deluxe, Freestyle® Solution Set, Freestyle® Basic, Freestyle® Motor Warranty

This predicate device has not been subject to a design-related recall.

REFERENCE DEVICES

Three additional Medela breast pumps are used as reference devices for the following rationales:

. Medela Sonata breast pump (K161725) as it includes the same Bluetooth communication to the MyMedela Application for mobile devices as the subject device.
. Medela Pump In Style® Advanced breast pump (K181937) as it includes the same PersonalFit Flex breast shields as the subject device.
Medela Symphony breast pump (K020518, K151632) as it is the original Medela device . studied with the same two-phase expression system as the subject device.

DEVICE DESCRIPTION:

The Freestyle Flex ™ breast pump provides the following user features:

. Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.

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o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
"Let-down" control to change between stimulation phase and expression phase. .
Option of either single or double breast pumping. .

INDICATIONS FOR USE:

The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Freestyle Flex™ breast pump is intended for a single user.

The breast pump is intended to be used in a home environment.

SUBSTATIAL EQUIVALENCE DISCUSSION

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

The table below identifies key similarities and differences between the subject device (Freestyle Flex™) breast pump and the legally marketed predicate device (K150499).

	Freestyle® Breast Pump(Predicate Device)K150499	Freestyle Flex™ Breast Pump(Subject Device)K191653
General Device Characteristics
Indications for Use	The Freestyle® is a powered breastpumpto be used by lactating women to expressand collect milk from their breasts.The Freestyle® is intended for a singleuser.	The Freestyle Flex™ breast pump is apowered breast pump to be used bylactating women to express and collect milkfrom their breasts.The Freestyle Flex™ breast pump isintended for a single user.The breast pump is intended to be used in ahome environment.
Single user device	Yes	Yes
Environment of Use	Home	Home
Regulation Number	21 CFR 884.5160	21 CFR 884.5160
Product Code	HGX	HGX
Device Class	II	II
Sterility	Not sterile	Not sterile

Table 1. Comparison of Freestyle Flex™ to Predicate Device

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	Freestyle® Breast Pump(Predicate Device)K150499	Freestyle Flex™ Breast Pump(Subject Device)K191653
User Interface and Controls
User Control	On/off switch, let-down button,vacuum/cycle adjustment controls,memory	5-button interface: on/off, let-down,increase vacuum, decrease vacuum,start/pause
Visual Indicator	LCD display	LED display
Pumping Options	Single or Double	Single or Double
Accessories	• Media separation• Media separation barrier• Bottle collars• Bottle discs• Bottles (5 oz) with lids• PersonalFit™ breast shields (21, 24,27, 30, 36 mm)• Bottle holders• AC adapter• Vehicle adapter• Battery• Tubing• Tote bag• Cooler bag• Ice pack• Milk Storage Bags• Nursing pads• Lanolin• Breastfeeding resource guide, log andstorage magnet• Cleaning soap• Microsteam bags• Easy expression bustier• Feeding nipples	• Freestyle Flex™ Connector sets(connector body and membrane)• Bottles (5 oz) with lids• PersonalFit™ Flex breast shields (21, 24,27, 30 mm)• Bottle stands• Freestyle Flex™ Tubing• Carry bag• Cooler with cooling element• USB charger• Nursing pads (sample)
	Freestyle® Breast Pump(Predicate Device)K150499	Freestyle Flex™ Breast Pump(Subject Device)K191653
Cleaning	• Tubing - wash or sanitize weekly, or ifmilk or condensation is present in thetubing• Breast pump kit and bottles - wash andsanitize• Breast pump carrying case/bag - wipewith clean, damp cloth	• Motor unit - wipe with clean towelmoistened with drinking-quality water• Breast shield, connectors andmembranes, bottles and lids - handwash in warm soapy water, rinse indrinking-quality water, air dry on aclean, unused towel; wash indishwasher alternatively; sanitize inboiling water• Tubing - rinse tubing with drinking-quality water, wash in warm soapywater, rinse with clear water, shake outand hang to air dry
Specifications
Power Supply	• Li-Ion battery• AC adaptor provided	• Li-ion battery (3.7 V, 2,750 mAh)• AC power adapter (Input: 100-240V,50-60Hz, max. 0.4A; Output: 5 V DC, 2A)• Electrical protection (Class II)
Adjustable SuctionLevels	Yes	Yes
Suction Settings(Pump Levels)	9	9
Suction Levels(stimulation)	-40 to -140 mmHg	-45 to -140 mmHg
Cycles per Second(stimulation)	1.7-1.93	1.85
Suction Levels(expression)	45 - 245 mmHg	45 - 245 mmHg
Cycles per Second(Expression)	0.83-1.36	0.75-1.25
Maximum vacuum	-270 mmHg	-270 mmHg
Let-Down Button	Yes	Yes
Back FlowProtection	Yes - connector with membrane providemedia separation to protect againstbackflow.	Yes - connector with membrane providemedia separation to protect againstbackflow.
Software	Embedded	Embedded
	Freestyle® Breast Pump(Predicate Device)K150499	Freestyle Flex™ Breast Pump(Subject Device)K191653
Cycling ControlMechanism	Microcontroller	Microcontroller
2-phase expression	Yes	Yes
Electronic DataInterface	N/A	Bluetooth® Low Energy (BLE, version4.0+) certified module. The BLE module isused to broadcast pumping session data tothe MyMedela application (on a compatibledevice). The pumping session datatransmitted by the breast pump include:pumping duration, pumping level, batterystatus. The breast pump cannot becontrolled via the BLE interface.

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The subject and predicate devices have identical indications for use and the same intended use expressing milk from the breasts of lactating women. The subject and predicate device have different technological features. The subject and predicate devices operate at different cycle values for stimulation and expression modes. The user interface varies between the subject, LED indicators, and predicate, LCD screen. The subject device also includes Bluetooth connectivity to transmit data to a mobile app. These differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

SUMMARY OF NON-CLINICAL TESTS

The Freestyle Flex TM breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. The following non-clinical performance data were provided in support of the substantial equivalence determination:

Biocompatibility evaluation was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated June 16, 2016, and concluded that no new testing was required as all patient-contacting materials are identical to those used in cleared Medela breast pumps (K181937).
Testing in accordance with the following standards:
- o AAMI / ANSI ES60601-1:2005/A1:2012, Medical Electrical Equipment: Part 1: General Requirements for Basic Safety and Essential Performance
- o IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-1-11:2015. Medical Electrical Equipment Part 1-11: General O Requirements for Basic Safety and Essential Performance - Collateral Standard:

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Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment

IEC 62133-2: 2017, Secondary Cells and Batteries Containing Alkaline or Other o Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries made from them, for use in Portable Applications - Part 2: Lithium Systems
ISO 10079-1: 2015 Medical Suction Equipment Part 1: Electrically Powered о Suction Equipment
Risk analysis in accordance with ISO 14971:2007 ●
Software Validation: The software/firmware verification and validation were provided in ● accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Bench performance testing was conducted with internal test protocols to determine the ● minimum and maximum vacuum levels of the pump, as well as cycle rate compared to its specifications. The specifications were met for vacuum levels and cycle rate, for single and double pumping with all breast shield sizes and both battery and AC power. Battery and pump use life testing were conducted to demonstrate the device maintains its specifications throughout its use life under varying power sources (AC, battery).

CONCLUSION:

The subject and predicate devices have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate the subject device is substantially equivalent to the 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).