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510(k) Data Aggregation
(276 days)
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or internittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.
In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheted peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. The Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
This document describes the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit and its substantial equivalence to a predicate device (Complex® C Continuous Peripheral Nerve Block Needle, K121846).
The information provided focuses on demonstrating substantial equivalence through technological characteristics and performance (bench) testing, rather than a clinical study involving human readers or a standalone algorithm performance. Therefore, many of the requested items related to AI/algorithm performance are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Document # / Parameter | Title and Bench Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| TM-0001 | Needle & Catheter Echogenicity Test Method: Confirm needle/catheter echogenicity via ultrasound | The test subject shall be visible in the ultrasonic machine. | Pass |
| TM-0002 | Needle Electro-Stimulation Test Method: Confirm needle will transmit an electronic signal observed on a RMS multi-meter | In all current settings of stimulator from low 0.1 to high 5.0mA, the Fascile needle shall be able to transmit the signal as observed on the RMS multi-meter. | Pass |
| TM-SR004A | Needle Sharpness Inspection: Visual and dimensional inspection for needle sharpness | Continuity of needle tip / edge no deformation. | Pass |
| TM-0005 | Tensile Strength Test Method: Measure needle and catheter tensile strength | Fascile catheter body: Tensile strength for 18Ga ≥ 2.25 lbf. Tensile strength for 16GA ≥ 2.25 lbf | |
| Fascile catheter hub: Tensile strength for 18Ga ≥ 2.25 lbf. Tensile strength for 16GA ≥ 2.25 lbf | |||
| Fascile needle hub: Tensile strength for 20Ga ≥ 12.14 lbf. Tensile strength for 18GA ≥ 2.25 lbf | |||
| Fascile Bond strength: ≥ 2.25 lbf | Pass | ||
| TM-0008 | Catheter and Extension Set Flow Test Method: Measure fluid flow rate through the extension set and catheter | Flow through predefined holes of a Fascile catheter is visible. | |
| Flow through Fascile catheter and extension set attached to a flow control tubing (test) does not drop below 20% compared to the flow of a flow control tubing alone (control). | Pass | ||
| TM-SR008A | Catheter Depth Mark Inspection: Visual and dimensional inspection for catheter depth marks | Depth marks exist and marking gaps meet drawing. | Pass |
| TM-SR009A | Catheter Curvature Inspection: Visual and dimensional inspection of catheter curvature | Correctness of curve orientation respect to arrow on hub. | Pass |
| TM-SR044A | Straightener Tube Test: Check for straightener tube functionality | Needle easily moves through the catheter without damage. | Pass |
| ISO 594-1:1986 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 1: ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
| ISO 594-2:1998 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 2: ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
| Biocompatibility (L929 Neutral Red Uptake Cytotoxicity Test) | Biocompatibility Testing: (Externally Communicating Devices (needle, Catheter, and Extension Set)) – Conformance to ISO 10993-1. Needle testing for limited exposure (24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and 24hrs and |
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