(223 days)
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
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
The provided document is a 510(k) Notification Summary for the Herrick Ultimate Punctum Plug. It does not contain information about acceptance criteria or specific studies proving device performance beyond a comparison to predicate devices and a statement that no clinical tests were performed.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document explicitly states "Clinical tests: None" and "Adverse S&E information: None," indicating that no performance studies of the type described in the request were conducted or reported for this submission. The basis for clearance appears to be substantial equivalence to predicate devices based on indications, function, design (dimensions), and material.
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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 Visionand Ciba Vision)Soft Plug™ (marketed by Oasis)Punctum Plug (marketed by FCI Ophthalmics) |
| Device description: | A flexible silicone ophthalmic device designed to fit andbe retained in the punctum. |
| Device use: | Used to enhance retention of eye fluids by occlusion ofone or more punctum, reducing lacrimal flow. Useful fortreatment of dry eye and other conditions whereenhancement of tear retention is indicated |
Comparison to predicate devices:
| Device nameFeatures | Herrick UltimatePunctum Plug(Lacrimedics) | Tapered Shaft PunctumPlug(Eagle Vision & Ciba) | Soft Plug(Oasis) | Punctum Plug(FCI Ophthalmics) | |
|---|---|---|---|---|---|
| 1. | Indicationsclaimed | Treatment of dry eyeAfter eye surgeryEnhance efficacy ofmedicationsTreatment of contactlens problemsAdjunctive treatment aid | Treatment of dry eye | Treatment of dry eyeAfter eye surgeryEnhance efficacy ofmedicationsTreatment of contactlens problemsAdjunctive treatment aid | (Not available) |
| 2. | Function | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater 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 |
|---|---|
| ------ | --------- |
N/A