(155 days)
The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.
The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.
Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.
The provided document is a 510(k) premarket notification letter and supporting documentation for the Protek Venous Dilator Sets. It focuses on demonstrating substantial equivalence to a predicate device for a medical dilator. This type of document does not include information related to acceptance criteria, study details, expert involvement, or statistical analysis typically found in an FDA submission for AI/ML-driven devices or diagnostic tools.
Therefore, I cannot provide the requested information for this specific document because it describes a physical medical device (dilator) and not a device that relies on AI/ML or requires a complex validation study with acceptance criteria related to diagnostic performance.
The document details non-clinical testing for the dilator, such as:
- Tensile Strength: "Pull test with objective acceptance criteria." Conclusion: "All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application."
- Deflection Test: "Compliance measurement with side-by-side comparison to similar sized predicate devices." Conclusion: "The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed."
- Biocompatibility: "Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours." Conclusion: "All tests passed."
This is the extent of the "acceptance criteria" and "study" information available in this document. It does not fit the format of an AI/ML-driven diagnostic study.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).