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510(k) Data Aggregation
(30 days)
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(132 days)
Hi bebe super (BT-150B) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
The Hi bebesuper (model: BT-150B) is an electrically powered, software-controlled breast pump intended to express and collect milk from the breast of lactating women. The breast pump system is comprised of a motor unit and pump kit including tubing.
BT-150B electrical breast pump is intended to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). BT-150B electrical breast pump also includes back flow protection and it is powered by a 12V DC adaptor or rechargeable lithium battery.
BT-150B electrical breast pump has three operating modes: massage mode, expression mode and program mode to save pressure level and cycle level and their mode (massage or expression) and their running time. Sixteen (16) vacuum pressure levels are available for operating mode ad massage mode. One cycle speed level is available for massage mode and three (3) cycle speed levels are available for expression mode. The device is capable of providing suction up to -270 mmHg.
The subject device is a modified version of BT-150S model of K200675. Compared to the predicate device, the following changes are made.
- Power source change. Both AC-powered mode and battery-powered mode are available.
- Vacuum pressure and cycle speed.
- User interface: Compared to the predicate device, the lamp button is removed, increase cycle speed button and decrease cycle speed button are combined as one cycle level change button, and the function of each button is modified.
- Dual motors system: The subject device includes dual pumps while the predicate device includes a single pump. Compared to the predicate device, a sub board has been removed and both pumps are connected to the main board.
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(139 days)
The Magic InBra™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.
The Magic InBra™ powered breast pump is intended for a single user.
This breast pump is intended to be used in a home environment.
The Magic InBra wearable breast pump is a single user pump to be used by lactating women to express and collect milk from their breasts in the home environment. Magic InBra is designed to fit most breast shapes and nursing bras allowing hands-free pumping. The pump is intended to be used by a single user for pumping on one breast with one Magic InBra breast pump or on both breasts at the same time with two Magic InBra breast pumps.
An optional smartphone application (app) for iPhone and Android, called "Medela Family Pump Control", connects to the breast pump via Bluetooth and, once connected, allows the user to control the breast pump remotely.
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(91 days)
The Wearable Breast Pump (Model S33) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model S33) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.
It is an electrically powered, software-controlled, digital pump. It is powered by a rechargeable lithium ion battery (3.7 V, 1000mAh) that can be charged using the USB cable provided with the device. The device is designed not to be used during charging. The device utilizes an embedded control program to manage all product functions and does not incorporate any off-the-shelf (OTS) software. The main components of this pump include pump motor, valve, flange, silicone diaphragm, USB charging cable, bra extension strap and milk collector. The pump is provided non-sterile and reusable by a single user in home environment.
There are four (4) operating modes available for the device – Stimulation mode, Expression mode, Massage mode, and Auto mode. The device includes nine (9) suction levels within each mode. Wearable Breast Pump (Model S33) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 91 -121 cycles per minute in Stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 27-88 cycles per minute in Expression mode, vacuum levels from 40-120 mmHg with cycling rates from 92-130 cycles per minute in Massage mode and vacuum levels from 40-245 mmHg with cycling rates from 27-121 cycles per minute in auto mode. The device is equipped with an LED status display that displays information regarding working mode, operating time, and battery status. The user interface includes on/off switch that also acts as mode selection switch (through long press), pause button and vacuum level adjustment buttons.
Wearable breast pump (Model S33) is designed to be used as a single pumping system that can be converted to double pumping by using two devices, one on each breast. To prevent milk from flowing into the vacuum system, the device uses a silicone diaphragm that physically separates the milk contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.
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(126 days)
The Momcozy Wearable Breast Pump (Model: BP223) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Momcozy Wearable Breast Pump is an electrically powered breast pump to be used in a home environment by a single user. It is intended to be used by lactating women to express and collect milk from their breast. The device is not sterile. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector.
The device includes stimulation mode, expression mode, and mixed mode with a maximum suction of -315mmHg. Each mode has multi-adjustable suction levels. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.
The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.
BP223 can connect wirelessly to a mobile device and be operated through a dedicated mobile application (M9 Mobile flow).
By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.
To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging cable. The user interface consists of buttons (On/off/Pause, Mode selection, Decrease pumping level Increase pumping level and Toggle button to select breast pump direction to left or right) and an LED display in which the user switches between modes and controls the vacuum pressure.
The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.
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(190 days)
The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model W6) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Wearable Breast Pump (Model W6) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump includes: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and hot compress modes and control the vacuum levels within those modes.
The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level <= 42 degrees Celsius. The Wearable Breast Pump (Model W6) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.
The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
This FDA 510(k) clearance letter pertains to a Wearable Breast Pump (Model W6), not an AI/software device that requires acceptance criteria for algorithm performance. The acceptance criteria and study detailed in the provided text are focused on the hardware performance, safety, and functionality of a physical medical device (a breast pump), not the diagnostic or analytical performance of an AI model.
Therefore, many of the requested items related to AI model evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and the studies performed to prove the device meets these criteria as described in the 510(k) summary, reframing them to fit the provided sections where possible.
