(591 days)
The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
The provided text describes the 510(k) premarket notification for the EasyTouch™ Safety Pen Needle (K163578). This document primarily establishes substantial equivalence to a predicate device (BD Autoshield™ Pen Needle, K060007) based on technical characteristics and non-clinical testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of a typical AI/ML medical device submission.
However, I can extract the information related to the device's performance based on the non-clinical testing performed, which serves as evidence for its safety and effectiveness, and thus acts as a form of "acceptance criteria" for the 510(k) submission.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table for a specific performance metric like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the requirements of the standards and regulations the device needs to comply with. The "reported device performance" is that the device "passed" these tests or "complies" with the standards.
| Acceptance Criteria (Implied by Test/Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity (ISO 10993-5) | No cytotoxicity |
| Biocompatibility: No skin irritation (ISO 10993-10) | No evidence of skin irritation |
| Biocompatibility: No skin sensitization (ISO 10993-10) | No evidence of sensitization |
| Biocompatibility: No acute systemic toxicity (ISO 10993-11) | No systemic toxicity |
| Biocompatibility: No pyrogenicity (ISO 10993-11) | All tests passed |
| Biocompatibility: No hemolysis (ISO 10993) | No evidence of hemolysis |
| Mechanical Testing: Proper functioning of safety feature (FDA Guidance: Medical Devices with Sharps Injury Prevention Features) | Safety feature function evaluated and passed |
| Pen Injector Compatibility: Proper function with multiple pen injectors (ISO 11608-1 and ISO 11608-2) | Pen needle works properly with multiple brands of pen injectors |
| Sterility: Sterility Assurance Level (SAL) of 10⁻⁶ | SAL: 10⁻⁶ (Ethylene Oxide sterilization) |
| Packaging Integrity, Permeability, Compression Resistance, Resistance to Bacteria for 5-year shelf life | Accelerated packaging testing assured a 5-year shelf life |
| Compliance with ISO 7864 (Sterile hypodermic needles for single use) | Testing performed to assure compliance |
| Compliance with ISO 9626 (Stainless steel needle tubing for medical devices) | Testing performed to assure compliance |
2. Sample size used for the test set and the data provenance
The document details non-clinical bench testing. It does not specify "sample sizes" for individual tests in the way an AI/ML study would for a test set of images. For mechanical testing of the safety feature, it states "utilizing both professional health care workers and non-clinician pen users using gloved hands." The exact number of users or devices tested is not provided.
- Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of devices for mechanical testing, number of runs for sterility).
- Data Provenance: Not applicable in the context of clinical patient data. The tests are bench tests performed in a lab setting, likely at the manufacturer's facility or a contract testing lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study described is a non-clinical device performance and safety study, not a study involving expert annotation or ground truth establishment for AI/ML algorithms. The "ground truth" for the tests is defined by the objective pass/fail criteria of the specified international standards (ISO) and FDA guidance documents.
4. Adjudication method for the test set
Not applicable. The performance is determined by objective measurement against established standards, not by expert adjudication of classifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a 510(k) submission for a physical medical device (safety pen needle), not an AI/ML software device. Therefore, MRMC studies and AI-assisted human reader performance are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on objective, measurable criteria defined by international standards (ISO) and FDA guidance documents for device performance, safety, and biocompatibility. For instance, a sterility test's ground truth is a quantified sterility assurance level, and biocompatibility tests have established biological endpoints.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).