Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile.

The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).

The Solo"M and Swing Maxi™ breast pumps feature 2-Phase Expression® technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features:

user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
a port for connection of the tubing that channels the vacuum for breast pumping;
a port for connection of the power supply;
a central LED light as status indicator; and
a textile lanyard as an interface to the user's clothes/body.

The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression.

Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Medela Solo™ / Swing Maxi™ breast pumps. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states that the breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. It also lists performance data provided to support the substantial equivalence determination. These performance data are:

Electrical Safety testing: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-11:2015.
Risk analysis: In accordance with ISO 14971:2007.
Electromagnetic compatibility testing: In accordance with IEC 60601-1-2:2014.
Biocompatibility evaluation: Completed according to FDA guidance "Use of International Standard ISO 10993-1," concluding no new testing was required as patient-contacting materials are identical to the predicate device.
Software validation: In accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The software was considered a "Moderate" level of concern.
Bench testing: Conducted to determine minimum and maximum vacuum levels and cycle rates compared to specifications.
Battery and pump use life testing: Conducted to demonstrate device maintenance of specifications throughout its use life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met for an AI/ML device because the provided text is for a traditional medical device (breast pump) and does not describe an AI/ML component or associated performance studies against specific AI/ML metrics.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the information you need.

Summary

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

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.

August 11, 2021

Medela LLC % Jenni Vescovo Team Leader Global Regulatory Affairs Medela AG Lättichstrasse 4b Baar, Zug 6340 Switzerland

Re: K210759

Trade/Device Name: Solo™, Swing MaxiTM Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 9, 2021 Received: July 12, 2021

Dear Jenni Vescovo:

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.

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

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 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

for Monica D. Garcia, Ph.D. 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

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

Indications for Use

510(k) Number (if known) K210759

Device Name Solo™M Swing Maxi™

Indications for Use (Describe)

The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.

The Solo™ / Swing Maxi™ breast pumps are intended for a single user.

The breast pumps are intended to be used in a home environment.

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

Registration under Part 21 CFR 801 Subpart D
Own-Use Construction (21 CFR 801 Subpart C)

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Medela LLC Solo™ / Swing Maxi™ Breast Pump Traditional 510(k)

5.1 510(k) Summary Information

In accordance with 21 C.F.R. §807.92(a) the following summary of information is provided:

Date Summary Prepared:	August 10, 2021
Submitter/Applicant:	Medela LLC1101 Corporate DriveMcHenry, IL 60050Phone: 815-578-2200Fax: 815-759-2548
Primary Contact Person:	Jenni VescovoMedela AGTeam Leader, Global Regulatory AffairsPhone: +41 41 562 1328Email: Jenni.Vescovo@medela.com
Device Information	Trade/Device Name: Solo™ / Swing Maxi™Regulation Name: Powered Breast PumpRegulation Number: 21 CFR§884.5160Product Code: HGX (Pump, Breast, Powered)Regulatory Class: II
Predicate Device Information	K191653Manufacturer: Medela AGDevice Name: Freestyle Flex™The predicate device has not been subject to a designrelated recall.

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

5.2 Device Description

The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).

user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
a port for connection of the tubing that channels the vacuum for breast pumping;
a port for connection of the power supply;
a central LED light as status indicator; and
a textile lanyard as an interface to the user's clothes/body.

{5}------------------------------------------------

Medela LLC Solo™ / Swing Maxi™ Breast Pump Traditional 510(k)

5.3 Indications for Use

The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.

The Solo™ / Swing Maxi™ breast pumps are intended for a single user.

The breast pumps are intended to be used in a home environment.

{6}------------------------------------------------

5.4 Comparison of Technological Characteristics

The Solo TM / Swing MaxilM breast pumps have similar indications for use, intended use, and has similar fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed, the Freestyle Flex™ breast pump (K191653). In addition, several Medela breast pumps are referenced to demonstrate further substantial equivalence to prior devices.

1. Medela Pump In Style® breast pump (K200508) as it includes the same connectors as the subject device.
1. Medela Pump In Style® Advanced breast pump (K181937) as it includes the same breast shields as the subject device.
1. Medela Symphony® (K020518, K151632) as it is the original Medela device with the same 2-Phase Expression® Technology (Stimulation and Expression) as the subject device.

