(30 days)
The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
The Rumble Tuff electrically powered breast pumps (models PA219DM and PA210DM) are intended for multi-user use to extract milk from lactating breasts. The PA209DM model is powered by a 9V AC/DC Power Adaptor and/or built-in 7.4V Li-lon battery. The PA210DM model is powered by a 12V AC/DC Power Adaptor and does not have a batter powered option. Pumping can be performed on one breast (single pumping) or on both breasts (double pumping). The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontrolled DC electric motor. The controlling program consists of 3 phases of speed control (Reflex, Swift, and Natural) and various suction settings. The subject devices utilize an LCD screen as a user interface. All patient-contacting and breast milk-contacting materials are identical to the predicate device.
This document is a 510(k) Premarket Notification for a Rumble Tuff Electric Breast Pump (models PA209DM and PA210DM). It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (Rumble Tuff Electric Breast Pump K113315).
Let's break down the information to address your specific points about acceptance criteria and the study proving the device meets them.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel AI/software medical device. Therefore, many of your requested points regarding AI/algorithm performance, ground truth establishment, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a breast pump.
Instead, the "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate, and that any technological differences do not raise new questions of safety or effectiveness. The "study" proving this largely relies on non-clinical tests comparing the new devices to the predicate and compliance with relevant voluntary standards.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical device (breast pump), the "acceptance criteria" are primarily related to meeting performance specifications similar to the predicate and complying with relevant safety and performance standards. There isn't a table of specific AI algorithm acceptance criteria and reported AI performance as one might expect for a software-as-a-medical-device (SaMD) submission.
However, we can infer some comparative performance points:
| Acceptance Criteria (Inferred from Predicate Comparison & Standards) | Reported Device Performance (Rumble Tuff PA209DM, PA210DM) |
|---|---|
| Intended Use (Equivalent to predicate) | "The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user." (Expanded use compared to predicate's "home use" only) |
| Environmental Use (Equivalent or expanded to predicate) | Hospital, Home (Expanded from predicate's "Home" only) |
| Vacuum Range (Comparable to predicate) | 75 – 250 mmHg (Predicate: 85 – 250 mmHg, showing comparable range) |
| Detailed breakdown for new devices: | |
| AC/DC Adaptor: Reflex (80-211 mmHg), Swift (80-176 mmHg), Natural (81-247 mmHg) | |
| Battery (PA209DM): Reflex (78-206 mmHg), Swift (80-172 mmHg), Natural (79-242 mmHg) | |
| Cycle Speed (Comparable to predicate) | Reflex: 20 cycles in 15 seconds |
| Swift: 82 – 115 cycles/min | |
| Natural: 30 – 76 cycles/min (Predicate: Stimulation mode: 168-100 cycles/min, Expression mode: 42-74 cycles/min, showing comparable functionality despite different modes) | |
| Backflow Protection (Equivalent to predicate) | Silicone Diaphragm (Same as predicate) |
| Material in Contact with User's Body (Equivalent to predicate) | Polypropylene for Breast shield; Silicone for Breast shield cover (Same as predicate) |
| Electrical Safety (Compliance with IEC 60601-1) | Compliance demonstrated. |
| Electromagnetic Compatibility (Compliance with IEC 60601-1-2) | Compliance demonstrated. |
| Safety for Home Setting (Compliance with IEC 60601-1-11) | Compliance demonstrated. |
| Software Verification and Validation (Compliance with FDA guidance) | Compliance demonstrated. |
| Backflow Protection Performance | Testing performed. |
| Vacuum Performance | Testing performed. |
| Use Life | Testing performed. |
| Risk Management (Compliance with EN ISO 14971) | Compliance demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in the context of a clinical test set with human subjects for performance evaluation like an AI model would have. For physical devices, "testing" usually refers to bench testing, engineering validation, and compliance verification. The tests listed are non-clinical (e.g., electrical safety, vacuum performance, use life).
- Data Provenance: Not applicable in the context of clinical data for an AI/algorithm system. The "data" here would be test results from physical device measurements. No explicit mention of country of origin or retrospective/prospective for these non-clinical tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This submission does not involve AI model performance evaluation requiring expert-established ground truth from medical images or clinical data. The tests are for the physical and functional aspects of a breast pump.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication process described as it's not a clinical study involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a breast pump, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical breast pump. While it has a "microcontrolled DC electric motor" and a "controlling program," the submission focuses on its overall functional safety and equivalence, not on the standalone performance of its internal software/algorithm in the way one would evaluate a diagnostic AI.
7. The Type of Ground Truth Used
- Not applicable / Engineering and Regulatory Standards. The "ground truth" for this device's performance would be defined by engineering specifications, validated test methods, and compliance with the limits set by voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). For comparison to the predicate, the predicate's established performance serves as a reference.
8. The Sample Size for the Training Set
- Not applicable. This refers to machine learning models. This document describes a physical medical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This refers to machine learning models.
Summary of the "Study that Proves the Device Meets the Acceptance Criteria"
The "study" in this context is a series of non-clinical tests and demonstrations of compliance with voluntary standards that support the claim of substantial equivalence.
These include:
- Risk Analysis: Developed in accordance with EN ISO 14971:2012.
- Electrical Safety Testing: In accordance with IEC 60601-1:2005-1:2005+CORR.2.2007+AM1:2012.
- Electromagnetic Compatibility Testing (EMC): In accordance with IEC 60601-1-2:2014.
- Safety Testing for Home Setting Use: In accordance with IEC 60601-1-11:2015.
- Software Verification and Validation Testing: Adhering to FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Backflow Protection Testing
- Vacuum Performance Testing
- Use Life Testing
The conclusion (Section 8) explicitly states: "The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence." This statement is the qualitative proof that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.
§ 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).