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The Electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It is intended for a single user.

The Electric breast pump is a single-patient reusable device, intended to be used by lactating women to express and collect milk from their breasts. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The Electric breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure. The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery. Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).

This document is a 510(k) Premarket Notification summary for an Electric Breast Pump, specifically models RH-228 and RH-338. It details the device's characteristics and the testing performed to demonstrate its substantial equivalence to a predicate device (Youha electric breast pump, Model YH-8006IV, K163136).

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with recognized consensus standards and meeting pre-defined specifications through performance testing. The document heavily relies on the concept of "substantial equivalence" to a predicate device, meaning the new device performs at least as safely and effectively as a legally marketed device.

• IEC 60601-1:2005+A1:2012 (General requirements for basic safety & essential performance)
• IEC 60601-1-11:2015 (Home healthcare environment)
• IEC 60601-1-2:2014 (Electromagnetic Compatibility) | Tests Conducted:
• Electrical Safety and Electromagnetic Compatibility: Specifically mentioned compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2. The implication is that the device met the requirements of these standards. |
  | Battery Safety | Compliance with IEC 62133:2012 (Secondary cells and batteries safety requirements) | Tests Conducted:
• Battery Performance Testing: Conducted to demonstrate the battery remains functional during its stated use-life.
• Battery Status Indicator Testing: Conducted to demonstrate the indicator remains functional during its stated battery life.
• Compliance with IEC 62133 for battery safety. The implication is that the battery met the requirements of these standards and performed as specified. |
  | Biocompatibility | Compliance with FDA guidance "Use of International Standard ISO-10993" (Part 1, 5, 10) | Tests Conducted:
• Cytotoxicity (ISO 10993-5:2009)
• Sensitization (ISO 10993-10:2010)
• Irritation (ISO 10993-10:2010)
  Result: "The user-contacting materials were shown to be biocompatible." |
  | Software Verification | Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) | Tests Conducted: Software verification and validation. The implication is that the software met the requirements of the guidance. |
  | Performance (Vacuum & Cycle Rate) | Device meets its own specifications for vacuum pressure and cycle rate at all settings. | Tests Conducted: "Vacuum pressure and cycle rate testing was conducted at all settings for each device model and demonstrated that the devices met their specifications." |
  | Performance (Backflow) | Liquid does not backflow into the tubing/pump. | Tests Conducted: "Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump." The implication is that the device prevented backflow. |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify sample sizes for performance testing (e.g., how many units were tested for vacuum pressure or backflow). It also does not discuss data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that "Non-clinical tests were conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This document describes non-clinical performance and safety testing directly against technical standards and specifications, not clinical studies involving human observers or "ground truth" derived from expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical testing against technical specifications, not human adjudication of results.

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 document is for an electric breast pump, a mechanical device, and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is not an algorithm, so standalone AI performance is not relevant.

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

The "ground truth" for this device's testing is primarily established engineering and medical device standards (e.g., IEC 60601 series, ISO 10993 series) and the device's own pre-defined design specifications (e.g., target vacuum pressure ranges, specific cycle rates). For biocompatibility, it's the biological response as defined by the ISO 10993 standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require 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.

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