PUNCTUAL OCCLUDER

K970631 · Odyssey Medical, Inc. · LZU · Apr 23, 1997 · OP

Device Facts

• Record ID: K970631
• Device Name: PUNCTUAL OCCLUDER
• Applicant: Odyssey Medical, Inc.
• Product Code: LZU · OP
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Punctal Occluders are intended for the treatment of “dry eye” conditions through the total occlusion of individual punctal openings.

Device Story

Punctal occluder; small plug-shaped device; inserted into punctal openings to treat dry eye. Material: medical-grade silicone with titanium dioxide colorant. Operation: mechanical occlusion of punctum; fully reversible; non-invasive; no tissue breach required. Used by clinicians in office settings. Benefits: provides relief for dry eye symptoms; avoids permanent surgical methods; allows for easy removal/reversal without tissue damage.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to pre-amendment predicate.

Technological Characteristics

Medical-grade silicone; titanium dioxide colorant; plug-shaped form factor; non-powered; mechanical occlusion principle.

Indications for Use

Indicated for patients with dry eye conditions requiring total occlusion of punctal openings.

Predicate Devices

• EV - Freeman Punctum Plug

Submission Summary (Full Text)

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n970631
ODYSSEY
APR 23 1997

# SECTION 5 - 510(K) SUMMARY

Submitted: February 15, 1997
By: Raymond G. Wallace
Trade Name: Punctal Occluder
Common Name: Punctum Plugs
Classification Name: Punctum Plugs (per 21 CFR § 886)

## Summary:

This device, made of medical grade silicone and titanium dioxide as a colorant under current good manufacturing practices, is a small, generally “plug” shaped design. Punctal Occluders are intended for the treatment of “dry eye” conditions through the total occlusion of individual punctal openings.

By material, design and intended use, the Odyssey Punctal Occluder is substantially equivalent to the pre-amendment EV - Freeman Punctum Plug.

Differences between the two devices may be described as follows:

1. The Eagle Vision plug has a slight “taper” which they have patent protection on, however, their pre-amendment device has no such “taper” and is identical to the Odyssey device. The claims made by Eagle Vision in favor of the “tapered shaft” have no known data to support them and no 510(k) to suggest that the design change is significant enough to warrant it.

2. The titanium dioxide present in both devices is used as a colorant. As such, it is Odyssey’s opinion that less titanium dioxide does not hinder the visibility of the device.

Alternative methods are either permanent or difficult to reverse. In contrast, the submitted method is both functionally safe and fully reversible. Unlike some other methods, this device does not require the breach of intact tissue surfaces nor the risk of damaging said surfaces should reversal become desirable.

ODYSSEY Medical, Inc. / 1710 Shelby Oaks Drive, Suite21 / Memphis, TN 38134 / 901-383-7777 / FAX [phone]