(28 days)
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No
The device description and performance studies focus on the physical characteristics and mechanical performance of a pen needle, with no mention of AI or ML technologies.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a needle for insulin injection, which is a drug delivery device, not a therapeutic device itself.
No
The device description clearly states its purpose is for "subcutaneous injection of insulin" using a pen injector. It's a single-use disposable device that facilitates drug delivery, not the diagnosis of a condition.
No
The device description clearly details physical components (stainless steel needle, plastic hub, shield, container, laminate seal) and manufacturing processes (epoxy bonding, gamma irradiation sterilization), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with a pen injector device for the subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not to test a sample from the body.
- Device Description: The description details a needle assembly for injection. It doesn't mention any components or processes related to analyzing biological samples (like blood, urine, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
This device is clearly intended for drug delivery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use for the modified device remains the same as the predicate device; for use with a pen injector device for the subcutaneous injection of insulin.
Product codes
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Device Description
The double-pointed Type 304 stainless steel needle is epoxy bonded to a plastic hub (polypropylene) and covered with a plastic needle shield (polyethylene). This needle/hub/shield assembly is placed in a plastic outer container (polyethylene), the open end of which is sealed closed with a laminate seal for subsequent protection. Gamma irradiation sterilization will be employed and the product will meet 10 * sterility assurance levels. During use, the laminate seal is pealed away and the exposed needle hub is screwed onto the Pen injector device. This exposed needle hub will penetrate the rubber septum of an insulin containing cartridge (supplied by others). After the needle shield is removed, it is ready for a subcutaneous insulin injection. The needle assembly is a single-use disposable device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The B-D 31g x 5/16" pen needle has been bench tested, which included needle pull-out, penetration and insulin injection forces and has proven to function in an equivalent manner as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
B-D 30g x 5/16" pen needle
Reference Device(s)
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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
SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 28 1997
1.0 Submitted By:
Peter Zurlo Manager, Regulatory Affairs BECTON DICKINSON CONSUMER PRODUCTS 1 Becton Drive Franklin Lakes, NJ 07417-1883 Phone: 201-847-6447 Fax: 201-848-0457
2.0 Device Name:
B-D 31g x 5/16" pen needle
3.0 Predicate Device:
B-D 30g x 5/16" pen needle
4.0 Device Description:
The double-pointed Type 304 stainless steel needle is epoxy bonded to a plastic hub (polypropylene) and covered with a plastic needle shield (polyethylene). This needle/hub/shield assembly is placed in a plastic outer container (polyethylene), the open end of which is sealed closed with a laminate seal for subsequent protection. Gamma irradiation sterilization will be employed and the product will meet 10 * sterility assurance levels. During use, the laminate seal is pealed away and the exposed needle hub is screwed onto the Pen injector device. This exposed needle hub will penetrate the rubber septum of an insulin containing cartridge (supplied by others). After the needle shield is removed, it is ready for a subcutaneous insulin injection. The needle assembly is a single-use disposable device.
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- Intended Use:
The intended use for the modified device remains the same as the predicate device; for use with a pen injector device for the subcutaneous injection of insulin.
- Intended Use:
1
~Technological Characteristics: 6.
The B-D 31g x 5/16" pen needle and the predicate device (the B-D 30g x 5/16" pen needle) have the same technological characteristics.
SEE ITEM 4 ABOVE FOR A DESCRIPTION.
N.B. The only change to the predicate device is the gauge size of the needle.
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- Performance Summary:
The B-D 31g x 5/16" pen needle has been bench tested, which included needle pull-out, penetration and insulin injection forces and has proven to function in an equivalent manner as the predicate device.
- Performance Summary:
Based on the results of bench testing the B-D 31g x 5/16" pen needle is considered safe and effective when used as intended.