AESCULAP POWER SYSTEM HANDPIECE

K960473 · Aesculap, Inc. · GET · Mar 7, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960473
• Device Name: AESCULAP POWER SYSTEM HANDPIECE
• Applicant: Aesculap, Inc.
• Product Code: GET · General, Plastic Surgery
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).

Device Story

Stainless steel powered surgical handpiece; holds/delivers power to surgical accessories (burrs, drills). Connects to electro-surgical motor units (Aesculap Elan-E or Microtron) via power drive cable. Features 21° shaft angle; 230 mm total length; 125 mm shaft length. Internal gear ratio 1:2; supports speeds 0-36,000 rpm (Elan-E) or 0-54,000 rpm (Microtron). Used in clinical surgical settings by surgeons to perform bone/tissue cutting or drilling. Modification from predecessor involves increased shaft length (75mm to 125mm) to improve reach/access.

Clinical Evidence

Bench testing only. No clinical data provided. Interface coupling verified against German DIN 13940 and ISO 3964 standards.

Technological Characteristics

Stainless steel construction; 1:2 internal gear ratio; 21° shaft angle; 125mm shaft length; 230mm total length. Compatible with 2.35mm shank diameter accessories. Powered by external electro-surgical motor units (Elan-E, Microtron). Interface coupling compliant with DIN 13940 and ISO 3964.

Indications for Use

Indicated for use in surgical procedures requiring powered accessories such as burrs and drills; intended for use by surgeons.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Aesculap Power System Handpiece (K770428)
• Hall Surgical handpiece (K864929)
• Midas Rex handpiece (K900388)

Submission Summary (Full Text)

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K960473
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510(k) Summary of Safety and Effectiveness

(in Accordance with SMDA of 1990)

Aesculap Power System Handpiece

January 31, 1996

Submitted by: Aesculap®, Inc
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Mary Ellen Holden
Phone: [phone] x348
FAX: [phone]

Product Name
Trade Name: Aesculap Power System Handpiece
Common Name: Powered Surgical Instrument Systems
Classification Name: Surgical Instrument Motors and Accessories (per 21 CFR Section 878.4820)

Predicate Device
The Power System Handpiece presented in this application is a modification to an existing device. Aesculap's modified Power System Handpiece is compared to it's predecessor which is subject to #K770428. The modified Power System Handpiece is also compared to handpieces by Hall Surgical (#K864929) and Midas Rex (#K900388).

Device Description
The only modification to the device is in the length of the handpiece shaft which has increased from 75mm to 125mm. Aesculap's modified Power System Handpiece is a stainless steel device used for holding and delivering power to surgical accessories (i.e. burrs, drills.) The device has an overall length of 230 mm with a shaft angle of 21°. The handpiece holds drills and burrs with a shank diameter of 2.35 mm and a length of 180 mm. The device is connected to an electro-surgical motor unit via a power drive cable. The Power System Handpiece is compatible with Aesculap's Elan-E and Microtron power units. The internal gear ratio is 1:2, allowing the device to run at speeds of 0-36,000 rpm with the Elan-E and 0-54,000 rpm with the Microtron power unit.

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]

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# 510(k) Summary of Safety and Effectiveness
*(in Accordance with SMDA of 1990)*

## Aesculap Power System Handpiece

### Intended Use

There has been no change in intended use for this modified device. The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).

### Comparison of Technological Characteristics

Aesculap’s Power System Handpiece is different from the predicate device from Aesculap only in the length of the shaft (increase from 75mm to 125mm). The shaft length is comparable to lengths offered by Hall Surgical and Midas Rex.

### Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device. However, the interface coupling on the Power System Handpiece meets the requirements of German DIN standard 13940 and International Standards Organization standard ISO 3964.

### Substantial Equivalence

Aesculap believes that the Power System Handpiece presented in this submission is substantially equivalent in design, function, and intended use to the presented devices from Aesculap, Hall Surgical and Midas Rex.