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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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The Kawasumi Multiple Sample Adapter with Pr-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, singleuse device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. As this device can be connected to various devices with female luer adapter, it is called "multiple sample adapter".

When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow. After obtaining the correct amount of blood, the blood collection tube is removed from the holder. When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow. Blood collection may be continued by connecting additional blood collection tubes, if required.

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

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, based on the requested information.

It's important to note that this document is a 510(k) summary for a medical device (blood specimen collection adapter), not an AI/ML software device. Therefore, many of the typical questions for an AI/ML device, such as those related to AI model training, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. The 'device' here refers to a physical, non-digital product.

Acceptance Criteria and Study Proving Device Performance

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct "acceptance criteria" table with specific quantitative limits for each test. Instead, it describes various performance tests conducted to demonstrate substantial equivalence (SE) to a predicate device. The general acceptance criterion for all tests is "meets design requirements and specifications" and "confirm performance," ultimately aiming to show comparable function and performance to the predicate device, thereby demonstrating substantial equivalence in terms of safety and effectiveness.

Here's an interpretation based on the "Non-Clinical Testing" section and "Technological Characteristics" comparison, outlining the tests performed to demonstrate that the device meets its design requirements and is substantially equivalent:

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of devices) used for each individual test. It lists the types of tests performed. For physical device testing, sample sizes are typically determined by relevant ISO standards or internal quality protocols.
• Data Provenance: The document does not specify the country of origin of the data. Given the "Kawasumi Laboratories, Inc." address in Tokyo, Japan, it is highly likely that testing was performed by or for the manufacturer, potentially in Japan or at contract labs globally.
• Retrospective or Prospective: These are non-clinical, controlled laboratory tests on manufactured devices, so the terms "retrospective" or "prospective" as they apply to clinical studies or real-world data collection are not applicable.

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

• This is a review of a physical medical device. The "ground truth" is established through engineering and laboratory testing against established physical, chemical, and biological standards (e.g., ISO, USP, ASTM). It does not involve human expert interpretation of data in the way an AI/ML device would. Therefore, the concept of "experts establishing ground truth" in this context is not applicable.

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

• Not applicable for a physical device undergoing laboratory testing. This concept is relevant for human interpretation tasks, often in AI/ML performance evaluations.

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 is a physical blood collection device, not an AI/ML radiology or diagnostic aid. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance.

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

• Not applicable. This is not an algorithm or software device.

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

• The "ground truth" for this device's performance is defined by adherence to established international standards (ISO, ASTM, USP) for physical properties, chemical properties, sterility, biocompatibility, and functional performance of medical devices. The predicate device's performance also serves as a benchmark for comparative testing to demonstrate equivalence.

8. The sample size for the training set:

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

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

• Not applicable. As above, there is no "training set" for a physical medical device.

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