APEX UNIVERSAL DRIVE SYSTEM

K964548 · Linvatec Corp. · ERL · Jan 17, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964548
• Device Name: APEX UNIVERSAL DRIVE SYSTEM
• Applicant: Linvatec Corp.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jan 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.

Device Story

Apex Universal Drive System comprises drive console, micro handpiece, blades/burrs/routers, and foot switches. Used in ENT and reconstructive surgery by surgeons. Device modification involves console software/chip upgrade to increase maximum RPM for forward/reverse and oscillation modes; intended to reduce bur chatter and increase resection rate. System provides mechanical power to surgical accessories for tissue/bone removal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable surgical drive system including console, micro handpiece, and accessories. Energy source: electric/pneumatic. Modification involves firmware/chip upgrade to increase motor speed (RPM).

Indications for Use

Indicated for patients undergoing otolaryngological and reconstructive surgery requiring soft tissue and bone shaving.

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.

Predicate Devices

• Apex Universal Drive System (K944476)
• XPS Straightshot Micro Resector System (K862807, K954796, K960856)
• Dyonics EP1 Surgical Drive System (K954989)

Submission Summary (Full Text)

{0}

K964548
Jan. 17, 1997
11311 Concept Boulevard Largo, Florida 34643 813 399-5334 Fax: [phone]

Carol A. Weideman, Ph.D.
Manager, Regulatory
and Clinical Affairs

November 12, 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Spinal System, 510(k) Number 96454B.

## A. Submitter

Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 33773-4908

## B. Company Contact

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs

## C. Device Name

Trade Name: Apex™ Universal Drive System
Common Name: Drive System
Classification Name: Surgical, ENT (electric or pneumatic), including handpiece

## D. Predicate/Legally Marketed Devices

Apex™ Universal Drive System
Linvatec Corporation

XPS™ Straightshot Micro Resector System
Xomed Endoscopy

Dyonics® EP1 Surgical Drive System
Smith and Nephew Endoscopy

A Bristol-Myers Squibb Company
21

{1}

Summary of Safety and Effectiveness
Apex™ Universal Drive System
510(k) #
November 12, 1996
Page 2 of 3

## E. Device Description

The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches.

The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection.

The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode.

## F. Intended Use

The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.

## G. Substantial Equivalence

The Apex Universal Drive System is substantially equivalent in design, function and intended use to the Apex™ Universal Drive System (Linvatec Corporation), XPS™ Straightshot Micro Resector System (Xomed Endoscopy) and Dyonics® EP1 Surgical Drive System (Smith and Nephew Endoscopy).

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

4

{2}

Summary of Safety and Effectiveness
Apex™ Universal Drive System
510(k) #
November 12, 1996
Page 3 of 3

## CHART OF SIMILARITIES AND DISSIMILARITIES

| Company | Device Name | Intended Use | Design |
| --- | --- | --- | --- |
| NEW PRODUCT
Linvatec | Apex™ Universal Drive System | ENT and Reconstructive Surgery | Micro Handpiece Speed
Maximum Forward/Reverse: 5,000 rpm
Maximum Oscillate: 2,500 rpm |
| PREDICTIVE
Linvatec
510(k) #
K944476 | Apex™ Universal Drive System | ENT and Reconstructive Surgery | Micro Handpiece Speed
Maximum Forward/Reverse: 3,500 rpm
Maximum Oscillate: 1,500 rpm |
| PREDICTIVE
Xomed
Endoscopy
510(k) #
K862807
K954796
K960856 | XPS™
Straightshot™
Micro Resector System | ENT | Handpiece Speed
Maximum Forward/Reverse: 6,000 rpm
Maximum Oscillate: 3,000 rpm |
| PREDICTIVE
Smith and Nephew
Endoscopy
510(k) #
K954989 | Dyonics® EP1 Surgical Drive System | ENT | Handpiece Speed:
Maximum Forward/Reverse: 8,000 rpm
Maximum Oscillate: 3,000 rpm |