(54 days)
No
The summary describes a standard electric breast pump with a motor, battery, display, and accessories. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on standard medical device testing like electrical safety, usability, and vacuum performance.
No
This device is a breast pump, used to express and collect milk, which does not fall under the typical definition of a therapeutic device designed to treat a medical condition or disease.
No
This device is a breast pump, used to express and collect milk. Its function is not to diagnose any medical condition, but rather to perform a physical action.
No
The device description explicitly details hardware components such as a motor unit, tubing, rechargeable battery, AC/DC power supply, and soft good accessories. It is a physical breast pump system, not solely software.
Based on the provided information, the Medela Freestyle® double electric breastpump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that applies negative pressure to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in a sample
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents or test kits
The device is clearly described as a "powered breastpump" and a "mobile, personal, medical device" used for a physical function related to lactation.
N/A
Intended Use / Indications for Use
The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Medela Freestyle® double electric breastpump system is comprised of the Freestyle® pump (motor unit), the Freestyle® media separation pump kit including tubing, the rechargeable battery, the AC/DC power supply and soft good accessories (tote bag, cooler bag with ice pack). The Medela Freestyle® pump is a double electric breastpump for pumping breastmilk from a single breast or simultaneously from both breasts of a lactating woman by applying a cyclic negative pressure.
The Freestyle® double electric breastpump is a mobile, personal, medical device that includes Medela's 2-Phase Expression technology and is intended to be used by a single user in a closed space as for example a home or office environment.
The Medela Freestyle® double electric breastpump is AC/DC powered and incorporates a DCmotor with membrane aggregate in its pump motor unit. A user friendly display offers information as for example duration of pump session or set vacuum level. The Freestyle® double electric breastpump is mobile and can be operated by connecting to the power supply and / or by rechargeable battery. The connection port for the power supply is located at the bottom side of the pump unit. The battery compartment is at the back of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. When the Freestyle® pump motor unit is connected to the power supply, the battery is recharged automatically.
A variety of accessories are available for use with the Freestyle® or are intended to be marketed with these pumps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts (used by lactating women)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or office 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Freestyle® double electric breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Cleaning Validation
- Biocompatibility Evaluation
- Software Validation
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards, respectively
- Safety testing for use in the home per IEC 60601-1-11 standard
- Usability evaluation and validation.
- . Performance testing demonstrating compliance with EN ISO 10079-1: 2009 Particular requirements for the safety of electrically powered suction equipment
- . Performance Testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, overflow performance, durability and pump temperatures during operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Lansinoh powered electric breast pump (K122474)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Medela Symphony (K020518)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2015
Medela Ag % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, WI 53118
Re: K150499
Trade/Device Name: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 23, 2015 Received: February 26, 2015
Dear Adrienne Lenz,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150499
Device Name Freestyle®
Indications for Use (Describe)
The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Medela AG, Freestyle ®
510(K) SUMMARY
4
510(k) Summary
K150499
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: April 20, 2015
SUBMITTER:
Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 769 51 51 Fax + 41 (0)41 769 51 00
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Orlando Antunes Vice President Regulatory Affairs Medela AG
DEVICE:
TRADE NAME: Freestyle®
COMMON/USUAL NAME: Double electric breastpump
CLASSIFICATION NAMES: 884.5160 Powered breast pump
PRODUCT CODE: HGX
PREDICATE DEVICE(S):
Lansinoh powered electric breast pump (K122474)
5
DEVICE DESCRIPTION:
The Medela Freestyle® double electric breastpump system is comprised of the Freestyle® pump (motor unit), the Freestyle® media separation pump kit including tubing, the rechargeable battery, the AC/DC power supply and soft good accessories (tote bag, cooler bag with ice pack). The Medela Freestyle® pump is a double electric breastpump for pumping breastmilk from a single breast or simultaneously from both breasts of a lactating woman by applying a cyclic negative pressure.
The Freestyle® double electric breastpump is a mobile, personal, medical device that includes Medela's 2-Phase Expression technology and is intended to be used by a single user in a closed space as for example a home or office environment.
The Medela Freestyle® double electric breastpump is AC/DC powered and incorporates a DCmotor with membrane aggregate in its pump motor unit. A user friendly display offers information as for example duration of pump session or set vacuum level. The Freestyle® double electric breastpump is mobile and can be operated by connecting to the power supply and / or by rechargeable battery. The connection port for the power supply is located at the bottom side of the pump unit. The battery compartment is at the back of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. When the Freestyle® pump motor unit is connected to the power supply, the battery is recharged automatically.
A variety of accessories are available for use with the Freestyle® or are intended to be marketed with these pumps.
INDICATIONS FOR USE:
The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Freestyle® double electric breastpump uses the same fundamental technology as the Lansinoh powered electric breast pump (K122474). Its 2-phase expression technology is the same as used in other Medela breast pumps, including the Medela Symphony (K020518).
