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510(k) Data Aggregation
(265 days)
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
The requested information regarding acceptance criteria and study details for the Advocate Insulin Pen Needles, based on the provided FDA 510(k) summary, is presented below.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with human readers or AI performance metrics. Therefore, several sections of your request related to AI, human reader improvement, and training set details are not applicable or cannot be extracted from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Normative References/Description | Acceptance Criteria (Implied by "All pre-determined acceptance criteria were met") | Reported Device Performance |
|---|---|---|---|
| Accelerated Shelf Life | ASTM F 1980-07, ISO 11607-1, ISO 11608-2, ASTM F 1929, ASTM F88 | Meet requirements of the referenced standards (e.g., maintain sterility, package integrity, and functional performance over simulated shelf life). | All pre-determined acceptance criteria were met. |
| EO Sterilization Validation | Validation process used a standard half-cycle method to demonstrate the efficacy of the EO sterilization process. | Efficacy of EO sterilization process demonstrated. | All pre-determined acceptance criteria were met. |
| EO Residual | Sterilant residual limit for limited exposure met of EO <4mg and ECH <9mg. | EO residual <4mg and ECH <9mg. | All pre-determined acceptance criteria were met. |
| Biocompatibility Testing | Cytotoxicity - ISO 10993-5, Sensitization - ISO 10993-10, Intracutaneous reactivity - ISO 10993-10, Systemic Toxicity - ISO 10993-11, Haemocompatibility - ISO 10993-4 | Meet the requirements of the referenced ISO 10993 standards (e.g., non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, haemocompatible). | All pre-determined acceptance criteria were met. |
| Performance Testing (Mechanical & Functional Compatibility) | ISO 11608 – 2 Includes mechanical testing and determination of functional compatibility with specific pen injector devices (NIS). | Meet the requirements of ISO 11608-2 (e.g., satisfactory mechanical strength, functional compatibility with NIS pen injectors). | All pre-determined acceptance criteria were met. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the exact sample sizes for each performance test. The tests are non-clinical, evaluating the physical and biological characteristics of the device itself (e.g., sterility, material properties, mechanical function) rather than performance on patient data.
- Sample Size: Not explicitly stated for individual tests.
- Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) as these are non-clinical device performance tests. The tests were conducted internally by the manufacturer or contract labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. These are non-clinical (engineering and laboratory) tests. "Ground truth" in this context refers to established scientific and engineering standards and validated test methodologies, not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to the resolution of disagreements among human expert evaluators, which is not relevant for objective non-clinical performance tests.
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
Not applicable. The document describes a medical device (insulin pen needles), not an AI diagnostic or assistive technology. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests is defined by established international and national standards (e.g., ISO, ASTM), validated laboratory methods, and manufacturing specifications. For example:
- Sterility: Absence of viable microorganisms, confirmed by validated methods.
- Biocompatibility: Absence of adverse biological reactions, confirmed by meeting ISO 10993 standards.
- Mechanical Performance: Meeting specified force, torque, and dimensional requirements according to ISO 11608-2.
- EO Residuals: Chemical analysis confirming levels below specified thresholds.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8).
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