(287 days)
8-D Interlink Syringe Cannula, Monoject Lifeshield Blunt Cannula, Monoject Lifeshield Blood Collection Device
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No
The device description and performance studies focus on the physical properties and safety of a blunt cannula, with no mention of AI or ML capabilities.
No.
The device is used for access to IV lines and medication vials, which are diagnostic or drug delivery functions, not therapeutic.
No
This device is a cannula used for accessing IV lines and medication vials. Its function is to facilitate fluid transfer, not to diagnose a condition or disease.
No
The device description clearly states it is a physical, sterile, lubricated plastic cannula with a female luer hub, and mentions configurations attached to piston syringes. This indicates a hardware medical device, not software.
Based on the provided information, the Monoject™ Blunt I.V. Access Cannula is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide access to pre-pierced IV line injection sites and medication vials. This is a direct interaction with the patient's IV line or medication, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics and how it's used for access, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for administering or accessing substances within a patient's IV system or medication vials, which falls under the category of medical devices used for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
The results of this testing will indicate that the Monoject™ Pointless Blunt I.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.
Key Metrics
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Predicate Device(s)
8-D Interlink Syringe Cannula, Monoject Lifeshield Blunt Cannula, Monoject Lifeshield Blood Collection Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.