ORTHO DEVELOPMENT ORION-I EMF SYSTEM

K012129 · Ortho Development Corp. · GEI · Aug 22, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012129
• Device Name: ORTHO DEVELOPMENT ORION-I EMF SYSTEM
• Applicant: Ortho Development Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The ORION-I EMF System is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

ORION-I EMF System is a line-voltage powered, bipolar radiofrequency (RF) generator; delivers up to 16 watts of power to electrode tip. Used for coagulation, cutting, and vaporization (ablation) of soft tissue. Includes sterile, single-use hand-pieces and electrodes. Operated by qualified medical personnel in clinical settings (orthopedic, arthroscopic, spinal, neurosurgical). Device transforms electrical energy into RF output at the electrode tip to achieve tissue effects. Physician controls application directly via hand-piece; output facilitates surgical tissue management, potentially benefiting patient through precise tissue ablation/coagulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, function, and material comparisons to legally marketed predicate devices.

Technological Characteristics

Bipolar radiofrequency generator; line-voltage powered; max power output 16 watts. Includes sterile, single-use hand-pieces and electrodes. No software or complex algorithms described.

Indications for Use

Indicated for general surgical coagulation, cutting, and soft tissue ablation in orthopedic, arthroscopic, spinal, and neurosurgical procedures. Contraindicated when, in the physician's judgment, an electrosurgical procedure is contrary to the patient's best interest.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Ellman Surgitron IEC II RF generator (K001986, K001407)
• ArthroCare System 2000 RF generator (K001588, K992581)
• Ellman Surgitron Hand-pieces (K001986)
• Kirwan Surgical Hand-pieces (K982176)
• Kirwan Surgical Electrodes (K982176)

Submission Summary (Full Text)

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## 510(k) Summary

## AUG 2 2 2001

## Ortho Development Corporation ORION-I EMF System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K012129 |
|--------------------------------|---------|
|--------------------------------|---------|

A. Submitter:

Ortho Development Corporation 106 West 12200 South Draper, UT 84020

Phone: [phone] [phone] Fax:

Carol Freasier Contact: Regulatory Affairs

Date Prepared: June 22, 2001

- B. Device Names:
ORION-I EMF System Trade Name: Electrosurgical generator and accessories Common/usual Name: Electrosurgical and Coagulation Unit and Accessories Classification Name:

#### C. Predicate Devices:

.

- K001986, K001407 Ellman Surgitron IEC II RF generator .
- ArthroCare System 2000 RF generator K001588, K992581
- K001986 Ellman Surgitron Hand-pieces ●
- K982176 Kirwan Surgical Hand-pieces .
- K982176 Kirwan Surgical Electrodes .

#### D. Device Description:

Dovios Doodlip.com and accessories, sterile, single-use hand-pieces and sterile, single-use electrodes. The and accessementor is a line-voltage powered, bipolar radiofrequency generator capable of delivering up to 16 watts of power at the electrode tip. The ORION-I utilizes controlled of dollivering up to 10 waste of perfor was and vaporization (ablation) of soft tissue during a variety of electrosurgical procedures in general surgical use, including orthopedic, arthroscopic, spinal, and neurosurgical procedures.

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- E. Intended Use:
The ORION-I EMF System is intended to be used for general surgical purposes in The Ortion FEM Oyelowanonization (ablation) of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

#### Contraindications

The use of the ORION-I EMF System is contraindicated, when in the judgment of the r he use of the Ortrol rrincedure would be contrary to the best interest of the patient.

- F. Comparison with the Predicate Device:
Oompanson with the Prodited between the Ortho Development ORION-I EMF System There are no orghineant anversely affect the use of the use of the device. The EMF and the prodicate do food which treatle predicate devices in design, function, materials, and indications for use/intended use.

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# AUG 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ortho Development Corporation c/o Michael Kwan, Ph.D. Principal Reviewer and Program Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K012129

Trade/Device Name: ORION-1 EMF System Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: August 3, 2001 Received: August 10, 2001

Dear Dr. Kwan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Michael Kwan, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). 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,

L. Mark N. Millburn

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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KO12129 510(k) Number (if known): __

Device Name: ORION-I EMF System

Indications for Use:

The ORION-I EMF System is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, curring and ablation of ook abouting rocedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle.

The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

### Contraindications

The use of the ORION-I EMF System is contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

for Mark N Wilkerson
(Division Sign-Off)

ivision of General, Restorative d Neurological Devices

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(Optional Format 1-2-96)