(210 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.
K963708, a 510(k) premarket notification for the Herrick Ultimate Punctum Plug, does not contain information related to acceptance criteria or studies proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing performance studies and acceptance criteria as a standalone device.
Specifically, the document states "Clinical tests: None" and "Adverse S&E information: None", indicating that no clinical studies were performed or are being presented in this submission. The comparison table focuses on features, indications, function, design (length, diameter), and material between the Herrick Ultimate Punctum Plug and predicate devices to establish substantial equivalence.
Therefore, I cannot provide the requested information based on the provided text.
{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 UltimatePunctum Plug(Lacrimedics) | Tapered Shaft PunctumPlug(Eagle Vision & Ciba) | Soft Plug(Oasis) | Punctum Plug(FCI Ophthalmics) | |
|---|---|---|---|---|---|
| Features | |||||
| 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 3-11-97
Dr. Robert S. Herrick, MD Date
CEO
N/A