Compact Wearable Pump

• K Number: K230469
• Device Name: Compact Wearable Pump
• Manufacturer: Lansinoh Laboratories
• Date Cleared: 2023-06-30 ( 129 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: K222726
• Predicate For: N/A

Intended Use

The Compact Wearable Pump is intended to express and collect breastmilk from lactating women for the purpose of feeding collected breastmilk to a baby. The Compact Wearable Pump is intended for a single user.

Device Description

The Compact Wearable Pump is a battery-powered breast pump which consists of the following components: pump body, breast flange, flange insert, diaphragm, manifold disk, collection cup, charging cord, and carrying bag. The subject device is capable of single pumping (using both packaged pumps independently). It is provided non-sterile and can be re-used by a single user. It does not incorporate off-theshelf (OTS) software or wireless technology/mobile app software functionality. The subject device cannot be operated while plugged into AC power. The Compact Wearable Pump is designed to work in a user's bra. The main body includes a press-button user interface, pump body, and LED indicator lights. The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Stimulation mode consists of 8 vacuum levels and fixed cycle speeds when used. Expression mode includes 8 vacuum levels with three different cycle speed configurations that vary duration between suction and let down for further customization by the user. The Compact Wearable Pump is capable of providing vacuum levels from 36-159 mmHg with cycling rates of 1.67-3.04 cycles per second in stimulation mode and vacuum levels from 78-280 mmHg with cycling rates from 0.53-1.99 cycles per second dependent on which expression mode is used. The Compact Wearable Pump is charged with a 5 V DC USB type C adaptor and powered by a 3.8 V, 1300mAh internal rechargeable lithium-ion battery. The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to 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) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

AI/ML Overview

This document is a 510(k) summary for a breast pump, which is a medical device. As such, the acceptance criteria and study described are not typical of AI/ML-driven devices. There is no AI involved, no human readers, no ground truth established by experts for image interpretation, and no training set. The acceptance criteria relate to the physical and electrical performance of the breast pump, as well as its biocompatibility.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria Category	Reported Device Performance (Summary)
   Biocompatibility	- Cytotoxicity: Non-cytotoxic (according to ISO 10993-5:2009)
   	- Sensitization: Non-sensitizing (according to ISO 10993-10:2010)
   	- Irritation: Non-irritating (according to ISO 10993-10:2010)
   Electrical Safety	- Compliant with ANSI/AAMI ES60601-1:2005/A2:2010
   	- Compliant with IEC 62133-2:2017 (for Lithium systems)
   	- Compliant with IEC 60601-1-11:2015 (for home healthcare environment)
   Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2:2014
   Software	Evaluated for moderate level of concern as per FDA guidance (2005)
   Performance Testing	- Vacuum levels: Verified to meet mode/cycle specifications (36-159 mmHg stimulation, 78-280 mmHg expression)
   	- Backflow protection: Verified that liquid does not backflow into tubing
   	- Use life: Demonstrated that the device maintains specifications throughout its proposed use life
   	- Battery performance: Demonstrated battery remains functional during its stated use-life
   	- Battery status indicator: Demonstrated indicator remains functional during stated battery life
   Milk-contacting components	Compliant with 21 CFR 174-179

2. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to a device that undergoes physical and electrical testing.
   • For biocompatibility, electrical safety, EMC, and performance testing, the "samples" would typically be a statistical number of physical devices or components of the device tested in a laboratory setting to ensure manufacturing consistency and adherence to specifications. The exact number of devices or components is not mentioned, but it would be determined by standard engineering and quality assurance practices for medical device manufacturing.
   • There is no mention of geographical origin or retrospective/prospective nature of data as this is physical device testing, not data collection from a population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the device is a physical breast pump, not an AI/ML diagnostic tool requiring expert consensus for ground truth. The "ground truth" here is adherence to technical standards and specifications, which is verified by engineering and laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic or prognostic studies, which is not the case here. Testing involves objective measurements and comparisons against predefined standards.

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:

   • Not applicable. This device is not an AI-assisted diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is not an algorithm or software-only product. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device is based on pre-defined technical specifications, international standards (ISO, IEC, ANSI/AAMI), and FDA regulations (e.g., 21 CFR). For example:
     • Biocompatibility: Ground truth is defined by the absence of cytotoxicity, irritation, and sensitization as determined by testing according to ISO 10993.
     • Electrical Safety & EMC: Ground truth is compliance with specified clauses and limits in IEC and ANSI/AAMI standards.
     • Performance (Vacuum levels, backflow protection, battery life): Ground truth is the device meeting its own design specifications (e.g., vacuum ranges, cycle rates, functional battery life) and demonstrating the intended mechanical and electrical functions without failure.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Regulation Number and Section

§ 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).