The table below summarizes the key specifications of the Freestyle® and the predicate devices.
6
Medela AG Freestyle® double electric breast pump
| Device name | Freestyle® Breastpump | Lansinoh powered electric
breast pump, now
marketed as Lansinoh
Affinity Pro (K122474) | Discussion |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Freestyle® is a powered
breastpump to be used by
lactating women to express
and collect milk from their
breasts. The Freestyle® is
intended for a single user. | The Powered Breast Pump
is intended to express and
collect the breast milk of a
nursing woman for the
purpose of feeding the
collected milk to a baby.
The Powered Breast Pump
is intended for a single user. | Equivalent. Both devices
express and collect milk.
Both devices are intended
for a single user. |
| Intended Use | Express and collect milk | Express and collect milk | Identical |
| Single user
device | Yes | Yes | Identical |
| Environment of
Use | Home | Home | Identical |
| User Interface | Hardware interfaces | Hardware interfaces | |
| User Control | On-off switch
Vacuum/Cycle-adjustment
control | On-off switch
Vacuum-adjustment control
Cycle-adjustment control | Equivalent - Affinity Pro has
two independent controls
for vacuum and cycles.
Freestyle's® uses a single
control to adjust vacuum
and cycles together.
Freestyle's® controls are the
same as reference
Symphony (K020518). |
| Visual Indicator | LCD display | LCD display | Equivalent |
| Pumping
Options | Single or Double | Single or Double | Equivalent |
| Accessories | A variety of accessories for:
• Collection of milk
• Storage of milk
• Breast care
• Providing Power
• Carrying
• Cleaning
• Feeding | A variety of accessories for:
• Collection of milk
• Storage of milk
• Breast care
• Providing Power
• Carrying | Equivalent - both systems
come with or make
available a variety of
accessories that can be
used with the pump for
collection and storage of
breast milk, providing
power, carrying and breast
pump. Freestyle® has
additional accessories for
cleaning its components
and feeding stored milk. |
| Media
Separation | Yes | Yes | Equivalent |
| Device name | Freestyle® Breastpump | Lansinoh powered electric
breast pump, now
marketed as Lansinoh
Affinity Pro (K122474) | Discussion |
| Specifications | | | |
| Power Supply | Li-Ion battery or AC adaptor provided | 6 AA batteries or AC adaptor provided | Equivalent |
| Suction Levels
(stimulation) | 40 - 140 mmHg | 55 - 140 mmHg | Equivalent - vacuum levels
are user adjustable, with
Freestyle® having the ability
to pump at a lower vacuum |
| Cycles per
Second
(stimulation) | 1.7-1.93 | 1.55 - 2.4 | Equivalent |
| Suction Levels
(expression) | 45 – 245 mmHg | 80 - 220 mmHg | Equivalent - vacuum levels
are user adjustable, with
Freestyle® having the ability
to pump at a lower vacuum |
| Cycles per
Section
(Expression) | 0.83-1.36 | 0.61-1.52 | Equivalent |
| Maximum
vacuum | 270 mmHg | Not available | Equivalent |
| Suction Settings | 9 | 8 | Equivalent |
| Adjustable
Suction Levels | Yes | Yes | Identical |
| Let-Down
Button | Yes | Yes | Identical |
| Cycling Control
Mechanism | Microcontroller | Microcontroller | Equivalent |
| Back Flow
Protection | Yes | Yes | Equivalent |
| Device name | Freestyle® Breastpump | Lansinoh powered electric
breast pump, now
marketed as Lansinoh
Affinity Pro (K122474) | Discussion |
| 2-phase
expression | Yes | Yes | Equivalent. Both devices
offer an initial simulation
phase that moves to
expression phase after two
minutes. Freestyle's® 2-
phase expression
technology is also
equivalent to reference
device Symphony
(K020518). Refer to Exhibit
12.1 for additional
discussion. |
7
8
SUMMARY OF NON-CLINICAL TESTS:
The Freestyle® double electric breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following quality assurance measures were applied to the development of the system:
- Risk Analysis ●
- Cleaning Validation
- Biocompatibility Evaluation
- Software Validation
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards, respectively
- Safety testing for use in the home per IEC 60601-1-11 standard
- Usability evaluation and validation.
- . Performance testing demonstrating compliance with EN ISO 10079-1: 2009 Particular requirements for the safety of electrically powered suction equipment
- . Performance Testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, overflow performance, durability and pump temperatures during operation.
9
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Freestyle® double electric breast pump to its predicate device. However, published research studies are referenced support marketing claims.
CONCLUSION:
The differences between the Freestyle® double electric breast pump and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.
From the results of nonclinical testing described, Medela AG concludes that the Freestyle® double electric breast pump is substantially equivalent to the legally marketed predicate device.