(207 days)
The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.
The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.
The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.
However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.
Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance:
The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Standards/Predicate) | Proposed Device (Arch-Flo CT Midline) Performance | Predicate Device (CT Midline) Performance |
|---|---|---|---|
| Max Power Injection Flow | 5cc/sec (matching predicate) | 5cc/sec | 5cc/sec |
| Priming Volume | Comparable to predicate | 0.36cc | 0.41cc |
| Gravity Flow | Comparable to predicate | 56 ml/min | 31.5 ml/min |
| Air Leakage | Meets ISO 10555-1 and ISO 10555-3 requirements | Tested and met | Implied met as predicate |
| Liquid Leakage | Meets ISO 10555-1 and ISO 10555-3 requirements | Tested and met | Implied met as predicate |
| Force at Break | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Elongation | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Chemical Exposure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Maximum Burst Pressure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Cyclic Flexure | Meets ISO 10555-1 requirements | Tested and met | Not specified |
| Sterilization (SAL) | 10^-6 (ANSI/AAMI/ISO 11135-1:2014) | SAL is 10^-6 | Not specified |
| ETO Residual Level |
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).