← Product Code [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX) · K210759
# Solo, Swing Maxi (K210759)
_Medela, LLC · HGX · Aug 11, 2021 · Obstetrics/Gynecology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K210759
## Device Facts
- **Applicant:** Medela, LLC
- **Product Code:** [HGX](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX.md)
- **Decision Date:** Aug 11, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5160
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **Attributes:** Therapeutic
## 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.
## Device Story
Powered breast pump system; includes pump unit, power adapter, tubing, breast shields, and connectors. Uses 2-Phase Expression technology (Stimulation and Expression phases) to mimic natural nursing rhythm. DC motor drives membrane aggregate to create cyclic negative pressure (suction) for milk extraction. Operated by lactating women in home/office settings. User controls include On/Pause/Off, Letdown mode, and vacuum intensity adjustment. Status indicated by central LED. Swing Maxi™ with Bluetooth® enables monodirectional wireless data transmission to Medela Family™ app on mobile devices for recording session length, vacuum levels, and manual milk volume input. Benefits include efficient milk expression and data tracking for user convenience.
## Clinical Evidence
Bench testing only. Performance data confirmed vacuum levels (-45 to -245 mmHg) and cycle rates (up to 111 cycles/min) met specifications. Biocompatibility evaluation confirmed materials are identical to predicate. Software validated as Moderate level of concern.
## Technological Characteristics
Powered breast pump; DC motor; 2-Phase Expression technology. Materials identical to predicate (ISO 10993-1). Vacuum range: -45 to -245 mmHg. Cycle speeds: 75-45 cpm (expression), 111 cpm (stimulation). Connectivity: Bluetooth® Low Energy (monodirectional). Power: Rechargeable Li-Ion battery (3.6V, 2500 mAh) or AC/DC adapter. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 14971.
## Regulatory Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.
## Predicate Devices
- Freestyle Flex™ ([K191653](/device/K191653.md))
## Reference Devices
- Medela Pump In Style® ([K200508](/device/K200508.md))
- Medela Pump In Style® Advanced ([K181937](/device/K181937.md))
- Medela Symphony® ([K020518](/device/K020518.md), [K151632](/device/K151632.md))
## Submission Summary (Full Text)
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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.
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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 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
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## 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)
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## 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 LLC 1101 Corporate Drive McHenry, IL 60050 Phone: 815-578-2200 Fax: 815-759-2548 |
| Primary Contact Person: | Jenni Vescovo Medela AG Team Leader, Global Regulatory Affairs Phone: +41 41 562 1328 Email: Jenni.Vescovo@medela.com |
| Device Information | Trade/Device Name: Solo™ / Swing Maxi™ Regulation Name: Powered Breast Pump Regulation Number: 21 CFR§884.5160 Product Code: HGX (Pump, Breast, Powered) Regulatory Class: II |
| Predicate Device Information | K191653 Manufacturer: Medela AG Device Name: Freestyle Flex™ The predicate device has not been subject to a design related recall. |
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#### 5.2 Device Description
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.
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## 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.
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#### 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.
- 2. Medela Pump In Style® Advanced breast pump (K181937) as it includes the same breast shields as the subject device.
- 3. 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 | |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | | | Without Bluetooth® | With Bluetooth® |
| 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. | 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. | 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. | |
| Single User Device | Yes | Yes | Yes | |
| Environment of Use | Home | Home | Home | |
| Sterility | Not sterile | Not sterile | Not sterile | |
| User Control/ Interface | • DC input terminal/power port • 5-button interface: On/Off, Let-down, Increase vacuum, Decrease vacuum, Start/Pause • Integral tubing ports for single or double pumping | • DC input terminal/ power port • 4-button interface: On/Pause/Off, Let- down, Increase vacuum, Decrease vacuum • Integral tubing port for single pumping | • DC input terminal/ power port • 4-button interface: On/Pause/Off, Let-down, Increase vacuum, Decrease vacuum • Integral tubing port for double or single pumping | |
| Visual Indicator | LED display | LED light (status indicator) | LED light (status indicator) | |
| Pumping Options | Single or double pumping | Single pumping | Single or double pumping | |
| Characteristic | Freestyle Flex™ (Predicate Version) - K191653 | Solo™ (Subject Device) - K210759 | Swing Maxi™ (Subject Device) – K210759 | |
