(158 days)
The Thrive 2-in-1 Breast Pump, Model P3 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.
Thrive 2-in-1 Breast Pump (Model P3) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from the breast. It is an electrically powered, software-controlled, digital pump. It is powered by a lithium ion battery (3.7 V, 2000 mAh) and utilizes an embedded control program to manage all product functions. The device is designed not to be used during charging.
The main components of this pump include pump, valve, flange and flange body, silicone diaphragm, USB charging cable, tubing with y-connector, bra extension strap and collection cups. The pump is provided non-sterile and reusable by a single user.
There are two (2) operating modes available for the device - Expression mode and Massage mode, with two frequency options – "High" and "Low" within each operating mode. The subject device includes nine (9) suction levels within each mode of operation. The Expression mode has a suction pressure range of 60 -245 mmHg and cycle frequency in the range 17-50 (High)/15-36 (Low) cycles per minute while Massage mode has a suction pressure range of 60-130 mmHg and cycle frequency range of 38-52 (High)/28-36 (Low) cycles per minute. The subject device has an LED status display, which displays working mode and battery indicator. The user interface includes power on/off/pause switch, mode/frequency switch, vacuum level adjustment buttons (up and down). The subject device is intended only for double pumping, with one collection cup intended for each breast.
The breast pump does not incorporate any off-the-shelf (OTS) software. All milk contacting components of the device are compliant with 21 CFR 177.
The provided FDA 510(k) Clearance Letter for the Thrive 2-in-1 Breast Pump (Model P3) primarily details the regulatory pathway for a medical device and its equivalence to a predicate device. While it lists various performance tests conducted (biocompatibility, electrical safety, EMC, software V&V, and performance/use life verification), it does not provide specific acceptance criteria or the study details proving the device meets those specific acceptance criteria for its core function (expressing and collecting milk with specified pressure/frequency ranges).
The document states that "Vacuum level and cycle frequency verification testing at each mode/level demonstrated that the device meets the mode/level specifications." However, it does not present the actual data or the thresholds for "meeting specifications."
Therefore, based solely on the provided text, much of the requested information regarding detailed acceptance criteria and the specifics of the study proving these are met cannot be fully extracted or inferred. The response below will highlight what is available and explicitly state what is not.
Acceptance Criteria and Device Performance Study Details
The provided 510(k) summary for the Thrive 2-in-1 Breast Pump (Model P3) focuses on establishing substantial equivalence to a predicate device (Lucy Breast Pump, K213311) through various engineering and safety tests. While performance tests are mentioned, the document does not explicitly list quantitative acceptance criteria for many aspects of its primary function (milk expression efficiency or user effectiveness) beyond general statements about meeting specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Given the provided text, specific quantitative acceptance criteria are not detailed for the performance of milk expression, nor are the precise resultant performance values reported in a comparative table format. The closest information is about the device's specifications for vacuum and cycle frequency.
| Performance Aspect | Acceptance Criteria (Not explicitly stated as such, but rather as device specifications) | Reported Device Performance (Summary statement, not specific data) |
|---|---|---|
| Vacuum Level Verification | Expression Mode: 60 - 245 mmHg | |
| Massage Mode: 60 - 130 mmHg | ||
| (These are the design specifications, presumed to be the criteria for verification. No specific "acceptance range" for deviation is provided, e.g., ±5mmHg.) | "Vacuum level and cycle frequency verification testing at each mode/level demonstrated that the device meets the mode/level specifications." (No numerical performance data is provided to show how it met them, e.g., what the measured vacuum was for a given setting.) | |
| Cycle Frequency Verification | Expression (High): 17-50 cycles/minute | |
| Expression (Low): 15-36 cycles/minute | ||
| Massage (High): 38-52 cycles/minute | ||
| Massage (Low): 28-36 cycles/minute | ||
| (These are the design specifications, presumed to be the criteria for verification. No specific "acceptance range" for deviation is provided, e.g., ±2 cycles/min.) | "Vacuum level and cycle frequency verification testing at each mode/level demonstrated that the device meets the mode/level specifications." (No numerical performance data is provided.) | |
| Backflow Protection | Not explicitly stated, but implied criterion is "liquid does not backflow into the tubing." | "Backflow protection testing was conducted to verify liquid does not backflow into the tubing." (Implies it passed, but no specific metric or failure rate presented.) |
| Use Life | Maintain specifications throughout proposed use life (specific duration of use life not stated, nor quantitative definition of "maintains specifications"). | "Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life." (No specific data or duration provided.) |
| Battery Performance | Implied criteria: adequate capacity, functional indicator, appropriate charging/discharging time. | "Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life including adequate battery capacity, battery status indicator, and charging/discharging time." (No specific data on capacity, charge/discharge times, or duration of "use-life" provided.) |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing per ISO 10993. | "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." (Based on referenced ISO 10993 standards.) |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133-2. | "The system complies with the following standards: [listed standards]." (Implies passing all requirements of these standards.) |
| Software V&V | Compliance with 2023 FDA Guidance: Content of Premarket Submissions for Device Software Functions. | "Software documentation including verification & validation was provided in accordance with 2023 FDA Guidance: Content of Premarket Submissions for Device Software Functions." (Implies the V&V was completed and documented per guidance.) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify sample sizes for any of the performance tests (e.g., how many units were tested for vacuum/cycle frequency verification, how many cycles for use life, how many battery charge/discharge cycles).
The data provenance is implied to be from Shenzhen TPH Technology Co., Ltd. in China, as they are the submitter and manufacturer, conducting the tests internally or through contracted labs. The document does not specify if the data is retrospective or prospective for any of the performance studies. These are engineering performance tests, not clinical studies with patients.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable or not provided for this device's type of testing. The tests described are engineering performance tests and safety/EMC compliance, not diagnostic AI performance studies involving expert interpretation of medical images or data from human subjects. Ground truth would be established by calibrated measurement equipment for physical parameters (vacuum, frequency) or standard laboratory assays for biocompatibility.
4. Adjudication Method for the Test Set
Not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. The tests described are objective engineering measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or implied. This type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is evaluated. The Thrive 2-in-1 Breast Pump is a mechanical device for milk expression, not a diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. The device is a "powered breast pump," a physical mechanism, not an AI algorithm. Its "software" controls the pump's mechanical functions (modes, vacuum levels, timing), not interpretable data for diagnosis.
7. Type of Ground Truth Used
For the performance tests mentioned, the "ground truth" would be established by:
- Calibrated Measurement Equipment: For vacuum level and cycle frequency, the ground truth is derived from readings by precision instruments.
- Standardized Laboratory Procedures: For biocompatibility, the ground truth is established by the results of validated assays (cytotoxicity, sensitization, irritation) according to ISO standards.
- Defined Specifications/Standards: For electrical safety, EMC, and software V&V, the ground truth is compliance with the requirements of the cited international and FDA standards/guidances.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical/electrical product, not an AI/machine learning model that requires a training set of data. Its "embedded control program" is likely rule-based or firmware-driven, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set. The "control program" functions are based on engineering design and specifications.
§ 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).