(90 days)
The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.
The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180
The provided document is a 510(k) summary for an "Intracardiac Introducing Sheath and Accessories." This type of submission focuses on demonstrating substantial equivalence to predicate devices for medical devices, rather than establishing efficacy through clinical trials with specific performance metrics akin to software device approval.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device does not apply to this document.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity). The acceptance criteria for this device revolve around demonstrating substantial equivalence to predicate devices in terms of design features, materials, and in vitro performance, ensuring no new safety or effectiveness issues.
- Reported Device Performance:
Test Type Reported Performance Biocompatibility testing Qualified the equivalence between the subject device and dilators. Sterilization validation Validated per ISO 11135 guidelines. Reliability testing Included shipping and accelerated aging of packaged units. Tensile testing Performed on critical bond joints. Rotational testing Performed on the sheath to luer bond. Leak, friction forces, insertion Performed in an in vitro setup, indicating performance as well as predicate devices for these aspects.
2. Sample sized used for the test set and the data provenance:
- This document describes in vitro testing, not a clinical study with human subjects or a dataset for AI. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on manufactured units of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications:
- Not applicable. This is not a study requiring expert readers to establish ground truth. Device performance was assessed through engineering and laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication process is relevant for this type of in vitro testing.
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 an intracardiac introducing sheath, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" in this context refers to established engineering standards, material properties requirements, and performance specifications for medical devices. For example, sterilization validation adheres to ISO 11135 guidelines, and tensile strength tests have defined pass/fail criteria based on material science and predicate device performance. The in vitro tests verify that the device meets these engineering and safety standards.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of available information:
The document details a 510(k) submission for a physical medical device. The "performance data" provided consists of various in vitro engineering and biocompatibility tests designed to demonstrate that the new device is substantially equivalent to existing predicate devices and does not raise new safety or effectiveness concerns. It does not involve AI or clinical studies with human subjects in the way your questions are framed.
§ 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).