(35 days)
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.
The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and is labeled as a restricted device.
The provided 510(k) summary for the Trebay Microdebrider does not contain any information regarding acceptance criteria or a study proving the device meets them.
This document describes a conventional surgical device (microdebrider) and focuses on its design, intended use, and substantial equivalence to existing devices. It is not a submission for an AI/ML-based medical device, which would typically require performance data against defined acceptance criteria.
Therefore, I cannot populate the requested table and answer the subsequent questions based on the provided input. The prompt's questions are designed for AI/ML device submissions, which include specific studies to evaluate algorithm performance.
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510(k) Summary Trebay Microdebrider
- 1.0 Date Prepared August 16, 1996
2.0 Submitter (Contact)
David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532
3.0 Device Name
| Proprietary Name: | Trebay Microdebrider(The product's tradename has not been finalized and may bechanged at a later date.) |
|---|---|
| Common Name(s): | Electrical surgical shavers, electrical microdebriders, mastoid drills,microdrill, ENT drills, handpieces and cutting blades and burs. |
| Classification Name: | ENT Surgical Drill |
4.0 Device Classification
| ENT Surgical Drill | Procode 77 ERL | Class II ; | 21 CFR 874.4250 | Tier 1 |
|---|---|---|---|---|
| ENT Bur | Procode 77 EQJ | Class I ; | 21 CFR 874.4140 | Tier 1 |
5.0 Device Description
The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and is labeled as a restricted device.
6.0 Intended Use
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.
7.0 Substantial Equivalence
The modified Trebay Microdebrider / XPS System that is described in this notification has the same intended use as the originally cleared device, the same technological characteristics as other ENT surgical drills currently on the market, and does not raise any new issues of safety or effectiveness.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.