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Enteral Feeding Bag and Set is intended to delivery, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).

The proposed device, Enteral Feeding Bag and Set, has two models: one is enteral feeding set integrated with bag, the other is an individual enteral feeding set with a puncture needle which can be used along with other pre-filled formula container. Other components include: Roller Clamp, which is used to adjust the feeding rate; Tubings, which are used to connected components; Drip Chamber, which is intended for the user to observe the feeding condition; Echelon Fitting, which is a non-luer fitting, to connect Enteral Access Device. This fitting is provided to avoid mis-connection with I.V. devices.

This submission describes an Enteral Feeding Bag and Set, a Class II medical device, intended to deliver liquid nutrition formulas via a feeding pump to an enteral access device. The submission focuses on demonstrating substantial equivalence to a predicate device, Hospira Enteral Feeding Sets (K061432).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific acceptance criteria as quantitative targets (e.g., flow rate must be X +/- Y%). Instead, it states that "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This suggests that the acceptance criteria were based on meeting internal design specifications and demonstrating performance comparable to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Laboratory testing".

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

The document states "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications..." However, it does not specify the sample size used for this testing. The data's provenance is from the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, located in Weihai City, Shangdong, China. The testing would have been prospective, as it was conducted to validate the new device.

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

This information is not applicable to this type of device submission. The "ground truth" for an enteral feeding bag and set is typically established through engineering specifications, international standards (e.g., ISO standards for medical devices), and comparison with the performance of a legally marketed predicate device. It does not involve expert interpretation of medical images or clinical data in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical cases (e.g., for diagnostic accuracy). The laboratory testing for this device would have involved objective measurements against specifications rather than subjective expert consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is being evaluated. For an enteral feeding set, the comparison is primarily based on functional performance against a predicate device and engineering specifications.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is not an algorithm or an AI system. The testing performed was on the physical medical device itself.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance was established by:

• Engineering Design Specifications: The device was tested to ensure it met its own predetermined design specifications.
• Performance of the Predicate Device: The device was tested to demonstrate "substantial equivalence" to the legally marketed predicate device (Hospira Enteral Feeding Sets, K061432). This implies that the predicate device's established performance served as a benchmark for acceptable "ground truth" performance.
• Compliance with relevant standards (deduced): Although not explicitly stated as "ground truth," medical devices like this typically adhere to various international and national standards (e.g., ISO standards for medical devices, biocompatibility standards), which would form part of the underlying "ground truth" for safety and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical product, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

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