(23 days)
Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardial placement of interventional devices. The sheath may be exchanged and placed in interventional position after transseptal puncture has been obtained using a different sheath.
The Soft Tip Intracardiac Introducing Sheath Kit consist of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart.
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 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
The provided 510(k) summary (K013866) for the Convoy™ Advanced Delivery Sheath Kit does not contain information related to software, artificial intelligence, or machine learning. Therefore, it is not possible to describe acceptance criteria, device performance, or study details relevant to AI/ML devices based on this document.
The document discusses an "Intracardiac Introducing Sheath" and focuses on its physical characteristics, intended use, and comparison to a predicate physical device. The "Summary of the Non-clinical Data" section mentions "testing conformed to the requirements of 21 CFR Part 58" and "Non-clinical tests conducted for the Sheath (Good Laboratory Practices) demonstrated substantial equivalence to the predicate device." This indicates that the evaluation was likely based on bench testing of the physical sheath's properties (e.g., dimensions, materials, strength, sterile integrity) rather than performance related to data processing or algorithmic output.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device. The K013866 document pertains to a traditional medical device (a catheter introducer sheath).
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.