(133 days)
The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial; Dental; and Endoscopic applications.
The specific applications include Craniotomy, Laminotomy, Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.
The Stryker Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
- Cutting bone, bone cement, and teeth;
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and
- Providing a location for the user to hold and grip the device system. ●
The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 17cm, and 20cm. The Stryker HD Attachments are offered in the following lengths: 9cm and 14cm. The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.
The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility.
The purpose of this submission is to gain clearance for colorant band modification for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".
The provided text is a 510(k) summary for the Stryker Elite and Heavy Duty (HD) Attachments, focusing on a colorant band modification. This document does not contain the detailed acceptance criteria or the study results for the original device's performance, but rather for the modification.
Therefore, I cannot populate all sections of your request comprehensively. However, I can provide information based on what is available regarding the modification to the device.
Here's a breakdown of the available information and what is missing:
Description of Acceptance Criteria and Study for Colorant Band Modification
The submission concerns a modification to the colorant band on the Stryker Elite and Heavy Duty (HD) Attachments. The primary purpose of this 510(k) is to gain clearance for this specific modification which "exceeds the threshold as per FDA Guidance, 'Deciding When to Submit a 510(k) for a Change to an Existing Device'". The underlying assumption is that the original device, without this specific color band modification, has already met its acceptance criteria through prior submissions (e.g., K143320).
The study performed here specifically addresses the safety and effectiveness of the new colorant band material and colorant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Color Band Modification) | Reported Device Performance (as stated in document) |
|---|---|
| Safety: No new questions of safety raised | "No new questions of safety and effectiveness were raised." |
| Effectiveness: No new questions of effectiveness raised | "No new questions of safety and effectiveness were raised." |
| Performance Bench Testing: Met all pre-defined acceptance criteria | "The Subject Device met all pre-defined acceptance criteria." |
| Biocompatibility: Followed ISO 10993-1:2018 and FDA Guidance for limited exposure ( |
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).