(119 days)
No
The description details pre-programmed suction patterns and user-adjustable vacuum levels, but does not mention any adaptive or learning capabilities indicative of AI/ML.
No.
A breast pump, while used for a bodily function, does not treat or cure any medical condition or disease, which is the definition of a therapeutic device.
No
The device is a breast pump used to express and collect milk, not to diagnose a medical condition. Its function is purely mechanical to aid in milk expression.
No
The device description explicitly lists multiple hardware components including a motor unit, connectors, breast shields, tubing, bottles, carry bag, cooler, and power adapter.
Based on the provided information, the Freestyle Flex™ breast pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts" for lactating women. This is a physical process involving 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 system designed to apply suction to the breast. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is clearly described as a powered breast pump for collecting milk, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HGX
Device Description
The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.
The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.
The Freestyle Flex ™ breast pump provides the following user features:
- . Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
- 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
- o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- "Let-down" control to change between stimulation phase and expression phase. .
- Option of either single or double breast pumping. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Used by lactating women in a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Biocompatibility evaluation was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated June 16, 2016, and concluded that no new testing was required as all patient-contacting materials are identical to those used in cleared Medela breast pumps (K181937).
- Testing in accordance with the following standards:
- o AAMI / ANSI ES60601-1:2005/A1:2012, Medical Electrical Equipment: Part 1: General Requirements for Basic Safety and Essential Performance
- o IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-1-11:2015. Medical Electrical Equipment Part 1-11: General O Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 62133-2: 2017, Secondary Cells and Batteries Containing Alkaline or Other o Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries made from them, for use in Portable Applications - Part 2: Lithium Systems
- ISO 10079-1: 2015 Medical Suction Equipment Part 1: Electrically Powered о Suction Equipment
- Risk analysis in accordance with ISO 14971:2007 ●
- Software Validation: The software/firmware verification and validation were provided in ● accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
- Bench performance testing was conducted with internal test protocols to determine the ● minimum and maximum vacuum levels of the pump, as well as cycle rate compared to its specifications. The specifications were met for vacuum levels and cycle rate, for single and double pumping with all breast shield sizes and both battery and AC power. Battery and pump use life testing were conducted to demonstrate the device maintains its specifications throughout its use life under varying power sources (AC, battery).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161725, 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.
October 17, 2019
Medela AG % Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street. N.W., Suite 1200 Washington, D. C. 20005
Re: K191653
Trade/Device Name: Freestyle Flex™ Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 17, 2019 Received: September 17, 2019
Dear Adrienne Lenz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191653
Device Name Freestyle Flex™
Indications for Use (Describe)
The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
The Freestyle Flex™ breast pump is intended for a single user.
The breast pump is intended to be used in a home environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K191653
In accordance with 21 CFR § 807.92, the following summary of information is provided:
DATE: October 17, 2019
SUBMITTER
Medela AG Lättichstrasse 4b 6340 Baar / Switzerland Phone: +41 (0) 41 562 5151 Fax: +41 (0) 41 562 5100
PRIMARY CONTACT PERSON
Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. Phone: 202-737-4292 Fax: 202-737-9329 Email: alenz@hpm.com
SECONDARY CONTACT PERSON
Judith Bernardo Global Regulatory Affairs Director Medela AG Phone +41 (0)41 562 16 56 Email: Judith.Bernardo@medela.ch
DEVICE
Trade/Device Name: Freestyle Flex™ Regulation Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Common Name: Powered Breast Pump Product Code: HGX Regulatory Class: II
PREDICATE DEVICE
K150499 Manufacturer: Medela AG
4
Device Name: Freestyle® Deluxe, Freestyle® Solution Set, Freestyle® Basic, Freestyle® Motor Warranty
This predicate device has not been subject to a design-related recall.
REFERENCE DEVICES
Three additional Medela breast pumps are used as reference devices for the following rationales:
- . Medela Sonata breast pump (K161725) as it includes the same Bluetooth communication to the MyMedela Application for mobile devices as the subject device.
- . Medela Pump In Style® Advanced breast pump (K181937) as it includes the same PersonalFit Flex breast shields as the subject device.
- Medela Symphony breast pump (K020518, K151632) as it is the original Medela device . studied with the same two-phase expression system as the subject device.
DEVICE DESCRIPTION:
The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.
The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.
The Freestyle Flex ™ breast pump provides the following user features:
- . Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
- 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
5
- o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- "Let-down" control to change between stimulation phase and expression phase. .
- Option of either single or double breast pumping. .
INDICATIONS FOR USE:
The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
The Freestyle Flex™ breast pump is intended for a single user.
The breast pump is intended to be used in a home environment.
SUBSTATIAL EQUIVALENCE DISCUSSION
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE COMPARED TO THE PREDICATE DEVICE
The table below identifies key similarities and differences between the subject device (Freestyle Flex™) breast pump and the legally marketed predicate device (K150499).
| | Freestyle® Breast Pump
(Predicate Device)
K150499 | Freestyle Flex™ Breast Pump
(Subject Device)
K191653 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | |
| Indications for Use | The Freestyle® is a powered breastpump
to be used by lactating women to express
and collect milk from their breasts.
