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The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

The SafeCross Vascular Introducer System is used to introduce various cardiovascular catheters into the vasculature including the heart. Unlike the predicate device, it does not include an RF Puncture Member and is not intended to cross the atrial septum. The subject device system includes three (3) components: the Steerable Introducer Sheath (SIS), a Long Access Dilator (LAD), and a Short Access Dilator (SAD). In the subject device, the SIS and LAD are identical to their respective corresponding components of the predicate device (K203459). The Vascular SIS features a compliant, specially shaped, atraumatic overhanging Positioning Balloon on its distal end to facilitate the accurate positioning and stability of the SIS while navigating the patient's vasculature. The physician is able to bi-directionally deflect the distal segment in a range of 0° to 180°. The subject device includes a new component, the SAD (12 Fr, 20 cm in length).

The provided text describes a 510(k) submission for the SafeCross Vascular Introducer System, claiming substantial equivalence to a predicate device. However, it does not contain a study that describes acceptance criteria for device performance or provides detailed results from such a study.

The document primarily focuses on:

• Device Description: What the SafeCross Vascular Introducer System is, its components (Steerable Introducer Sheath - SIS, Long Access Dilator - LAD, Short Access Dilator - SAD), and its intended use.
• Comparison to Predicate Device: How the subject device is similar to and different from the SafeCross Transseptal Puncture Device and Introducer (TSP/I) System (K203459). Key differences include the removal of the transseptal puncture indicator, the addition of a Short Access Dilator (SAD), and expansion of the indication to include peripheral vasculature.
• Reference Device: Use of the Oscor Destino™ Reach Steerable Sheath (K151951) as a reference for assessing safety and effectiveness, particularly for the expanded vascular access.
• Performance Testing Mentioned:
  • Leveraging prior testing from the predicate device due to similar geometry and functionality of common components (SIS and LAD).
  • A "new specification for the SIS deflection angle (149.6°)" was retroactively applied to existing predicate device testing, and it was stated that "Testing was not repeated" because the identical SIS component met this new specification. This indicates a specification change based on a risk assessment related to extended navigation pathways, not a new performance study.
  • Biocompatibility testing was performed only on the newly introduced Short Access Dilator (SAD) due to its new material.

Therefore, based on the provided text, a detailed study with specific acceptance criteria and performance results (as would be expected for a typical device performance study) for the entire SafeCross Vascular Introducer System is not present. The information available is limited to:

1. Biocompatibility testing for the SAD: This is the only new performance testing explicitly mentioned.

I will provide the information based on what is available in the document, and explicitly state what is not present.

1. Table of acceptance criteria and the reported device performance:

Note: The document explicitly states: "While no new design verification or validation testing was performed on the subject device..." This indicates that performance data beyond what was inherited from the predicate (and new biocompatibility for the SAD) is not presented as new testing.

2. Sample size used for the test set and the data provenance:

• SIS Deflection Angle: Not explicitly stated. The text only mentions "bench deflection angle testing" and that the predicate device's SIS "met the 149.6° specification" without re-testing the subject device.
• Biocompatibility for SAD: Not explicitly stated. Biocompatibility tests are typically performed on samples of the device material. The data provenance is implied to be from laboratory testing performed according to ISO 10993-1.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. The testing described (SIS deflection and biocompatibility) does not involve expert ground truth establishment in the context of diagnostic performance.

4. Adjudication method for the test set:

• Not applicable/Not mentioned.

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. This device is a vascular introducer system, not an AI or diagnostic imaging device.

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

• Not applicable. This device is a vascular introducer system, not an algorithm.

7. The type of ground truth used:

• Not applicable for the reported mechanical and biocompatibility testing. The "ground truth" would be the measured mechanical properties meeting engineering specifications and biocompatibility tests meeting ISO 10993-1 criteria.

8. The sample size for the training set:

• Not applicable. This device is a vascular introducer system, not a machine learning model.

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

• Not applicable.

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