(164 days)
The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.
The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.
This document is a 510(k) summary for the Ally Blood Collection Device, a blood specimen collection device. It outlines the device's technical characteristics, its comparison to a predicate device, and the performance testing conducted to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or detailed numerical results for each test. Instead, it broadly states that "The subject Ally device met all predetermined acceptance criteria." The table below summarizes the listed performance tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical/Mechanical Performance | |
| Flow Conduit Inner Diameter | Met predetermined criteria |
| Flow Conduit Outer Diameter | Met predetermined criteria |
| Flow Conduit Effective Length and Flow Conduit Exposure Length | Met predetermined criteria |
| Open-System Introducer Length | Met predetermined criteria |
| Extension Tubing Inner Diameter | Met predetermined criteria |
| Flow Conduit-to-Extension Tubing Assembly Tensile | Met predetermined criteria |
| Extension Leg-to-Stop Ring Assembly Tensile | Met predetermined criteria |
| Extension Tubing-to-Proximal Luer Assembly Tensile | Met predetermined criteria |
| Guide Cannula-to-Introducer Assembly Tensile | Met predetermined criteria |
| Introducer to Housing Retention | Met predetermined criteria |
| Sheathing Cannula Tensile Testing | Met predetermined criteria |
| Kink Diameter | Met predetermined criteria |
| Aspiration Flow Rate | Met predetermined criteria |
| Leak Decay | Met predetermined criteria |
| Housing Seal Leak Decay Testing | Met predetermined criteria |
| Particulate testing per USP | Met predetermined criteria |
| **Biocompatibility (per ISO 10993-1 for external communicating device, limited ( |
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.