TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

K963246 · Medtronic Xomed · ERL · Sep 23, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963246
• Device Name: TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
• Applicant: Medtronic Xomed
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Sep 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.

Device Story

Trebay Microdebrider system; includes power control unit, foot pedal, and three motorized reusable electric handpieces. Handpieces utilize interchangeable cutter blades and bur tips for bone/tissue removal. System supports suction and irrigation. Operated by healthcare professionals in surgical settings. Provides mechanical cutting/drilling action for ENT/head and neck procedures. Enhances surgical precision and tissue removal efficiency.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System includes power control unit, foot pedal, and motorized electric handpieces. Uses interchangeable cutter blades and bur tips. Supports suction and irrigation. Class II (ENT Surgical Drill) and Class I (ENT Bur) per 21 CFR 874.4250 and 874.4140.

Indications for Use

Indicated for use by healthcare professionals for cutting and removal of bone and tissue during ENT, otolaryngology, and head and neck surgical procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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K963246

# 510(k) Summary
## Trebay Microdebrider

SEP 23 1996

### 1.0 Date Prepared

August 16, 1996

### 2.0 Submitter (Contact)

David Timlin
Xomed Surgical Products
Jacksonville, FL
[phone]

### 3.0 Device Name

Proprietary Name: Trebay Microdebrider
(The product’s tradename has not been finalized and may be changed 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 interchangable 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.

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