(63 days)
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No
The summary describes a physical medical device (punctual occluder) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "treatment" of "dry eye" conditions.
No
Explanation: The device, a punctal occluder, is intended for treatment of "dry eye" conditions by total occlusion of punctal openings. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is made of medical grade silicone and titanium dioxide, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of "dry eye" conditions by physically occluding punctal openings. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical plug made of silicone and titanium dioxide, designed to be inserted into the body. This is consistent with a medical device used for treatment, not a reagent or instrument used for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the device described is a medical device intended for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
Product codes
LVK
Device Description
This device, made of medical grade silicone and titanium dioxide as a colorant under current good manufacturing practices, is a small, generally "plug" shaped Punctal Occluders.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
punctum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
the pre-amendment EV - Freeman Punctum Plug
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized circle and the word "ODYSS". The circle is thick and black, with a series of vertical lines extending from the left side, creating a visual effect of movement or energy. To the right of the circle, the word "ODYSS" is written in a simple, sans-serif font, with each letter clearly spaced and outlined in black.
APR 23 1997
5-1
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 Punctal Occluders are intended for the treatment of "dry eye" design. 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:
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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.
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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.