(101 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 use 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 and 31G) and lengths (5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), nontoxic 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. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (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 this 510(k) Premarket Notification is to expand the product offering to include a 32G x 4mm Pen Needle. The intended use for the modified device remains the same as the predicate device.
This document describes the regulatory submission for the BD 32G x 4mm Pen Needle, demonstrating its substantial equivalence to predicate devices. The primary study presented is a clinical evaluation of glycemic control.
1. Acceptance Criteria and Reported Device Performance
| Performance Characteristic/Test Description | Acceptance Criteria (Implicit from ISO 11608-2) | Reported Device Performance |
|---|---|---|
| Clinical Performance: Comparison of Glycemic Control among Diabetics using the 4mm x 32G BD Pen Needle vs. the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle. | Equivalent glycemic control and a similar safety profile to predicate pen needles. (Implicit) | This study demonstrated that the 4 mm x 32G pen needle tested provides equivalent glycemic control and a similar safety profile to two predicate pen needle products - the 5mm x 31G and 8 mm x 31G pen needles. The clinical study summary can be found in Section XV, Clinical Performance. |
| Bench Testing (per ISO 11608-2): | ||
| Tubing diameters | Section 4.3.1 (tubing dimensions meet OD and ID requirements) | Tubing dimensions meet OD and ID requirements. |
| Patency of lumen | Section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely) | Stylet, having a diameter equivalent to 80% ±2% of lumen ID, passes through freely. |
| Needle points | Section 4.5 (visually sharp at 2.5X magnification) | Visually sharp at 2.5X magnification. |
| Needle dislocation (angularity) | Section 4.8 (4 mm patient end needle length meets needle dislocation requirements) | 4 mm patient end needle length meets needle dislocation requirements. |
| Type A needles (length) | Section 4.3 (patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm) | Patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm. |
| Cannula load test (No pre-conditioning) | Section 4.9 (cannula holds force of 22N for 5 seconds) | Cannula holds force of 22N for 5 seconds. |
| Cannula load test (with pre-conditioning) | Section 4.9 (cannula holds force of 22N for 5 seconds) | Cannula holds force of 22N for 5 seconds. |
| Siliconization (lubrication) | Section 4.7 (no visible droplets inside/outside surfaces of cannula) | No visible droplets inside/outside surfaces of cannula. |
| Universal Fit Compatibility Testing | Section 4.1 (connectivity (torque) and dose accuracy testing) | Connectivity (torque) and dose accuracy testing were successfully met for all pen families. The full set of insulin pen families available in the U.S. were tested with the BD 32G x 4mm Pen Needle for compatibility. Connectivity acceptance criteria per ISO 11608-2 were successfully met for all pen families. (From Section 7) |
2. Sample Size and Data Provenance
- Test Set (Clinical Study): The document does not explicitly state the sample size (number of subjects) for the clinical study "BDDC-08-011". It only mentions "subjects' glycemic control".
- Data Provenance: The document does not specify the country of origin for the clinical study data. It is a "clinical study conducted on the BD 32G x 4mm Pen Needle," indicating it was prospective.
- Test Set (Bench Testing): The document does not specify sample sizes for each bench test performed according to ISO 11608-2.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a medical device like a pen needle) does not typically involve "experts" establishing ground truth in the way it would for AI/diagnostic algorithms.
- For the Clinical Study: The "ground truth" for glycemic control would be established through objective laboratory measurements (fructosamine levels) and clinical observation of safety profiles. While medical professionals (e.g., endocrinologists, nurses) would oversee the study, their role is not to establish a "ground truth" in the diagnostic sense, but to collect and interpret data against pre-defined clinical endpoints. No specific number or qualification of experts for "ground truth establishment" is provided or expected.
- For Bench Testing: The "ground truth" is based on adherence to the specified International Standard ISO 11608-2. This is based on objective, quantifiable measurements and visual inspections against defined criteria within the standard. The "experts" involved would be qualified technicians and engineers performing these standardized tests, but their qualifications are not detailed in the summary.
4. Adjudication Method
- Clinical Study: Not applicable in the context of diagnostic AI. Clinical endpoints are typically adjudicated by an independent committee (e.g., Clinical Events Committee) if there are subjective elements, but the document does not specify any such process. For glycemic control, the primary data (fructosamine levels) are objective.
- Bench Testing: Not applicable. Measurements are objective and compared against ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is more relevant for diagnostic imaging or interpretation tasks where human readers might be assisted by AI. For a pen needle, the focus is on physical and functional performance and direct clinical outcomes like glycemic control, not AI-assisted interpretation.
6. Standalone (Algorithm Only) Performance Study
- No standalone (algorithm only) performance study was done. This device is a physical medical device (pen needle), not an AI algorithm. Therefore, "algorithm only performance" is not applicable.
7. Type of Ground Truth Used
- Clinical Study (BDDC-08-011): The ground truth for the clinical study was based on outcomes data, specifically "fructosamine levels" to assess glycemic control, and an evaluation of the "safety profile." Fructosamine is an objective biochemical marker indicating average blood glucose levels over a period.
- Bench Testing: The ground truth for bench tests was adherence to specified objective criteria and measurements as defined by the international standard ISO 11608-2.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device and does not involve AI/machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).