Acceptance Criteria and Device Performance for Wearable Breast Pump (Model W6)
Given that this document describes a physical medical device (a breast pump) and not an AI/software for diagnosis or analysis, the acceptance criteria and performance studies are focused on the device's functional safety and efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated) | Reported Device Performance (from "Summary of Non-Clinical Performance Testing") |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for patient contact materials. | Leveraged from predicate device; in accordance with 2023 FDA guidance. Implies successful demonstration of biocompatibility. |
| Electrical Safety | Compliance with IEC 60601-1 Ed 3.2, IEC 62133-2:2017, and IEC 60601-1-11 Ed 3.1. | Testing conducted successfully. Implies successful demonstration of electrical safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014+A1:2020. | Testing conducted successfully. Implies successful demonstration of electromagnetic compatibility. |
| Software Functionality | Software functions as intended and meets "Basic Documentation level" requirements per FDA guidance. | Evaluated at the Basic Documentation level successfully. Implies successful verification of software functionality. |
| Vacuum Level Verification | Devices meet specified vacuum ranges (±5 mmHg) for each mode. - Stimulation: 40-120 mmHg - Expression: 105-245 mmHg - Massage: 40-150 mmHg - Auto: 40-245 mmHg | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual vacuum levels fall within the stated ranges. |
| Cycle Speed Verification | Devices meet specified cycling rates (±2 cycles/minute) for each mode. - Stimulation: 90-143 cycles/min - Expression: 30-105 cycles/min - Massage: 87-128 cycles/min - Auto: 30-143 cycles/min | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual cycle speeds fall within the stated ranges. |
| Backflow Protection | Liquid does not backflow into the tubing. | Testing verified liquid does not backflow into the tubing. Implies successful backflow protection. |
| Use Life Consistency | Devices maintain specifications throughout their proposed use life. | Testing conducted to demonstrate devices maintain specifications. Implies successful use life performance. |
| Battery Performance | Battery remains functional during its stated battery use-life. | Testing conducted to demonstrate battery remains functional. Implies successful battery performance. |
| Battery Status Indicator Functionality | Battery status indicator remains functional during its stated battery life. | Testing conducted to demonstrate indicator remains functional. Implies successful battery status indicator performance. |
| Hot Compress Temperature | Hot compress function remains functional during stated use-life and provides a heating level ≤ 42 ºC. | Testing conducted to demonstrate hot compress function remains functional. Implies successful temperature control (≤ 42 ºC) and functionality throughout use-life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each performance test (e.g., number of units tested for vacuum, cycle speed, use-life, etc.). It only states that "testing was conducted."
- Data Provenance: Not specified in terms of country of origin or whether the underlying studies were retrospective or prospective. These are typically laboratory performance tests, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This relates to evaluation of AI/diagnostic algorithms. For a physical device like a breast pump, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human graders of images or clinical data.
4. Adjudication Method for the Test Set
- Not applicable. This relates to resolving discrepancies in expert labeling for AI/diagnostic algorithms. For device performance testing, adjudication is generally a process of reviewing test results against predefined engineering limits and specifications, not expert consensus on qualitative data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, not specified and not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes the performance of a physical breast pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable for the overall device performance in the context of typical AI review. While the breast pump does have "embedded software," the performance described (vacuum, cycle speed, battery, etc.) is the device's standalone performance, not an algorithm's diagnostic or analytical performance. The document states "Software was evaluated at the Basic Documentation level," which refers to standard software validation processes for medical devices, not an "algorithm-only" performance study in the AI sense.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is derived from established international standards (IEC 60601 series, ISO 10993-1) and the device's own design specifications (e.g., specific vacuum ranges, cycle speeds, temperature limits). These are objective, measurable criteria. For example, a vacuum gauge provides the "ground truth" for vacuum level, and a timer/counter for cycle speed.
8. The Sample Size for the Training Set
- Not applicable. This device does not use a "training set" in the context of machine learning. Its internal software is "embedded" and controls device functions based on pre-programmed logic, not learned from data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8).
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(30 days)
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user
I apologize, but the provided FDA 510(k) clearance letter for the "Wearable Breast Pump" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The letter is a standard clearance notification that states the device is substantially equivalent to legally marketed predicate devices. It covers:
- The device name and model numbers.
- The regulation number and name.
- The regulatory class and product code.
- Dates of submission and clearance.
- General controls provisions of the Act that apply to the device.
- Links to FDA guidance documents and regulations (e.g., QS regulation, UDI rule, MDR).
- Contact information for FDA resources.
- The Indications for Use statement for the device.
There is no mention of performance studies, clinical trials, specific acceptance criteria, or data related to the device's functional performance (e.g., milk expression efficiency, comfort, battery life, etc.). The FDA's substantial equivalence determination for this type of device typically relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. This often involves engineering bench tests and comparisons of specifications rather than detailed clinical performance studies, especially for well-established device types like breast pumps.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because that information is not present in the provided document.
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