(30 days)
The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.
Straight (TSMG-/-LES) and Curved (TSCMG-/-LES) Lunderquist® Extra Stiff Wire Guide. PTFE-coated stainless steel wire guides with lengths ranging from 90 cm to 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil for enhanced visibility. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.
Double curved (TSCMG-/-LESDC) and extended double curved (TSCMG-/-E-LESDC) Lunderquist® Extra Stiff DC Wire Guide. PTFE-coated stainless steel wire guides with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. TSCMG-/-LESDC has a primary/secondary curve radius on 75/15 mm, and TSCMG-/-E-LESDC has an extended primary/secondary curve radius on 55/15 mm.
The Lunderquist® Extra Stiff Wire Guide is used both to assist in anatomical access for other devices (notincluded) and to support the delivery of medical devices. The wire guide is introduced into the target vessel; other devices, such as a sheath, catheter, stent, or endo vascular graft can then be passed over the wire guide to be positioned or manipulated within the vascular system.
The Lunderquist® Extra Stiff Wire Guides are available in different lengths, shapes, etc. to accommodate different anatomical applications.
The provided document, a 510(k) premarket notification for the Lunderquist Extra Stiff Wire Guides, does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.
The document states that the purpose of the submission is to "clarify the intended use statement and update device labeling based on postmarket surveillance information." It explicitly mentions:
"No changes to the design, materials, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and testing provided for the predicate device (K171513) remains applicable."
This indicates that new performance testing, particularly for the type of criteria and study you're asking about (which are typical for AI/ML device evaluations), was not conducted for this submission because the device itself and its function have not changed. The device is a physical catheter guide wire, not a software algorithm.
Therefore, I cannot provide the requested information based on the given text. The questions you've posed relate to the validation of AI/ML models, which is not applicable to a submission for a physical medical device like a wire guide, especially one where no design changes have been made.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.