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The ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.

The Estech Percutaneous Dilator Insertion Kit is a sterile, single-use, physicians convenience kit to dilate blood vessels to allow for the insertion of large diameter catheters. The kit consists of seven pieces:

• 1. One 18 gage stainless steel insertion needle
• 2. One stainless steel 0.035" or 0.038" guidewire
• 3. Five plastic dilators, sized 8, 12, 16, 20 and 24 Fr.
     These pieces may be packaged, sterilized and sold separately.

This is a 510(k) premarket notification for a medical device, the ESTECH Percutaneous Dilator Insertion Kit. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, ground truth, and reader studies is not directly applicable or available in this 510(k) summary. This document focuses on demonstrating equivalence through design, materials, intended use, and manufacturing testing.

Here's the breakdown of what is available based on the provided text, and where your requested information is not present:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable/Not Provided. This 510(k) does not present data from a clinical "test set" in the sense of patient data for diagnostic performance. The "testing" mentioned refers to manufacturing inspection and biocompatibility analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided. No ground truth for a diagnostic test set was established as no such study was conducted or required for this type of device and submission.

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

• Not Applicable/Not Provided. No test set or adjudication for diagnostic performance was performed.

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/Not Provided. This device is a physical medical instrument (vessel dilator), not an AI/diagnostic software. Therefore, an MRMC study is not relevant.

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

• Not Applicable/Not Provided. This device is a physical medical instrument, not an algorithm. Standalone performance as typically described for AI is not relevant.

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

• Not Applicable/Not Provided. No clinical ground truth was established for "diagnostic" performance. The "ground truth" for the device's acceptable performance is its compliance with established standards (ISO 10993 for biocompatibility) and its ability to meet engineering specifications through manufacturing tests.

8. The sample size for the training set

• Not Applicable/Not Provided. This device is not an AI/machine learning model, so there is no "training set."

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

• Not Applicable/Not Provided. There is no training set for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in this 510(k) is essentially a bench testing and biocompatibility analysis rather than a clinical trial or diagnostic performance study.

• Biocompatibility Analysis: The kit components underwent biocompatibility analysis to demonstrate compliance with ISO 10993. This standard assesses the biological response of medical devices in contact with the human body. The results showed compliance.
• Manufacturing Inspection and Testing: The device components were subjected to manufacturing inspections and various performance tests to ensure they met their predetermined engineering and performance specifications. The details of these specific tests (e.g., tensile strength, dimensional accuracy, ease of use, etc.) are not elaborated upon in this summary but are implied by the statement "Manufacturing inspection and testing demonstrate that the kit meets its performance specifications."

The ultimate proof of the device meeting its acceptance criteria, particularly for a 510(k) submission, is the demonstration of substantial equivalence to a previously legally marketed predicate device (Maxxim Medical Vessel Dilator, K963388). This equivalence is based on:
* Identical intended use.
* Similar design principles (minor differences in hub and range of diameters were deemed not to raise new safety/efficacy concerns).
* Similar materials.
* Similar packaging and sterilization methods (sterile, single-use, ethylene oxide sterilized).

The FDA's decision to clear the device (K070749) confirms that, based on the submitted data, it was found to be substantially equivalent to the predicate device, thereby meeting the regulatory acceptance criteria for market entry under the 510(k) pathway.

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