(1127 days)
MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.
This document, K200452, pertains to the FDA 510(k) premarket notification for MERIL-BONEWAX™. As a 510(k) submission, it aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be typical for a new device requiring a PMA.
Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to performance tests designed to establish substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of precise quantitative acceptance criteria with corresponding performance values for parameters like sensitivity, specificity, or quantifiable clinical outcomes. Instead, the acceptance criteria are generally qualitative or based on demonstrating equivalence to predicate devices and adherence to established standards.
| Acceptance Criteria Category | Description of Performance Test | Reported Performance / Outcome |
|---|---|---|
| Usability | Kneadability Test | Demonstrated device usability |
| Spreadability Test | Demonstrated device usability | |
| Hemostasis Effectiveness | Animal Performance Test (Porcine Model) | Effective in control of bleeding from the bone surface |
| Biocompatibility | Tests according to ISO 10993-1 | Test results suggest the device is biocompatible |
| Sterilization | Assessed via ISO 11137-1:2006 and ISO 11137-2:2013 | Sterilization method (Gamma irradiation) is established as per standards |
| Bacterial Endotoxin | Limulus amebocyte lysate (LAL) test by Gel Clot Technique | Test results met the specification of |
N/A