(87 days)
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using silicone based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10 by gamma irradiation. The purpose of this Special 510(k) is to expand the needle range to include the 31G and 32G Extra Thin Wall (XTW) pen needles with PentaPoint™ design. The intended use for the modified device remains the same as the predicate devices. Also it is BD's intent to notify the Agency of a non-significant change to the cannula point bevel geometry from 3 bevels (PentaPoint™).
The provided document describes the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™ and their performance testing to demonstrate substantial equivalence to predicate devices. It does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, some of the requested information regarding AI models, experts, adjudication methods, and training sets is not applicable based on the provided text.
Here's an analysis of the provided information, focusing on the acceptance criteria and performance studies for the pen needle:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Section) | Device Performance (Metric) | Meets Criteria? |
|---|---|---|
| Tubing diameters (ISO 11608-2, section 4.3.1) | OD and ID requirements met | Yes |
| Patency of lumen (ISO 11608-2, section 4.4) | Stylet (80% ±2% of lumen ID) passes freely | Yes |
| Needle points (ISO 11608-2, section 4.5) | Visually sharp at 2.5X magnification, designed to minimize coring and fragmentation | Yes |
| Type A Needle (length) (ISO 11608-2, section 4.3.2) | Patient end within indicated length ± 1.25 mm | Yes |
| Cannula load test (No pre-conditioning) (ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13.1) | Cannula holds force of 22N for 5 seconds | Yes |
| Cannula load test (with pre-conditioning) (ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13) | Cannula holds force of 22N for 5 seconds | Yes |
| Lubrication (ISO 11608-2, section 4.7) | No visible droplets inside/outside surfaces of cannula | Yes |
| Compatibility Testing (ISO 11608-2, section 4.10) | Connectivity (torque) | Yes |
| Penetration Testing (BD Test Method TP700279) | Not specified (assumed to meet internal standard for substantial equivalence) | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each bench test. The studies are bench tests, meaning they are conducted in a controlled laboratory environment on the device itself, rather than with human subjects or patient data. Data provenance is not applicable in the sense of country of origin for patient data, as no patient data was used for these tests. The tests were performed internally by Becton, Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these performance metrics is established by the specifications defined in the international standards (ISO 11608-2 and ISO 7864) and the internal BD test method (TP700279), not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. The tests are direct measurements against predefined physical and performance specifications, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for imaging or diagnostic devices where human interpretation is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a physical medical device (pen needle), not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for these performance tests are:
- International Standards: ISO 11608-2 (Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define objective, measurable specifications for the physical and functional characteristics of pen needles.
- Internal Test Method: BD Test Method TP700279 for penetration testing. While the details are not provided, it's assumed to be an objective, repeatable test method.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
§ 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).