Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1050](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1050) → QIJ — Endoscopic Transhepatic Venous Access Needle

# QIJ · Endoscopic Transhepatic Venous Access Needle

_Gastroenterology, Urology · 21 CFR 876.1050 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QIJ

## Overview

- **Product Code:** QIJ
- **Device Name:** Endoscopic Transhepatic Venous Access Needle
- **Regulation:** [21 CFR 876.1050](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1050)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In combination with the general controls of the FD&C Act, the endoscopic transhepatic venous access needle is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.
(4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:
(i) Needle crumple testing;
(ii) Tensile testing;
(iii) Dimensional verification for all components; and
(iv) Simulated use testing.
(6) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding device preparation;
(ii) The recommended training for safe use of the device; and
(iii) A shelf life for any sterile components.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN180062](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QIJ/DEN180062.md) | EchoTip Insight Portosystemic Pressure Gradient Measuring System | Cook Ireland, Ltd. | Nov 20, 2019 | DENG |

## Top Applicants

- Cook Ireland, Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QIJ](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QIJ)

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