(85 days)
The OASIS® Medical Silicone Punctal Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the punctum
Silicone Punctal Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pyterygium, blepharitis, keratitis, red lid margins, recurrent chalazions, recurrent corneal erosion, filamentry keratitis and other external eye diseases.
Other patients that may benefit are: cataract patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.
The OASIS Medical Silicone Punctal Plug is designed to be inserted into the punctal opening in order to block tear drainage through the canaliculus. Each Punctal Plug is molded from medical grade silicone and comes premounted on an inserter. The plugs are available in the following sizes: Micro, Mini, Petite, Small, Medium.
The provided text is a 510(k) summary for the OASIS Medical Silicone Punctal Plug. It describes the device, its intended use, and its substantial equivalence to a previously marketed device. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.
The 510(k) process is primarily a premarket notification to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics and performance to the predicate, rather than establishing specific acceptance criteria and performing a new clinical study to meet those criteria from scratch.
Therefore, I cannot fulfill your request for the structured table and detailed answers concerning acceptance criteria and a study to prove they are met because the necessary information is not present in the provided text.
Specifically, the document states:
- "The OASIS Medical Silicone Punctal Plug is substantially equivalent to the OASIS Medical Silicone Punctal Plug (K945906)." This indicates that the regulatory pathway was based on equivalence, not on fulfilling novel acceptance criteria with a new clinical study.
- "The OASIS Medical Silicone Punctal Plug is identical to the predicate device except for its physical design and a modifieed inserter." This further emphasizes the focus on design comparison rather than a new performance study.
Without information detailing a specific study performed to demonstrate achievement of defined acceptance criteria, I cannot complete the requested output.
N/A