Characteristic	Freestyle Flex™(Predicate Version) -K191653	Solo™(Subject Device) –K210759	Swing Maxi™(Subject Device) – K210759
			WithoutBluetooth®	WithBluetooth®
Indications for Use	The Freestyle Flex™breast pump is a poweredbreast pump to be usedby lactating women toexpress and collect milkfrom their breasts.The Freestyle Flex™breast pump is intendedfor a single user. Thebreast pump is intendedto be used in a homeenvironment.	The Solo™ / Swing Maxi™ breast pumps are powered breastpumps to be used by lactating women to express and collect milkfrom their breasts.The Solo™ / Swing Maxi™ breast pumps are intended for a singleuser.The breast pumps are intended to be used in a home environment.	The Solo™ / Swing Maxi™ breast pumps are powered breastpumps to be used by lactating women to express and collect milkfrom their breasts.The Solo™ / Swing Maxi™ breast pumps are intended for a singleuser.The breast pumps are intended to be used in a home environment.
Single UserDevice	Yes	Yes	Yes
Environmentof Use	Home	Home	Home
Sterility	Not sterile	Not sterile	Not sterile
User Control/Interface	• DC inputterminal/power port• 5-button interface:On/Off, Let-down,Increase vacuum,Decrease vacuum,Start/Pause• Integral tubing portsfor single or doublepumping	• DC input terminal/power port• 4-button interface:On/Pause/Off, Let-down, Increasevacuum, Decreasevacuum• Integral tubing port forsingle pumping	• DC input terminal/ power port• 4-button interface: On/Pause/Off,Let-down, Increase vacuum,Decrease vacuum• Integral tubing port for double orsingle pumping
VisualIndicator	LED display	LED light (statusindicator)	LED light (status indicator)
PumpingOptions	Single or doublepumping	Single pumping	Single or double pumping
Characteristic	Freestyle Flex™(Predicate Version) -K191653	Solo™(Subject Device) -K210759	Swing Maxi™(Subject Device) – K210759
			WithoutBluetooth®	WithBluetooth®
AdjustableSuctionLevels	Yes	Yes	Yes
Breast Shields	PersonalFit Flex™ breastshields (21, 24, 27, 30mm) featuring 360°rotatable oval-shape, softrim, and 105° openingangle PersonalFit Flex™	PersonalFit Flex™ breastshields (21, 24, 27, 30mm) featuring 360°rotatable oval-shape, softrim, and 105° openingangle	PersonalFit Flex™ breast shields (21, 24, 27, 30 mm) featuring 360° rotatable oval-shape, soft rim, and 105° opening angle
Replaceable/DetachableComponentsof the BreastPump	• Connector sets(connector body andmembrane)• Bottles 5 oz (150 ml)with lids• Bottle stands• Freestyle Flex™Tubing• Carry bag• Cooler with coolingelement• USB power adaptorwith cable• Nursing pads (sample)	• Connectors (membraneand connector body)• Bottles 5 oz (150 ml)with lids• Bottle stands• Tube assembly Solo• USB power adaptorwith cable	• Connectors (membrane and connector body)• Bottles 5 oz (150 ml) with lids• Bottle stands• Tube assembly Swing Maxi/Freestyle Flex• USB power adaptor with cable
CleaningMethod	• Pump unit: wipe withclean towel, moistenedwith drinking-qualitywater• Breast shields,connectors, andmembranes, bottles,and lids: hand wash inwarm soapy water,rinse in drinking-quality water, air dryon a clean, unused;wash in dishwasheralternatively; sanitizein boiling water• Tubing: rinse tubingwith drinking-qualitywater, wash in warmsoapy water, rinse withclear water, shake outand hang to air dry	• Pump unit: wipe withclean, damp towel.• Breast shields,connectors, andmembranes, bottles,and lids: wash andsanitize.• Tubing: Rinse tubingby pouring cool waterinto both short tubingends until it flows outof the long tubing end.Wash the tubing inwarm, soapy water andrinse tubing with clearwater. Shake out waterdroplets and hang toair dry.	• Pump unit: wipe with clean, damptowel.• Breast shields, connectors, andmembranes, bottles, and lids: washand sanitize.• Tubing: Rinse tubing by pouringcool water into both short tubingends until it flows out of the longtubing end. Wash the tubing inwarm, soapy water and rinse tubingwith clear water. Shake out waterdroplets and hang to air dry.
AC/DC PowerSource	• Input: 100-240 V AC,50/60 Hz, 0.4 A max.• Output: 5 V DC, 2 A	• Input: 100-240 V AC,50/60 Hz, 0.5 A max• Output: 5 V DC, 2 A	• Input: 100-240 V AC, 50/60 Hz, 0.5A max• Output: 5 V DC, 2 A
Characteristic	Freestyle Flex™(Predicate Version) - K191653	Solo™(Subject Device) – K210759	Swing Maxi™(Subject Device) – K210759
			WithoutBluetooth®	WithBluetooth®
Battery PowerSource	Rechargeable Li-Ionbattery, 3.7 V DC –2,750 mAh	Rechargeable Li-Ionbattery, 3.6 V DC –2,500 mAh	Rechargeable Li-Ion battery, 3.6 V DC – 2,500 mAh
Software	Embedded	Embedded	Embedded
ElectronicData Interface	Bluetooth® Low Energy(BLE, version 4.0+)certified module. TheBLE module is used tobroadcast pumpingsession data to theMyMedela application(on a compatible device).The pumping sessiondata transmitted by thebreast pump includepumping duration,pumping level, batterystatus. The breast pumpcannot be controlled viathe BLE interface.	-	Bluetooth® LowEnergy (BLE, version4.0+) certified module.The BLE module isused to broadcastpumping session datato the MedelaFamily™ application(on a compatibledevice). The pumpingsession data transmittedby the breast pumpinclude pumpingduration, pumpinglevel, battery status.The breast pumpcannot be controlledvia the BLE interface.
2-phaseexpression	Yes	Yes	Yes
Let-Downbutton	Yes	Yes	Yes
CyclingControlMechanism	Microcontroller	Microcontroller	Microcontroller
AdjustableSuctionLevels	Yes	Yes	Yes
SuctionSettings(PumpingLevels)	9	9	9
VacuumRange	• Stimulation:-45 to -140 mmHg• Expression:-45 to -245 mmHg	• Stimulation:-45 to -140 mmHg• Expression:-45 to -245 mmHg	• Stimulation:-45 to -140 mmHg• Expression:-45 to -245 mmHg
MaximumVacuumExpression	-270 mmHg	-270 mmHg	-270 mmHg
Cycle Speed(cycle perminute)	• Stimulation:111• Expression:75 (at lowest vacuumlevel) to 45 (at highestvacuum level)	• Stimulation:111• Expression:75 (at lowest vacuumlevel) to 45 (at highestvacuum level)	• Stimulation:111• Expression:75 (at lowest vacuum level) to 45 (athighest vacuum level)
Characteristic	Freestyle Flex™(Predicate Version) -K191653	Solo™(Subject Device) –K210759	Swing Maxi™(Subject Device) – K210759
			WithoutBluetooth®	WithBluetooth®
BackflowProtection	Yes - connector withsilicone membraneprevents milk backflowinto the tubing andpumping mechanism.	Yes - connector withsilicone membraneprevents milk backflowinto the tubing andpumping mechanism.	Yes - connector with siliconemembrane prevents milk backflow intothe tubing and pumping mechanism.

