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510(k) Data Aggregation
(70 days)
MONOJECT SAFETY NEEDLE
The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.
The proposed device consists of a sterile, single-lumen hypodermic needle with an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip operation or by pressing the shield against a hard surface. Once activated, the safety shield is securely and permanently locked.
The Kendall Monoject® Safety Needle is a hypodermic needle with a sharps injury prevention feature.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative format, nor does it report specific numerical performance metrics for the device's efficacy in preventing sharps injuries. Instead, it focuses on demonstrating biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility according to ISO 10993-1 and FDA modified matrix | Device meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size or details of the test set used for the biocompatibility testing. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study is a non-clinical biocompatibility test, not one involving expert review of medical images or diagnoses to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable for a biocompatibility study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document refers to "Nonclinical Testing" for biocompatibility, not a clinical study involving human readers or comparative effectiveness with AI.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. This device is a physical medical device (hypodermic needle), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" for the biocompatibility testing would be adherence to the established scientific guidelines and benchmarks outlined in the ISO 10993-1 standard and FDA's modified matrix for biological evaluation of medical devices. This is based on standardized scientific protocols and laboratory testing rather than expert clinical consensus, pathology, or outcomes data in the typical sense of AI studies.
8. Sample Size for the Training Set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
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