(2 days)
The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.
The Engage device consists of an introducer sheath with hemostasis valve and sideport for 3-way stopcock, hub, dilator, and guidewire. At the end of the sheath is a snap fit hub that is equipped with a hemostasis valve and sideport containing tubing ending with a 3way stopcock valve. The 3-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. The dilator lumen is designed to provide close fit to appropriately sized guidewires by incorporating a tapered distal tip.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the St. Jude Medical Ultimum/Engage/Engage TR Hemostasis Introducer (K091137):
Executive Summary:
The provided 510(k) summary for the Engage Introducer does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria. Instead, the submission states that "This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required." The basis for clearance is substantial equivalence to previously cleared predicate devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such a study was explicitly stated as not required for this particular submission.
Detailed Breakdown of Information (as available from the provided text):
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not applicable Not applicable Explanation: The document explicitly states, "This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required." This means there were no new performance acceptance criteria established for this specific submission nor any new performance data generated to meet them. The device is being cleared based on its substantial equivalence to previously cleared devices which would have met their own performance criteria at the time of their clearance.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable (no new testing was performed for this submission).
- Data Provenance: Not applicable (no new testing was performed for this submission).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable (no new testing was performed for this submission, thus no ground truth established by experts for a test set).
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Adjudication Method for the Test Set:
- Not applicable (no new testing was performed for this submission).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? No.
- Effect size improvement: Not applicable.
Explanation: MRMC studies are typically for evaluating diagnostic or imaging devices where human readers interpret data, often with or without AI assistance. This device is a medical introducer (a physical tool) and does not involve such diagnostic interpretation.
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Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- Was one done? No.
Explanation: This concept is relevant for AI algorithms or software devices. The Engage Introducer is a physical medical device.
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Type of Ground Truth Used:
- Not applicable (no new testing was performed for this submission).
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Sample Size for the Training Set:
- Not applicable (no new testing or AI model training performed for this submission).
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How the Ground Truth for the Training Set Was Established:
- Not applicable (no new testing or AI model training performed for this submission).
Summary of the K091137 Submission:
The K091137 submission for the St. Jude Medical Ultimum/Engage/Engage TR Hemostasis Introducer is a 510(k) Pre-market Notification primarily focused on indication clarification and establishing substantial equivalence to existing predicate devices.
- Rationale for Clearance: The submission asserts that the Engage Introducer is substantially equivalent to two predicate devices:
- Key Argument for Substantial Equivalence:
- No device changes: The submission explicitly states, "there have been no device changes."
- Same intended use, principles of operation, and technological characteristics as the cleared Ultimum Hemostasis Introducer.
- Similar sub-indications for use and principles of operations as the Terumo GlideSheath.
- The "differences between this device and its predicate device do not raise new questions of safety or efficacy."
- Purpose of Submission: To provide "further clarity to the physicians regarding the indications for use of Ultimum in procedures requiring vessel access, including but not limited to femoral, radial, and brachial approach."
In essence, this submission is an administrative update to the labeling of an existing device (or a renamed existing device) to broaden or clarify its listed indications for use, without making any physical changes to the device itself, and therefore, without requiring new performance testing.
§ 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).