| | | | Without Bluetooth® | With Bluetooth® |
| Adjustable Suction Levels | Yes | Yes | Yes | |
| Breast Shields | PersonalFit Flex™ breast shields (21, 24, 27, 30 mm) featuring 360° rotatable oval-shape, soft rim, and 105° opening angle PersonalFit Flex™ | PersonalFit Flex™ breast shields (21, 24, 27, 30 mm) featuring 360° rotatable oval-shape, soft rim, and 105° opening angle | PersonalFit Flex™ breast shields (21, 24, 27, 30 mm) featuring 360° rotatable oval-shape, soft rim, and 105° opening angle | |
| Replaceable/ Detachable Components of the Breast Pump | • Connector sets (connector body and membrane) • Bottles 5 oz (150 ml) with lids • Bottle stands • Freestyle Flex™ Tubing • Carry bag • Cooler with cooling element • USB power adaptor with cable • Nursing pads (sample) | • Connectors (membrane and connector body) • Bottles 5 oz (150 ml) with lids • Bottle stands • Tube assembly Solo • USB power adaptor with 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 | |
| Cleaning Method | • Pump unit: wipe with clean towel, moistened with drinking-quality water • Breast shields, connectors, and membranes, bottles, and lids: hand wash in warm soapy water, rinse in drinking- quality water, air dry on a clean, unused; wash in dishwasher alternatively; sanitize in boiling water • Tubing: rinse tubing with drinking-quality water, wash in warm soapy water, rinse with clear water, shake out and hang to air dry | • Pump unit: wipe with clean, damp towel. • Breast shields, connectors, and membranes, bottles, and lids: wash and sanitize. • Tubing: Rinse tubing by pouring cool water into both short tubing ends until it flows out of the long tubing end. Wash the tubing in warm, soapy water and rinse tubing with clear water. Shake out water droplets and hang to air dry. | • Pump unit: wipe with clean, damp towel. • Breast shields, connectors, and membranes, bottles, and lids: wash and sanitize. • Tubing: Rinse tubing by pouring cool water into both short tubing ends until it flows out of the long tubing end. Wash the tubing in warm, soapy water and rinse tubing with clear water. Shake out water droplets and hang to air dry. | |
| AC/DC Power Source | • 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, 0.5 A max • Output: 5 V DC, 2 A | |
| Characteristic | Freestyle Flex™ (Predicate Version) - K191653 | Solo™ (Subject Device) – K210759 | Swing Maxi™ (Subject Device) – K210759 | |
| | | | Without Bluetooth® | With Bluetooth® |
| Battery Power Source | Rechargeable Li-Ion battery, 3.7 V DC – 2,750 mAh | Rechargeable Li-Ion battery, 3.6 V DC – 2,500 mAh | Rechargeable Li-Ion battery, 3.6 V DC – 2,500 mAh | |
| Software | Embedded | Embedded | Embedded | |
| Electronic Data Interface | Bluetooth® Low Energy (BLE, version 4.0+) certified module. The BLE module is used to broadcast pumping session data to the MyMedela application (on a compatible device). The pumping session data transmitted by the breast pump include pumping duration, pumping level, battery status. The breast pump cannot be controlled via the BLE interface. | - | Bluetooth® Low Energy (BLE, version 4.0+) certified module. The BLE module is used to broadcast pumping session data to the Medela Family™ application (on a compatible device). The pumping session data transmitted by the breast pump include pumping duration, pumping level, battery status. The breast pump cannot be controlled via the BLE interface. | |
| 2-phase expression | Yes | Yes | Yes | |
| Let-Down button | Yes | Yes | Yes | |
| Cycling Control Mechanism | Microcontroller | Microcontroller | Microcontroller | |
| Adjustable Suction Levels | Yes | Yes | Yes | |
| Suction Settings (Pumping Levels) | 9 | 9 | 9 | |
| Vacuum Range | • 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 | |
| Maximum Vacuum Expression | -270 mmHg | -270 mmHg | -270 mmHg | |
| Cycle Speed (cycle per minute) | • Stimulation: 111 • Expression: 75 (at lowest vacuum level) to 45 (at highest vacuum level) | • Stimulation: 111 • Expression: 75 (at lowest vacuum level) to 45 (at highest vacuum level) | • Stimulation: 111 • Expression: 75 (at lowest vacuum level) to 45 (at highest vacuum level) | |
| Characteristic | Freestyle Flex™ (Predicate Version) - K191653 | Solo™ (Subject Device) – K210759 | Swing Maxi™ (Subject Device) – K210759 | |
| | | | Without Bluetooth® | With Bluetooth® |
| Backflow Protection | Yes - connector with silicone membrane prevents milk backflow into the tubing and pumping mechanism. | Yes - connector with silicone membrane prevents milk backflow into the tubing and pumping mechanism. | Yes - connector with silicone membrane prevents milk backflow into the tubing and pumping mechanism. | |
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# Solo™ / Swing Medela LLC
Solo™ / Swing Maxi™ Breast Pump
Traditional 510(k)
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# Solo™ / Swing Medela LLC
Solo™ / Swing Maxi™ Breast Pump
Traditional 510(k)
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## 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.
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#### 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.
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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K210759](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K210759)
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