(287 days)
The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.
The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials. The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.
The provided document (K960982) is a 510(k) summary for the Monoject™ Blunt I.V. Access Cannula, submitted to the FDA in 1996. It outlines the device's classification, intended use, and substantial equivalence to other marketed devices.
This document describes comparative testing to demonstrate substantial equivalence, but it does not contain the information requested regarding detailed acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, or specific performance metrics in the format of a typical AI/ML device study.
The document predates the widespread use of AI/ML in medical devices and therefore does not include the type of studies and data typically associated with AI/ML performance evaluation (e.g., standalone performance, MRMC studies, specific metrics like sensitivity, specificity, AUC).
Instead, the document focuses on mechanical and biological safety testing against existing devices.
Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device performance from the provided text.
Summary of available information vs. requested information:
- Acceptance Criteria & Reported Performance: The document lists types of comparative testing (Insertion Force Test, Bend Test, Break Resistance and Resilience Test, Cytotoxicity, etc.) and states the results "will indicate that the Monoject™ Pointless Blunt l.V. Access Cannula perform equivalently to or better than the B-D Interlink Cannula product." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests (e.g., "Insertion force < X Newtons" and "Reported: Y Newtons").
- Sample Size (Test Set), Data Provenance: Not applicable for an AI/ML context; the document does not specify sample sizes for the mechanical or biocompatibility tests.
- Number of Experts, Qualifications, Adjudication Method: Not applicable as this is not an AI/ML study requiring expert ground truth.
- MRMC Comparative Effectiveness Study: No, this is not an AI/ML device.
- Standalone Performance: No, this is not an AI/ML device.
- Type of Ground Truth: Not applicable for an AI/ML context. The "ground truth" here would be the physical properties and biological reactions, measured directly, rather than expert interpretation.
- Sample Size (Training Set): Not applicable for an AI/ML context.
- How Ground Truth for Training Set was Established: Not applicable for an AI/ML context.
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ATTACHMENT #1
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.
510(k) Summary of Safety & Effectiveness Monoject™ Blunt I.V. Access Cannula
DEC 23 1996
Sherwood Medical Co., 1915 Olive St. Submitted By: St. Louis, MO 63103. (314) 241-5700 Cheryl Winters-Heard, Manager. Regulatory Affairs Contact : Date Prepared: March 6, 1996
The Monoject™ Blunt I.V. Access Cannula is a Class II device per 21 CFR 880.5860, General Hospital Devices Panel 80. Procode FMF.
The Monoject™ Blunt I.V. Access Cannula is a sterile, lubricated plastic cannula with a female luer hub. It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.
The Monoject™ Blunt I.V. Access Cannula will be available in the following configurations: Individual Blunt Cannula; Blunt I.V. Access Cannula attached to piston syringe of 3 ml, 6ml and 12 ml sizes.
The Monoject™ Blunt I.V. Access Cannula is substantially equivalent in its intended use and function to the following currently marketed devices: 8-D Interlink Syringe Cannula, Monoject Lifeshield Blunt Cannula, Monoject Lifeshield Blood Collection Device.
The Monoject™ Blunt I.V. Access Cannula and SE devices have undergone the following comparative testing:
Insertion Force Test Bend Test Break Resistance and Resilience Test
In addition, the following testing will be performed to confirm that no issues of biological safety or effectiveness are raised.
Cytotoxicity Intracutaneous Irritation Acute Systemic Toxicity Sensitization Hemolysis Subchronic Toxicity Drug Compatibility Testing.
lhe results of this testing will indicate that the Monoject™ Pointless Blunt l.V. Access Cannula perform equivalently to or better than the B-D Interlink Cannula product. No new issues relating to safety or efficacy were raised.
The Monoject™ Blunt I.V. Access Cannula will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).