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The Stiffer Coaxial Micro-Introducer Kit is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F.

The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.

The Enpath Medical, Inc. Stiffer Coaxial Micro-Introducer Set (K071574) did not provide traditional acceptance criteria with quantitative performance metrics in the provided document. This submission is for a medical device that introduces a guidewire/catheter, not an AI/ML powered diagnostic device, so the typical AI/ML powered diagnostic study information is not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility testing.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for the performance or biocompatibility testing. These tests are typically conducted on a small number of devices or material samples, as appropriate for non-clinical testing of a physical medical device.
• Data Provenance: The data is generated from non-clinical testing conducted by the manufacturer, Enpath Medical, Inc., presumably at their facilities. There is no mention of country of origin of data in a geographic sense, as it is laboratory testing. It is inherently prospective in the sense that the new device was manufactured and then tested.

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

• This information is not applicable to this type of device submission. Ground truth, in the context of diagnostic devices, usually refers to clinical diagnoses or pathology reports. For this introducer set, the "ground truth" is adherence to engineering specifications and performance standards through physical and material testing. The experts involved would be engineers and material scientists performing the tests and comparing results to established standards or predicate device performance. Their qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or expert reviewers. For non-clinical performance and biocompatibility testing of a physical device, results are typically objective measurements or observations against predefined criteria, not subject to subjective adjudication in this manner.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often comparing AI-assisted performance against unaided human performance. The Stiffer Coaxial Micro-Introducer Kit is a physical device, and its safety and effectiveness are assessed through non-clinical performance and biocompatibility testing, not through MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This concept is entirely irrelevant for a physical medical device like an introducer set, which does not involve an algorithm or artificial intelligence.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily:
  • Engineering specifications and design requirements: The device's physical dimensions, materials, and functional characteristics are designed to meet specific criteria.
  • Performance standards: The device is tested to ensure it performs its intended function (e.g., smoothly introducing a guidewire/catheter, maintaining integrity under stress).
  • Biocompatibility standards: Materials are tested to ensure they are safe for contact with the body.
  • Predicate device characteristics: The new device's performance, dimensions, and materials are compared to the legally marketed predicate device (Enpath Medical, Inc. Coaxial Micro-Introducer Set K990705) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product and does not involve AI/ML.

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

• This information is not applicable, as there is no AI/ML training set for this device.

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