(117 days)
The Bipore Accuflex™ Percutaneous Sheath Introducer is recommended for percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.
The Bipore Accuflex™ Percutaneous Sheath Introducer is a flexible tube designed for the percutaneous introduction of various devices into arteries and/or veins for a variety of diagnostic and therapeutic procedures. The product consists of a tube fabricated out of nylon based, flouropolymer lined material, reinforced by a flexible stainless steel wire within the tube. Proximally located on the flexible tube is an integral side port/hemostasis valve and/or female luer connection for attachment to a Touhy Borst adaptor. The side port, which provides a means of introducing contrast media or other fluids, is fabricated from non-DEHP PVC. The hemostasis valve is made from silicone rubber. The Touhy Borst adapter is a separate or connected component purchased from B.Braun. This purchased component is used in a manner consistent with B.Braun specification and premarket clearance. The proximal end contains a 24 karat gold radiopaque marker. The stainless steel coil enables the introducer to kink resistant during normal use. The proximal end may also contain a 45° to 180° radius bend. This pre-bend allows the product to be directed by transferring distal torque to steer the proximal tip. The reinforced tube, through which a vessel dilator or catheter is introduced is available in 5,6,7 and 8 French sizes and in lengths ranging from 5 cm to 110 cm.
The provided text is a 510(k) summary for a medical device: "Bipore Accuflex™ Percutaneous Sheath Introducer." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the context of clinical performance or diagnostic accuracy.
The 510(k) summary states: "Test results indicate that the modified product is in conformance with Bipore specifications and is substantially equivalent to the predicate device." However, it does not elaborate on what specific "Bipore specifications" were used as acceptance criteria, nor does it describe the "test results" or the study methodology, sample sizes, ground truth establishment, or expert involvement usually associated with assessing the clinical performance or diagnostic accuracy of a device.
Therefore, most of the requested information cannot be extracted from this document.
Here's an attempt to answer based only on the provided text, highlighting what is missing:
1. Table of acceptance criteria and the reported device performance:
The document mentions "Bipore specifications" are the acceptance criteria, and the reported performance is "conformance" with these specifications. However, the specific metrics and thresholds for these specifications are not provided.
| Acceptance Criteria (Specific Metrics & Thresholds) | Reported Device Performance |
|---|---|
| Not specified in the provided document | In conformance with Bipore specifications |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not specified
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "Test results indicate..." without further detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The 510(k) process for this type of device typically relies on engineering and performance testing to ensure substantial equivalence, rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable/Not specified. There is no mention of a human-read test set or adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable/Not specified. This is a medical introducer sheath, not an AI-powered diagnostic device. An MRMC study is not relevant to its type.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not specified. This is not an algorithm-based device.
7. The type of ground truth used:
The "ground truth" for this device's performance would primarily be defined by engineering specifications and performance standards for introducer sheaths (e.g., kink resistance, hemostasis valve integrity, material compatibility, dimensions). The document states "Test results indicate that the modified product is in conformance with Bipore specifications." However, the specific ground truth definitions (e.g., a specific tensile strength value, burst pressure, or flow rate) are not detailed.
8. The sample size for the training set:
Not applicable/Not specified. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable/Not specified. As above, this concept does not apply to this device type.
Summary of what the document does tell us about the "study":
- The modifications include changes to the exterior dimensions of the hemostasis valve body, additional size offerings (lengths up to 110cm), and an optional polyethylene dilator.
- The modifications aim to improve manufacturability, user handling, and accommodate longer length devices and patient anatomy.
- "Test results" were conducted.
- These "test results" indicate conformance with "Bipore specifications."
- The ultimate conclusion is that the modified product is "substantially equivalent" to the predicate device (Bipore Accuflex™ Percutaneous Sheath Introducer K051513).
- The FDA reviewed these "test results" and agreed with the substantial equivalence determination.
Without access to the actual test reports cited in the original 510(k) submission, the detailed information on acceptance criteria and study methodology requested cannot be provided from this summary document alone.
§ 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).