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Female luer type
· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood collection tube or blood culture bottle.

Male luer type
· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

The Kawasumi Multiple Sample Adapter with Pre-attached Holder (MBCH) is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a luer adapter. There are two types of the device with difference in luer adapter type; male luer adapter type and female luer adapter type. The predicate device (K190485) is the male luer type and the proposed device is the female luer type, and the subject of this special 510(k) premarket notification submission.

• The male luer adapter type is used to collect blood specimen into blood collection tube by . connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. (predicate [Item number MBCH-01])
• The female luer adapter type is used to transfer blood from a syringe into blood collection tube . or blood culture bottle. After drawing patient blood into a syringe, connect the female luer adapter of the device to the syringe. When inserting a tube, the blood is transferred into the tube using tube's vacuum. (subject [Item number MBCH-02])

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

The provided text describes a 510(k) summary for the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH), specifically focusing on the newly introduced female luer type (MBCH-02) and comparing it to the legally marketed male luer type (MBCH-01) as the predicate device. The information details the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices tested) for each non-clinical test. The testing is described as "Non-Clinical Performance Testing," suggesting laboratory-based assessments rather than clinical studies with patient data. Therefore, there is no information on data provenance in terms of country of origin or retrospective/prospective nature.

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 to the provided document. The device is a blood specimen collection device, and the testing described is non-clinical performance testing against established standards (e.g., ISO, USP, ASTM, IEC). There is no mention of experts establishing a "ground truth" related to medical diagnosis or interpretation for this type of device and testing.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts evaluate cases to establish a consensus-based ground truth. The presented tests are objective, laboratory-based performance assessments.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the Kawasumi Multiple Sample Adapter.

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 physical medical instrument (blood specimen collection adapter), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests is defined by the referenced industry standards and in-house specifications (e.g., ISO 80369-7:2021 for luer connectors, USP for particulate contamination). The device's performance is measured against the criteria established in these standards.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML model 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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