(162 days)
A single use disposable introducer needle/cannula intended for precise placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, in non-vascular laparoscopic procedures.
The Sterile Stainless Steel Introducer Needle/Cannula with Guide Base is indicated for use to provide temporary percutaneous placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, during minimally invasive laparoscopic procedures.
The Stainless Steel Introducer Needle/Cannula with Guide Base is a single use disposable introducer needle/cannula intended for the precise placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, in non-vascular laparoscopic procedures. The Introducer Needle/Cannula provides a temporary percutaneous guide to facilitate the placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, into the abdominal cavity for surgical procedures and specifically for use during EMG monitoring. The Introducer Needle/Cannula with Guide Base has three main components: a Concentric Guide Tube, an Introducer Needle with Ring Hub and an Introducer Needle Guide Base.
This document describes the regulatory submission for a medical device (K103200) and does not contain information about a study proving the device meets acceptance criteria or details about device performance metrics, sample sizes, expert involvement, or ground truth establishment.
The provided text is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating equivalence through comparison to an existing device, adherence to recognized standards, and basic safety and performance testing (which are not detailed in this summary).
Therefore, I cannot provide the requested information, which typically comes from specific performance studies.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria/Performance Table: The document doesn't list specific performance metrics or acceptance criteria for the device, nor does it present results from a performance study against such criteria.
- No Study Details: There is no mention of a specific clinical or technical study designed to "prove the device meets acceptance criteria." The submission is based on demonstrating substantial equivalence to a predicate device (K013040), not on presenting novel performance data from a new study.
- No Sample Sizes, Data Provenance, Experts, Adjudication, MRMC studies, Standalone Performance, Ground Truth for Test or Training Sets: All these points relate to specific performance studies, which are not described in this 510(k) summary. The document focuses on regulatory classification, device description, intended use, and comparison to a predicate.
In summary, the provided document is a regulatory submission for premarket clearance and does not contain the detailed study information requested.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).