(91 days)
The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- Determine the potential effectiveness of permanent occlusion, .
- Temporarily treat dry eye syndrome, and the dry eye components of various ocular . surface diseases,
- . Temporarily enhance the efficacy of topical medications or ocular lubricants.
- . Temporarily treat contact lens intolerance secondary to dry eye, and
- Temporarily treat dry eye after ocular surgery.
Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO).
The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.
This document describes a 510(k) premarket notification for the Comfortear® Lacrisolve™ Absorbable Punctum Plug. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria in the clinical performance sense (e.g., diagnostic accuracy or treatment effectiveness).
The "acceptance criteria" discussed in the document are primarily related to safety, material biocompatibility, and manufacturing controls, aligning with the requirements for justifying substantial equivalence.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of quantitative acceptance criteria and device performance for clinical effectiveness per se. Instead, it outlines testing performed to ensure safety and manufacturing consistency. The "acceptance criteria" are implied by compliance with established international and FDA standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10⁻⁶ or better (EN ISO 11135-1:2007) | Validated with a half-cycle; independent lab monitoring. |
| Ethylene Oxide (EO) Sterilization Residuals (ANSI/AAMI/ISO 10993-7:2008(R)2012) | Results "fell far below" the standard. Upper control limit set at 3 times measured value for routine testing, which is "well below" ISO standards. |
| Endotoxin Limit (Bacterial Endotoxins Test, LAL) for medical devices (not more than 20.0 EU/device, and not more than 2.15 EU/device for CSF contact devices) (ANSI/AAMI ST72:2011, USP , USP , EP 2.6.14, JP 4.01) | Detected Endotoxin: , USP , EP 2.6.14, and JP 4.01 (e.g., |
N/A