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For use with Medrad Mark II, III,and IV Angiographic Injectors.

The Coeur syringe is a six piece device (plunger jacket, barrel, retainer, dust cap, fill tube) which is used in conjunction with power injectors to inject diagnostic fluids associated with angiographic procedures. In particular, the plunger jacket acts as the seal when the plunger is moved to aspirate or inject the contrast media solution. This premarket notification describes the modification to the Coeur syringe, which is a material change to the plunger jacket. The new material Coeur intends to use for the plunger jacket is chlorobutyl.

This document is a 510(k) summary for a medical device submitted to the FDA, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the same way a new drug or novel medical device might.

Based on the provided text, the acceptance criteria and study information are quite limited, as the submission focuses on a material modification to an existing device (changing the plunger jacket material from natural rubber to chlorobutyl). The performance evaluation is primarily comparative to the original device.

Here's an attempt to extract and interpret the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "Pre-production testing" and "the test product," but does not specify the number of syringes or tests conducted.
• Data Provenance: Not explicitly stated, but implied to be internal testing conducted by Coeur Laboratories, Inc. (the manufacturer). This would be considered retrospective testing of internal manufacturing and material changes. There is no mention of country of origin for the data, but the company is based in Raleigh, NC, USA.

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

• Not applicable/Not mentioned. This type of submission (material change to a syringe) does not typically involve expert consensus to establish "ground truth" in the way clinical diagnostic devices do. The "truth" is established by adherence to functional and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, which is not the focus here. The performance was assessed against predefined functional and biocompatibility criteria.

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

• No. This type of study is not relevant for a material change to a syringe. MRMC studies are used for diagnostic accuracy involving human readers interpreting images or data.

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

• No. This is a physical medical device (syringe), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering and biocompatibility standards and benchmarks, specifically comparing the chlorobutyl material's performance to the previously used natural rubber, and ensuring it meets established functional requirements for angiographic syringes, along with acceptable biocompatibility profiles according to recognized tests. This is a conformance to specifications approach rather than a diagnostic "ground truth."

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.

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

• Not applicable/Not mentioned. See point 8.

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