(63 days)
For the introduction of various types of pacing or defibrillator leads and catheters. AND For the introduction of various types of catheters.
The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis. The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.
The medical device being described is a Large bore splittable introducer kit manufactured by Thomas Medical Products, Inc.
Based on the provided 510(k) summary and official letter, this submission is for establishing substantial equivalence to a previously cleared device (Thomas Medical Products, Inc., Tear-away sheath introducer kit - K934901). Substantial equivalence means that the new device has the same intended use and technological characteristics as the predicate device(s).
Crucially, the provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it focuses on demonstrating equivalence to an already marketed device.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study designed to meet specific performance metrics. The information regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for these performance studies is also absent from this specific 510(k) submission document.
Summary of what can be extracted from the provided text:
- Device Name: Large bore splittable introducer kit
- Manufacturer: Thomas Medical Products, Inc.
- Intended Use: To provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads. More specifically: "For the introduction of various types of pacing or defibrillator leads and catheters." and "For the introduction of various types of catheters."
- Predicate Device: Thomas Medical Products, Inc., Tear-away sheath introducer kit (K934901).
- Basis for Clearance: Substantial equivalence to the predicate device, not performance against specific acceptance criteria. The document states: "The technological characteristics of the device are the same as those of the predicate devices." and "The Thomas Medical Products Inc. Large bore splittable introducer kit has similar general intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. Large bore splittable introducer kit is substantially equivalent to the legally marketed predicate devices."
In the context of 510(k) clearances based on substantial equivalence, specific clinical performance studies with detailed acceptance criteria and expert reviews are often not required if the new device is sufficiently similar to a legally marketed predicate device. The FDA's review in such cases focuses on comparing the new device's technological characteristics and intended use to those of the predicate device to ensure it raises no new questions of safety or effectiveness.
§ 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).