ACE SYSTEM

K960853 · Xomed, Inc. · EQJ · Apr 3, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960853
• Device Name: ACE SYSTEM
• Applicant: Xomed, Inc.
• Product Code: EQJ · Ear, Nose, Throat
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4140
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)

Device Story

Electric surgical drill system; console, electric motor handpiece, foot pedal, accessories. Console mounts to IV pole/cart; controls handpiece speed, direction, irrigation. Operates one or two handpieces (angled/straight). Used in OR by surgeons for bone incision/removal. Enhanced speed/torque compared to traditional electric drills; performance matches pneumatic systems. Benefits: combines pneumatic-level power with electric-system control/design.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electric surgical drill system. Components: console, electric motor handpiece, foot pedal. Features: irrigation, variable speed/direction control. Supports angled and straight handpieces. Class II (drill) and Class I (bur).

Indications for Use

Indicated for patients requiring controlled incision or removal of bone in ENT, neurosurgical, hand, and plastic surgery procedures.

Regulatory Classification

Identification

An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

Predicate Devices

• Micro-Craft® Power System (K791407)
• Synergy™ (unknown)
• Jedmed Otologic Drill (unknown)
• UltraPower™ Complete Drill System (unknown)
• Bone Dissecting System (K926547)

Submission Summary (Full Text)

{0}

K960853

APR - 3 1996

# 510(k) Summary ACE System

## 1.0 Date Prepared

February 27, 1996

## 2.0 Submitter (Contact)

David Timlin
Xomed Surgical Products
Jacksonville, FL
[phone]

## 3.0 Device Name

Proprietary Name: ACE System
Common Name: Electric Surgical Drill System
Classification Name: ENT electric or pneumatic surgical drill AND
ENT bur

## 4.0 Device Classification

Currently marketed products of this type have been classified by the Ear, Nose and Throat Panel as follows:

| ENT electric or pneumatic surgical drill | 77ERL | Class II | 874.4250 |
| --- | --- | --- | --- |
| ENT bur | 77EQJ | Class I* | 874.4140 |

*ENT burs have been exempted from premarket notification.

## 5.0 Device Description

The ACE System is made up of a console, electric motor handpiece, foot pedal and various accessories. The Console is designed to mount onto an IV pole or to set on a cart and provides control of various functions such as handpiece speed and direction and irrigation. It has the ability to operate one or two handpieces (one selected at a time), angled and straight, and incorporates irrigation capability.

## 6.0 Intended Use

The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)

59

{1}

K960853

## 7.0 Substantial Equivalence

The new ACE System is substantially equivalent to the following currently marketed surgical drills in that it has the same intended use (controlled incision of bone) and equivalent features (irrigation, handpiece styles, etc.) and performance characteristics (speed and torque):

| DEVICE | Manufacturer | 510K Number |
| --- | --- | --- |
| Micro-Craft® Power System | Xomed | K791407 |
| Synergy™ | Smith & Nephew - Richards | unknown |
| Jedmed Otologic Drill | Bien-Aire
(Marketed by Jedmed) | unknown |
| UltraPower™ Complete Drill System | Hall Surgical / Zimmer | unknown |
| Bone Dissecting System | Med^{next} | K926547 |

## 7.1 Discussion of Differences

There are no substantial differences between the ACE System and the equivalent electrical drill systems other than in device performance, as noted by the enhanced speed and torque with the ACE System. The improved performance of the ACE System is equivalent to the performance of pneumatic drills currently on the market. The ACE System combines the speed and torque of the equivalent Pneumatic drills with the design and controls of the equivalent electrical systems.

60