(781 days)
The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.
The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.
Here's a summary of the acceptance criteria and study information for the Kahook Dual Blade Glide, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document does not explicitly present a table of quantitative acceptance criteria with corresponding performance directly within the "Performance Data" section for each specific test in the same way a software validation might. However, it states that "Results of the non-clinical bench testing demonstrate that the Kahook Dual Blade Glide meets the defined specifications and functions as intended." It broadly indicates that "All samples met the acceptance criteria" for tests like corrosion, endotoxin, visual inspection, bubble leak, tensile test, and non-cytotoxicity, non-sensitizer, non-irritant, and non-toxic for biocompatibility.
For clinical effectiveness, the primary endpoint was used as an acceptance criterion, and device performance is reported against it.
| Test/Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | (Implicit: Meets defined specifications and functions as intended) | |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-Cytotoxic |
| Sensitization | Non-sensitizer (ISO 10993-10) | Non-Sensitizer |
| Irritation | Non-irritant (ISO 10993-10) | Non-irritant |
| Acute Systemic Toxicity | Non-toxic (ISO 10993-11) | Non-toxic |
| Sterilization | Sterility Assurance Level of 10^-6 (ISO 11137-1, ISO 11137-2) | Assurance level of 10^-6 |
| Corrosion testing | All samples meet acceptance criteria (ISO 13402) | All samples met the acceptance criteria |
| Autoclave Testing | Material's Heat Deflection Temperature |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.