(149 days)
No
The device description details standard breast pump functionality with user-adjustable controls and preprogrammed vacuum levels and cycle rates. While one configuration includes Bluetooth for data transmission to a mobile app, the description of the app's functionality (recording data, manual input, low battery notification) does not indicate the use of AI or ML for analysis, prediction, or adaptation.
No
While breast pumps can be helpful for lactating women, they are not typically classified as therapeutic devices as they do not treat or diagnose a disease or condition. They are aids for a natural physiological process.
No
This device is a breast pump, used to express and collect milk. Its function is not to diagnose any medical condition.
No
The device description clearly outlines physical components like a pump unit, power adapter, connectors, breast shields, bottles, tubing, a DC motor, and user-adjustable controls. While one configuration includes Bluetooth for data transmission to a mobile app, the core functionality and components are hardware-based.
Based on the provided text, the Solo™ / Swing Maxi™ breast pumps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves testing blood, urine, tissue, etc., outside of the body.
- Breast Pump Function: The Solo™ / Swing Maxi™ breast pumps are mechanical devices used to physically express and collect breast milk from a lactating woman's breast. They do not analyze or test any biological specimens to provide diagnostic information.
- Intended Use: The intended use clearly states the purpose is to "express and collect milk from their breasts." This is a physical process, not a diagnostic one.
- Device Description: The description details the mechanical components and operation of the pump, focusing on creating negative pressure to extract milk. There is no mention of analyzing the milk or using it for diagnostic purposes.
Therefore, the Solo™ / Swing Maxi™ breast pumps fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes
HGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women / home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K200508, K181937, K020518, K151632
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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 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. |
4
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.
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.
-
- Medela Pump In Style® breast pump (K200508) as it includes the same connectors as the subject device.
-
- Medela Pump In Style® Advanced breast pump (K181937) as it includes the same breast shields 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. | |
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.