The Freestyle® is intended for a single
user. | 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. |
| Single user device | Yes | Yes |
| Environment of Use | Home | Home |
| Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Product Code | HGX | HGX |
| Device Class | II | II |
| Sterility | Not sterile | Not sterile |
Table 1. Comparison of Freestyle Flex™ to Predicate Device
6
| | Freestyle® Breast Pump
(Predicate Device)
K150499 | Freestyle Flex™ Breast Pump
(Subject Device)
K191653 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface and Controls | | |
| User Control | On/off switch, let-down button,
vacuum/cycle adjustment controls,
memory | 5-button interface: on/off, let-down,
increase vacuum, decrease vacuum,
start/pause |
| Visual Indicator | LCD display | LED display |
| Pumping Options | Single or Double | Single or Double |
| Accessories | • Media separation
• Media separation barrier
• Bottle collars
• Bottle discs
• Bottles (5 oz) with lids
• PersonalFit™ breast shields (21, 24,
27, 30, 36 mm)
• Bottle holders
• AC adapter
• Vehicle adapter
• Battery
• Tubing
• Tote bag
• Cooler bag
• Ice pack
• Milk Storage Bags
• Nursing pads
• Lanolin
• Breastfeeding resource guide, log and
storage magnet
• Cleaning soap
• Microsteam bags
• Easy expression bustier
• Feeding nipples | • Freestyle Flex™ Connector sets
(connector body and membrane)
• Bottles (5 oz) with lids
• PersonalFit™ Flex breast shields (21, 24,
27, 30 mm)
• Bottle stands
• Freestyle Flex™ Tubing
• Carry bag
• Cooler with cooling element
• USB charger
• Nursing pads (sample) |
| | Freestyle® Breast Pump
(Predicate Device)
K150499 | Freestyle Flex™ Breast Pump
(Subject Device)
K191653 |
| Cleaning | • Tubing - wash or sanitize weekly, or if
milk or condensation is present in the
tubing
• Breast pump kit and bottles - wash and
sanitize
• Breast pump carrying case/bag - wipe
with clean, damp cloth | • Motor unit - wipe with clean towel
moistened with drinking-quality water
• Breast shield, connectors and
membranes, bottles and lids - hand
wash in warm soapy water, rinse in
drinking-quality water, air dry on a
clean, unused towel; 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 |
| Specifications | | |
| Power Supply | • Li-Ion battery
• AC adaptor provided | • Li-ion battery (3.7 V, 2,750 mAh)
• AC power adapter (Input: 100-240V,
50-60Hz, max. 0.4A; Output: 5 V DC, 2
A)
• Electrical protection (Class II) |
| Adjustable Suction
Levels | Yes | Yes |
| Suction Settings
(Pump Levels) | 9 | 9 |
| Suction Levels
(stimulation) | -40 to -140 mmHg | -45 to -140 mmHg |
| Cycles per Second
(stimulation) | 1.7-1.93 | 1.85 |
| Suction Levels
(expression) | 45 - 245 mmHg | 45 - 245 mmHg |
| Cycles per Second
(Expression) | 0.83-1.36 | 0.75-1.25 |
| Maximum vacuum | -270 mmHg | -270 mmHg |
| Let-Down Button | Yes | Yes |
| Back Flow
Protection | Yes - connector with membrane provide
media separation to protect against
backflow. | Yes - connector with membrane provide
media separation to protect against
backflow. |
| Software | Embedded | Embedded |
| | Freestyle® Breast Pump
(Predicate Device)
K150499 | Freestyle Flex™ Breast Pump
(Subject Device)
K191653 |
| Cycling Control
Mechanism | Microcontroller | Microcontroller |
| 2-phase expression | Yes | Yes |
| Electronic Data
Interface | N/A | 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. |
7
8
The subject and predicate devices have identical indications for use and the same intended use expressing milk from the breasts of lactating women. The subject and predicate device have different technological features. The subject and predicate devices operate at different cycle values for stimulation and expression modes. The user interface varies between the subject, LED indicators, and predicate, LCD screen. The subject device also includes Bluetooth connectivity to transmit data to a mobile app. These differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL TESTS
The Freestyle Flex TM breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. The following non-clinical performance data were provided in support of the substantial equivalence determination:
- Biocompatibility evaluation was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated June 16, 2016, and concluded that no new testing was required as all patient-contacting materials are identical to those used in cleared Medela breast pumps (K181937).
- Testing in accordance with the following standards:
- o AAMI / ANSI ES60601-1:2005/A1:2012, Medical Electrical Equipment: Part 1: General Requirements for Basic Safety and Essential Performance
- o IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 60601-1-11:2015. Medical Electrical Equipment Part 1-11: General O Requirements for Basic Safety and Essential Performance - Collateral Standard:
9
Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 62133-2: 2017, Secondary Cells and Batteries Containing Alkaline or Other o Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries made from them, for use in Portable Applications - Part 2: Lithium Systems
- ISO 10079-1: 2015 Medical Suction Equipment Part 1: Electrically Powered о Suction Equipment
- Risk analysis in accordance with ISO 14971:2007 ●
- Software Validation: The software/firmware verification and validation were provided in ● accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
- Bench performance testing was conducted with internal test protocols to determine the ● minimum and maximum vacuum levels of the pump, as well as cycle rate compared to its specifications. The specifications were met for vacuum levels and cycle rate, for single and double pumping with all breast shield sizes and both battery and AC power. Battery and pump use life testing were conducted to demonstrate the device maintains its specifications throughout its use life under varying power sources (AC, battery).
CONCLUSION:
The subject and predicate devices have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate the subject device is substantially equivalent to the predicate device.