(119 days)
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 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. .
This document is a 510(k) Summary for the Medela Freestyle Flex™ breast pump and focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle® Breast Pump K150499) rather than presenting a study to prove performance against specific acceptance criteria in the traditional sense of clinical performance measures (e.g., sensitivity, specificity, accuracy for diagnostic devices).
Therefore, some of the requested information regarding acceptance criteria and study design (especially related to expert ground truth, adjudication, MRMC, and standalone performance metrics) is not applicable or cannot be directly extracted from this type of regulatory submission for a powered breast pump. This submission is primarily concerned with safety and effectiveness through technological comparison and conformance to standards.
However, I can extract information related to the technical specifications and non-clinical testing performed to support the substantial equivalence claim.
Here's the closest representation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a breast pump, "acceptance criteria" primarily revolve around meeting technical specifications for functionality, safety standards, and equivalence to a predicate device. The "reported device performance" refers to the device adhering to these specifications during testing.
| Acceptance Criteria (Specification) | Reported Device Performance (as stated in submission) |
|---|---|
| General Device Characteristics | |
| Indications for Use (same as predicate) | The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. Intended for a single user in a home environment. (Identical to predicate) |
| Single user device | Yes (Identical to predicate) |
| Environment of Use | Home (Identical to predicate) |
| Regulation Number | 21 CFR 884.5160 (Identical to predicate) |
| Product Code | HGX (Identical to predicate) |
| Device Class | II (Identical to predicate) |
| Sterility | Not sterile (Identical to predicate) |
| Functional Specifications | |
| Adjustable Suction Levels | Yes (Identical to predicate) |
| Suction Settings (Pump Levels) | 9 (Identical to predicate) |
| Suction Levels (stimulation) | -45 to -140 mmHg (Predicate: -40 to -140 mmHg. Small difference noted but deemed not to raise new questions of safety/effectiveness). The Freestyle Flex™ breast pump is capable of providing vacuum levels from -45 to -245 mmHg. |
| Cycles per Second (stimulation) | 1.85 (Predicate: 1.7-1.93. Difference noted but deemed not to raise new questions of safety/effectiveness). The powered breast pump is capable of providing cycle rates up to 111 cycles per minute (1.85 cycles/sec). |
| Suction Levels (expression) | 45 - 245 mmHg (Identical to predicate) The Freestyle Flex™ breast pump is capable of providing vacuum levels from -45 to -245 mmHg. |
| Cycles per Second (Expression) | 0.75-1.25 (Predicate: 0.83-1.36. Difference noted but deemed not to raise new questions of safety/effectiveness). The powered breast pump is capable of providing cycle rates up to 111 cycles per minute. |
| Maximum vacuum | -270 mmHg (Identical to predicate) |
| Let-Down Button | Yes (Identical to predicate) |
| Back Flow Protection | Yes - connector with membrane provide media separation to protect against backflow. (Identical to predicate) |
| 2-phase expression | Yes (Identical to predicate) |
| Safety and Performance Standards | |
| Electrical Safety | Complies with AAMI / ANSI ES60601-1:2005/A1:2012 |
| EMC | Complies with IEC 60601-1-2:2014 |
| Home Healthcare Environment Use | Complies with IEC 60601-1-11:2015 |
| Battery Safety | Complies with IEC 62133-2: 2017 |
| Medical Suction Equipment | Complies with ISO 10079-1: 2015 |
| Risk Analysis | Complies with ISO 14971:2007 |
| Software Validation | Complied with FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. |
| Vacuum Levels and Cycle Rate | Met specifications 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 | Conducted to demonstrate the device maintains its specifications throughout its use life under varying power sources (AC, battery). |
| Biocompatibility | No new testing required, all patient-contacting materials identical to those in cleared Medela breast pumps (K181937), compliant with ISO-10993. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not specify a "test set" in the context of clinical data. The performance claims are based on non-clinical bench testing. Therefore, sample sizes for human subjects or data provenance (country/retrospective/prospective) are not applicable or provided here. The tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth from experts is not a concept used in this type of non-clinical bench testing for a breast pump. Performance is measured against predefined engineering specifications and international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant for a breast pump's regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to bench testing of the pump's physical and electrical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests are the engineering specifications and established international safety and performance standards for powered breast pumps and electrical medical equipment. For example, a vacuum level output of -245 mmHg is measured directly against a known standard.
8. The sample size for the training set
Not applicable. This device does not use machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).