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The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets.

The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

The DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, non-pyrogenic, syringe that is designed for use with all versions of the DANA Diabcare® Insulin pump that have been cleared for marketing in the U.S. (K001604, K022317, and K063126). The syringe reservoir is a 3 ml polypropylene syringe with a 300 unit insulin capacity that is supplied with a 22 gauge, 12.7 mm straight needle. The reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for entrapped air, the needle is removed and the syringe reservoir is inserted into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin pump. The syringe has groves cut into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin Pump.

The proposed DANA 3cc Syringe Insulin Reservoir is a modification of the insulin reservoir accessory described in K001604, the original 510(k) premarket notification for the DANA Diabecare® Insulin Pump. The modification was limited to a change in the gasket configuration and material. The proposed DANA 3cc Syringe Insulin Reservoir has a ring shape gasket that is manufactured from silicone.

The provided text describes a 510(k) submission for the DANA 3cc Syringe Insulin Reservoir, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly detail specific, quantified acceptance criteria or a comprehensive study report with detailed methodologies and results as one might expect from a formal performance study section.

Based on the provided information, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantified acceptance criteria with pass/fail thresholds for specific performance metrics. Instead, it broadly states that "Design verification activities... included evaluation of physical and functional characteristics, and shelf-life testing. The results confirm that the DANA 3cc Syringe Insulin Reservoir showing to may insulin reservoir for all legally marketed versions of the DANA Diabecare® Insulin Pumps and support the claimed shelf life."

This indicates that the device met internal performance standards, but those specific standards and their numerical results are not provided in this summary. The "Comparison Chart for Determination of Substantial Equivalence" focuses on shared design features rather than performance metrics.

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

The document does not provide specific details on the sample sizes used for the design verification tests (physical, functional, shelf-life). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The tests were conducted internally by Sooil Development Co., Ltd. as part of their "Design verification activities."

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

This type of information is not applicable and not provided in the context of this device. The "ground truth" for an insulin reservoir's performance would typically be established through engineering tests measuring physical and functional attributes against predefined specifications, rather than expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment where discrepancies need resolution, such as in image analysis or clinical trials. Performance testing for a medical device like an insulin reservoir involves objective measurements, not human adjudication of subjective data.

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

No. An MRMC study is not relevant for this type of device. MRMC studies are used to evaluate the diagnostic performance of human readers (e.g., radiologists) in interpreting medical images, often comparing performance with and without AI assistance. This device is an insulin reservoir, not a diagnostic imaging AI.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a "standalone" performance evaluation was conducted in the sense that the device's physical and functional characteristics were tested independently. The "Design verification activities" were focused on the device itself. While the device is an accessory intended for human use with an insulin pump, the performance reported here is of the reservoir itself, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing would be established by predefined engineering specifications, design requirements, and recognized industry standards for insulin delivery devices and sterile medical components. For example, a "ground truth" for capacity would be 300 units as measured by calibrated equipment, or for sterility, it would be the absence of microbial growth as per validated sterilization methods.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (an insulin reservoir), not an AI algorithm or a diagnostic tool that requires a "training set" of data in the machine learning sense.

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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