Search Results

Single use devices that are 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 SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (

The provided text describes the 510(k) summary for the UltraSafe Passive Needle Guard, a medical device designed to prevent accidental needlesticks. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. The "acceptance criteria" are implied by the performance data and the conclusion of substantial equivalence.

Ask a specific question about this device