(151 days)
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.
The document describes the submission for a medical device called "Fetzer Medical Self-Retaining Retractors" for 510(k) clearance. The device is a self-retaining retractor for neurosurgery.
Here's an analysis of the acceptance criteria and the study used to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Acceptance Criteria Category) | Test Method Summary | Reported Device Performance (Results) |
|---|---|---|
| Reprocessing Validation | Verification that devices can be cleaned with provided cleaning steps as per IFU. Contamination of accessible, interior, and exterior surfaces (worst-case) with visible contamination (red blood cells), residual protein, and organisms. Effectiveness evaluated by comparing contamination between control and test instruments. (Acc. ANSI/AAMI ST81 and AAMI TIR 30). | This validation provides evidence that viable microbiological contamination as well as a soil contamination of the "Self-retaining retractors" are removed by the given cleaning and disinfection instructions. |
| Sterilization Testing | Verification that devices can be sterilized with the provided sterilization procedure described in the IFU. Test specimens contaminated with bioindicators or challenge suspension and tested for sterility after the sterilization process. Part-cycle sterilization performed to assure a SAL of 10^-6. | A reduction of test bacteria was observed and assured showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization. |
| Biocompatibility Testing | Verification of biocompatibility of all patient-contacting materials according to ISO 10993-1. Devices considered "tissue/bone contacting" with contact duration |
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).