(62 days)
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings.
This 510(k) summary (K090938) describes a Micro Flow Punctal Occluder, a medical device intended for the treatment of "dry eye" conditions. The submission makes a case for substantial equivalence to a predicate device (Odyssey Punctal Occluder, K970631) rather than directly presenting a study to prove new acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them is not explicitly available in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device.
Here's an explanation based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the form of measurable acceptance criteria or performance metrics derived from a study. The submission asserts substantial equivalence based on material, design, and intended use.
- Study Details: There is no description of a study conducted to demonstrate the device's performance against specific acceptance criteria.
Key points from the 510(k) summary regarding the device and its comparison to the predicate:
- Device Description: The Micro Flow Punctal Occluder is made of medical grade silicone with titanium dioxide as a colorant and a proprietary surface treatment. It's a small, "plug" shaped design.
- Intended Use: Treatment of "dry eye" conditions through partial occlusion of individual punctal openings.
- Predicate Device: Odyssey Punctal Occluder (K970631).
- Differences from Predicate (Micro-Flow vs. Original Odyssey Plug):
- Original: Larger angle nose, no through hole, shorter length.
- Micro-Flow (New):
- Has a through hole for partial occlusion.
- A 0.002 ridge on the nose to support the through hole.
- Smaller angle on the nose (tip).
- Safety and Reversibility: The document highlights that the submitted method is functionally safe and fully reversible, unlike some alternative methods that are permanent or difficult to reverse, or risk damaging intact tissue.
In summary, the provided document does not contain the details of a study with acceptance criteria, sample sizes, expert qualifications, or adjudication methods as requested. It is a 510(k) submission relying on substantial equivalence to a predicate device.
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