QOI · Intravenous Catheter Force-Activated Separation Device.
General Hospital · 21 CFR 880.5220 · Class 2
Overview
| Product Code | QOI |
|---|---|
| Device Name | Intravenous Catheter Force-Activated Separation Device. |
| Regulation | 21 CFR 880.5220 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.
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, intravenous catheter force-activated separation device is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Separation force testing; (ii) Validation of anti-reconnect features; (iii) Air and liquid leakage testing, both before and after separation; (iv) Luer connection testing; (v) Flow rate testing; (vi) Particulate testing; and (vii) Microbial ingress testing. (3) The device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate that the device is sterile and non-pyrogenic. (5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (6) Device labeling must include: (i) Instructions for use; and (ii) A discussion of catheter dressings intended to be used with the device.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241415 | Orchid Safety Release Valve | Linear Health Sciences, LLC | Sep 6, 2024 | SESE |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | Oct 3, 2023 | SESE |
| K231957 | SafeBreak® Vascular | Lineus Medical | Sep 29, 2023 | SESE |
| K223486 | SafeBreak® Vascular | Lineus Medical | May 19, 2023 | SESE |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | May 4, 2023 | SESE |
| K222791 | SafeBreak Vascular | Lineus Medical, LLC | Oct 16, 2022 | SESE |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | May 3, 2022 | SESE |
| DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | May 27, 2021 | DENG |
Top Applicants
- Linear Health Sciences, LLC — 4 clearances
- Lineus Medical — 2 clearances
- Lineus Medical, LLC — 1 clearance
- Site Saver, Inc. D/B/A Lineus Medical — 1 clearance
