(144 days)
Becton Dickinson Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
The BD Nano™ 2nd Gen Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs. It consists of a needle, base, and shield assembly. The BD Nano™ 2nd Gen Pen Needle is offered in a 32 gauge size and 4mm length. It is a singleuse disposable device that is provided sterile. The BD Nano™ 2nd Gen Pen Needle is nontoxic and non-pyrogenic.
The provided text describes the 510(k) summary for the BD Nano 2nd Gen Pen Needle, primarily focusing on its substantial equivalence to a predicate device (BD Contoured Base Pen Needle, K182320) after a material change.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the acceptance criteria are based on ISO 11608-2:2012 for functional performance and ISO 10993-1:2018 for biocompatibility. The reported device performance is that it "passed" these tests. Specific quantitative acceptance criteria or performance values are not detailed in this summary.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 11608-2:2012 (Functional Performance) | Passed |
| ISO 10993-1:2018 (Biocompatibility) | Passed |
Functional Performance Tests (per ISO 11608-2):
- Determination of Flow Rate through Needle
- Bond between Hub and Cannula
- Pen Installation and Removal Torque
- Dose Accuracy
Biocompatibility Tests (per ISO 10993-1):
- Cytotoxicity
- Intracutaneous Reactivity
- Skin Sensitization
- Acute Systemic Toxicity
- Subacute / Subchronic Toxicity
- Genotoxicity Bacterial and Mammalian
- Material-Mediated Pyrogenicity
- Implantation
- Bacterial Endotoxin
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test (e.g., number of needles tested for flow rate or bond strength). It refers to "testing" and "validated the design," implying samples were used as per the standards, but the specific number is not provided.
The data provenance is retrospective as the device's design (excluding material changes) and its predicate are already established, and the testing validates the modified device against established standards. The explicit country of origin for the data is not mentioned, but the submission is to the U.S. FDA by a company based in Franklin Lakes, New Jersey, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies evaluating expert interpretation or clinical diagnosis. The "ground truth" for these tests are the objective measurements defined by the ISO standards and their pass/fail criteria.
4. Adjudication Method for the Test Set
This section is not applicable as the described studies are non-clinical performance and biocompatibility tests, not studies involving human judgment or clinical endpoints that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study was included in this submission." The evaluation focuses on non-clinical performance and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a "pen needle," a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by:
- Objective performance criteria derived from ISO 11608-2:2012 for functional characteristics (e.g., specific flow rates, torque values, dose accuracy).
- Biological safety endpoints and criteria derived from ISO 10993-1:2018 for biocompatibility (e.g., demonstrating non-cytotoxicity, no sensitization).
These are engineering/materials performance standards and biological safety standards, not clinical pathology, expert consensus, or outcomes data in the usual sense for diagnostic or prognostic devices.
8. The Sample Size for the Training Set
This section is not applicable as the device is a physical medical device (pen needle), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the device is a physical medical device, not an AI algorithm.
§ 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).