(251 days)
The Pakter Curved Needle Set is intended for discography, diagnostic sampling, aspiration, and injection.
The Pakter Curved Needle Set is manufactured as a coaxial needle set and includes a preshaped curved needle and an introducer needle. The curved needle consists of a nitinol cannula connected to a polycarbonate hub at the proximal end and is characterized with a distal curve and a 30° bevel distal tip. It also includes a stainless steel stylet that is designed for a transitional fit. The curved needle with stylet is 25 gage in diameter and has a length of 20 or 15 centimeters. The introducer needle consists of a stainless steel cannula connected to an acrylic hub at the proximal end. The introducer needle is also designed with a stainless steel stylet. The introducer needle with stylet is 21 gage in diameter and has a length of 15 or 10 centimeters. When used as intended, the introducer needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the introducer needle stylet, the curved needle is then inserted through the introducer needle cannula and slowly advanced to the target anatomy. The Pakter Curved Needle Set is sterilized by ethylene oxide and intended for one-time use.
This document describes the premarket notification for the Pakter Curved Needle Set (K173155), a Class II medical device intended for discography, diagnostic sampling, aspiration, and injection. The submission aims to demonstrate substantial equivalence to a predicate device, the Atraumatic Standard Sprotte® Needle (K911260).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength - Curved Needle Cannula Hub-to-Shaft | Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Curved Needle Stylet Hub-to-Shaft | Peak tensile load ≥ 11 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Introducer Needle Cannula Hub-to-Shaft | Peak tensile load ≥ 44 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Tensile Strength - Introducer Needle Stylet Hub-to-Shaft | Peak tensile load ≥ 22 N (in accordance with BS EN ISO 7864:2016 and BS EN ISO 11070:2014) | The acceptance criterion was met. |
| Stiffness - Introducer Needle Cannula and Stylet | Deflection |
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).