(105 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 allows 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 a silicone based lube for ease of injection and rubber septum penetration. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peelaway (tear drop) label to provide sterility 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 bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized.
The purpose of the 510(k) is to expand the needle range to include the 23G x 7 mm pen needle size. Future needle range expansions may include 24G to 28G in various lengths for which appropriate verification and validation activities will be conducted. The intended use for the modified device remains the same as the predicate device.
The provided text describes the performance testing of the BD 23G X 7mm Pen Needle, focusing on its equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Standard Reference |
|---|---|---|
| Tubing diameters | Tubing dimensions meet OD and ID requirement. | ISO 11608-2, section 4.3.1 |
| Patency of lumen | Stylet, having a diameter equivalent to 80% ±2% of lumen ID, passes through freely. | ISO 11608-2, section 4.4 |
| Needle points | Visually sharp at 2.5X magnification, designed to minimize coring and fragmentation. | ISO 11608-2, section 4.5 |
| Non-Type A Needle (length) | Patient end within indicated length ± 1.25 mm. | ISO 11608-2, section 4.3.3 |
| Cannula load test (No pre-conditioning) | Cannula holds force of 34N for 5 seconds. | ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13.1 |
| Cannula load test (with pre-conditioning) | Cannula holds force of 34N for 5 seconds. | ISO 11608-2, section 4.9 and 9; ISO 7864 |
| Lubrication | No visible droplets inside/outside surfaces of cannula. | ISO 11608-2, section 4.7 |
| Compatibility Testing | Connectivity (torque) meets acceptance criteria. | ISO 11608-2, section 4.10 |
| Cover Impact Testing | Meets acceptance criteria. | BD design verification protocol (specific criteria not detailed in the provided text) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each bench test. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as "bench tests," implying laboratory-based evaluations rather than clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. Bench testing for medical devices like pen needles typically relies on objective measurements against international standards (e.g., ISO) and internal design specifications, rather than expert consensus on subjective observations.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable to the described bench tests. These methods are typically used in clinical trials involving interpretation of medical images or patient outcomes, where human experts might disagree on subjective assessments. The tests for the pen needle are objective, measurable parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document describes bench tests comparing the new device to predicate devices on physical and mechanical properties, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument (pen needle), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was established by international standards (ISO 11608-2, ISO 7864) and internal BD design verification protocols. These standards define the acceptable physical and mechanical properties of pen needles. For example, the patency of the lumen is verified by the passage of a stylet of a specific diameter, which is a direct, objective measurement against a defined standard, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical pen needle, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for a physical device like a pen needle.
§ 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).