{7}------------------------------------------------

Solo™ / Swing Medela LLC

Solo™ / Swing Maxi™ Breast Pump
Traditional 510(k)

{8}------------------------------------------------

Solo™ / Swing Medela LLC

Solo™ / Swing Maxi™ Breast Pump
Traditional 510(k)

{9}------------------------------------------------

Medela LLC Solo™ / Swing Maxi™ Breast Pump Traditional 510(k)

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 similar technological features. The subject and predicate device differ in the battery specifications and provided accessories. These differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

{10}------------------------------------------------

ર્સ રે રી mmary of Non-Clinical Tests

The Solo™ / Swing Maxi™ breast pumps comply with voluntary standards for electrical saf ectromagnetic compatibility, use in the home healthcare environment and usability. The ollowing performance data are provided in support of the substantial equivalence determination:

Electrical Safety testing in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance.
Electrical safety testing for use in home in accordance with IEC 60601-11:2015 (Edition 2.0), Medical Electrical Equipment - Part 1-11: General requirements for Basic Safety and issential Performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Risk analysis in accordance with ISO 14971:2007 (Second Edition), Medical Devices -Application of Risk Management to Medical Devices.
Electromagnetic compatibility testing in accordance with IEC 60601-1-2:2014 (Edition 4.0), Medical electrical equipment - Part 1-2: General requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
Biocompatibility evaluation was completed according to the FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: valuation and testing within a risk management process," dated September 04, 2020 and concluded that no new testing was required as all patient-contacting materials are identical those used in the predicate device Freestyle Flex™ (K191653).
The software validation as 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. The software for the subject device was considered as a Moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain.
Bench testing was conducted with settings to determine the minimum and maximum vacuum levels of the pumps as well as cycle rate compared to the specifications. The specifications ere met under conditions of single pumping (for Solo 110) and of single and double pumping or Swing Maxi™) modes with power supply from both the internal battery and external C/DC power adaptor.
Battery and pump use life testing was conducted to demonstrate that the device maintains its pecifications throughout its use life.

5.6 Conclusions

The subject and predicate devices have the same intended use and the technological differences ot raise different questions of safety or effectiveness. The performance data demons ject 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).