(115 days)
The 0.9% Sodium Chloride Injection, USP, Pre-filled Syringe is intended for flushing of IV catheters and IV tubing only. The syringe is provided to convenience kit packers/OEMs to be placed in surgical procedure kits that may undergo ethylene oxide (EO) sterilization according to their validated processes per ANSI/AAMI/ISO 11135:2014.
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
This FDA 510(k) clearance letter pertains to a medical device: 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe, specifically for flushing IV catheters and IV tubing. This document is a regulatory approval and does not contain information about a study that assesses the device's performance against detailed acceptance criteria in the manner requested (e.g., using AI, human readers, ground truth, sample sizes for training/testing).
The information provided describes the regulatory classification, intended use, and general compliance requirements for the device. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory and often bench-testing-based comparison, not a clinical performance study with the metrics you've requested.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria in terms of metrics like sensitivity, specificity, or reader improvement.
- Sample sized used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set is discussed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a pre-filled syringe, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe received 510(k) clearance (K191378) from the FDA. The clearance indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness.
Indications for Use: The device is intended for flushing of IV catheters and IV tubing only. It is also noted that the syringe is provided to convenience kit packers/OEMs to be placed in surgical procedure kits that may undergo ethylene oxide (EO) sterilization according to their validated processes per ANSI/AAMI/ISO 11135:2014.
Regulatory Class: Class II
Product Code: NGT
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
§ 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).