EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES

K061134 · Efs Eberle Feinwerktechnische Systeme · HRX · Sep 1, 2006 · Orthopedic

Device Facts

• Record ID: K061134
• Device Name: EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
• Applicant: Efs Eberle Feinwerktechnische Systeme
• Product Code: HRX · Orthopedic
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.

Device Story

EBERLE Shaver System C2 is a powered surgical instrument system comprising a control unit, footswitch, handpiece, and shaver blades. Used in arthroscopic procedures; operated by qualified surgeons in a clinical/surgical setting. System performs mechanical shaving, burring, abrading, cutting, and resecting of fibrous tissue, cartilage, and bone. Components are designed to operate as an integrated unit. Output is mechanical tissue removal; assists surgeons in performing arthroscopic interventions. Benefits include precise tissue/bone resection during minimally invasive surgery.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, design analysis, and biocompatibility assessment.

Technological Characteristics

Powered surgical instrument system consisting of a control unit, footswitch, handpiece, and shaver blades. Blades are autoclavable/reusable (sterile or non-sterile). Materials selected for biocompatibility, consistent with predicate devices. System is designed for integrated operation.

Indications for Use

Indicated for arthroscopic surgical procedures including shaving, burring, abrading, cutting, and resecting of fibrous tissue, cartilage, and bone. For use by qualified surgeons only.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Stryker Total Performance System Shaver (K973195)
• KSEA Powershaver System S2 (K030009)
• Linvatec E9000 System (K990524)
• Linvatec Advantage Drive System (K002523)

Submission Summary (Full Text)

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K061134

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System

SEP - 1 2006

April 17th, 2006

## 1. Submitter Information:

| a. Correspondent/ Distributor: | |
|--------------------------------|---------------------------------------|
| Name: | Innovative Endoscopy Components, LLC |
| Address: | 731-733 Shotgun Road |
| | Ft. Lauderdale, FL 33326 |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Registration No: | 1064152 |
| Owner/ Operator No: | 9026517 |
| b. Manufacturer: | |
| Name: | EFS Eberle Feinwerktechnische Systeme |
| | GmbH & CO. KG |
| Address: | Glasbronnenstrasse 6 |
| | D-75449 Wurmberg |
| | GERMANY |
| Telephone: | ([phone] |
| Fax: | ([phone] |
| E-Mail: | [e-mail] |
| Registration No: | |
| Owner/ Operator No: | |
| 2. Device Name: | |
| Classification Name: | Arthroscope and Accessories |
| Common Name: | Surgical Shaver and Accessories |

EBERLE Shaver System C2 and Shaver Blades

### 3. Classification

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Proprietary Name:

CFR 888.1100 Class II Classification Number: Product Code: HRX

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- 4. Indication for use:
The EBERLE. Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.

- 5. Description of Device:
The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile).

All these components are designed, constructed and intended to be operated exclusively as a unit.

- 6. Substantial Equivalence:
K973195, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K002523, Linvatec Advantage Drive System

#### 7. Description of Safety:

The selection of the materials for the EBERLE Shaver System C2 and Blades has been determined through demonstrated appropriate levels of biocompatibility. The materials are similar or identical to those used for predicate devices as well as other brands legally sold in the United States.

- 8. Summary:
Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA.

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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EFS Eberle Feinwerktechnische System % Innovative Endoscopy Components, LLC Mr. Florian Gruber 1112 Weston Road, PMB 227 Ft. Lauderdale, Florida 33326

SEP - 1 2006

Re: K061134

Trade/Device Name: EBERLE Shaver System C2 and Shaver Blades Regulation Number: 21 CFR 888.1100 Regulation Name: Athroscope Regulatory Class: II Product Code: HRX Dated: July 28, 2006 Received: August 1, 2006

Dear Mr. Gruber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Florian Gruber

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

kn
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): (イベイト

Device Name: EBERLE Shaver System C2 and Shaver Blades Indications For Use:

> The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartillage tissue and bone conducted by qualified surgeons only.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sion Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L061134

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