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510(k) Data Aggregation
(99 days)
NOVAGUARD S A SAFETY SYSTEM
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
The proposed device, NovaGuard SA Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8" The NovaGuard SA Safety System consist of two components, a subassembly (syringe holder, sleeve and spring) and a clip. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.
The provided text describes the NovaGuard SA Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. However, the document is a 510(k) summary for FDA clearance and does not contain detailed information about specific acceptance criteria or a comprehensive study report in the format requested.
Therefore, I cannot populate all the fields in the table or answer all the questions directly from the provided text. The information is primarily focused on demonstrating substantial equivalence to predicate devices and fulfilling FDA guidance requirements.
Here's what can be extracted and inferred, along with limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a detailed quantitative manner as "acceptance criteria X and reported performance Y." Instead, the document mentions compliance with general principles and performance requirements for sharps injury prevention devices.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Device functions as intended. | "It was confirmed that the device functioned as intended." (Bench testing) |
| Biocompatibility requirements met. | "Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited ( |
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