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The Kawasumi Laboratories Empty Solution Container is a sterile, single use device used as a reservoir for the purpose of administering solution to a patient. The Empty Solution Container is filled with the desired solution(s) commonly used in hospitals. After use, the bag is discarded.

The device comprises of a plastic bag with an entry port used for the introduction of solution(s) into the bag and two ports for accessing the bag with a solution administration set

The Kawasumi Laboratories Empty Solution Container is a Class II device (product code KPE) intended as a sterile, single-use reservoir for administering solutions to patients in a hospital setting. The device is a plastic bag with an entry port for introducing solutions and two ports for accessing the bag with a solution administration set.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated. The submission mentions "biocompatibility tests" and "pyrogenicity test requirements" were conducted, implying testing on representative device samples, but the specific number of units tested is not provided.
• Data Provenance: The studies were conducted by Kawasumi Laboratories. Given the company's location (3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan), the testing was likely conducted in Japan, or under their supervision, to comply with regulatory requirements for their market submission to the FDA in the US. The data is retrospective relative to the submission date.

3. Number of Experts and Qualifications for Ground Truth

• This device is a physical medical device, not a diagnostic algorithm. The "ground truth" for its performance is established through standard laboratory and material science testing protocols rather than expert clinical review. Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

• Not applicable. As stated above, this device's performance is verified through laboratory testing, not through expert consensus or adjudication of diagnostic findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a physical medical device (an empty solution container), not an AI/algorithm-based diagnostic tool. Therefore, an MRMC study is not applicable.

6. Standalone Performance Study

• Yes, implicitly. The biocompatibility and pyrogenicity tests, along with the assessment of performance and technological characteristics, represent standalone performance evaluation of the device itself. The objective was to demonstrate that the device, on its own, meets safety and functional requirements and is substantially equivalent to a predicate device.

7. Type of Ground Truth Used

• Standardized Laboratory Testing and Material Science Data: The "ground truth" for this device's safety and performance is based on the results of validated biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) and pyrogenicity tests, conducted according to established international or national standards for medical devices. The functional "ground truth" is based on the device's ability to safely hold and facilitate the administration of solutions, as demonstrated by its "performance characteristics" (e.g., integrity, leak resistance – implied by the claim of no new characteristics compared to the predicate).

8. Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question is irrelevant to the device.

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