ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

• K Number: K103143
• Device Name: ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
• Manufacturer: ARSTASIS, INC.
• Date Cleared: 2011-02-02 ( 100 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K102728

Intended Use

The System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Device Description

Arstasisone is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting studies for the Arstasisone Latchwire Access System, based on the provided document:

Acceptance Criteria and Device Performance

The document states generally that the device met all acceptance criteria, but it does not provide specific quantitative acceptance criteria or detailed performance metrics. Instead, it offers a summary of testing performed.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Specific Metrics/Result (if available)
Bench Testing	Met all performance testing acceptance criteria.	- Functionality testing Passed
		- Deployment forces Passed
		- Corrosion resistance Passed
		- Compression and torque loading Passed
		- Flexibility Passed
		- Tensile strength (Latchwire and Access Needle) Passed
Biocompatibility	Met acceptance criteria per ISO-10993-1.	Passed assessments
Animal Studies	Preliminary studies conducted.	Short term safety and clinical performance established.
Cadaver Assessments	Assessments conducted.	Short term safety and clinical performance established.
Clinical Investigations	Multiple evaluations conducted. Short term safety and clinical performance established. Long term safety and ability to access/re-access retrospectively studied.	Short term safety and clinical performance established. Long term safety and ability to access/re-access assessed in a smaller cohort.

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Study Details:

1. Sample Size and Data Provenance:

   • Test Set (Clinical Investigations): The document mentions "multiple clinical evaluations" and "a smaller cohort of patients" for the retrospective long-term safety and re-access study. However, specific sample sizes for these clinical investigations are not provided.
   • Test Set (Bench Testing): "Test units" were used for bench testing, but the exact number of units is not specified.
   • Data Provenance: Not explicitly stated, but clinical investigations typically involve human subjects from a specific region/country. Given the company (Arstasis, Inc.) is based in San Carlos, CA, USA, it's likely the clinical data originated from the United States, but this is not confirmed. The clinical investigations were both prospective (for short-term safety and performance) and retrospective (for long-term safety and re-access). Animal studies and cadaver assessments were also performed.

2. Number of Experts and Qualifications for Ground Truth (Test Set):

   • The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical investigations. Clinical studies implicitly rely on medical experts (physicians) for patient assessment and outcomes, but explicit details are absent.

3. Adjudication Method (Test Set):

   • The document does not describe any specific adjudication method used for the test set data (e.g., 2+1, 3+1).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical access tool, not an imaging or diagnostic device that typically involves human readers interpreting data. Therefore, the concept of "improving human readers with AI vs. without AI assistance" does not apply.

5. Standalone Performance (Algorithm Only):

   • No, a standalone (algorithm only) performance study was not done because this is a physical medical device, not an AI/algorithm-based diagnostic or assistive software.

6. Type of Ground Truth Used:

   • For the clinical investigations, the ground truth would be based on clinical outcomes data (e.g., hemostasis achievement, adverse events, ability to access/re-access the vessel).
   • For biocompatibility, the ground truth is established by adherence to ISO-10993-1 standards and testing results.
   • For bench testing, the ground truth is based on engineering specifications and predefined performance thresholds for mechanical properties.

7. Sample Size for Training Set:

   • This question is not applicable as the Arstasisone Latchwire Access System is a physical medical device, not a machine learning or AI algorithm that requires a "training set." The development process would involve iterative design, prototyping, and testing, rather than an AI training paradigm.

8. How Ground Truth for Training Set was Established:

   • This question is not applicable for the same reason as point 7.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).