(257 days)
The Lansinoh® Signature Pro™ Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
The Lansinoh® Smartpump™M Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
The Lansinoh Powered Breast Pumps are intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.
The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.
This document describes the premarket notification (510(k)) for the Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2). The purpose of this submission is to update the indications for use to include multiple users, leveraging the previously cleared Lansinoh Double Electric Breast Pump (K122474) as the predicate.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds in the typical sense for a diagnostic AI device. Instead, it focuses on demonstrating that the new devices' performance characteristics are similar to or do not raise new questions of safety and effectiveness compared to the predicate device, especially considering the expanded "multiple user" indication. The performance data presented are primarily focused on hardware and safety aspects of the breast pump, not an AI or diagnostic algorithm.
However, we can infer some criteria and reported performance from the "Device Comparison Table" and "Performance Data" sections:
| Feature/Test | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| Primary Indication for Use | Be intended to express and collect breastmilk for feeding to a baby. (No new questions of safety/effectiveness compared to predicate, despite "multiple user" inclusion). | The Lansinoh® Signature Pro™ and Smartpump™ are intended to express and collect breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users. (Different from predicate in that it allows multiple users, but this difference does not alter the intended use or raise different questions of safety/effectiveness). |
| Suction Levels (Stimulation) | Within a clinically acceptable and safe range (Predicate: 55-140 mmHg). | 46-140 mmHg. (Similar; slightly lower suction level but does not raise different questions of safety and effectiveness). |
| Cycles per Second (Stimulation) | Within a clinically acceptable and safe range (Predicate: 1.55-2.4). | 1.61-2.33. (Similar; slightly different cycle rates but does not raise different questions of safety and effectiveness). |
| Suction Levels (Expression) | Within a clinically acceptable and safe range (Predicate: 80-220 mmHg). | 95-280 mmHg. (Different; higher pressure levels for expression than the predicate, but this difference does not raise different questions of safety and effectiveness). |
| Cycles per Second (Expression) | Within a clinically acceptable and safe range (Predicate: 0.61-1.52). | 0.58-1.69. (Similar; slightly different cycle rate but does not raise different questions of safety and effectiveness). |
| Suction Settings | Same as predicate (8). | 8. (Same) |
| Expression Modes | Same as predicate (3). | 3. (Same) |
| Power Supply | Same as predicate (6 AA batteries, AC adapter). | a) 6 AA alkaline batteries b) AC Adapter. (Same) |
| Pumping Option | Same as predicate (Single or Double). | Single or Double. (Same) |
| Back Flow Protection | Presence and effectiveness in preventing milk from entering tubing/pump. (Yes). | Yes. (Same). Demonstrated at maximum pressure/cycle settings (Expression Mode 3, Level 8) and various orientations, no milk was present in tubing, confirming diaphragm prevents backflow. |
| Let Down Function | Presence. (Yes). | Yes. (Same) |
| Cycling/Suction Control Mechanism | Same as predicate (Microprocessor). | Microprocessor. (Same) |
| Communication with mobile app (Smartpump only) | No alteration of intended use or new questions of safety/effectiveness (N/A for predicate). | Bluetooth. (Different; SmartPump has Bluetooth capability, but this does not alter the intended use or raise different questions of safety and effectiveness). |
| Bench Performance (Suction Curves) | Meets specifications and performs within specified working ranges of pressure and cycle speed for each mode/level. | Demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level. |
| Battery Life | Meets specified battery life (approx. 90 minutes). | Approximately 90 minutes at the highest level (Expression Mode 3, Level 8). |
| Cleaning | Instructions provided for reusable, non-sterile device. | Cleaning instructions are provided in the labeling. |
| Shelf-life | Not applicable due to low degradation likelihood; expected use-life of 500 hours (per IEC 60601-1:2005/(R)2012). | Demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting. |
| Biocompatibility | Patient-contacting materials meet FDA's Food Additive criteria (21 CFR 175-179) and are equivalent to predicate (K122474). | No changes to patient-contacting materials since previous clearance (K122474). All milk-contacting components tested to meet FDA's Food Additive criteria. (Leverages K122474 data). |
| Electrical Safety & EMC | Meets applicable test limits per ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2007. | Demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards. |
| Software Function (if applicable) | Functions as intended, consistent with a minor level of concern (per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005). | Documentation consistent with a minor level of concern demonstrated the software functions as intended. |
| Cybersecurity (if applicable) | Appropriate mitigations implemented based on device risk level. | Evaluated through a risk-based approach; appropriate mitigations implemented based upon the level of risk of the devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes various performance tests, but it does not specify exact sample sizes (e.g., number of units tested) for each. For example:
- Bench Performance (Suction Curves, Battery Life, Backflow Test, Shelf-Life): "Devices were evaluated," "Devices were tested." No specific number of devices is mentioned.
- Biocompatibility: Leveraged data from K122474, implying no new testing sample for this submission. The materials are the same.
- Electrical Safety and EMC: "The device was tested." No specific number of devices is mentioned.
- Software and Cybersecurity: "The software was evaluated," "Cybersecurity for the subject devices was evaluated."
Data Provenance: The tests appear to be conducted by the manufacturer, Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti., which is based in Turkey. The studies mentioned (Bench Performance, Battery Life, Backflow Test, Shelf-Life, Electrical Safety, EMC, Software, Cybersecurity) are retrospective relative to the submission date, as they were completed to support the 510(k). They are engineering/performance verification tests conducted in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the device is a breast pump, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is determined by engineering specifications and objective measurements (e.g., pressure, cycle rates, battery life, absence of milk in tubing).
4. Adjudication Method for the Test Set:
This information is not applicable as the device is a breast pump. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for diagnostic devices where human experts disagree on interpretations (ground truth). The performance tests described are objective engineering measurements.
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:
This information is not applicable. The device is a breast pump and does not involve AI assistance for human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable. The device is a breast pump. While it has a microprocessor and software, it's not an "algorithm" in the diagnostic AI sense, and its performance is about mechanical function, not diagnostic accuracy.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests is based on:
- Engineering Specifications: Defined parameters for suction levels, cycle rates, battery life, etc.
- Objective Measurements: Using testing equipment to measure pressure, time, and physical presence of milk (for backflow).
- Industry Standards: Compliance with standards like ANSI/AAMI ES60601-1:2005/(R)2012 for electrical safety and IEC 60601-1-2:2007 for EMC.
- FDA Regulations: Compliance of patient-contacting materials with FDA's Food Additive criteria (21 CFR 175-179).
- Prior Clearance Data (K122474): For biocompatibility, the ground truth established for the predicate device was leveraged.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI or machine learning device requiring a training set. The software mentioned is likely embedded control software for the pump's operation, not a learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set mentioned or implied 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).