EXOJET TISSUE MANAGEMENT SYSTEM

K031406 · Mitek Worldwide · HRX · May 30, 2003 · Orthopedic

Device Facts

• Record ID: K031406
• Device Name: EXOJET TISSUE MANAGEMENT SYSTEM
• Applicant: Mitek Worldwide
• Product Code: HRX · Orthopedic
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

Device Story

EXOJET Tissue Management System is an arthroscopic surgical tool for soft and hard tissue management. System components include a reusable power control unit, sterile disposable pump cartridge/tubing, and sterile disposable handpieces. Handpieces feature a rotating burr driven by a liquid-jet motor. Device performs cutting, ablation, shaping of soft tissue, and decorticating, removing, and smoothing of bone; provides electrocauterization for bleeding control. Used by surgeons in arthroscopic procedures. Benefits include precise tissue removal and simultaneous hemostasis during joint surgery.

Clinical Evidence

No clinical data provided. Biocompatibility studies were conducted to demonstrate the device is non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Technological Characteristics

System includes reusable power control unit, disposable pump cartridge, tubing, and handpieces. Handpieces utilize a liquid-jet driven motor to rotate burrs/drills. Provides mechanical tissue cutting/ablation and electrocauterization. Components are sterile and disposable. Biocompatibility verified via non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity testing.

Indications for Use

Indicated for patients undergoing orthopedic surgical procedures requiring cutting, removal, or shaping of soft tissue, hard tissue, or bone, and bleeding control, in small and large joint arthroscopic procedures.

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

• Hydrocision ARTHROJET System with Cautery and TurboBurr (K020688, K002764, K993009, K982266)

Submission Summary (Full Text)

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# MAY 3 0 2003

## SECTION 2 – 510(k) SUMMARY

#### EXOJET Tissue Management System

| Submitter's Name and<br>Address: | Mitek Worldwide<br>a division of ETHICON Inc.<br>a Johnson & Johnson Company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Sergio J. Gadaleta, Ph.D.<br>Manager, Regulatory Affairs<br>Mitek Worldwide<br>a division of ETHICON Inc.<br>a Johnson & Johnson Company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone:<br>781-251-2018<br>Facsimile:<br>781-278-9578<br>e-mail:<br>[e-mail] |
| Name of Medical Device | Classification Name:<br>Arthroscope and Accessories<br>Common/Usual Name:<br>Arthroscope and Accessories<br>Proprietary Name:<br>EXOJET Tissue Management |
| Substantial Equivalence | EXOJET Tissue Management System is substantially equivalent to:<br>Hydrocision ARTHROJET System with Cautery and TurboBurr<br>K020688, K002764, K993009, K982266 – Distributed by Mitek<br>Worldwide a division of Ethicon, Inc., a Johnson & Johnson<br>Company, 249 Vanderbilt Avenue, Norwood, MA 02062 and<br>manufactured by Hydrocision Inc., 100 Burtt Road G01, Andover,<br>MA 01810. |
| Device Classification | Arthroscopes and accessories are classified by FDA as a Class II<br>Medical Devices under the generic category of Arthroscope<br>(reference 21 CFR §888.1100), product code HRX. |

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Mitek's EXOJET Tissue Management System consists of reusable Device Description power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills. The Mitek EXOJE T* system is indicated for orthopedic surgical Indications for Use procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures. Biocompatibility studies have demonstrated the EXOJET Tissue Safety Management System to be non-toxic, non-irritating, nonsensitizing, and non-cytotoxic.

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MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sergio J. Gadaleta, Ph.D. Manager, Regulatory Affairs Mitek Worldwide a division of Ethicon. Inc. 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K031406

Trade/Device Name: EXOJET Tissue Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 2, 2003 Received: May 20, 2003

Dear Dr. Gadaleta:

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 set 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 - Sergio J. Gadaleta, Ph.D.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Celia M. Witten, Ph.D., M.D. 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): ____________________________________________________________________________________________________________________________________________________

Device Name: EXOJET Tissue Management System

Indications for Use:

The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

for Mark A. Millerson
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number ***_***K031406

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use***_***_