(109 days)
The Motif Aura Glow breast pump (Model Motif Aura Glow) 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 Motif Aura Glow breast pump (Model Motif Aura Glow) 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 Motif Aura Glow breast pump (Model Motif Aura Glow) is powered by a lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from massage, expression, cluster feeding, and general pumping modes and control the vacuum levels within those modes.
Massage, expression, and general pumping modes consist of 9 vacuum levels. Cluster feeding mode consists of 5 vacuum levels. The Motif Aura Glow breast pump (Model Motif Aura Glow) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-120 cycles per minute in massage mode, vacuum levels from 120-245 mmHg with cycling rates from 30-85 cycles per minute in expression mode, vacuum levels from 40-200 mmHg with cycling rates from 45-120 cycles per minute in cluster feeding mode, and vacuum levels from 60-245 mmHg with cycling rates from 30-120 cycles per minute in general pumping mode. The Motif Aura Glow breast pump (Model Motif Aura Glow) 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 device is for repeated use by a single user in a home environment. The device is provided not 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 device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
Based on the provided FDA Clearance Letter for the Motif Aura Glow breast pump (Model Motif Aura Glow), here's an analysis of the acceptance criteria and the study that proves the device meets them:
Important Note: This document is an FDA Clearance Letter, which is a summary of the FDA's decision regarding substantial equivalence. It does not contain detailed study reports or raw data typically found in clinical trial results or full submission documents. Therefore, some of the requested information (especially quantitative effectiveness data for AI-assisted human reading, if this were an AI device) is not present here, as this is a breast pump, not an AI diagnostic device. I will address each point based on the information available and indicate where information is not applicable (N/A) or not provided in this specific document.
Device: Motif Aura Glow breast pump (Model Motif Aura Glow)
Device Type: Powered Breast Pump (Medical Device, not an AI/Software as a Medical Device for diagnostic purposes)
Product Code: HGX
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a breast pump and not a diagnostic AI device, the "acceptance criteria" revolve around functional performance, safety, and equivalence to a predicate device, rather than diagnostic metrics like sensitivity/specificity.
| Acceptance Criterion | Reported Device Performance | Source of Performance Data |
|---|---|---|
| Functional & Performance Specifications | ||
| Vacuum Range: Massage Mode | -40 to -160 (±5) mmHg | Performance Testing (Vacuum level verification) |
| Vacuum Range: Expression Mode | -120 to -245 (±5) mmHg | Performance Testing (Vacuum level verification) |
| Vacuum Range: Cluster Feeding Mode | -40 to -200 (±5) mmHg | Performance Testing (Vacuum level verification) |
| Vacuum Range: General Pumping Mode | -60 to -245 (±5) mmHg | Performance Testing (Vacuum level verification) |
| Cycle Speed: Massage Mode | 75 to 120 (±2) cycles/minute | Performance Testing (Vacuum level verification) |
| Cycle Speed: Expression Mode | 30 to 85 (±2) cycles/minute | Performance Testing (Vacuum level verification) |
| Cycle Speed: Cluster Feeding Mode | 45 to 120 (±2) cycles/minute | Performance Testing (Vacuum level verification) |
| Cycle Speed: General Pumping Mode | 30 to 120 (±2) cycles/minute | Performance Testing (Vacuum level verification) |
| Backflow Protection | Verified liquid does not backflow into the tubing | Performance Testing (Backflow protection testing) |
| Use Life | Maintains specifications throughout its proposed use life | Performance Testing (Use life testing) |
| Battery Performance | Battery remains functional during its stated battery use-life | Performance Testing (Battery performance testing) |
| Battery Status Indicator | Remains functional during its stated battery life | Performance Testing (Battery status indicator testing) |
| Software Functionality | Evaluated at Basic Documentation level; Device motor unit operates on embedded software; Software updates by end-users are not supported. | Software Evaluation |
| Safety and Regulatory Compliance | ||
| Biocompatibility | Information provided in accordance with ISO 10993-1 | Biocompatibility testing |
| Electrical Safety | Tested in accordance with: ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, IEC 60601-1-11:2015 | Electrical Safety testing |
| Electromagnetic Compatibility (EMC) | Tested in accordance with: IEC 60601-1-2:2014 | EMC testing |
| Sterility | Provided not sterile | Device Description |
| Milk-contacting components compliance | Compliant with 21 CFR 174-179 | Device Description |
| Single-user intention | Intended for a single user | Indications for Use & Device Description |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample sizes for the individual performance, safety, or biocompatibility tests. It only states that "Testing was conducted" and "Performance testing was conducted." For a physical device like a breast pump, "test set" typically refers to the number of units tested. This information is not detailed in the summary letter.
- Data Provenance: The manufacturer is "Shenzhen TPH Technology Co., Ltd." in Shenzhen, Guangdong, China. The testing was conducted as part of their 510(k) submission to the US FDA. The document does not specify whether the tests themselves were conducted in China or elsewhere, nor whether they were retrospective or prospective studies (this concept mostly applies to clinical data collection, which is not detailed here for this device type).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable (N/A): For a breast pump, there isn't a concept of "ground truth" established by experts in the same way as for a diagnostic AI device (e.g., radiologists interpreting images). The acceptance criteria are based on engineering specifications, safety standards, and functional performance. The "ground truth" is typically defined by the device's design specifications and industry standards, verified through objective measurements and validated test methods.
4. Adjudication Method for the Test Set
- N/A: As "ground truth" from human experts is not established for this device type, there is no adjudication method among experts. Performance is measured against predefined objective standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: An MRMC comparative effectiveness study is typically conducted for diagnostic devices (especially AI-powered ones) to assess the impact of the device on human reader performance. This is a physical breast pump, not a diagnostic device, so such a study is not applicable.
6. If a Standalone Performance Study (Algorithm Only) was done
- Yes, in essence. The performance testing (e.g., vacuum level verification, cycle speed, backflow protection, battery life) are "standalone" tests of the device's inherent functional capabilities against its specifications. The software evaluation was also a standalone assessment of the embedded control program. There isn't an "algorithm-only" performance in the sense of an AI model's output being compared to ground truth, but the physical and software functionalities were tested independently of human interaction for their core performance.
7. The Type of Ground Truth Used
- Objective Engineering Specifications and International/National Standards: The "ground truth" for this device's performance acceptance is based on its own design specifications (e.g., stated vacuum ranges and cycle speeds), and adherence to recognized electrical safety (e.g., IEC 60601 series), EMC, and biocompatibility (e.g., ISO 10993-1) standards. For instance, a stated vacuum level of -160 mmHg is verified by direct measurement using calibrated equipment; the "ground truth" is the measurement itself, compared to the specification.
8. The Sample Size for the Training Set
- N/A: This is a physical breast pump with embedded control software, not a machine learning/AI model that requires a "training set" of data in the common sense (e.g., for image classification or prediction). The software is a "fixed function" embedded control program.
9. How the Ground Truth for the Training Set was Established
- N/A: As there is no "training set" in the context of machine learning, this question does not apply. The "ground truth" for the device's design and functionality is derived from engineering principles and regulatory requirements for powered breast pumps.
§ 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).