(223 days)
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Not Found
No
The summary describes a physical device (a punctum plug) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for the "treatment of dry eye and other conditions where enhancement of tear retention is indicated," which signifies a therapeutic purpose.
No
The device is described as "Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow." This indicates a treatment function (enhancement of tear retention for dry eye and related conditions), not a diagnostic function.
No
The device description clearly states it is a "flexible silicone ophthalmic device," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "flexible silicone ophthalmic device designed to fit and be retained in the punctum" to "enhance retention of eye fluids by occlusion of one or more punctum." This is a physical device that is inserted into the body to alter a physiological process (tear drainage).
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is therapeutic, aimed at treating dry eye and similar conditions by physically blocking tear drainage.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.
Product codes
86LZU
Device Description
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Clinical tests: None
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for Lacrimedics, Inc. The logo consists of an eye with a teardrop falling from it, followed by the company name in a stylized font. A horizontal line is underneath the company name. The logo is black and white.
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190 N. Arrowhead Ave., Suite B • Rialto, CA 92376-9908 USA
APR 1 4 1997
510(k) NOTIFICATION SUMMARY
| Device name: | Herrick Ultimate Punctum Plug |
|---|---|
| Device common name: | Punctum Plug |
| Classification name: | Punctum Plug (86LZU) |
| Predicate devices: | Tapered-Shaft Punctum Plug (marketed by Eagle Vision |
| and Ciba Vision) | |
| Soft Plug™ (marketed by Oasis) | |
| Punctum Plug (marketed by FCI Ophthalmics) | |
| Device description: | A flexible silicone ophthalmic device designed to fit and |
| be retained in the punctum. | |
| Device use: | Used to enhance retention of eye fluids by occlusion of |
| one or more punctum, reducing lacrimal flow. Useful for | |
| treatment of dry eye and other conditions where | |
| enhancement of tear retention is indicated |
Comparison to predicate devices:
| | Device name
Features | Herrick Ultimate
Punctum Plug
(Lacrimedics) | Tapered Shaft Punctum
Plug
(Eagle Vision & Ciba) | Soft Plug
(Oasis) | Punctum Plug
(FCI Ophthalmics) |
|----|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 1. | Indications
claimed | Treatment of dry eye
After eye surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment aid | Treatment of dry eye | Treatment of dry eye
After eye surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment aid | (Not available) |
| 2. | Function | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention |
| 3. | Design - length | 1.8 mm | 1.8 mm | 2.0 mm | 2.0 mm |
| | diameter (typical) | 0.8 mm | 0.7 mm | 0.9 mm | 0.8 mm |
| 4. | Material | Medical grade silicone | Medical grade silicone | Medical grade silicone | Medical grade silicone |
| Clinical tests: | None |
|---|---|
| Adverse S&E information: | None |
Robert S. Herrick, MD
Dr. Robert S. Herrick, MD
CEO
| Date | 3-11-97 |
|---|---|
| ------ | --------- |