(56 days)
The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
The PV 1900 is a member of the Synchro® Guidewire family of products having a 0.016" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Boston Scientific (K903606)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. A traditional range of flexibility profiles shall also be provided ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
This is a 510(k) premarket notification for a medical device (a guidewire), not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation are not applicable.
However, I can extract the information relevant to the device's performance given the context of this document.
Summary of Device Performance Information Provided:
Since this is a filing for a traditional medical device (guidewire) and not an AI/ML diagnostic or prognostic system, the requested information (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance) for AI/ML devices is not directly applicable in the sense of predictive or classification performance metrics.
Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate guidewires by meeting various physical and mechanical performance characteristics. The "study" refers to the engineering and biological testing performed on the device.
Here's an attempt to map the requested AI/ML-centric questions to the provided information for this traditional medical device:
-
Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in a quantifiable table with corresponding performance values for each criterion as one would for an AI/ML device (e.g., sensitivity >X%, specificity >Y%). Instead, it states that "Performance testing of materials comprising the PV 1900 Synchro® 0.016" Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." and "Subject product testing has yielded acceptable safety & performance outcomes."
The performance aspects tested and the general outcome are listed.
Acceptance Criteria (Implicit) Reported Device Performance Compliance with ISO 10993-1 for Biocompatibility (for external communicating, blood contact, short duration
§ 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.