(210 days)
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Not Found
No
The summary describes a physical device (a punctum plug) with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is used for the "treatment of dry eye and other conditions" by enhancing tear retention, which is a therapeutic purpose.
No
The device is used for treatment (enhancing fluid retention, treatment of dry eye) and does not describe any diagnostic function like detecting, diagnosing, or monitoring a disease or condition.
No
The device description explicitly states it is a "flexible silicone ophthalmic device," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device is a "flexible silicone ophthalmic device designed to fit and be retained in the punctum." Its function is to physically occlude the punctum to enhance tear retention.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples taken from the body. It is a physical device used to treat a condition directly within the eye.
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
LZU
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
punctum
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical tests: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows a close-up of a stylized eye with a teardrop falling from it. The eye is drawn in black and white, with thick lines defining the upper and lower lids. The teardrop is also stylized, with a rounded shape and a small loop at the bottom.
Image /page/0/Picture/2 description: The image shows the logo for Lacrimedics, Inc. The logo consists of a stylized eye symbol on the left, followed by the company name "Lacrimedics, Inc." in a bold, sans-serif font. The word "Lacrimedics" is larger than "Inc.", and there is a trademark symbol above and to the right of the "s" in "Lacrimedics".
APR 1 4 1997
190 N. Arrowhead Ave., Suite B • Rialto, CA 92376-9908 USA
Herrick Ultimate Punctum Plug Device name: Punctum Plug Device common name: Punctum Plug (86LZU) Classification name: Tapered-Shaft Punctum Plug (marketed by Eagle Vision Predicate devices: and Ciba Vision) Soft Plug™ (marketed by Oasis) Punctum Plug (marketed by FCI Ophthalmics) A flexible silicone ophthalmic device designed to fit and Device description: be retained in the punctum. Used to enhance retention of eye fluids by occlusion of Device use: one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.
510(k) NOTIFICATION SUMMARY
Comparison to predicate devices:
| | Device name | Herrick Ultimate
Punctum Plug
(Lacrimedics) | Tapered Shaft Punctum
Plug
(Eagle Vision & Ciba) | Soft Plug
(Oasis) | Punctum Plug
(FCI Ophthalmics) |
|----|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Features | | | | |
| 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 3-11-97
Dr. Robert S. Herrick, MD Date
CEO