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The DUPLOREACH Extended Applicator, in conjunction with the DUPLOJECT Double-Barreled Syringe Applicator Device, is intended for the mixing and delivery of TISSEEL VH Fibrin Sealant.

The DUPLOREACH Extended Applicator, which consists of a stainless steel encased dual-lumen cannula that attaches to the DUPLOJECT Double-Barreled Syringe Applicator device via two screw-on leur style connectors, is used for the delivery of TISSEEL Fibrin Sealant in hard to reach locations. The Extended Applicator is equipped with a replaceable tip that is attached via a sliding lock mechanism, ensuring the tip does not detach during use. A trigger mechanism on the body of the device locks and unlocks the tip. A window above the trigger provides the user with a clear indication when the tip is in the fully locked position. Two replacement spray tips are supplied with each Extended Applicator device. The primary changes from the predicate device are the adaptations necessary to allow the DUPLOREACH Extended Applicator to be used with the DUPLOJECT applicator device and the extension of the dual-lumen cannula before the mixing chamber. Other minor modifications were made to either support these primary changes or to enhance the functionality of the device. No modifications were made to the DUPLOJECT device to accommodate the DUPLOREACH Extended Applicator. The modified device has been shown to be substantially equivalent to the predicate device through in vitro testing, in which the mixing of TISSEEL Fibrin Sealant was shown to be equivalent in both the cleared and modified devices.

The DUPLOREACH Extended Applicator is a medical device designed for the mixing and delivery of TISSEEL VH Fibrin Sealant in hard-to-reach locations. The device's substantial equivalence to a predicate device, the SEALOUETTE Fibrin Sealant Applicator (K992351), was established through in vitro testing. This study focused on demonstrating equivalent mixing performance between the new device and the predicate.

Here's a breakdown of the available information regarding acceptance criteria and the study:

1. Acceptance Criteria and Reported Device Performance

• Note: The specific quantitative metrics for "equivalent mixing" (e.g., blend uniformity, setting time, tensile strength of the mixed sealant) are not provided in the submission summary. The statement simply asserts that equivalence was demonstrated.

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

• Sample Size: This information is not explicitly stated in the provided summary. The summary refers to "in vitro testing", which typically involves multiple experimental runs, but the exact number of tests or samples is not disclosed.
• Data Provenance: The study was in vitro testing, meaning it was conducted in a controlled laboratory environment rather than on human or animal subjects. The country of origin of the data is not specified, but the submitter is Baxter BioScience, an American company.

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

• This information is not applicable to this type of submission. The "ground truth" for in vitro performance studies is typically established by laboratory measurements and established scientific protocols for evaluating sealant mixing, not by expert consensus or interpretations in the way it would be for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment of data (e.g., radiology reads) where there might be disagreement among experts. For in vitro testing, the results are derived from objective measurements.

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

• No, an MRMC comparative effectiveness study was not done. MRMC studies are related to human performance in interpreting data (e.g., medical images) and are not relevant for an in vitro performance study of a device like this.

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

• Yes, a standalone study was done. The "in vitro testing" mentioned is inherently a standalone performance evaluation of the device itself, without human-in-the-loop performance enhancement. It assesses the device's ability to perform its intended function (mixing TISSEEL Fibrin Sealant).

7. The Type of Ground Truth Used

• The ground truth was established through objective laboratory measurements related to the mixing of TISSEEL Fibrin Sealant. While the specific metrics are not detailed, this would typically involve assessing the homogeneity of the mixed components, potentially looking at physical properties like setting time or ultimately the integrity/performance of the formed sealant.

8. The Sample Size for the Training Set

• This information is not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance was evaluated through direct testing of the physical device.

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

• This information is not applicable, as there was no training set for an AI/ML model.

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